61 FR 58158­02
1996 WL 655415 (F.R.)
(Cite as: 61 FR 58158)



PROPOSED RULES DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration 42 CFR Part 121 Organ Procurement and Transportation Network; Organ Allocation Policies Wednesday, November 13, 1996
*58158 AGENCY: Health Resources and Services Administration, DHHS. ACTION: Request for additional public comment on proposed rule; notice of public hearings. SUMMARY: This document announces that the Secretary of Health and Human Services is formally inviting additional *58159 public comment on the Notice of Proposed Rulemaking (NPRM) published on September 8, 1994, to establish rules governing the operation of the Organ Procurement and Transportation Network (OPTN). The Secretary is seeking additional comments on policies affecting the allocation of human livers for transplantation. In addition, this document announces that a public hearing will be held at which interested individuals may submit oral comments regarding such policies as well as regarding methods to increase organ donation. DATES: Hearing: The hearing will be held on December 10­11, 1996, beginning at 9 a.m. each day. Requests to testify must be submitted by December 2, 1996. Comments: For those who choose to send written comments only, comments must be submitted by December 13, 1996 in order to ensure full consideration. Because the issue of organ donation is not part of the rulemaking process, we will accept comments and suggestions on this issue at any time. ADDRESSES: Written requests to testify and written comments on allocation policies should be transmitted to: Ms. Judith Braslow, Director, HRSA Division of Transplantation, Room 7­29, 5600 Fishers Lane, Rockville, Maryland 20857. In light of the short period for submitting requests to testify, such requests may also be submitted by telefax to Ms. Braslow at (301) 594­6095. Comments will be available for public inspection three business days after their receipt in Room 7­29, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland, Monday through Friday of each week from 8:00 a.m. to 4:30 p.m. To view public comments in Washington, D.C., call (202) 690­7890 to make an appointment for inspection in Room 309 G of the Hubert Humphrey Building, 200 Independence Avenue, S.W. The hearing will be held at the Natcher Center on the National Institutes of Health campus in Bethesda, Maryland. FOR FURTHER INFORMATION CONTACT: Ms. Braslow at the address listed above. Telephone: (301) 443­7577. SUPPLEMENTARY INFORMATION: Allocation of human livers for transplantation has been debated within the transplant community for several years. On September 8, 1994, the Department published an NPRM to establish rules governing the operation of the OPTN (59 FR 46482­99). The public comment period expired on December 7, 1994, although additional comments were received and accepted after that date. As part of the preamble to the NPRM, the Department solicited comments on the organ­allocation policies used to distribute organs by the OPTN (59 FR 46487). Since that time, the OPTN has undertaken a major review of its policies governing the allocation of livers, and the Board of Directors of the OPTN has proposed a revised policy to allocate livers. The revisions proposed by the Board have generated considerable controversy within the transplant community. In view of sections 372­375 of the Public Health Service Act, 42 U.S.C. 274­ 274c, which vest responsibility in the Secretary of Health and Human Services for oversight of the OPTN, the Department has concluded that further public participation in the development of allocation policies related to livers is desirable. Accordingly, we have decided to seek additional comments on the NPRM and to accept oral testimony and written comments on liver allocation policies and the processes by which they may be developed. In addition, we recognize that the difficult issues associated with establishing allocation policies stem from a central problem: the medical need for organs far exceeds organs donated. Accordingly, we have decided to use a public hearing as an opportunity to solicit public comments on methods to increase organ donation and general awareness of organ transplantation as a therapeutic alternative for end­stage organ disease. Participants in the hearing will be limited to ten minutes per individual (or institution). Those requesting to testify should indicate whether their comments will address allocation policies, organ donation, or both. We are particularly interested in comments addressing the following issues: 1. Allocation of Human Livers for Transplantation The Organ Procurement and Transplantation Network (OPTN) currently allocates human livers for transplantation in accordance with the following policy: To local Status 1 patients first in descending point order; then to local Status 2 patients in descending point order; then to all other local patients in descending point order; then to Status 1 patients in the Host OPO's (organ procurement organization) region in descending point order; then to Status 2 patients in that region in descending point order; then to all other regional patients in descending point order; then to Status 1 patients in all other regions in descending point order; then to Status 2 patients in all other regions in descending point order; and finally to all other patients in all other regions in descending point order. The Status definitions, in pertinent part, are as follows: A patient listed as Status 1 is in a hospital's Intensive Care Unit (ICU) due to acute or chronic liver failure with a life expectancy without a liver transplant of less than 7 days. A patient listed as Status 2 is continuously hospitalized in an acute care bed for at least five days, or is ICU bound. A patient listed as Status 3 requires continuous medical care. A patient listed as Status 4 is at home and functioning normally. A patient listed as Status 7 is temporarily inactive­­patients who are temporarily unsuitable for transplant are listed as Status 7. The OPTN Board's proposed policy would revise the definitions of several of the status groups and would revise the "local" area which constitutes the first allocation area. In seeking additional comment, the Secretary invites comments on the following questions: a. Does the OPTN Board's policy achieve the best outcome that can reasonably be expected for the patients of America? If not, what revisions to the policy, alternative policy, or combination of policies would yield a superior result? Please present data and other information that support your view; for example, success measures or factors mentioned in the NPRM which include (1) equitable distribution of organs; (2) improvement in graft and patient survival, and (3) enhanced patient choice among transplant programs. In particular, please indicate the measures you considered most important in assessing the relative efficacy of various policy options. b. Would changes in other OPTN policies related to liver allocation, such as those noted below, yield a better outcome for the patients of America than the present system? Should such changes be implemented in addition to a change in the OPTN Board's allocation policy or phased in with a change? ­ Criteria for entering patients on the waiting list for liver transplant. ­ Definition of the status categories for patients on the waiting list for liver transplant. ­ Procedures for ensuring compliance with OPTN policies affecting liver allocation.*58160 ­ Use of performance measures, e.g., quality of transplant outcomes and annual number of transplants performed, in determining the eligibility of transplant centers to receive donor livers. 2. Donation of Organs for Transplantation The medical need for livers and other human organs for transplantation continues to exceed the number of donor organs by a considerable margin. No organ allocation policies, no matter how well crafted or effectively implemented, can be expected to compensate for serious short­falls in the supply of organs relative to the demand. a. What are the major impediments to organ donation? b. How can the Department, organ procurement organizations, hospitals, and other entities improve current efforts to promote organ donation? c. Where and to what extent are further initiatives necessary to ensure that members of racial and ethnic minority groups are appropriately apprised regarding such matters as the role of organ transplantation within the health­ care system, the unique health benefits that can ensue from successful transplantation, the limitations associated with transplant procedures, and the challenges involved in recruiting organ donors? Dated: November 6, 1996. Ciro V. Sumaya, Administrator. Approved: November 7, 1996. Donna E. Shalala, Secretary. [FR Doc. 96­29145 Filed 11­8­96; 10:52 am] BILLING CODE 4160­15­M 61 FR 58158­02, 1996 WL 655415 (F.R.) END OF DOCUMENT ________________________________________________________________________________ Client Identifier: HHP Date of Request: 03/25/98 The Current Database is FR Your Terms and Connectors Query: "ORGAN TRANSPLANT!" ________________________________________________________________________________ FOR EDUCATIONAL USE ONLY Copr. (C) West 1998 No Claim to Orig. U.S. Govt. Works 59 FR 46482­01 1994 WL 481993 (F.R.) (Cite as: 59 FR 46482)
PROPOSED RULES DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service 42 CFR Part 121 RIN: 0905­AD26 Organ Procurement and Transplantation Network Thursday, September 8, 1994
*46482 AGENCY: Public Health Service, DHHS. ACTION: Notice of proposed rulemaking. SUMMARY: This notice sets forth the Secretary's proposal for rules governing the operation of the Organ Procurement and Transplantation Network (OPTN). The proposed rules establish requirements and procedures for membership in the OPTN, for listing transplant candidates on a nationwide computer network, for allocating organs, and for maintaining records and reporting by member Organ Procurement Organizations (OPOs) and transplant hospitals. DATES: To be considered, comments must be received by December 7, 1994. In addition, as indicated in Section G of this Preamble, the Department has decided to initiate the process of obtaining public comment on the organ allocation policies of the OPTN. These comments should also be received by December 7, 1994. Subject to consideration of the comments submitted, the Department intends to publish final regulations. ADDRESSES: Comments should be submitted to Ms. Judith B. Braslow, Director, Division of Organ Transplantation, room 7­18, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT:Judith B. Braslow (301) 443­7577. SUPPLEMENTARY INFORMATION: I. Background The OPTN was established under section 372(b)(2) of the PHS Act, as enacted by the National Organ Transplant Act of 1984 (Pub. L. 98­507), and amended by Pub. L. 100­607 and Pub. L. 101­616. Section 372 requires the Secretary to provide by contract for the establishment and operation of the OPTN to: (A) establish in one location or through regional centers­­ (i) a national list of individuals who need organs, and (ii) a national system, through the use of computers and in accordance with established medical criteria, to match organs and individuals included on the list, especially individuals whose immune system makes it difficult for them to receive organs, (B) establish membership criteria and medical criteria for allocating organs and provide to members of the public an opportunity to comment with respect to such criteria, (C) maintain a twenty­four­hour telephone service to facilitate matching organs with individuals included on the list, (D) assist organ procurement organizations in the nationwide distribution of organs equitably among transplant patients, (E) adopt and use standards of quality for the acquisition and transportation of donated organs, including standards for preventing the