Mark S. Nadel & Carolina A. Nadel, Commentary, USING RECIPROCITY TO MOTIVATE ORGAN DONATIONS, 5 Yale J. of Health Pol., L. & Ethics 293 (2005).
The allocation of organs among those on the UNOS waiting is based, to a large degree, on compatibility.
[FN37] For example, for kidneys, a standardized formula awards points to potential recipients based on factors like tissue type, immune status, time on the waiting list, and distance from the donor. [FN38] For most organs, consideration is first given to recipients located within the same donation service area (DSA) as the donor. Nationwide, there are fifty eight DSAs, which are regional combinations of organ procurement organizations (or OPOs) and their transplant center networks. The organ is given to the person in the DSA with the highest UNOS score. [FN39] If there are no suitable recipients in the donor's DSA, the organ is offered next to the candidates in the donor's OPO region (there are eleven OPO regions nationwide), again, based on their scores. If there are no suitable recipients in that region, then the organ is offered nationwide based on those UNOS scores. [FN40] This “local first” policy has been *301 widely criticized. [FN41]. Id. at 300-01.
[FN37]. See Munson, supra note 15, at 47-51. OPOs, however, cannot consider an organ seeker's ethnicity, gender, or religion, and some OPOs also have policies against discrimination against prison inmates. See, e.g., James Sterngold, Inmate's Transplant Prompts Questions of Costs and Ethics, N.Y. Times, Jan. 31, 2002 at A18.
But is "Native American" an "ethnicity"?
[FN38]. UNOS Organ Distribution Policies § 3.5-3.9 (July 2004) (rules for kidneys, livers, and hearts), http://www.unos.org/policiesandbylaws/policies.asp?resources=true; see also Marlies Ahlert et al., Kidney Allocation in Eurotransplant, 23 Analyse & Kritik 156 (2001); Johan De Meesters et al., The New Eurotransplant Kidney Allocation System, 66 Transplantation 1154 (1998).
[FN39]. With some exceptions (e.g., special priority is given to O-type recipients, see Galen, supra note 20, at 357-58), the organ is offered first to the transplant team of the person on the top of the list from the DSA. Meanwhile, doctors of the patients scoring highest will decline an organ when their patient is not willing and healthy enough to undergo major surgery immediately or insufficiently compatible with the donor.
[FN40]. See 1993 GAO Report, supra note 27, at 18-19.
[FN41]. The justification given for the “local first” policy is that organs deteriorate rapidly and that the policy
encourages local donors. Livers, however, are generally offered to the medically suitable patient with the most
urgent need nationwide, rather than local, subject to travel time constraints. See infra notes 139-142 and accompanying text.
[FN139]. The maximum allowable transport time for organs removed for transplant (also known as cold ischemic time) limits how far they can be sent to recipients. See Introduction to Transplants, at http://
www.ustransplant.org/primer_intro.php (last updated July 9, 2004). There is also a cost advantage to minimizing transport time. See Mark A. Schnitzler et al., The Economic Impact of Preservation Time in Cadaveric Liver Transplantation, 1 Am. J. Transplantation 360 (2001).
[FN142]. See 1999 IOM Report, supra note 136, at 52-53 (1999) (reporting that both a 1998 Gallup poll and a 1995 Southeastern Inst. of Research poll found little patient preference for local recipients over more needy patients in the nation). On the other hand, a local preference probably serves to improve the morale and motivation of those involved in encouraging organ donation in each community. See Koch, supra note 36, at 74, 97-99. This policy also reflects the efforts of smaller, local transport centers to protect themselves and their patients. See Jeffrey Prottas, The Politics of Transplantation, in Organs and Tissue Donation, supra note 27, at 3, 17.
