Wednesday, December 23, 2015

Should the United States adopt a different system from the current Opt-In system for organ procurement?

One of the more acknowledged problems in healthcare that receives some attention yet little is actually done about is the lack of available organs for transplant. Based on recent data at least 114,000 people in the United States are waiting for an organ transplant that will significantly increase their remaining lifespan.1,2 Unfortunately most of those waiting will die before receiving that desired organ due to the dramatic gap between the available supply of organs for transplant and those waiting for one.

To understand and appreciate the extent of this gap according to the Scientific Registry of Transplant Recipients (SRTR) between 2000 and 2009 the annual number of deceased organ donors (the most viable for most types of transplants) in the U.S. increased from 5,985 to 8,022 whereas the number of individuals waiting for a transplant increased from 74,635 to 111,027.3 In the first half of 2010s there was not significant deviation from this trend. Note that this increase in the waiting list occurred despite an increase in organ transplants. In either absolute numbers or relative percent change, there is an increasing gap between available organs and those who need them. While various aspects of biological research are working to create an environment where new organs can be grown in a lab with low rejection probabilities, thus significantly mitigating this supply problem, such a reality still appears to be a long way off. Therefore, should changes be made to the current organ donation system to speed the closure of this gap and save lives?

While each state has their own laws on organ donation the general model has always followed the Uniform Anatomical Gift Act (UAGA), which was first passed in 1968 and amended in both 1987 and 2006. UAGAs are created by the National Conference of Commissioners on Uniform State Laws (NCCUSL) as a means to create uniformity among states on various laws where uniformity makes sense due to a lack of special circumstances; however in the end states have the option to adopt, decline, or simply use the act as a skeleton for their own laws. The original 1968 UAGA established the general goal of organ donation as a system based on altruism through voluntarism due to the opt-in nature of the program and created legislative guidelines for donation of fetal organs and tissues.4

In 1987 the UAGA experienced two significant changes among other smaller changes: first it was amended to forbid persons from “knowingly, for valuable consideration, purchase or sell a part for transplantation or therapy, if removal of the part is intended to occur after the death of the decedent.” Second, a narrow form of presumed consent was added whereby a medical examiner could remove any needed organs or tissue in the absence of any objection by the decedent or decedent’s next of kin.5 This presumed consent addition was not unique for numerous states already had similar types of regulations in their organ donation laws mostly concerning cornea removal.

In 2006 the UAGA was further revised to remove the presumed consent regulations largely due to a number of lawsuits filed against those measures.6,7 Almost all states followed the pattern of the UAGA by either officially enacting its recommendations or making changes to their own state laws to flow in close proximity with its recommendations including the removal their own presumed consent regulations as well, with only a few states retaining very restrictive guidelines concerning cornea removal.6

As noted above while the idea of characterizing organ donation as an altruistic gesture is certainly a nice idea in theory, especially when 90+% of people support organ donation and 70+% of polled individuals would consider being an organ donor; in reality when only about 42% of U.S. adults are registered organ donors when lives are on the line, clearly theory and reality are in conflict.1,2

The difference between those who claim to be interested in being a donor and those who actually are donors suggest some significant problems with the opt-in system. One of the major issues appears to be physicians adhering to the wishes of next of kin to not harvest organs even though the decedent was an organ donor; a decision that makes no sense. Also there can be problems with organ procurement agents obtaining referrals from donors.7 A lack of public campaigning to raise awareness regarding the organ shortfall and the benefits of organ donation has also played a role in the lower than expected donor rates. Finally another less fixable problem is the psychological reluctance of most individuals to contemplate death and plan appropriately for it. This “kicking the can” strategy concerning death typically creates numerous problems when handling end of life decisions, including issues involving organ donation. So, if these are the problems associated with the opt-in system, what are other options that could increase the number of individuals willing to donate?