acquisition of organs that are infected with the etiologic agent for acquired immunodeficiency syndrome, (F) prepare and distribute, on a regionalized basis (and, to the extent practicable, among regions on a national basis), samples of blood sera from individuals who are included on the list and whose immune system makes it difficult for them to receive organs, in order to facilitate matching the compatibility of such individuals with organ donors, (G) coordinate, as appropriate, the transportation of organs from organ procurement organizations to transplant centers, (H) provide information to physicians and other health professionals regarding organ donation, (I) collect, analyze, and publish data concerning organ donations and transplants, (J) carry out studies and demonstration projects for the purpose of improving procedures for organ procurement and allocation, (K) work actively to increase the supply of donated organs, and (L) submit to the Secretary an annual report containing information on the comparative costs and patient outcomes at each transplant center affiliated with the OPTN. The House Report (H.R. Rep. No. 575, 98th Congress, 1st Session, 1983) which accompanied Public Law 98­507 stated that the Committee intended that the OPTN be a strong, active national network for matching donated organs and for making available to OPOs a variety of services and resources to assist and enhance their operation. Until the enactment of the Omnibus Budget Reconciliation Act of 1986 (Pub. L. 99­509), membership in the OPTN was voluntary. Section 9318 of Public Law 99­ 509 added a new section 1138 to the Social Security Act. Section 1138(a)(1)(B) requires Medicare and Medicaid participating hospitals that perform organ transplants to be members of and abide by the rules and requirements of the OPTN. Section 1138(b)(1)(D) requires that for organ procurement costs attributable to payments to an OPO to be paid by Medicare or Medicaid, the OPO must be a member of and abide by the rules and requirements of the OPTN. Although not required by Federal law, other entities (for example, histocompatibility laboratories) may be members of the OPTN. Section 102(c) of the Balanced Budget and Emergency Deficit Control and Reaffirmation Act of 1987 (Pub. L. 100­119) delayed the effective date of section 1138(a) of the Social Security Act concerning hospitals from October 1, 1987, to November 21, 1987, and section 4009(g) of the Omnibus Budget Reconciliation Act of 1987 (Pub. L. 100­203) further delayed the effective date of section 1138(b) of the Act concerning OPOs to April 1, 1988. The Organ Transplant Amendments of 1988 (Title IV of Pub. L. 100­607) amended section 372 of the Public Health Service Act to require that the OPTN establish membership criteria and subject its policies to public review and comment. On March 1, 1988 (53 FR 6526), the Department (HHS) published final rules that included the requirement that hospitals participating in Medicare and Medicaid which perform transplants and designated OPOs be members of and abide by the rules and requirements of the OPTN (42 CFR 485.305 and 482.12(c)(5)(ii)) in order to qualify for Medicare or Medicaid payments. There has been much discussion between HHS and the United Network for Organ Sharing (UNOS), the contractor operating the OPTN, concerning the policies that should constitute a rule or requirement of the Network and what procedures will be used to determine whether an entity is a member of the OPTN and, more specifically, the process by which the Secretary will approve or disapprove actions of the OPTN and announce these decisions to the public. On December 18, 1989, the Department published a general notice in the Federal Register (54 FR 51802) announcing its policy regarding this matter. The notice stated as follows: In order to be a rule or requirement of the OPTN, and therefore mandatory or binding on hospitals and OPOs participating in Medicare or Medicaid, the Secretary must have given formal approval to the rule or requirement. Approved rules and requirements will be issued in accordance with the Administrative Procedure Act (APA) (5 *46483 U.S.C. 501 et seq.). If an OPTN rule or requirement would constitute a "rule" within the meaning of the APA and is not exempt from the publication requirement, it will be published in the Federal Register. No hospital will be considered out of compliance with section 1138(a)(1)(B) of the Act or the regulations at 42 CFR 482.12(c)(5)(ii), and no OPO will be considered to be out of compliance with section 1138(b)(1)(D) of the Act or regulations at 42 CFR 485.305 unless the Secretary has given the OPTN formal notice approving the decision to exclude the entity from the OPTN and has also notified the entity in writing. II. Purpose of the Proposed Rules In keeping with the policy announced by the Department on December 18, 1989, we are proposing regulations which set a framework for the operation of the OPTN. The proposed rules provide for Federal oversight of the processes by which the OPTN allocates organs for transplantation. They focus the Federal role on ensuring that those processes are fair and equitable, and provide for public participation. Under the proposed regulations, the OPTN has responsibility for developing policies governing organ transplantation, and the day­to­day operation of the OPTN. Matters which are covered under existing Federal and State statutes and rules are not included in the proposed rules. For example, Medicare transplant hospitals must already comply with Federal statutory requirements or rules establishing Medicare hospital conditions of participation (42 CFR Part 482), governing end stage renal disease (ESRD) facilities (42 CFR Part 405, Subpart U), and Medicare coverage of heart transplantation (52 FR 10935) and adult liver transplantation (56 FR 15006). The Department has extensive rules regarding blood (21 CFR Parts 606, 610, and 640). The Department has also published final rules governing virtually all laboratories operating in interstate commerce. As discussed below, existing civil rights regulations govern all of these facilities. Any experimental work regarding transplantation is subject to HHS rules protecting the human subjects of research (45 CFR Part 46). Rules establishing conditions for coverage for OPOs are set forth in 42 CFR Part 485, Subpart B. However, we request comment on the desirability of adding policies to the body of HHS regulations governing transplantation. Such proposals would be most helpful if they refer specifically to proposed provisions to be added, provide a specific rationale for the suggested addition, and provide empirical evidence in support of any proposed addition. We prefer evidence that the policy is not merely desirable, but so essential as to justify suspending a transplant program's access to organs for transplantation if not followed. Set forth below are regulations proposed as rules and requirements of the OPTN which, if adopted in final form by the Secretary, will regulate the Organ Procurement and Transplantation Network. III. Description of the Proposed Rules In addition to focussing on ensuring public participation in the process by which organ allocation and other policies are developed, the proposed rules create an enforceable standard which OPTN member transplant programs must meet to qualify to receive organs for transplantation. Where the proposed rules call for review, evaluation, or appeal actions by the Secretary, decisionmaking will be carried out by the Health Resources and Services Administration (HRSA), PHS, to whom authorities under Section 372 of the PHS Act have previously been delegated. As appropriate, HRSA will consult with interested agencies in carrying out these responsibilities. A. Applicability The proposed rules apply to the operation of the Organ Procurement and Transplantation Network. In addition, the proposed rules set forth those requirements of the OPTN with which its member OPOs and transplant hospitals must comply as a condition of participation in Medicare and Medicaid (42 CFR 482.12(c)(5)(ii) and 485.305). The rules do not separately refer to civil rights requirements. However, participating transplant hospitals and OPOs are already subject to applicable Federal civil rights requirements and sanctions. Thus, for example, Title VI of the Civil Rights Act of 1964 (race and national origin discrimination) and Section 504 of the Rehabilitation Act of 1973 (disability discrimination) apply to any program or activity receiving Federal financial assistance. Other civil rights laws also apply to recipients of Federal financial assistance. For example, the Age Discrimination Act of 1975 prohibits age discrimination by recipients of Federal assistance; Title IX of the Education Amendments of 1972 prohibits sex discrimination in education programs receiving Federal assistance. B. Membership The proposed rules support broad­based membership. In accordance with section 372 of the Public Health Service Act, the proposed rules allow organizations, institutions, and individuals to become members of the OPTN. Under proposed s121.3(c)(1), OPOs designated by HHS under section 1138(b) of the Social Security Act are required to be admitted as members of the OPTN. Similarly, under proposed s121.3(c)(2), all hospitals which are subject to section 1138 of the Social Security Act because they perform transplants will be admitted as members of the OPTN. OPOs will be required to abide by the rules and requirements of the OPTN in order to be reimbursed under Medicare or Medicaid for organs which they procure. Similarly, transplant hospitals subject to section 1138 must abide by the rules and requirements of the OPTN as a condition of their continued participation in Medicare and Medicaid. Failure to abide by these rules may subject them to termination from Medicare and Medicaid, unless they no longer provide transplantation services. With reference to membership of newly designated OPOs, the Department anticipates no administrative conflict between these proposed rules and the requirement for designation by HHS under section 1138(b) of the Social Security Act which calls for membership in the OPTN. Since the purpose of this requirement of section 1138(b) is to ensure that OPOs are required to follow OPTN rules, OPOs designated by HHS are automatically made members of the OPTN. The proposed rules require that other institutions, organizations, and individuals that wish to become members demonstrate an ongoing interest in the field of organ transplantation. The Department encourages participation of transplant recipients and donor families in the deliberations of the OPTN, and it is our intent that membership be broadly based to invite such participation. Under proposed s121.3(d), the OPTN will review and make decisions on applications for membership. Applicants rejected for membership may appeal to the Secretary. The Department solicits public reaction to the idea of expanding the membership base of the OPTN, and to suggestions on how this can be accomplished. Proposed s121.3(a) provides for the establishment of a Board of Directors to develop general policies, procedures, and issuances; medical criteria and related policies for the fair and equitable allocation of human donor organs; policies consistent with recommendations of the Centers for Disease Control and Prevention to *46484 prevent the spread of infectious diseases; and standards for the training and experience of transplant surgeons and physicians. See the discussion at H. below. The proposed rules also require the OPTN to provide to the Secretary copies of any policies, procedures, and issuances as they are adopted, and to make them available to the public upon request. The Secretary will periodically publish lists of these documents in the Federal Register. To ensure appropriate representation, the proposed rules require that the