Thursday, February 25, 2010
Thoughts on affirmative defenses
If a tribe operated a parallel organ-matching service, it is unlikely to be a violation of either a federal or state statute relating to organ donation or transplantation. But even if it were a violation of some kind of statute, the tribe would likely enjoy immunity. The actors involved, such as the physicians and nurses performing the operation, may not enjoy such immunity, although one wonders what, if any, statute they would risk violating. At any rate, that's a real concern that is outside the scope of my inquiry.
Focusing on the tribal network itself: if the network is operated by tribes, then the tribes should enjoy immunity from state action. There is authority about tribal businesses not enjoying that immunity, however. Thus, tribes would need to structure the network within the prevailing legal environment to provide the best possible protection.
I got the following from William C. Canby, Jr., American Indian Law (4th. ed. 2004), 95-102.
If the tribes are immune, they would be immune from states, Kiowa Tribe of Okla. v. Mfg. Techs., Inc., 523 U.S. 751 (1998), but not the federal government, EEOC v. Karuk Tribe Housing Auth., 260 F.3d 1071, 1075 (9th Cir. 2001). Suits might be brought by individuals in federal court, at least in the 10th Circuit, if the claimant is non-Indian and no remedy is available in tribal court, see Ute Distribution Corp. v. Ute Indian Tribe, 149 F.3d 1260, 1266 n.8 (10th Cir. 1998).
Tribal officers can be enjoined, Santa Clara Pueblo v. Martinez, 436 U.S. 49 (1978). Citizens have standing under a federal statute, and tribal immunity is waived, only if expressly authorized in the statute, see Northern States Power Co. v. Prairie Island Mdewakanton Sioux Indian Cmty., 991 F.2d 458 (8th Cir. 1993).
"If a tribally-chartered corporation operates independently of the tribal government and does not engage in governmental functions, however, it may no qualify for immunity in the first place because it is not an arm of the tribe. See Dixon v. Picopa Constr. Co., 72 P.2d 1104 (Ariz. 1989)." Canby, at 102.
Focusing on the tribal network itself: if the network is operated by tribes, then the tribes should enjoy immunity from state action. There is authority about tribal businesses not enjoying that immunity, however. Thus, tribes would need to structure the network within the prevailing legal environment to provide the best possible protection.
I got the following from William C. Canby, Jr., American Indian Law (4th. ed. 2004), 95-102.
If the tribes are immune, they would be immune from states, Kiowa Tribe of Okla. v. Mfg. Techs., Inc., 523 U.S. 751 (1998), but not the federal government, EEOC v. Karuk Tribe Housing Auth., 260 F.3d 1071, 1075 (9th Cir. 2001). Suits might be brought by individuals in federal court, at least in the 10th Circuit, if the claimant is non-Indian and no remedy is available in tribal court, see Ute Distribution Corp. v. Ute Indian Tribe, 149 F.3d 1260, 1266 n.8 (10th Cir. 1998).
Tribal officers can be enjoined, Santa Clara Pueblo v. Martinez, 436 U.S. 49 (1978). Citizens have standing under a federal statute, and tribal immunity is waived, only if expressly authorized in the statute, see Northern States Power Co. v. Prairie Island Mdewakanton Sioux Indian Cmty., 991 F.2d 458 (8th Cir. 1993).
"If a tribally-chartered corporation operates independently of the tribal government and does not engage in governmental functions, however, it may no qualify for immunity in the first place because it is not an arm of the tribe. See Dixon v. Picopa Constr. Co., 72 P.2d 1104 (Ariz. 1989)." Canby, at 102.
OPTN rules are non-binding?
That's what it says in a footnote, clearly written by a lawyer (or, like myself, a brilliant law student), of a 2008 GAO report.
