Thursday, February 25, 2010
The UNOS scoring system
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.
Thoughts on affirmative defenses
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?
"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
Wednesday, February 24, 2010
Why not sell organs?
"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
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
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.
Native beliefs about organ donation
Kennedy Institute of Ethics Journal - Volume 8, Number 3, September 1998, pp. 275-305
The Johns Hopkins University Press.
Scientific science, cont'd
As of 1999, the rate of renal transplants for American Indian/Alaska Native ESRD patients was 0.7
transplants/100 patient years on dialysis compared to a rate of 1.8 transplants/100 patient years for Caucasian
Americans. At 79.
There is a "Growing need for renal and other organ and tissue transplantation among Native Americans." At 79.
Genetic similarity "among the Sioux increases the likelihood of finding well matched donors among the Sioux or other Native Americans." At 87.
Scientific science says Native-to-Native organ transplants could increase success
"The Native American population has one of the greatest needs for organ donors because of a high incidence of diabetes and end-stage renal disease, yet many are reluctant to donate a kidney because of a belief that they need to take their body intact to the spiritual world when they die. If they donate, many believe, their spirit will be restless.
Researchers with the Johns Hopkins Immunogenetics Laboratory say characterizing the specific HLA genes among different Indian tribes will identify their similarities and differences with other populations, helping to ensure compatible organ transplants. Their new report, published in the January issue of the journal Human Immunology, identifies two new alleles, or alternate gene forms, among the Lakota Sioux tribe.
"Because so many Native Americans volunteered to be in this study, we hope that their awareness of the value of tissue compatibility may make the message of donation more welcome," says Mary S. Leffell, Ph.D., lead study author and professor and director of the Hopkins laboratory. "Our study provides the first look at the HLA proteins and alleles present among the Sioux people at a time when their need for transplantation is rapidly increasing. The findings show that there is a much higher probability of finding a really good organ match among other Native Americans than among other racial/ethnic groups. Certain Asian populations share some of the same HLA proteins as the Sioux and also could be good donor choices."
The study is cited as Leffell, M.S. et al, "HLA Alleles and Haplotypes Among the Lakota Sioux: Report of the ASHI Minority Workshops, Part III", Human Immunology, January 2003, Vol. 65, Issue 1, pages 78-89.
Natives at risk of worse organ transplant outcomes
"Aboriginals (i.e. Native American Indians) experience a very high rate of chronic kidney disease and comprise a
disproportionate number of individuals receiving renal replacement therapy." At 1875.
Natives are at risk of worse long-term outcomes after kidney transplants, at 1877. One of the factors is longer wait times, at 1878. Also, Natives are generally unhealthier ("Other than renal disease, Aboriginals are disproportionately affected by diabetes, hypertension, substance abuse, trauma and many other conditions."). At 1880.
Minorities less likely to get a living organ transplant
St. Louis, MO, at 10.
However, an analysis of the CMS 2728 form showing the likelihood of being informed of kidney transplantation, being placed on the kidney transplant waitlist, or of receiving a living donor transplant, revealed that approximately 73% of patients beginning renal replacement therapy for the first time (in July-Dec. 2005) were informed of their kidney transplant options (Figure 3), while 1.75 percent received a preemptive living donor transplant (Figure 4). In addition, the data showed that African Americans, Hispanics and Asians were more likely to be informed than Native Americans and Whites. However, African Americans, Hispanics, Asians, and Native Americans were less likely to be placed on the waitlist or receive a living donor transplant than Whites.
Monday, February 22, 2010
Organ Donation: Troubling Statistics
Health Insurance Woes
Thursday, February 18, 2010
OPTN regs: directed donation
(a) Policy development. The Board of Directors established under §121.3 shall develop, in accordance with the policy development process described in §121.4, policies for the equitable allocation of cadaveric organs among potential recipients. Such allocation policies:
(1) Shall be based on sound medical judgment;
(2) Shall seek to achieve the best use of donated organs;
(3) Shall preserve the ability of a transplant program to decline an offer of an organ or not to use the organ for the potential recipient in accordance with §121.7(b)(4)(d) and (e);
(4) Shall be specific for each organ type or combination of organ types to be transplanted into a transplant candidate;
(5) Shall be designed to avoid wasting organs, to avoid futile transplants, to promote patient access to transplantation, and to promote the efficient management of organ placement;
(6) Shall be reviewed periodically and revised as appropriate;
(7) Shall include appropriate procedures to promote and review compliance including, to the extent appropriate, prospective and retrospective reviews of each transplant program's application of the policies to patients listed or proposed to be listed at the program; and
(8) Shall not be based on the candidate's place of residence or place of listing, except to the extent required by paragraphs (a)(1)–(5) of this section.
(b) Allocation performance goals. Allocation policies shall be designed to achieve equitable allocation of organs among patients consistent with paragraph (a) of this section through the following performance goals:
(1) Standardizing the criteria for determining suitable transplant candidates through the use of minimum criteria (expressed, to the extent possible, through objective and measurable medical criteria) for adding individuals to, and removing candidates from, organ transplant waiting lists;
(2) Setting priority rankings expressed, to the extent possible, through objective and measurable medical criteria, for patients or categories of patients who are medically suitable candidates for transplantation to receive transplants. These rankings shall be ordered from most to least medically urgent (taking into account, in accordance with paragraph (a) of this section, and in particular in accordance with sound medical judgment, that life sustaining technology allows alternative approaches to setting priority ranking for patients). There shall be a sufficient number of categories (if categories are used) to avoid grouping together patients with substantially different medical urgency;
(3) Distributing organs over as broad a geographic area as feasible under paragraphs (a)(1)–(5) of this section, and in order of decreasing medical urgency; and
(4) Applying appropriate performance indicators to assess transplant program performance under paragraphs (c)(2)(i) and (c)(2)(ii) of this section and reducing the inter-transplant program variance to as small as can reasonably be achieved in any performance indicator under paragraph (c)(2)(iii) of this section as the Board determines appropriate, and under paragraph (c)(2)(iv) of this section. If the performance indicator “waiting time in status” is used for allocation purposes, the OPTN shall seek to reduce the inter-transplant program variance in this indicator, as well as in other selected performance indicators, to as small as can reasonably be achieved, unless to do so would result in transplanting less medically urgent patients or less medically urgent patients within a category of patients.
NOTA: human organ paired donation
NOTA: prohibition of sales
5. Interstate commerce (as state law, see UAGA, also prohibits sales in-state)
NOTA: implies non-network activities
OPTN policies: diversity
OPTN policies
OPTN Waiting List policies
OPTN goals
A set of challenging program performance goals were then developed for the organ transplantation program by HHS and OMB."
OPTN responsibilities
facilitating the organ matching and placement process through the use of the computer system and a fully staffed Organ Center operating 24 hours a day
developing consensus based policies and procedures for organ recovery, distribution (allocation), and transportation
collecting and managing scientific data about organ donation and transplantation
providing data to the government, the public, students, researchers, and the Scientific Registry of Transplant Recipients�[Exit Disclaimer], for use in the ongoing quest for improvement in the field of solid organ allocation and transplantation
developing (1999) and maintaining a secure Web-based computer system, which maintains the nation's organ transplant waiting list and recipient/donor organ characteristics
providing professional and public education about donation and transplantation, the activities of the OPTN and the critical need for donation"