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Organ Transplantation: New Regulations to Alter Distribution of Organs
Published online by Cambridge University Press: 01 January 2021
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On December 17, 1999, President Clinton signed the Ticket to Work and Work Incentives Improvement Act of 1999, which instituted a 90-day comment period for the amended Organ Procurement and Transplantation Network (“OPTN”) Final Rule (“Final Rule”), a comprehensive set of guidelines that would affect how organs are allocated throughout the country. Barring further legislative action, the Final Rule, which has been over five years in the making, will be effective on March 16,2000.
The Final Rule, issued by the Department of Health and Human Services (‘‘DHHS”) pursuant to the National Organ Transplant Act, was originally publishedApril 2, 1998. It provided a number of substantive changes to the process through which organs are allocated by the United Network for Organ Sharing (UNOS), a private, non-profit organization charged with administering the national organ transplantation network.
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References
H.R. 1180, 106th Cong. § 413 (1999).Google Scholar
See 64 Fed. Reg. 71,626 (1999).Google Scholar
See id; Health Resources and Services Administration, Fact Sheet on Improving the Nation's Organ Transplantation System (visited Feb. 10, 2000) <http://www.hrsa.gov/osp/dot/Fact%20Sheet.pdf>..' href=https://scholar.google.com/scholar?q=See+id;+Health+Resources+and+Services+Administration,+Fact+Sheet+on+Improving+the+Nation's+Organ+Transplantation+System+(visited+Feb.+10,+2000)+.>Google Scholar
42 U.S.C. §§ 216, 273–274d; 42 U.S.C. §§ 1302,1306, 1320b-8, 1395hh.Google Scholar
See 64 Fed. Reg. 71,626 (1999).Google Scholar
See United Network for Organ Sharing, Comments Sought on UNOS Liver Allocation Plan (visited Feb. 22, 2000) <http://www.unos.org/frame_Default.asp?Category=Newsroom>. UNOS combines “medical, scientific, and educational” sources to determine how organs should be allocated from both medical and ethical viewpoints. United Network for Organ Sharing, Public Comment: Policy and By-Law Proposals (visited Feb. 22, 2000) <http://www.unos.org/frame_Default.asp?Category=Pcomment> (“On January 1, 1997, “UNOS received a federal contract to continue operation of the national OPTN and develop an equitable, scientific, and medically-sound organ allocation system.”)..+UNOS+combines+“medical,+scientific,+and+educational”+sources+to+determine+how+organs+should+be+allocated+from+both+medical+and+ethical+viewpoints.+United+Network+for+Organ+Sharing,+Public+Comment:+Policy+and+By-Law+Proposals+(visited+Feb.+22,+2000)++(“On+January+1,+1997,+“UNOS+received+a+federal+contract+to+continue+operation+of+the+national+OPTN+and+develop+an+equitable,+scientific,+and+medically-sound+organ+allocation+system.”).>Google Scholar
Health Resources and Services Administration, Fact Sheet on Improving the Nation's Organ Transplantation System (visited Feb. 10, 2000) <http://www.hrsa.gov/osp/dot/Fact%20Sheet.pdf>..' href=https://scholar.google.com/scholar?q=Health+Resources+and+Services+Administration,+Fact+Sheet+on+Improving+the+Nation's+Organ+Transplantation+System+(visited+Feb.+10,+2000)+.>Google Scholar
See generally infra notes 12–23 and accompanying text (describing the relative merits of the proposed Final Rule).Google Scholar
See Health Resources and Services Administration, Fact Sheet on Improving the Nation's Organ Transplantation System (visited Feb. 10, 2000) <http://www.hrsa.gov/osp/dot/Fact%20Sheet.pdf> (noting that “[a]lmost 5000 patients die each year, some 13 each day, while awaiting an organ for transplantation”). (noting that “[a]lmost 5000 patients die each year, some 13 each day, while awaiting an organ for transplantation”).' href=https://scholar.google.com/scholar?q=See+Health+Resources+and+Services+Administration,+Fact+Sheet+on+Improving+the+Nation's+Organ+Transplantation+System+(visited+Feb.+10,+2000)++(noting+that+“[a]lmost+5000+patients+die+each+year,+some+13+each+day,+while+awaiting+an+organ+for+transplantation”).>Google Scholar
See United Network for Organ Sharing, Justification for Equitable Organ Allocation (visited Feb. 22, 2000) <http://www.unos.org/frame_Default.asp?Category=Newsroom>..>Google Scholar