Board include: two members each from, and elected by, the association representing transplant coordinators, the association representing organ procurement organizations, and the association representing histocompatibility experts; at least two representatives each, elected by the OPTN membership, from the following categories: transplant surgeons, transplant physicians, representatives of transplant hospitals, voluntary health organizations, patient advocacy groups and the general public; and one representative elected by the members from each region of the OPTN. At present, the OPTN has, at its discretion, established 11 regions. Therefore, if the current regional structure were in place under the proposed rules, the Board of Directors would have eleven regional representatives. Board members would serve two­year terms, and would be required to elect an Executive Committee from the membership of the Board, and to establish other committees whose chairpersons shall be selected to ensure continuity in leadership. In addition, the proposed rules require that not more than 50 percent of the Board of Directors and the Executive Committee be surgeons and physicians directly involved in organ procurement and transplantation. Proposed s121.3(a) also requires that the Board have a diverse membership, including minority and gender representation reflecting the diversity of the population of organ donors and recipients served by the OPTN. The Department requests comment on the composition of the Board of Directors and the method by which the Board and Executive Committee are elected. In addition, the Department seeks comment on the best way to ensure ethnic and racial diversity. C. Listing Requirements The proposed rules implement the statutory requirement for a national system to match donor organs and individual transplant candidates, and contain a number of specific requirements with respect to the listing of transplant candidates. Proposed s121.4(a)(2) requires that transplant hospitals list all transplant candidates on the national list as soon as they are determined to be candidates for transplantation. Moreover, the transplant program with which the listed transplant candidate is associated must, according to proposed s 121.4(a)(1), be approved for allocation of organs in accordance with proposed s 121.8. See the discussion at H. below. There were 27,147 new patients listed in 1993 compared with 20,764 in 1990. Proposed s121.4(a)(3) authorizes the OPTN to collect registration fees for each transplant candidate listed by a transplant hospital on the national list. The amount of the fee may be determined by the OPTN subject to review by the Secretary. Payment for patient registration fees is received from transplant hospitals on behalf of their patients. The fees, which are generally reimbursed by third­party and other payors, principally Medicare or Medicaid, are necessary to support OPTN transplant candidate registration and donor/recipient matching activities beyond the direct Federal funding available for the OPTN contract. Proposed s121.4(b) requires members that procure organs to provide to the OPTN timely information on each organ procured. The Department has included this requirement to convey the importance of keeping the computer match program up­ to­date. See the discussion at E. below. In 1993, there were 14,701 organs donated and transplanted from 4,860 cadaveric donors, an average of three organs per donor. It should also be pointed out that nothing in the proposed rules prohibits patients from being listed by more than one transplant hospital. Three percent of waiting list patients are listed at two or more centers. The proposed rules are consistent with the current voluntary policy which permits transplant candidates to appear on more than one local list. See the discussion at G. below. The public is invited to comment on this policy. An issue related to patient listing concerns the apparent disparity in kidney transplantation between blacks and whites. There has been significant research exploring this question. The most recent study, sponsored by the Department of Health and Human Services and conducted by the RAND/UCLA Center for Policy Research in Health Care Financing, examined a number of issues related to access, including cadaveric kidney procurement, distribution, and allocation of organs by OPOs. The study team used data from seven large OPOs, the OPTN, and the ESRD program of the Health Care Financing Administration. That work (Joel D. Kallich, et al., "Access to Cadaveric Kidney Transplantation." RAND, 1993, pp. 59­61) concludes: "* * * that blacks experience problems getting on kidney transplant waiting lists maintained by transplant centers across the country. Once on a list, however, the difference in waiting times to transplant between blacks and whites appears to be the result of biologic differences between the races. "Lower rates of access to the waiting lists are not entirely explained by currently available data on medical condition of the ESRD patient (age, hospitalizations, and cause of renal failure) or regional differences. Medical variables account for some differences, but not all of the racial disparity in access to transplant waiting lists." "In our examination of the hazards ratio of getting on a waiting list once an individual has entered Medicare's ESRD program, we found disparities in access to the UNOS waiting list. Again, available medical/biologic variables do not explain much of the difference between the races." "We do not have any evidence that the differences between the races that we found is due to conscious or unconscious bias on the part of health care professionals. Moreover, it is not surprising that we have found that blacks are having access problems in regard to kidney transplantation. Blacks in America have a history of suffering worse health care outcomes and having greater problems in gaining access to the health care system than white Americans * * *. Yet kidney transplantation causes special concern about issues of fairness, because of federal entitlement to medical care services for all persons with ESRD, * * *" The Department, too, believes that federal entitlement to ESRD­related medical services necessitates careful exploration of the observed disparity between blacks and whites in access to the kidney transplantation waiting list, especially those which may be without medical or biological foundation. Consequently, the Department invites comment and is especially interested in data which may illuminate and assist further in examination of the movement of ESRD patients to the waiting lists for kidney transplantation. D. Organ Procurement Proposed s121.5 is intended to establish minimum requirements to improve the outcome of transplantation and minimize the potential for wastage of organs. These proposed requirements apply only to cadaveric organs and not to organs (such as kidneys and liver lobes) from living donors. Proposed s121.5(a) requires that OPTN members that procure organs *46485 screen donors, in accordance with OPTN policies, to determine any contraindications for donor acceptance. Under policies now voluntarily followed by OPTN members, screening is done for HIV­1, HIV­2, HTLV I/II, hepatitis B, the presence of metastasizing malignancies, including tumors of the liver, sepsis, or evidence that the donor received human pituitary derived growth hormone or dura mater products. The latter are included because of the potential for transmitting Creutzfeldt­Jakob Disease (CJD). Proposed s121.5(b), in keeping with sections 371(b) and 372(b) of the PHS Act, specifies that members are prohibited from procuring organs from donors known to have Human Immunodeficiency Virus (HIV­1 or HIV­2). Screening potential donors for HIV infection has been conducted since 1985, when tests for HIV antibody became available. Although this screening has markedly reduced the potential for transmission of HIV through organ donation, the possibility­­however remote­­still exists because antibodies may not be detected until three to six months after infection. Following a recent finding of HIV infection among recipients of organs and tissue from a donor who tested negative for HIV infection, the Centers for Disease Control and Prevention is developing recommendations on HIV testing of transplant recipients. Proposed s 121.3(a)(6)(i)(C) requires the OPTN Board of Directors to develop policies consistent with recommendations of the Centers for Disease Control and Prevention related to the control of infectious diseases, particularly HIV. Under proposed s121.5(c), transplant hospitals may establish donor acceptance criteria. If they do so, the proposed rules require the hospitals to provide the criteria to OPOs with which they have agreements and to the OPTN. Donor acceptance criteria enable the OPO and the OPTN to make speedy determinations about where to offer an organ. For example, if a transplant hospital specifies the age range of donors from which it would accept organs for transplant, the OPTN's computer match program would automatically exclude patients at that transplant hospital from the list of potential recipients of an organ whose donor exceeded that age range. Thus, the potential for delay and organ wastage would be minimized. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­     Number and Percent of Donors 55 to 64 and 65 and over­­1991, 1992, 1993 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­                       1991                   1992  1993                  No.      Percent       No.      Percent  No.      Percent ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 55 to 64 .......... 377 ....... 8.3 ...... 449 ....... 9.9 ..... 497 ..... 10.3 65 and over ....... 127 ....... 2.8 ...... 175 ....... 3.9 ..... 211 ...... 4.4 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ E. Identification of Organ Recipient Proposed s121.6 establishes the regulatory framework within which operate the various cadaveric organ allocation schemes developed under proposed s121.7. See the discussion at F. below. Under proposed s121.6(b), an OPTN member which procures an organ is required to run the computer match program to identify and rank potential recipients of the organ. Ranking would be determined in accordance with the allocation policies developed by the OPTN under proposed s121.7. Proposed s121.6(a) also provides that organs which do not meet a transplant hospital's donor acceptance criteria will not be offered to transplant candidates of that hospital. Thus, a transplant candidate will not appear on a listing of potential recipients for a donor organ which does not meet the acceptance criteria of the candidate's hospital. Under proposed s121.6(b), organs must be offered to potential recipients in rank order, and only to potential recipients listed with transplant hospitals having transplant programs of the same type as the organ procured and which meet the requirements of proposed s121.8. For all organ offers, proposed s 121.6(b)(4) requires transplant hospitals to accept or reject the offer within a time limit established by the OPTN, provided sufficient information is given to enable a decision to be made. The time limit, which is presently one hour, is established to assure prompt consideration of an offer and the ability to make an offer to subsequently ranked candidates before the organ becomes too old to be transplanted. Under proposed s121.6(c), the OPTN member that procures a donated organ is responsible for arranging for its transportation to the transplant hospital, and for ensuring that it is accompanied by appropriate documentation and is packaged properly. The Department has not included in these proposed rules detailed requirements for documentation and packaging, because such standards have been well­established in medical practice and are included in the OPTN policies. The