One way to close the gap and improve donation rates is to provide an incentive for individuals to be “altruistic” (the irony of having to provide incentives for individuals to be altruistic is somewhat hilarious). However, with the sale of organs illegal, incentives must be creative in a sense, but also be of significant value. Israel and Singapore are two countries that utilize a low-cost incentive program that involves influencing organ allocation. In the U.S. a national waiting list is maintained where transplant candidates are ranked largely based their overall health (how long they have left to live without the organ) and when their name was placed on the list. However, in the determination of who receives an organ there is no “bonus” to those who are donors. The priority rule or preferred donation system used by Israel and Singapore provides some level of preference to future donors over those who do not plan to be future donors.

For example in Israel potential organ recipients are rated on a multiple point scale and whether or not they are planning to be a donor is also part of that criteria.8 Additional consideration can be gained if a direct family member of a potential recipient has signed a donor card or has already donated in the past be it as a live non-designated donor or a deceased donor.8 In Israel this program largely arose from the perceived repugnant behavior that a number of individuals were willing to accept an organ transplant, but would never be willing to donate an organ even after death. For Israel this program, as well as other supplemental small incentive programs, dramatically increased the rate of organ donations, especially in its early years of its adoption 2011 and 2012.9

While the initial logic associated with the priority rule program appears sound, for it makes sense that future organ donors should receive some level of priority over those who do not plan to donate, there are some important issues. The first problem is the system in Israel is not legally binding in that an individual can agree to become a donor, but back out later. This type of system creates problems on both fronts because instituting a rule that once a person has agreed to be a donor then that individual can never withdraw from being a donor would see an immediate court challenge that would probably result in the elimination of such a condition. However, if the system remains as such one can simply declare donor intentions when it is advantageous and withdraw when it is no longer advantageous making a mockery of the system. One way to address this issue may be instituting a time limit where no benefits are acquired until an individual has declared donor intentions for at least x number of years, thus at least eliminating individuals who join solely for selfish short-term reasons.

The second problem is such a system raises potential moral questions when non-medical elements outside of time are introduced into the organ selection process. While on its face such a system appears to have a “tit-for-tat” characteristic, it would not be hard for one to produce a potential slippery slope argument. A common argument would be that the individual who agrees to become a donor is receiving some form of preferential treatment because he/she is offering something of value to the organ bank, replacing the used organ as well as offering others. Some could argue that in this environment how is it justified for an alcoholic poor person to receive a liver over a philanthropic millionaire? The millionaire provides dramatically more benefit to society if he/she survives over the alcoholic. While this argument should be irrelevant because the priority rule system only addresses organ donation specifically… sometimes certain parties just need a small window of opportunity to change a system significantly and the United States does not have a quality track record for societal fairness.

The third problem is such a system could be unconstitutional on the grounds that it would violate equal protection in that government could provide an organ to one individual over another based on non-medical factors. For a violation of equal protection it must be determined that the groups being compared are similarly situated otherwise government or another agency can apply different standards as long as those standards are not discriminatory.10 It is unknown how a court would rule in this case because providing a benefit only based on the notion that the receiver made a non-binding declaration of donation would require the court to determine the intent of the parties and whether that intent makes other groups distinguishable, which could potentially open a nasty can of legal worms.7 Any “perks” for donor kin would be an instant no-go because granting a benefit to someone simply on the basis of relation is inherently discriminatory.

The fourth and final major issue is would religious objections to organ donations cause problems for such a system in a discriminatory fashion? Initially it appears that religious objections should not cause a significant problem because discriminatory intent requires that the principal purpose of creating a law in the eyes of its creators be to produce discrimination; if the law is neutral and indirect discrimination is simply derived from its enforcement then no legal discrimination exists. This general legal structure was noted in Personnel Administrator of Massachusetts v. Feeney.11 However, while religious objections should not be a problem, religion can make these types of things more complicated.