"Under a 1986 addition to the Social Security Act, hospitals that participate in Medicare and Medicaid and perform organ transplants are required to be members of and abide by the rules of the OPTN. Pub. L. No. 99-509, § 9318, 100 Stat. 1874, 2009 (adding section 1138 to the Social Security Act) (codified as amended at 42 U.S.C. § 1320b-8). HHS interpreted this provision to require that to be considered a rule or requirement of the OPTN and therefore binding on participating hospitals, the rule or requirement must be formally approved by the Secretary. 54 Fed. Reg. 51802 (Dec. 18, 1989); see also 42 C.F.R. § 121.4(b)(2) and (c) (2007) (regulation providing framework for submission of OPTN policies to the Secretary for review and approval). As of February 2008, the Secretary had not approved any OPTN policies for this purpose. Although OPTN policies have not been formally approved by the Secretary, HRSA has indicated that certain data submitted to the OPTN are mandatory under 42 C.F.R. § 121.11(b)(2) and that failure to submit these data accurately and completely could be considered a violation of this section." (emphasis supplied).
U.S. GEN. ACCOUNTING OFFICE, Report to the Ranking Member, Committee on Finance, U.S. Senate, ORGAN TRANSPLANT PROGRAMS: Federal Agencies Have Acted to Improve Oversight, but Implementation Issues Remain, GAO-08-412, at 10 n.16 (2008).
Ultimately, the OPTN doesn't have much teeth itself.
"On its own, the OPTN can impose certain sanctions against noncompliant transplant programs, such as issuing a letter of warning or placing a program on probation. The OPTN can also request that the Secretary of Health and Human Services impose stronger enforcement actions, including terminating a program’s ability to receive organs or reimbursement under Medicare." Id. at 11.
"Under a 1986 addition to the Social Security Act, hospitals that participate in Medicare and Medicaid and perform organ transplants are required to be members of and abide by the rules of the OPTN. Pub. L. No. 99-509, § 9318, 100 Stat. 1874, 2009 (adding section 1138 to the Social Security Act) (codified as amended at 42 U.S.C. § 1320b-8). HHS interpreted this provision to require that to be considered a rule or requirement of the OPTN and therefore binding on participating hospitals, the rule or requirement must be formally approved by the Secretary. 54 Fed. Reg. 51802 (Dec. 18, 1989); see also 42 C.F.R. § 121.4(b)(2) and (c) (2007) (regulation providing framework for submission of OPTN policies to the Secretary for review and approval). As of February 2008, the Secretary had not approved any OPTN policies for this purpose. Although OPTN policies have not been formally approved by the Secretary, HRSA has indicated that certain data submitted to the OPTN are mandatory under 42 C.F.R. § 121.11(b)(2) and that failure to submit these data accurately and completely could be considered a violation of this section." (emphasis supplied).
U.S. GEN. ACCOUNTING OFFICE, Report to the Ranking Member, Committee on Finance, U.S. Senate, ORGAN TRANSPLANT PROGRAMS: Federal Agencies Have Acted to Improve Oversight, but Implementation Issues Remain, GAO-08-412, at 10 n.16 (2008).
Ultimately, the OPTN doesn't have much teeth itself.
"On its own, the OPTN can impose certain sanctions against noncompliant transplant programs, such as issuing a letter of warning or placing a program on probation. The OPTN can also request that the Secretary of Health and Human Services impose stronger enforcement actions, including terminating a program’s ability to receive organs or reimbursement under Medicare." Id. at 11.
Medicare payment for organ transplants requires OPTN participation
72 Fed. Reg. 15198 (codified in pertinent part at 42 C.F.R. pt. 482, subpt. E).
Wednesday, February 24, 2010
Why not sell organs?
Lots of reasons, including the harvesting of poor people.
"Dr. Jacob's plan to offer compensation but not follow-up care to foreign vendors of organs was arguably quite damning for the organ sales cause, but it was by no means the only element of the rationale for the ban on valuable consideration. In fact, there was a lively debate about such issues as the potential for exploitation of the poor, the risk of undermining the ethical precepts of medicine, and the moral impropriety of treating parts of the body as commodities."