Department believes that it is unnecessary to codify them into Federal rules. In addition, information about state­of­the­art practice is available from the OPTN. We expect that OPTN members will continue to follow accepted medical practices. In the event that a transplant hospital decides not to use the organ it receives for the potential recipient for whom it was offered, proposed s 121.6(d) requires the transplant hospital to offer the organ to another potential recipient in accordance with proposed s121.6(b). Proposed s121.6(e) in effect suspends the allocation requirements of proposed s121.6 when circumstances arise which would otherwise cause an organ to be wasted. It requires that an OPO or transplant hospital report to the OPTN, within time limits established by the OPTN, any situation in which it did not follow these requirements, and the precise circumstances surrounding the failure to follow the allocation requirements. The Department believes that this provision provides OPOs and transplant hospitals with the regulatory flexibility needed to ensure that organ wastage is minimized. F. Allocation of Organs Proposed s121.7 provides that the OPTN Board of Directors shall develop policies for allocating organs for transplantation. It requires that such policies be patient­based and take into account established medical criteria for transplantation, the length of time potential recipients have been on the national list, and potential recipients whose immune system makes it difficult for them to receive organs, while minimizing wastage of the scarce supply of human organs for transplantation and improving the outcomes of transplantation. These proposed rules do not apply to organs from living donors, either related or unrelated, and proposed s121.7(d) explicitly permits *46486 the allocation of cadaveric organs to individual recipients named by those authorized to make the donation. Proposed s121.7(b) requires that the Board of Directors provide opportunity for the membership of the OPTN to comment on proposed policies. Concurrently, the Secretary would publish the proposed policies or a notice about the proposed policies in the Federal Register to give the public an opportunity to comment. Further, the proposed rule provides that the Secretary shall review final allocation policies and provide comments and/or objections. The OPTN must consider the Secretary's comments before the policies are finalized. If the Secretary objects to a policy, the OPTN may be directed to revise the policy consistent with the Secretary's direction. OPTN members, individuals and entities objecting to final policies may appeal to the Secretary within 30 days of their adoption. The Department recognizes that the present organ allocation policies, which will be the subject of these public comment procedures, raise difficult issues. For example, efforts to promote service to the sickest patients first versus those likely to survive the longest may conflict. Similarly, some policies intended to maximize transplant outcomes and based on sound scientific data may have adverse implications for one ethnic group in particular, or for residents of particular geographic areas. The Department is committed to a full public debate on these and related issues that arise in the context of organ allocation policies. As set forth below, the Department is circulating the present OPTN policies for the purpose of public debate, but wishes to make clear that publication of the policies does not indicate agreement or disagreement with them in their present form. The process is being initiated to allow the earliest possible adoption of final allocation policies, and the Department reserves its judgment on the wisdom of the present OPTN policies until the public comments can be considered. Under the existing organ procurement and transplantation system, members have followed organ­specific allocation policies developed by UNOS. For the purposes of this rulemaking, the Department considers these policies to be proposed policies and intends for the public to have an opportunity to comment on them. However, to avoid disruption in the allocation of organs, the Department expects the OPTN to continue to utilize, and OPOs and transplant hospitals to follow, these policies during the review and comment process. So that this proposed rule may be considered in the context of these allocation policies, following is general information about them. G. Existing Organ Allocation Policies The organ allocation policies now being followed by transplant hospitals and OPOs were developed by UNOS through special committees established by the OPTN. In their proposed form, these policies were circulated to a wide variety of groups and individuals interested in the field of transplantation, and their comments were considered before the policies were finalized. Taken together, these policies comprise a national system of organ allocation which has been in operation, albeit frequently modified, since establishment of the OPTN in 1984. Following is a table which shows, by organ, the number of transplants performed in 1990 and 1993 the number of people on the waiting list at the end of that year, and the 2 year graft survival by organ for transplants performed between October 1, 1987 and December 31, 1991. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­    Organ        No. of transplants    No. of patients on wait    2 year graft list [FN1]  survival for transplants between 10/1/87 and 12/31/91 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­                  1990        1993        1990         1993                               as of December 31, Kidney ........... 9,886 .... 10,265 ..... 17,883 ..... 25,069 .......... 72.8% Liver ............ 2,682 ..... 3,442 ...... 1,237 ...... 2,982 .......... 62.3% Heart ............ 2,107 ..... 2,299 ...... 1,788 ...... 2,833 .......... 76.2% Pancreas ........... 537 ....... 773 ........ 473 ...... 1,110 .......... 65.2% Lung ............... 202 ....... 664 ........ 308 ...... 1,255 .......... 53.1% Heart­lung .......... 52 ........ 60 ........ 225 ........ 203 .......... 47.7% ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ FN1 Because of multiple listing, the number of patients on the wait list is   higher than the actual number of individual patients waiting for a   transplant. However, the number on the wait list is smaller than the total   number of patients likely to benefit from transplantation because many do not   get listed due to inability to pay, fear of surgery, etc. The allocation policies call for matching donated cadaveric organs with potential transplant recipients registered on a national, computerized list of transplant candidates. Matching organs to potential recipients is based on medical criteria such as blood type, histocompatibility, sensitivity of the patient to transplantation (panel reactive antibody), and degree of urgency. Other criteria taken into account are time on the waiting list and geography. Generally, donated organs are allocated first to medically qualified candidates locally, then regionally, and then nationally. The policy effective in July 1993 defines local as the OPO service area in most cases. Potential recipients are identified by generating local and regional lists of names from the national list of transplant candidates. Following is a table showing the range of median waiting times among OPOs by region. Range of Median Waiting Times by Days Among OPOs in Region ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­                                     [1992]   Region        Kidney           Liver            Heart   Pancreas ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 1 ................. 505­725 ........ 91­375 ........ 168­265  ( [FN2]) 2 ................. 397­772 ....... 108­209 ......... 68­540  ( [FN2]) 3 ................. 125­826 ......... 20­78 ......... 72­265  ( [FN2]) 4 ................. 223­523 ........ 70­105 ......... 55­325  ( [FN2]) 5 ................. 130­786 ........ 18­197 ........ 130­355  ( [FN2]) 6 .................. 94­533  [FN1]56 ................ 56­182  ( [FN2]) 7 ................. 448­695 ........ 31­256 ........ 226­641  ( [FN2]) 8 ................. 271­539 ........ 26­121 ......... 92­381  ( [FN2]) 9 ................. 213­698 ....... 279­443 ........ 255­268  ( [FN2]) 10 ................ 185­348 ........ 33­194 ......... 89­591  ( [FN2]) 11 ................ 151­723 ........ 30­276 ........ 111­767  ( [FN2]) United   States ........... 94­826 ........ 18­443 ......... 55­767  ( [FN2]) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ FN1 Two OPOs in Region 6 that contain liver transplant centers; both with   waiting times of 56 days. FN2 Insufficient data because of small number of cases. *46487 Potential recipients of hearts, heart­lung­combinations, and lungs are ranked according to medical urgency, time on the national list, and logistics. For kidneys, livers, and pancreata, potential recipients are ranked, using a point system, according to point values for the criteria established in each organ allocation policy, To calculate the number of points for time, for example, if there are 75 potential recipients in blood group O on the list for kidneys, the person with the longest time would have a number of points equal to 75 divided by 75, times 1; or 1 point. If a potential recipient had a position number of 60 on the list of 75 potential recipients in blood group O, that person would have a number of points equal to 60 divided by 75, times 1; or 0.8 points. The policy also awards 0.5 additional points for each year above one year on the list. The kidney allocation policy also establishes point values for the quality of antigen match emphasizing the lack of mismatches, and degree of panel reactive antibody. It also specifies that potential recipients five years old or younger receive an additional two points, and that potential recipients who are six through ten years old receive an additional one point. Additional points are awarded to children because they generally do not do well on dialysis, the alternative to kidney transplantation. The current policies also permit variances to the point system and the establishment of alternative local units for distributing organs, subject to the approval of the OPTN. For example, they permit interregional and intraregional groups to develop organ sharing arrangements, allow transplant hospitals and OPOs to assign different point values to the organ allocation criteria, and permit OPOs to institute alternative arrangements to distribute hearts and heart­lung combinations within the boundaries of the OPO. Other existing policies require an OPO receiving a six antigen matched kidney to "pay back" a kidney to the OPTN and, in the case of simultaneous kidney­pancreas transplantation, require only one of the kidneys procured to be offered for a six antigen matched recipient. The Department requests comment on the use of variances and alternative local units by the OPTN and whether they should be permitted to continue. The Department recognizes that there is significant public interest in the present organ allocation policies of the OPTN. In order to expedite the process of the public comment on those policies, the Department has decided to initiate the process described in the proposed rule set forth below. Accordingly, anyone interested in commenting on the present allocation policies may obtain a copy by writing to the United Network for Organ Sharing, 1100 Boulders Parkway, suite 500, Post Office Box 13770, Richmond VA 23225­8770. The Department asks that anyone who wishes to comment on the present organ allocation policies submit written comments to Ms. Judith B. Braslow, Director, Division of Organ Transplantation, room 7­18, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, by December 7, 1994. In addition, a copy should be submitted at the