Overall these potential issues do raise the question of the true value of changing the existing opt-in system to a priority rule donation system. So if a priority rule system is not preferred what other options remain? Another possible system for donor expansion removes the passivity from the opt-in system while maintaining its spirit, the mandated choice system.

Execution of the mandated choice system is rather straight-forward; when individuals over the age of 18 acquire or renew their driver’s license they are asked whether or not they wish to be an organ donor. This system attempts to maintain the altruistic characteristic of organ donation while eliminating the obligation of the potential donor to initiate the process to become a donor. Such a system has been utilized in both Texas and Virginia before other systems replaced them and is currently operating in Illinois, Colorado and California.12 Of course there are certain conditions that must be followed outside of simply asking “Do you want to be an organ donor.”

For example the American Medical Association has noted that in the mandated choice system the asked individual must be properly informed regarding the elements that are involved in organ donation to ensure that the individual understands the procedure and can be regarded as meeting the principles of informed consent.13 Also some might argue that a mandated choice system is not constitutional on First Amendment grounds in that an individual has the right not to speak and asking the question of organ donation without providing a means to simply not answer without consequence would be unlawful.

Realistically the First Amendment argument more than likely fails if the question embodying the mandated choice system is asked in a neutral manner with no legitimate attempt to favor a particular decision. With this condition in mind the question medium would more than likely have to be paper for one could interpret certain pressures upon an individual when asked verbally whether or not they want to be an organ donor. Such pressures are commonly associated with “being put on the spot”, which can favor a yes response over a no response, especially with a moral issue like organ donation and being asked by a government official (DMV employee). The question itself should simply ask “Would you like to make your organs available for transplant into other parties after your death?” or something similar, just a neutral question with no positive or negative overtones.

The success level of mandated choice programs have varied over time for both Texas and Virginia eventually overturned their programs because of strong negative reaction from the public including an increase in donation rejection in Texas up to 80%.14 Whereas in Illinois organ donation participants have increased to 60%.7 It is difficult to reconcile these two results. The best potential explanation may simply be political in the context of how individuals view government involvement in society. Both Texas and Virginia lean more conservatively and some may simply be offended that government even asks in the first place while the more liberal leaning Illinois is not offended by such behavior. Overall if this is the case then it is difficult to see how a mandate choice program would make significant in-roads towards increasing organ donation rates as potential increases in some places may be offset by other potential decreases in others.

The final major option to increase organ donation rates would be to simply return to the presumed consent days (i.e. Opt-Out over Opt-In), yet expand the program to include all organs not simply corneas or John/Jane Does. Clearly to ensure significant positive changes this presumed consent program would have to be hard/strong (after death if the individual did not opt-out then next of kin have no say in the issue of organ donation) versus soft/weak (next of kin can still reject organ donation for the deceased). Not surprisingly such a change could produce strong objections from some individuals for presumed consent/opt-out would in essence redefine the rule of who owns a deceased’s organs from next of kin to the government. Others would argue that such a policy poses a direct attack on individual liberty, autonomy and privacy by restricting freedom of choice, the very factors that some believe grant acceptability to an opt-in system.

The notion that an individual loses liberty, autonomy and privacy in an opt-out system is basically ridiculous. In short there is no threat to these elements in such a system because the individual has sufficient opportunity to declare their intentions to not be an organ donor while still alive. Once an individual dies the rights associated with liberty, autonomy, privacy, etc. are heavily handicapped, thus eliminating any meaningful violations in this circumstance.

Any minor opposition on the grounds that legislating altruism is not a responsibility of the government is a non-starter because the issue of establishing an opt-out system over the current opt-in system is a matter of public health due to the significant gap between available organs and individual need, not altruism and again there is no violation of personal autonomy because the individual is dead, thus the individual no longer possesses the capacity for autonomy.