See, for example, Health Resources and Services Administration, Secretary Shalala Statement (visited Feb. 10, 2000) <http://www.hrsa.gov/osp/dot/Sec%20Statement.pdf> (stating that, “[o]rgan sharing must take place over broad enough areas to ensure that organs can reach the patients who need them most, and for whom transplantation is most medically appropriate”); see also Health Resources and Services Administration, Fact Sheet on Improving the Nation's Organ Transplantation System (visited Feb. 10, 2000) <http://www.hrsa.gov/osp/dot/Fact%20Sheet.pdf>..' href=https://scholar.google.com/scholar?q=See,+for+example,+Health+Resources+and+Services+Administration,+Secretary+Shalala+Statement+(visited+Feb.+10,+2000)++(stating+that,+“[o]rgan+sharing+must+take+place+over+broad+enough+areas+to+ensure+that+organs+can+reach+the+patients+who+need+them+most,+and+for+whom+transplantation+is+most+medically+appropriate”);+see+also+Health+Resources+and+Services+Administration,+Fact+Sheet+on+Improving+the+Nation's+Organ+Transplantation+System+(visited+Feb.+10,+2000)+.>Google Scholar
Health Resources and Services Administration, Fact Sheet on Improving the Nation's Organ Transplantation System (visited Feb. 10, 2000) <http://www.hrsa.gov/osp/dot/Fact%20Sheet.pdf>; see also United Network for Organ Sharing, Justification for Equitable Organ Allocation (visited Feb. 22, 2000) <http://www.unos.org/frame_Default.asp?Category=Newsroom> (“At present, there are no rules governing what the patient's condition must be in order to be added to the list.”).; see also United Network for Organ Sharing, Justification for Equitable Organ Allocation (visited Feb. 22, 2000) (“At present, there are no rules governing what the patient's condition must be in order to be added to the list.”).' href=https://scholar.google.com/scholar?q=Health+Resources+and+Services+Administration,+Fact+Sheet+on+Improving+the+Nation's+Organ+Transplantation+System+(visited+Feb.+10,+2000)+;+see+also+United+Network+for+Organ+Sharing,+Justification+for+Equitable+Organ+Allocation+(visited+Feb.+22,+2000)++(“At+present,+there+are+no+rules+governing+what+the+patient's+condition+must+be+in+order+to+be+added+to+the+list.”).>Google Scholar
Health Resources and Services Administration, Fact Sheet on Improving the Nation's Organ Transplantation System (visited Feb. 10, 2000) <http://www.hrsa.gov/osp/dot/Fact%20Sheet.pdf>..' href=https://scholar.google.com/scholar?q=Health+Resources+and+Services+Administration,+Fact+Sheet+on+Improving+the+Nation's+Organ+Transplantation+System+(visited+Feb.+10,+2000)+.>Google Scholar
See id. It should be noted that this does not necessarily imply doctors abuse the system. It only suggests that, without a uniform standard, doctors in some regions may classify patients differently than doctors in other regions. This may produce unequal results to the extent that such classifications are then used to allocate organs.Google Scholar
See id.Google Scholar
Id. See also Health Resources and Services Administration, HHS Rule Calls for Organ Allocation Based on Medical Criteria, Not Geography (visited Feb. 22, 2000) <http://www.hrsa.dhhs.gov/News-PA/organreg.htm> (stating that “allocation of scarce organs [should] be based on common medical criteria, not accidents of geography”).+(stating+that+“allocation+of+scarce+organs+[should]+be+based+on+common+medical+criteria,+not+accidents+of+geography”).>Google Scholar
It should be mentioned that, while the criteria for allocating organs differ with each organ (e.g., certain organs require extensive prescreening to find a positive match with the patient; certain organs remain viable prior to transplant for different periods of time), these differences are immaterial to the Final Rule. The regulation requires UNOS to implement the standards for organ allocation, and in no way requires the same set of criteria for each organ; the differences will be adjusted by UNOS under the rule.Google Scholar
See Health Resources and Services Administration, Fact Sheet on Improving the Nation's Organ Transplantation System (visited Feb. 10, 2000) <http://www.hrsa.gov/osp/dot/Fact%20Sheet.pdf> (“allocating organs to most medically urgent patients does not require transporting organs so far that organ viability would be threatened, but instead recognizes that medical factors limit the transportability of organs; the final rule does not require a single “national list” for allocation, but rather calls on the OPTN to develop adequately broad allocation areas to ensure best use of organs to save lives….”). (“allocating organs to most medically urgent patients does not require transporting organs so far that organ viability would be threatened, but instead recognizes that medical factors limit the transportability of organs; the final rule does not require a single “national list” for allocation, but rather calls on the OPTN to develop adequately broad allocation areas to ensure best use of organs to save lives….”).' href=https://scholar.google.com/scholar?q=See+Health+Resources+and+Services+Administration,+Fact+Sheet+on+Improving+the+Nation's+Organ+Transplantation+System+(visited+Feb.+10,+2000)++(“allocating+organs+to+most+medically+urgent+patients+does+not+require+transporting+organs+so+far+that+organ+viability+would+be+threatened,+but+instead+recognizes+that+medical+factors+limit+the+transportability+of+organs;+the+final+rule+does+not+require+a+single+“national+list”+for+allocation,+but+rather+calls+on+the+OPTN+to+develop+adequately+broad+allocation+areas+to+ensure+best+use+of+organs+to+save+lives….”).>Google Scholar