same time to the United Network for Organ Sharing. Depending on the public comments submitted in response to this proposed rule, the Department may revise the process of comment on the allocation policies. However, in anticipation that the final rule will be substantially the same in this regard as the proposed rule, the Department felt it wise to expedite the comment process by announcing the availability of the present organ allocation policies simultaneously with the publication of this proposed rule. The final analysis of comments on the present allocation policies will, of course, await the publication of the final rule. In addition, the Department requests comment specifically on moving toward single regional listings of potential recipients drawn from the national list for the purpose of allocating organs, and whether the use of regional listings is feasible and would lead to a fairer and more equitable allocation system. In seeking comments on an allocation system, the Department stresses that it is not committed to those policies presently in place. The public is invited to propose any alternative methods for allocating organs, including systems which may differ markedly from the current allocation schemes. Among the features which may be considered are a framework which is national in scope and at the same time patient focused; consideration of equitable distribution of organs; the extent to which the allocation system will foster improvements in graft and patient survival; and the extent to which a patient may select among transplant programs once having been placed on the transplantation waiting list. The Department, of course, is committed to disclosure to patients and physicians of data on transplant program performance and any available cost information pertinent to transplant programs regardless of the allocation policies in place. The Department will use the comprehensive transplantation data system in reviewing the data presented and the questions raised by commentors on the allocation policies. The data shown below is an illustration of the information available on organ allocation. Transplant program performance and volume information is also available. Allocation of Organs­­1991, 1992, 1993 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­                     [Percentage]                           Kidneys    Hearts   Livers ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 1991: Transplanted locally ........ 70.6 .... 65.9 .. 48.5 Shared within region ........ 11.2 .... 17.2 .. 30.1 Shared outside region ....... 18.2 .... 16.4 .. 20.3 1992: Transplanted locally ........ 73.6 .... 70.9 .. 55.6 Shared within region ......... 9.8 .... 15.0 .. 28.3 Shared outside region ....... 16.5 .... 14.5 .. 15.6 1993: Transplanted locally ........ 74.7 .... 70.6 .. 56.8 Shared within region ......... 9.2 .... 14.7 .. 27.7 Shared outside region ....... 15.7 .... 14.0 .. 14.6 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Heart and Liver One­Year Graft Survival Rate by Patient Description at Time of                                   Transplant ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­                                  [Percentage]         Patient description                  Heart  Liver ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Working/attending school full time .................. 93.6 ............... 79.1 Working/attending school part time .................. 84.4 ............... 75.2 Homebound/failing to thrive ......................... 83.5 ............... 74.4 Hospitalized ........................................ 81.0 ............... 68.1 In intensive care ................................... 82.4 ............... 64.0 On life support ..................................... 72.8 ............... 47.5 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ H. Designated Transplant Program Requirements The Department believes that, in enacting the National Organ Transplantation Act, the Congress intended that establishment of the OPTN would ensure that human organ transplantation is conducted in facilities properly equipped and staffed to carry out these complex procedures. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­           Number of OPTN Approved Centers, 1993  KIdney    Liver    Pancreas    Heart    Heart­lung   Lung ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 246 ......... 109 ....... 112 .... 164 .......... 89 .. 76 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ *46488 The Department also believes that, although its regulations should be minimal with as much flexibility as possible, it has a statutory responsibility to ensure that the rule maintain, and indeed promote, high quality care. For example, the Department's rules published on April 12, 1991, to include coverage of liver transplants under Medicare are explicit in stating that a goal of the criteria for facilities to qualify for reimbursement is to maintain the quality of services. (56 FR 15009). These proposed rules complement the criteria established for coverage of organ transplantation under Medicare. The Medicare requirements place emphasis on the facilities in which transplantation is performed; that is, criteria are established for facility experience in terms of numbers of transplants performed and survival rates. Thus, for example, as of November 1993 only 33 of the existing 109 liver transplant programs in the United States qualify for Medicare reimbursement; 49 of the liver transplant programs applied. Complementing the Medicare criteria, the proposed OPTN transplant program requirements provide that transplant programs which meet the Medicare requirements are automatically qualified to receive organs for transplantation. For those which do not, the proposed rules set out service and support requirements which are similar to those required under Medicare. However, because new transplant programs do not yet have the transplant experience and survival rates that are needed for Medicare reimbursement, the proposed OPTN rules include requirements to be established by the OPTN Board of Directors for the education and training of transplant surgeons and physicians, thus ensuring the quality of care in transplant programs which are not yet approved for Medicare reimbursement. In developing this proposed rule, the Department considered allowing all Medicare participating hospitals which performed transplants (regardless of their qualification for Medicare reimbursement for transplantation) to be eligible to receive organs for transplantation without having to meet additional criteria. The Department rejected this alternative for the same reason it rejected a similar alternative regarding Medicare coverage of heart and liver transplants; that it would permit uncontrolled proliferation of transplant facilities, raising all the concomitant questions about the quality of services, given the limited availability of donor organs and experienced teams. (56 FR 15018). Under this option to impose no facility standards on hospitals beyond those already required of them through their participation in Medicare and Medicaid, all transplant hospitals which have a provider agreement under Medicare or which participate in Medicaid would automatically be approved (assuming that they met the remainder of the regulation's requirements) to receive organs through the OPTN. The assumption underlying this option is that Federal regulation in this area should focus only on a national system for matching organs and for allocating them equitably, rather than on standards for conducting transplantation. It also takes the position that, although there is a theoretical argument that equitable allocation could be harmed if transplantation itself were not regulated to prevent organ wastage, such Federal regulation must be premised on the existence of evidence that significant numbers of organs are unnecessarily wasted because of the lack of Federally mandated standards. We invite comment on this option, and specifically request that commenters provide evidence in support of their position. Another alternative was to add volume and quality minimums (e.g., 75 percent success rate on more than 20 procedures a year) which would exclude hospitals which perform at lower levels. For example, a mere showing that the average success rate of hospitals meeting a certain volume level or other standard is several percentage points higher than the average success rate of other hospitals would not, in our view, be a sufficient basis for denying other hospitals access to organs. Both the absolute difference and the standard error of such estimates would have to allow a high level of certainty that a particular standard would reduce wastage of many organs and would not exclude meritorious hospitals that handle sicker than average patients. Furthermore, no such standard should be adopted if its effect were to exclude hospitals from newly entering the field of transplantation. We are reviewing hospital­specific data collected through the Scientific Registry, a repository of data on transplant recipients that is operated under contract with the Department, and may identify patterns which *46489 support establishing such a standard. One factor that patients consider in selecting a transplant center is the annual number of transplants performed there. The data show that for kidney transplantation, the risk of graft failure within one year after transplant is about the same across centers regardless of the number of transplants performed. Liver transplants at centers doing fewer than 6 transplants were 2.8 times more likely to fail within the first year than were transplants at centers doing 32­66 transplants. Heart transplants at centers doing fewer than 9 transplants were 3.5 times more likely to fail within the first year than were transplants at centers performing 26 to 45 transplants. The best results for pancreas transplants appeared to be at centers that performed more than 10 transplants. We will consider suggestions, and will consider proposing a standard if it is supportable scientifically and sound from a regulatory standpoint. Any commenters proposing such standards should provide empirical data, if possible, on the extent of the problem and on likely improvement. Another approach was to base the OPTN regulatory criteria on the standards for Medicare coverage (i.e., eligibility for reimbursement) of heart and adult liver transplants, or to require compliance with the many Medicare and Medicaid regulatory provisions directed at or affecting transplantation (e.g., the social services or laboratory requirements in the end stage renal disease supplier conditions of coverage­­42 CFR Part 405, Subpart U). The Department believes that this approach would create a number of problems, including the creation of unnecessary, duplicative standards and the potential for conflicts in enforcement where the standards are slightly different. Nevertheless, we invite comment on this approach and any variations. Commenters advocating any approach to regulating transplantation should specify the precise benefits expected and their likely empirical magnitude, address whether these benefits will be significant in furthering the purposes of the organ transplantation provisions of the Public Health Service and Social Security Acts, and discuss whether other alternatives inside or outside the scope of this proposed regulation (e.g., efforts to increase organ retrieval or increased reliance on antigen matching in allocation priorities) might better achieve these benefits. The "User's Guide" accompanying the 1991 Report of Center­Specific Graft and Patient Survival Rates notes a number of factors patients should take into consideration in selecting a transplant center. Some of the most important factors are: ­ The graft and patient survival rates of the particular program. ­ The experience, training