Also some could argue that soft/weak presumed consent provide respect for the decedent’s relatives who are more than likely grieving the loss by allowing them to preserve the state of the loved one. However, there is a notion of hypocrisy in this idea for individuals in a presumed consent system can opt-out, thus why is it alright that the wishes of the next of kin supercede the wishes of the decedent if the decedent never opted out? Any “psychological” detriment born by the next of kin due to a hard/strong presumed consent system is the fault of their own selfishness and/or arrogance, not the system.

A more relevant issue is the question of next of kin property rights. Although it may sound grizzly, when an individual dies the body and its contents (in a sense) basically become property of the next of kin, especially with relation to burial rights. Some next of kin could challenge a presumed consent system on the grounds that it interferes with property rights or even religious services. However, in case of previous presumed consent laws, courts almost always side against such claims. For example in Tillman v. Detroit Receiving Hosp, a Michigan court ruled that the state’s presumed consent law for cornea extraction did not violate the privacy right of the decedent or her next of kin and the cornea removal did not constitute sufficient mutilation to void such action.15

However, one could argue that this case only involved cornea extraction not the extraction of numerous and various other organs, which would occur in a more thorough presumed consent system. While there certainly would be more incisions made in the individual, the individual would receive the appropriate remediation treatment through stitches and if properly dressed should have no significant mutilation or ascetical issues apart from an individual who simply had corneas removed.

Moreover pertaining to the issue of next of kin property, government should be able to utilize eminent domain to support the acquisition of the decedent’s organs. Eminent domain is the power of government to take private property for public use and while it commonly refers to land, it should also be applicable in a presumed consent environment when the individual did not choose to opt-out as a donor. Clearly in the case of a presumed consent environment the government would exert authority for the organs, but not the body, unless legally required.

How could the government manage the Takings Clause of the Fifth Amendment in such a scenario? Overall one could simply validate the acquisition of the organs under the “public use” requirement, for the organs are certainly going to be used for a “public purpose” through the increase of deceased organ donation rates resulting in more lives saved. From a standpoint of organ value, if one wanted to, realistically no monetary compensation could be expected. For the next of kin, who would own the organs, have a product with ephemeral functionality and due to the fact that one cannot legally sell an organ, a monetary value of zero dollars.

The ephemeral nature of organ functionality is important because it cannot be argued that the organs may have monetary value later due to a change in the law, thus compensation would be required to satisfy this potential future value. Therefore just compensation or “fair market value” is simply zero dollars. This reality is helpful because it avoid questions regarding organ value in the context of the various associated parties like the government, the next of kin or a potential recipient. However, while it can be argued that technically the government would not have to pay any monetary sum to the next of kin for the acquisition of the organs, it stands to reason that the government could make a small good-faith gesture tied to addressing funeral costs (i.e. 200-500 dollars).

A final initial question regarding a presumed consent system would be whether or not it actually increases the number of available organs. Official literature can be somewhat murky on this issue for some studies find that when controlling outside factors presumed consent does increase organ donations rates significantly,16,17 but others suggest that the casual link is not appropriate due to the level of heterogeneity that exists in transplantation systems throughout the world.19

The chief problem with analyzing existing systems is the lack of strong data regarding hard/strong presumed consent. Of the more studied presumed consent systems in Europe (Austria, Belgium, France, Italy, Norway, Spain and Sweden), only Austria typically sees genuine practice as a hard/strong presumed consent system whereas the others are either soft/weak or physicians almost default to a soft/weak system for various reasons.12 Unfortunately most soft/weak systems have few differences from an opt-in system, thus identifying any significant differences becomes quite difficult limiting the value of the analysis.