Staff Discussion Paper, President's Council on Bioethics, Alan Rubenstein, On the Body and Transplantation: Philosophical and Legal Context, 2007, http://www.bioethics.gov
"Dr. Jacob's plan to offer compensation but not follow-up care to foreign vendors of organs was arguably quite damning for the organ sales cause, but it was by no means the only element of the rationale for the ban on valuable consideration. In fact, there was a lively debate about such issues as the potential for exploitation of the poor, the risk of undermining the ethical precepts of medicine, and the moral impropriety of treating parts of the body as commodities."
Staff Discussion Paper, President's Council on Bioethics, Alan Rubenstein, On the Body and Transplantation: Philosophical and Legal Context, 2007, http://www.bioethics.gov
Selling organs & other alternatives
From ASSESSING INITIATIVES TO INCREASE ORGAN DONATIONS, JUNE 3, 2003, HOUSE OF REPRESENTATIVES, COMMITTEE ON ENERGY AND COMMERCE.
On the one hand, allowing people to pay for organs is a way to put another option "on the table."
"Given that so many people die each year waiting for an organ transplant, I believe all options should be put on the table as we discuss ways to increase organ donations." Comment of Rep. James Greenwood, 3.
Counterpoint: encourage poor people to sell organs is discriminatory.
It has been against the public policy of this country to pay people for organ donations for many, many years, and the reason is because legislative bodies have felt that it was repugnant to give financial incentives to folks to donate their own organs, and the feeling is that it would unduly put pressure on low-income individuals to do that. Comment of Rep. DeGette, 4.
Although there has been an increase in the number of organ donors
in recent years, the rate of increase has not kept pace with
the need of donated organs. Studies have found that less than 50
percent of potential eligible donors actually become donors. As a result,
there is a significant potential for increased organ donation to
take place and for an increased number of lives to be saved.
We simply need thoughtful policies to take advantage of this potential.
Comment of Joseph Roth, then-president-elect of UNOS, at 16.
On the one hand, allowing people to pay for organs is a way to put another option "on the table."
"Given that so many people die each year waiting for an organ transplant, I believe all options should be put on the table as we discuss ways to increase organ donations." Comment of Rep. James Greenwood, 3.
Counterpoint: encourage poor people to sell organs is discriminatory.
It has been against the public policy of this country to pay people for organ donations for many, many years, and the reason is because legislative bodies have felt that it was repugnant to give financial incentives to folks to donate their own organs, and the feeling is that it would unduly put pressure on low-income individuals to do that. Comment of Rep. DeGette, 4.
Although there has been an increase in the number of organ donors
in recent years, the rate of increase has not kept pace with
the need of donated organs. Studies have found that less than 50
percent of potential eligible donors actually become donors. As a result,
there is a significant potential for increased organ donation to
take place and for an increased number of lives to be saved.
We simply need thoughtful policies to take advantage of this potential.
Comment of Joseph Roth, then-president-elect of UNOS, at 16.
UAGA in the news: conflict of interest
The UAGA says that the doctor who calls "time of death" can't be the same doctor who wants the organs.
This conflict was illustrated in a recent newspaper story.
"In procuring organs from patients like Amanda, doctors have created a new class of potential organ donors who are not dead but dying. By arbitrarily drawing a line between death and life — five minutes after the heart stops — they have raised difficult ethical questions. Are they merely acknowledging death or hastening it in their zeal to save others’ lives?"
Darshak Sanghavi, "When Does Death Start," N.Y. Times, Dec. 20, 2009.
This conflict was illustrated in a recent newspaper story.
"In procuring organs from patients like Amanda, doctors have created a new class of potential organ donors who are not dead but dying. By arbitrarily drawing a line between death and life — five minutes after the heart stops — they have raised difficult ethical questions. Are they merely acknowledging death or hastening it in their zeal to save others’ lives?"
Darshak Sanghavi, "When Does Death Start," N.Y. Times, Dec. 20, 2009.
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