and education of the transplant team and the medical and nursing care available throughout the process from candidate evaluation through transplantation and follow­up. ­ The cost of the transplant procedure, physician services, hospitalization and medications. ­ The location of the transplant program and how close it is to the patient's home and how easily the patient can reach it. ­ The friends and family available to the patient for assistance before, during and after the transplant. ­ The support facilities of the transplant center. We are soliciting comments on how the current OPTN policies or other alternative allocation systems would maximize a patient's ability to choose among transplant centers using the above factors. In addition, the Department is concerned about the regulation of organ transplantation in light of health care reform with respect to issues of equity, access, and cost. The Department solicits comments on the effect of alternative allocation policies on these issues. I. Review, Evaluation, and Appeals To determine compliance with the rules and requirements of the OPTN, under proposed s121.9(a) the Secretary or her/his designee may conduct reviews and evaluate the activities of member OPOs and transplant hospitals. Proposed s 121.9(b) requires the OPTN to develop plans and procedures, subject to approval by the Secretary, for reviewing membership applications from OPOs and transplant hospitals, and for conducting ongoing reviews and evaluations of member OPOs and transplant hospitals. The purpose of these reviews and evaluations is to monitor compliance with the regulations and to conduct such studies as the Secretary deems necessary. The Secretary may, under proposed s 121.9(c), suspend a transplant program's eligibility to receive organs for transplantation if, upon consideration of recommendations based on reviews or evaluations by the OPTN, the Secretary determines that the entity has failed to comply with these regulations. Moreover, the Secretary may decide that, by virtue of section 1138, an OPO is no longer eligible for reimbursement under Medicare and Medicaid. Proposed s121.10(a) provides that any individual or entity may appeal any policy, procedure, or issuance of the OPTN to the Secretary. The Secretary will solicit the comments of the OPTN on the appeal and when warranted will take appropriate action to resolve it. The Secretary intends that such appeals will be filed only when the enforcement of the policies at issue implicates an important public policy or where there is a potential for some penalty to be imposed either by the OPTN or the Secretary. Proposed s121.10(b) provides that the Secretary may object to any policy, procedure, or issuance of the OPTN, and that the OPTN may be directed to revise the item consistent with the Secretary's direction. J. Record Maintenance and Reporting The record maintenance and reporting requirements of the proposed rules are limited to the OPTN itself, and to OPOs and transplant hospitals which are members of the OPTN. The Department's policy is to assure that transplantation data collected on its behalf are readily available for scientific and evaluative analysis, and that the OPTN provides the data to the public, subject to Privacy Act restrictions. Under proposed s121.11(a), records are to be maintained and made available consistent with applicable limitations based on personal privacy. Proposed s121.11(a)(1) requires the OPTN to operate an automated system for managing information about organ transplant candidates, recipients, and donors, including a computerized waiting list, in accordance with the listing requirements of proposed s121.4. The OPTN shall maintain patient records in association with the list. Proposed s121.11(a)(2) requires OPOs and transplant hospitals to maintain and make available to the Secretary and Comptroller General, or their designees, records on patients and donors for which they are responsible. Under the reporting requirements of proposed s121.11(b)(2), OPOs and transplant hospitals which are members of the OPTN must provide to the OPTN information about transplantation candidates, recipients, and donors for which they are responsible. Such information includes patient and donor identification, medical data necessary for operating the computer match system, and post­transplant information about graft survival. The OPTN is required by proposed s121.11(b)(1) to report to the Secretary at least annually the information that the Department believes is needed to *46490 assess the effectiveness of the Nation's organ donation, procurement, and transplantation system. This provision also requires the OPTN to report data on transplant candidates and recipients to the Scientific Registry. IV. Data Availability Throughout this Preamble the Department has presented data to augment the description of the organ transplantation system. Commentors have been asked to support their comments with pertinent data where appropriate. In particular, we request that comments on the system for organ allocation (see sections F and G) be supported by information which clearly demonstrates advantages derived from the alternative methods proposed. The Department expects to use data as well in evaluating the potential effects of proposed changes in organ allocation. There is considerable information in the literature about the clinical issues in transplantation, specifically those factors which affect survival of the transplanted organs and their recipients. Examples of the kinds of data which may be useful in performing these analyses are displayed below: BILLING CODE 4160­15­M TABULAR OR GRAPHIC MATERIAL SET FORTH AT THIS POINT IS NOT DISPLAYABLE *46494 BILLING CODE 4160­15­C *46495 The above charts show the variation in median waiting times, wait list mortality, and patient status at time of transplant for various organs within OPTN regions. (There is no patient status data at time of transplant for kidney transplant patients). In preparing their responses, commenters may wish to refer to the following: "The 1991 Report of Center­Specific Graft and Patient Survival Rates," and "The 1993 Annual Report of the U.S. Scientific Registry of Transplant Recipients and the Organ Procurement and Transplantation Network." Both of these documents are available from the United Network for Organ Sharing, 1100 Boulders Parkway, suite 500, Post Office Box 13770, Richmond, VA 23225­8770. V. Economic Impact Executive Order 12866 requires that all regulations reflect consideration of alternatives, of costs, of benefits, of incentives, of equity, and of available information. Regulations must meet certain standards, such as avoiding unnecessary burden. Regulations which are "significant" because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues, require special analysis. The Regulatory Flexibility Act requires that we analyze regulatory proposals to determine whether they create a significant impact on a substantial number of small entities (for purposes of the Act, all hospitals and all OPOs are categorized by HHS as small entities). In part, because of the procedural emphasis of this proposal, it is premature to analyze the costs and health benefits of regulatory alternatives as is ordinarily required by Executive Order No. 12866. For example, per­patient data currently available show that the government's annual cost for renal dialysis is $40,000. The cost for a kidney transplant is $87,000. Because of post­transplant costs, it is not until the third year after dialysis that a successful kidney transplant becomes more cost effective than dialysis. This analysis is limited to costs and does not include consideration of nonmonetary benefits to the patient or society as a whole. To aid the policy discussion that will follow this Notice the Department will, to the maximum extent possible, provide comparative analyses on a range of options it considered, including the existing OPTN policies. These options will be based on comments received. VI. Paperwork Reduction Act of 1980 This proposed rule contains information collections which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1980. Proposed s121.11(a)(2) requires OPOs and transplant hospitals which are members of the OPTN to maintain records on organ donors and transplant patients, and proposed s121.11(b)(2) requires them to report to the OPTN information based on those records. The title, description, and respondent description of the information collection are shown below with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Title: Organ Procurement and Transplantation Network. Description: Information will be collected from transplant hospitals and organ procurement organizations for the purpose of matching donor organs with potential recipients, monitoring compliance of member organizations with system rules, conducting statistical analyses, and developing policies relating to organ procurement and transplantation. Description of Respondents: Non­profit institutions and small organizations. [Note:  The following TABLE/FORM is too wide to be displayed on one screen. You must print it for a meaningful review of its contents.  The table has been divided into multiple pieces with each piece containing information to help you assemble a printout of the table.  The information for each piece includes: (1) a three line message preceding the tabular data showing by line # and character # the position of the upper left­hand corner of the piece and the position of the piece within the entire table; and (2) a numeric scale following the tabular data displaying the character positions.] ******************************************************************************* ******** This is piece 1. ­­ It begins at character 1 of table line 1. ******** ******************************************************************************* ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­                      Estimated Annual Reporting and Recordkeeping Burden    Section             Activity          Annual number  Annual                                               of  frequency                                           respondents ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 121.6(e) ...... Transplant to prevent                   organ wastage ................... 268 ............ 4 . 121.11(b)(2) .. Transplant candidate                   registration [FN1] ............... 67 .......... 597 . 121.11(b)(2) .. Donor registration [FN1] ............................ 67 .......... 248 . 121.11(b)(2) .. Potential recipient [FN1] ............................ 67 .......... 266 . 121.11(b)(2) .. Donor histocompatibility [FN1] ............................ 49 .......... 145 . 121.11(b)(2) .. Transplant recipient                   histocompatibility                   [FN1] ............................ 49 .......... 347 . 121.11(b)(2) .. Transplant recipient registration [FN1] .............. 605 ........... 28 . 121.11(b)(2) .. Transplant recipient follow­up [FN1] ................. 605 .......... 228 . 1...+...10....+...20....+...30....+...40....+...50....+...60....+...70.. ******************************************************************************* ******* This is piece 2. ­­ It begins at character 73 of table line 1. ******** ******************************************************************************* ­­­­­­­­­­­­­­­­­­­­­­   Average      Annual  burden per    burden   response     hours ­­­­­­­­­­­­­­­­­­­­­­ ........ 0.1 ..... 107 ........ 0.1 ... 4,000 ........ 0.2 ... 3,320 ........ 0.1 ... 1,780 ........ 0.1 ..... 710 ........ 0.1 ... 1,700 ....... 0.25 ... 4,280 ....... 0.14 .. 19,280 73....80....+...90.... ******************************************************************************* ******* This is piece 3. ­­ It begins at character 1 of table line 25. ******** ******************************************************************************* Total .........  ­­­­­­­­­­­­­­­­­­­­­ ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ FN1 The data collection forms for these   Office of Management and Budget under   0915­0157). 1...+...10....+...20....+...30....+...4 ******************************************************************************* ******* This is piece 4. ­­ It begins at character 40 of table line 25. ******* *******************************************************************************   ­­­­­­­­­­­­­­   ­­­­­­­­­­­­   ­­­­­­­­­­­ .. 35,177 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­  activities have been approved by the  the Paperwork Reduction Act (OMB No. 40..+...50....+...60....+...70....+...80....+...90....+ The proposed rules also require OPOs and transplant hospitals to maintain records, as follows: ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­    Section                        Requirement ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 121.6(b)(3) ... Documentation of reason for refusal. 121.6(c)(2) ... Documentation of suitability tests. 121.11(a)(2) .. Maintain records on organ donors and recipients. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ According to staff of OPOs and transplant hospitals, such recordkeeping is integral to the operation of these facilities. Therefore, these recordkeeping requirements impose no additional burden. The Department has submitted a copy of this proposed rule to OMB for its review of the reporting and recordkeeping requirements. Organizations and individuals desiring to submit comments on these information collection requirements should direct them to the agency official whose name appears in this preamble and to the Office of Information and Regulatory Affairs, OMB, New Executive Office Building, (room 3208), Washington, DC 20503, ATTN: Desk Officer for HHS. List of Subjects in 42 CFR Part 121 Organs­­human, Organ procurement and transplantation network, Organ transplantation, Hospitals. *46496 Dated: October 15, 1993. Philip R. Lee, Assistant Secretary for Health. Approved: May 16, 1994. Donna E. Shalala, Secretary. Accordingly, the Department of Health and Human Services proposes to add 42 CFR Part 121 to subchapter K to read as follows: PART 121­­ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK Sec. 121.1 Applicability. 121.2 Definitions. 121.3 Composition. 121.4 Listing requirements. 121.5 Organ procurement. 121.6 Identification of organ recipient. 121.7 Allocation of organs. 121.8 Designated transplant program requirements. 121.9 Review and evaluation. 121.10 Appeals of OPTN policies and procedures. 121.11 Record maintenance and reporting requirements. Authority: Sections 215 and 372 of the Public Health Service Act (42 U.S.C. 216 and 274); section 1138 of the Social Security Act (42 U.S.C. 1320b­8). s121.1 Applicability. (a) The provisions of this part apply to the operation of the Organ Procurement and Transplantation Network (OPTN). (b) In accordance with section 1138 of the Social Security Act, hospitals in which organ transplants are performed and which participate in the programs under titles XVIII or XIX of that Act, and organ procurement organizations designated under section 1138(b)(1)(F) of the Social Security Act are subject to the requirements of this part. s121.2 Definitions. As used in this part­­ Act means the Public Health Service Act, as amended. Designated transplant program means a transplant program that meets the requirements of s121.8. National list means the OPTN computer­based list of transplant candidates nationwide. OPTN computer match program means a computer­based program to ensure the matching of donated organs with the best medically­suited transplant candidates. Organ means a human kidney, liver, heart, lung, or pancreas. Organ procurement organization or OPO means an entity so designated by the Secretary under section 1138(b) of the Social Security Act. Organ procurement and transplantation network or OPTN means the network established pursuant to section 372 of the Act. Potential transplant recipient or potential recipient means a transplant candidate who has been identified as medically qualified to receive a transplant of a specific donated organ. Scientific registry means the registry of information on transplant recipients established pursuant to section 373 of the Act. Secretary means Secretary of Health and Human Services and any official of the Department of Health and Human Services to whom the authority involved has been delegated. Transplant candidate means an individual who has been identified as medically qualified to benefit from an organ transplant. Transplant hospital means a hospital in which organ transplants are performed. Transplant program means a program within a transplant hospital for transplantation of a particular type of organ. Transplant recipient means a person who has received an organ transplant. s121.3 Composition. The OPTN shall be comprised of organizations, institutions, and individuals. (a) Board of Directors. The OPTN shall establish a Board of Directors to be comprised of not less than 14 or more than 35 members as follows: (1) Composition. The Board of Directors shall include: (i) two members each from, and elected by, the association representing transplant coordinators, the association representing organ procurement organizations, and the association representing histocompatibility experts; (ii) individual elected by a majority vote of the voting OPTN membership, including at least two representatives each from the following categories: (A) transplant surgeons; (B) transplant physicians; (C) transplant hospitals; (D) voluntary health associations; (E) patient advocacy groups; and (F) the general public including, but not limited to, patients, donor families, and individuals from the fields of law, theology, hospital administration, ethics, health care financing, computer science, economics, sociology, and behavioral sciences; and (iii) one representative elected by the membership in each of the regions, if any, established by the OPTN. (2) Diversity. The Board of Directors shall include: (i) individuals representing the diversity of the population of organ donors and recipients served by the OPTN, including minority and gender representation reflecting that diversity; and (ii) not more than 50 percent surgeons and physicians directly involved in organ procurement and transplantation. (3) Term. Individuals on the Board shall serve a two­year term. (4) Executive committee. The Board of Directors shall every two years elect an Executive Committee from the membership of the Board to ensure continuity of leadership. The Executive Committee shall include not more than 50 percent surgeons and physicians directly involved in organ procurement and transplantation. (5) Executive director. The Board of Directors shall appoint an Executive Director of the OPTN whose term shall not exceed four years. The Executive Director may be reappointed to successive terms upon the Board's determination that she/he has successfully carried out her/his responsibilities. (6) Duties. (i) The OPTN Board of Directors shall be responsible for developing, with the advice of the OPTN membership and other interested parties: (A) general policies, procedures, and other issuances within the mission of the OPTN as set forth in section 372 of the Act and the Secretary's contract for the operation of the OPTN: (B) medical criteria and related policies for the fair and equitable allocation of human donor organs; (C) policies, consistent with recommendations of the Centers for Disease Control and Prevention, for the testing of organ donors and follow­up of transplant recipients to prevent the spread of infectious diseases; and (D) standards for the training and experience of transplant surgeons and transplant physicians required by s121.8(a)(2)(ii) and (iii). The OPTN shall develop these standards in accordance with the public participation process set forth in s121.7(b). (ii) The OPTN Board of Directors shall provide to the Secretary copies of the policies, procedures, and issuances as they are adopted, and make them available to the public upon request. The Secretary will periodically publish lists of these documents in the Federal Register. (b) Committees. Committees established by the Board of Directors shall include, to the extent practicable, minority and gender representation reflecting the diversity of the population *46497 of organ donors and recipients served by the OPTN. (c) OPTN membership. The OPTN shall admit and retain as members the following: (1) All organ procurement organizations designated by HHS under section 1138(b) of the Social Security Act; (2) All hospitals participating in the Medicare or Medicaid programs which perform transplants; and (3) Organizations (other than OPOs described in paragraph (c)(1) of this section and transplant hospitals described in paragraph (c)(2) of this section), institutions, or individuals that have an ongoing interest in the field of organ transplantation. (d) Review of applications and documentation. (1) To apply for membership in the OPTN: (i) OPOs shall provide to the OPTN the name and address of the OPO, and the latest year of designation under section 1138(b) of the Social Security Act; (ii) hospitals shall provide to the OPTN in writing the name and address of the hospital, a list of its transplant programs, if any, by type of organ; and (iii) organizations, institutions, and individuals eligible under paragraph (c)(3) of this section shall provide to the OPTN documentation which demonstrates their interest in the field of organ transplantation. (2) The OPTN shall accept as members entities described in paragraphs (c) (1) and (2) of this section and shall accept or reject applications from entities described in paragraph (c)(3) of this section. (3) Applicants rejected for membership in the OPTN may appeal to the Secretary. Appeals shall be submitted in writing within 30 days of rejection of the application. The Secretary may: (i) deny the appeal; or (ii) direct the OPTN to take action consistent with the Secretary's response to the appeal. s121.4 Listing requirements. (a) Transplant candidate listing. (1) An OPTN member may list transplant candidates only for a designated transplant program. (2) Transplant hospitals shall assure that all transplant candidates are placed on the national list as soon as they are determined to be candidates for transplantation. The OPTN shall from time to time advise members of the information needed for such listing. (3) An OPTN member shall pay a registration fee to the OPTN for each transplant candidate it places on the national list. The amount of such fee shall be determined by the OPTN with the approval of the Secretary. (b) Donor listing. OPTN members that procure organs shall submit to the OPTN such data as the OPTN shall prescribe on each organ procured, within the time prescribed by the OPTN. s121.5 Organ procurement. The suitability of organs donated for transplantation shall be determined as follows: (a) Tests. An OPTN member procuring an organ shall assure that laboratory tests and clinical examinations of potential organ donors are performed to determine any contraindications for donor acceptance, in accordance with policies established by the OPTN. (b) HIV. Organs from potential donors known to be infected with Human Immunodeficiency Virus shall not be procured for transplantation. (c) Acceptance criteria. Transplant programs may establish criteria for organ acceptance, and shall provide such criteria to their OPOs and to the OPTN. s121.6 Identification of organ recipient. (a) List of potential transplant recipients. (1) An OPTN member procuring an organ shall operate the OPTN computer match program within such time as the OPTN may prescribe to identify and rank potential recipients for each cadaveric organ procured. (2) The rank order shall be determined for each cadaveric