Interestingly enough the studies focus so much on potential confusion associated with multiple factors in the donation environment that they discard simple logic in that under a strong presumed consent system everyone who does not opt-out will become a donor upon death, thus it stands to reason that donation rates would significantly increase on two counts of logic. First, no one who has opted-in should opt-out, thus theoretically the worst a presumed consent system does is break-even. Second, studies have shown that most of the time people often choose the assigned default option, among various instances, possibly due to a lack of strong feelings or a lack of desire to spending the resources and time required to change the option.19-22

In the end among the three major donation methods, beyond opt-in, that could potentially increase the number of available organs for transplant, all three have their positives and negatives. Priority rule systems incentivize the donation process, but have numerous holes in how this incentive is effectively applied and could have a number of potential constitutional issues associated with their application. Mandated response systems are able to effectively transfer the initiation of the donation process from the individual to the government significantly eliminating situations of ignorance to the existence and operation of the donation system. However, there are questions to how effective such a system is in actually increasing the available number of organs for donation. Presumed consent systems increase the available number of organs as well as do not appear to have any obvious legal issues, but must address elements of methodological opposition largely brought on by government paranoia and contempt in some camps as witnessed by the failure to establish such a system in New York, Illinois, and Colorado.

Overall it appears that a presumed consent program is the best option for quickly increasing the total number of available organs for transplant, but pursuit of this strategy must involve a strong commitment to establishing such a system over the personal objections of a number of individuals despite the ability to opt-out.

Citations –

1. 2012 National Donor Designation Report Card by the Donate Life America:

2. 2013 National Donor Designation Report Card by the Donate Life America:

3. Scientific Registry of Transplant Recipients 2012:

4. Uniform Anatomical Gift Act (1968).

5.Revised Uniform Anatomical Gift Act (1987).

6. Revised Uniform Anatomical Gift Act (2006).

7. August, J. “Modern Models of Organ Donation: Challenging Increases of Federal Power to Save Lives.” 394 Hastings Constitutional Law Quarterly Vol. 40:2 393-422.

8. Lavee, J. “A New Law for Allocation of Donor Organs in Israel.” The Lancet. 2010. 375(9720):1131-1133.

9. Even, D. “Dramatic Increase in Organ Transplants Recorded in Israel in 2011.” Haaretz. Jan. 12, 2012.

10. Vacco v. Quill, 521 U.S. 793, 799. 1997.

11. Personnel Adm’r of Massachusetts v. Feeney, 442 U.S. 256. 1979.

12. Rodriguez, S. “No Means No, But Silence Means Yes? The Policy and Constitutionality of the Recent State Proposals for Opt-Out Organ Donation Laws.” FIU Law Review. 7:149-186.

13. AMA Recommendation. Opinion 2.155 – Presumed Consent and Mandated Choice for Organs from Deceased Donors. American Medical Association.

14. Siminoff, L, and Mercer, M. “Public Policy, Public Opinion, and Consent for Organ Donation.” Camb Q Healthc Ethics. 2001. 10(4):377-86.

15. Tillman v. Detroit Receiving Hosp., 360 N.W.2d 275, 277. 1984.

16. Hawley, Z, Li, D, and Schnier, K. “Increasing Organ Donation via Changes in the Default Choice or Allocation Rule.” Journal of Health Economics. 2013. 32.6:1117-1129.

17. Abadie, A, and Gay, S. “The Impact of Presumed Consent Legislation on Cadaceric Organ Donation: A Cross-Country Study. Journal of Health Economics. 2006. 25.4:599-620.

18. Boyarsky, B, et Al. “Potential Limitations of Presumed Consent Legislation.” Transplantation. 2012. 93.2:136-140.

19. Samuelson, W, and Zeckhauser, R. “Status Quo Bias in Decision Making.” Journal of Risk and Uncertainty. 1988. 1(1):57-59.

20. Madrian, B, and Shea, D. “The Power of Suggestion: Inertia in 401(k) Participation and Savings Behavior.” Quarterly Journal of Economics. 116(4): 1149-1187.

21. Johnson E, and Goldstein, D. “Defaults and Donation Decisions.” Transplantation. 2004. 78(12): 1713-1716.

22. Gäbel, H. “Donor and Non-Donor Registries in Europe.” Stockholm, Sweden: on behalf of the committee of experts on the Organizational Aspects of Co-operation in Organ Transplantation of the Council of Europe. 2002.