See United Network for Organ Sharing, IOM Report Released (visited Feb. 22, 2000) <http://www.unos.org/frame_Default.asp?Category=Newsroom>. However, it is not clear why sending organs to a different geographic location for those most in need would deter potential donors. Furthermore, if the fear is that local transplant centers will close, thus reducing donor visibility, public information campaigns could easily reverse this decline..+However,+it+is+not+clear+why+sending+organs+to+a+different+geographic+location+for+those+most+in+need+would+deter+potential+donors.+Furthermore,+if+the+fear+is+that+local+transplant+centers+will+close,+thus+reducing+donor+visibility,+public+information+campaigns+could+easily+reverse+this+decline.>Google Scholar
See United Network for Organ Sharing, Transcript of Dr. Hunsicker's Testimony (visited Feb. 22, 2000) <http://www.unos.org/frame_Default.asp?Category=Newsroom>. This argument questionably presupposes that the length of the patient's wait will be a relevant factor; it also ignores that at some point the smaller center patients will have waited the same amount of time as the larger centers (especially if they are continually passed over in favor of said larger centers).. This argument questionably presupposes that the length of the patient's wait will be a relevant factor; it also ignores that at some point the smaller center patients will have waited the same amount of time as the larger centers (especially if they are continually passed over in favor of said larger centers).' href=https://scholar.google.com/scholar?q=See+United+Network+for+Organ+Sharing,+Transcript+of+Dr.+Hunsicker's+Testimony+(visited+Feb.+22,+2000)+.+This+argument+questionably+presupposes+that+the+length+of+the+patient's+wait+will+be+a+relevant+factor;+it+also+ignores+that+at+some+point+the+smaller+center+patients+will+have+waited+the+same+amount+of+time+as+the+larger+centers+(especially+if+they+are+continually+passed+over+in+favor+of+said+larger+centers).>Google Scholar
See Health Resources and Services Administration, Fact Sheet on Improving the Nation's Organ Transplantation System (visited Feb. 10, 2000) <http://www.hrsa.gov/osp/dot/Fact%20Sheet.pdf> (noting the views of the Final Rule's critics). (noting the views of the Final Rule's critics).' href=https://scholar.google.com/scholar?q=See+Health+Resources+and+Services+Administration,+Fact+Sheet+on+Improving+the+Nation's+Organ+Transplantation+System+(visited+Feb.+10,+2000)++(noting+the+views+of+the+Final+Rule's+critics).>Google Scholar
See United Network for Organ Sharing, Transcript of Dr. Hunsicker's Testimony (visited Feb. 22, 2000) <http://www.unos.org/frame_Default.asp?Category=Newsroom>; United Network for Organ Sharing, IOM Report Released (visited Feb. 22, 2000) <http://www.unos.org/frame_Default.asp?Category=Newsroom> (explaining that “Congress made clear when it passed the National Organ Transplant Act 15 years ago that crucial medical decisions about transplantation should be made by the medical community.”).; United Network for Organ Sharing, IOM Report Released (visited Feb. 22, 2000) (explaining that “Congress made clear when it passed the National Organ Transplant Act 15 years ago that crucial medical decisions about transplantation should be made by the medical community.”).' href=https://scholar.google.com/scholar?q=See+United+Network+for+Organ+Sharing,+Transcript+of+Dr.+Hunsicker's+Testimony+(visited+Feb.+22,+2000)+;+United+Network+for+Organ+Sharing,+IOM+Report+Released+(visited+Feb.+22,+2000)++(explaining+that+“Congress+made+clear+when+it+passed+the+National+Organ+Transplant+Act+15+years+ago+that+crucial+medical+decisions+about+transplantation+should+be+made+by+the+medical+community.”).>Google Scholar
In addition to the broad latitude afforded UNOS in implementing the specifics of the Final Rule's provisions, the step can always be retraced if experience proves the rule-makers wrong.Google Scholar