organ using the organ specific allocation criteria established in accordance with s121.7. (3) Where a donor organ does not meet a transplant program's donor acceptance criteria, as established under s121.5(c), transplant candidates of that hospital shall not be ranked among potential recipients of that organ and shall not appear on a roster of potential recipients of that organ. (b) Offer of organ to potential recipients. (1) Organs shall be offered to potential recipients in rank order, in accordance with policies adopted under s121.7. (2) Organs may be offered only to potential recipients listed with transplant hospitals having designated transplant programs of the same type as the organ procured. (3) An organ offer is made by the OPTN member which procured the organ when all information necessary to determine whether to transplant the organ into the potential recipient has been given to the transplant hospital. (4) A transplant hospital shall either accept or refuse the offered organ within such time as the OPTN may prescribe. A transplant hospital shall document the reasons for refusal. (c) Transportation of organ to potential recipient. (1) Transportation. The OPTN member that procures a donated organ shall arrange for transportation of the organ to the transplantation site. (2) Documentation. The OPTN member that is transporting an organ shall assure that it is accompanied by written documentation of activities conducted to determine the suitability of the organ donor. (3) Packaging. The OPTN member that is transporting an organ shall assure that it is packaged to assure viability upon receipt. (d) Receipt of an organ. Upon receipt of an organ, the transplant hospital responsible for the potential recipient's care shall determine whether to proceed with the transplant. In the event that an organ is not transplanted into the potential recipient, the transplant hospital must offer the organ to another potential recipient in accordance with paragraph (b) of this section. (e) Wastage. Nothing in this section shall prohibit any OPTN member from transplanting an organ into any medically suitable candidate if to do otherwise would result in the organ not being used for transplantation. The member shall notify the OPTN of the circumstances justifying each such action within such time as the OPTN may prescribe. s121.7 Allocation of organs. (a) Policy development. The Board of Directors established under s121.3(a) shall develop policies for the fair and equitable allocation of human cadaveric organs among potential recipients. Such policies shall be patent­based and take into account significant factors affecting quality of care and patient and organ graft survival including: (1) established medical criteria for transplantation of organs; (2) the length of time potential recipients have been on the national list; (3) potential recipients whose immune system makes it difficult for them to receive organs; and (4) minimizing wastage of the scarce supply of human organs for transplantation. (b) Public participation. (1) The OPTN shall provide opportunity for the OPTN membership and other interested parties to comment on proposed policies and, at the same time, provide the proposed policies to the Secretary for publication in the *46498 Federal Register to obtain comments from the public. (2) The Board of Directors shall take into account the comments received in developing and adopting final policies for implementation by the OPTN. (3) The OPTN shall provide the proposed final policies to the Secretary, who shall have 30 days in which to provide comments and/or objections. The OPTN shall take into account any comments the Secretary may provide. If the Secretary objects to a policy, the OPTN may be directed to revise the policy consistent with the Secretary's direction. (4) OPTN members, individuals, or entities objecting to final policies may submit appeals to the Secretary in writing within 30 days of adoption of the final policies by the OPTN. The final policy remains in effect during this period. The Secretary may: (i) deny the appeal; or (ii) direct the OPTN to revise the policies consistent with the Secretary's response to the appeal. (c) Policy implementation. (1) The OPTN shall implement allocation policies adopted and approved by the Secretary, and provide information to OPTN members about these policies and the rationale for them. (2) The Board of Directors shall update policies developed in accordance with this section to keep them current with scientific and technological advances. (d) Directed donation. Nothing in this section shall prohibit the allocation of an organ to a recipient named by those authorized to make the donation. s121.8 Designated transplant program requirements. (a) To receive organs for transplantation, transplant programs shall abide by these rules and OPTN policies, procedures, and issuances, and shall: (1) be an organ transplant program approved by HHS under applicable regulations for reimbursement under Medicare and Medicaid; or (2) be an organ transplant program which: (i) has letters of agreement or contracts with an OPO; (ii) has on site a transplant surgeon qualified in accordance with standards developed under s121.3(a)(6)(i)(D); (iii) has on site a transplant physician qualified in accordance with standards developed under s121.3(a)(6)(i)(D); (iv) has available operating and recovery room resources, intensive care resources and surgical beds and transplant program personnel; (v) shows evidence of collaborative involvement with experts in the fields of radiology, infectious disease, pathology, immunology, anesthesiology, physical therapy and rehabilitation medicine and, as appropriate, hepatology, pediatrics, nephrology with dialysis capability, and pulmonary medicine with respiratory therapy support; (vi) has immediate access to microbiology, clinical chemistry, tissue typing, radiology and blood banking services, as well as the facilities required for monitoring immunosuppressive drugs; and (vii) makes available psychiatric and social support services for transplant recipients and their families; or (3) be a transplant program in a Veterans Administration hospital which is a Dean's Committee hospital which shares a common university­based transplant team of a transplant program which meets the requirements of s121.8(a) (1) or (2). (b) To apply to be a designated transplant program, transplant programs shall provide to the OPTN such documents as the OPTN may require which show that they meet the requirements of s121.8(a) (1), (2), or (3). (c) The OPTN shall accept or reject applications to be a designated transplant program. (d) Applicants rejected for designation may appeal to the Secretary. Appeals shall be submitted in writing within 30 days of rejection of the application. The Secretary may: (1) deny the appeal; or (2) direct the OPTN to take action consistent with the Secretary's response to the appeal. s121.9 Review and evaluation. (a) Review and evaluation by the Secretary. The Secretary or her/his designee may perform any reviews and evaluations of member OPOs and transplant hospitals which the Secretary deems necessary to carry out her/his responsibilities under the Public Health Service Act and the Social Security Act. (b) Review and evaluation by the OPTN­­ (1) The OPTN shall design appropriate plans and procedures, including survey instruments and data systems, for purposes of: (i) reviewing applications submitted under s121.3(d)(1) for membership in the OPTN; (ii) reviewing applications submitted under s121.8(b) to be a designated transplant program; and (iii) conducting ongoing and periodic reviews and evaluations of each member OPO and transplant hospital for compliance with these regulations. (2) Upon the approval of the Secretary, the OPTN shall furnish review plans and procedures, including survey instruments and a description of data systems, to each member OPO and transplant hospital. The OPTN shall furnish any revisions of these documents to member OPOs and hospitals, after approval by the Secretary, prior to their implementation. (c) Enforcement of OPTN rules. (1) OPTN recommendations. The Board of Directors shall advise the Secretary of the results of any reviews and evaluations conducted under paragraph (b)(1)(iii) of this section which, in the opinion of the Board, indicate noncompliance with this part, and provide any recommendations for appropriate action by the Secretary. (2) Secretary's action on recommendations. Upon the Secretary's review of the Board of Directors' recommendations, the Secretary may: (i) request further information from the Board of Directors or the alleged violator, or both; (ii) decline to accept the recommendation; (iii) accept the recommendation, and notify the alleged violator of the Secretary's decision; or (iv) take such other action as the Secretary deems necessary. s121.10 Appeals of OPTN policies and procedures. (a) Any individual or entity may appeal to the Secretary any policy, procedure, or issuance of the OPTN. Any such appeal shall include a statement of the basis for the appeal. The Secretary will seek the comments of the OPTN on the issues raised in the appeal. The Secretary may deny the appeal or direct the OPTN to revise the policy, procedure, or issuance consistent with the Secretary's response to the appeal. (b) The Secretary may object to any policy, procedure, or issuance of the OPTN, and the OPTN may be directed to revise the policy, procedure, or issuance in accordance with the Secretary's direction. s121.11 Record maintenance and reporting requirements. (a) Record maintenance. Records shall be maintained and made available subject to applicable limitations based on personal privacy as follows: (1) OPTN­­(i) The OPTN shall maintain and operate in accordance with s121.4 an automated system for managing information about organ transplant candidates, recipients, and donors, including a computerized national list of individuals waiting for transplants. *46499 (ii) The OPTN shall maintain records of all transplant candidates, all organ donors and all transplant recipients. (2) Organ procurement organizations and transplant hospitals­­(i) Maintenance of records. All OPOs and transplant hospitals shall maintain such records pertaining to each potential donor identified, each organ retrieved and each recipient transplanted as the Secretary deems necessary to carry out her/his responsibilities under the Act. (ii) Access to facilities and records. OPOs and transplant hospitals shall permit the Secretary and the Comptroller General, or their designees, to inspect facilities and records pertaining to any aspect of services performed related to organ donation and/or transplantation. (b) Reporting requirements. (1) The OPTN shall: (i) in addition to special reports which the Secretary may require, submit to the Secretary a report once every fiscal year on a schedule prescribed by the Secretary. The report shall include the following information in a form prescribed by the Secretary: (A) Information that the Secretary prescribes as necessary to assess the effectiveness of the Nation's organ donation, procurement and transplantation system. (B) Any other information that the Secretary prescribes. (ii) provide to the Scientific Registry data on transplant candidates and recipients, and other information that the Secretary deems appropriate. The information shall be provided in a form and on a schedule prescribed by the Secretary. (2) An organ procurement organization or transplant hospital shall, as specified from time to time by the Secretary, submit to the OPTN information regarding transplantation candidates, recipients and donors of organs. Such information shall be in the form required and shall be submitted in accordance with the schedule prescribed. [FR Doc. 94­21993 Filed 9­7­94; 8:45 am] BILLING CODE 4160­15­M 59 FR 46482­01, 1994 WL 481993 (F.R.) END OF DOCUMENT