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Appendix D: The “Final Rule”
Pages 199-214

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From page 199... ... (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) Read the entire page →
From page 200... ... National list means the OPTN computer-based list of transplant candidates nationwide. OPTN computer match program means a set of computer-based instructions which compares data on a cadaveric organ donor with data on transplant candidates on the national list and ranks the candidates according to OPTN policies to determine the priority for allocating the donor organist. Read the entire page →
From page 201... ... Individuals representing the diversity of the population of transplant candidates and recipients served by the OPTN, including, to the extent practicable, minority and gender representation reflecting the population of potential transplant candidates served by the OPTN; (ii) No more than 50 percent transplant surgeons or transplant physicians; and (iii) Read the entire page →
From page 202... ... Representation by transplant coordinators, organ procurement organizations, and transplant hospitals, and at least one transplant candidate, transplant recipient, organ donor, or family member; and (ii) to the extent practicable, minority and gender representation reflecting the diversity of the population of potential transplant candidates served by the OPTN. Read the entire page →
From page 203... ... Reform of allocation policies based on assessment of their cumulative effect on socioeconomic inequities; (4) Policies regarding the training and experience of transplant surgeons and transplant physicians in designated transplant programs as required by Sec. Read the entire page →
From page 204... ... The Secretary will publish lists of these documents in the Federal Register, indicating which ones are subject to the special compliance requirements and potential sanctions of section 1138 of the Social Security Act. The OPTN shall also continuously maintain OPTN policies for public access on the Internet, including current and proposed policies. Read the entire page →
From page 205... ... (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. Read the entire page →
From page 206... ... (1) Minimum listing criteria for including transplant candidates on the national list shall be standardized and, to the extent possible, shall contain explicit thresholds for listing a patient and be expressed through objective and measurable medical criteria. Read the entire page →
From page 207... ... When the OPTN revises organ allocation policies under this section, it shall consider whether to adopt transition procedures that would treat people on the national list and awaiting transplantation prior to the adoption or effective date of the revised policies no less favorably than they would have been treated under the previous policies. The transition procedures shall be transmitted to the Secretary for review together with the revised allocation policies. Read the entire page →
From page 208... ... The OPTN's transmittal to the Secretary of proposed allocation policies and performance indicators shall include such supporting material, including the results of modelbased computer simulations, as the Secretary may require to assess the likely effects of policy changes and as are necessary to demonstrate that the proposed policies comply with the performance indicators and transition procedures of paragraph (a) of this section. Read the entire page →
From page 209... ... Makes available psychiatric and social support services for transplant candidates, transplant recipients and their families; or (3) Be a transplant program in a Department of Veterans Affairs hospital which is a Dean's Committee hospital which shares a common university-based transplant team of a transplant program which meets the requirements of Sec. Read the entire page →
From page 210... ... (3) At the request of the Secretary, the OPTN shall conduct special reviews of OPOs and transplant programs, where the Secretary has reason to believe that such entities may not be in compliance with these rules or OPTN policies or may be acting in a manner which poses a risk to the health of patients or to public safety. Read the entire page →
From page 211... ... Maintain and operate an automated system for managing information about transplant candidates, transplant recipients, and organ donors, including a computerized national list of individuals waiting for transplants; (ii) Maintain records of all transplant candidates, all organ donors, and all transplant recipients; (iii) Read the entire page →
From page 212... ... (2) An organ procurement organization or transplant hospital shall, as specified from time to time by the Secretary, submit to the OPTN, to the Scientif~c Registry, as appropriate, and to the Secretary information regarding transplantation candidates, transplant recipients, donors of organs, transplant program performance, and other information that the Secretary deems appropriate. Read the entire page →
From page 213... ... No State or local governing entity shall establish or continue in effect any law, rule, regulation, or other requirement that would restrict in any way the ability of any transplant hospital, OPO, or other party to comply with organ allocation policies of the OPTN or other policies of the OPTN that have been approved by the Secretary under this part. Read the entire page →
From page 214... ... The OPTN's transmittal to the Secretary of proposed allocation policies and performance indicators shall include such supporting material, including the results of modelbased computer simulations, as the Secretary may require to assess the likely effects of policy changes and as are necessary to demonstrate that the proposed policies comply with the performance indicators and transition procedures of paragraph (a) of this section. Read the entire page →

From page 199...

... (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)

Appendix D: The “Final Rule” Pages 199-214

Appendix D: The “Final Rule”
Pages 199-214