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Patient Selection Criteria

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Factors Involved In Developing Patient Selection Criteria
Annotated Bibliography

David A. Wilson
The University of Dayton School of Law
Spring 2000

Introduction

Groundbreaking advances in medical technology, throughout the last fifty years, have let to the availability of new life saving procedures, medicines, and services. However, these resources are not infinite, and their administration may be limited by many different factors. In all systems, where the demand for services outweighs the supply, rationing of resources is practiced to some extent. Rationing of services, or limiting patient access to resources takes several different forms. There is implicit rationing, practiced in the United States, where doctors, HMO's, and the individual's ability to pay, control who gets limited resources.(1) There is also explicit rationing, practiced in Great Britain and other European countries, were the government, through public health authorities, controls the allocation of limited resources.(2) Regardless of the form of resource rationing, patient selection criteria are grounded in personal and social values that almost always result in an inequitable distribution of healthcare resources.(3)

This Annotated Bibliography will focus primarily on the explicit rationing of healthcare resources. As many people call for government involvement in the American healthcare system, this paper will consider the issues and inequities that arise with the explicit rationing of healthcare services. Within the current American healthcare system, explicit rationing takes two major forms: 1) The allocation of organs for transplantation; and 2) The allocation of beds in intensive care units.(4) Because the allocation of organs for transplantation is the most visible form of rationing, involving the most apparent patient selection criteria, this paper will primarily focus on the organ transplant selection process.

In 1984, the federal government became involved with the rationing of limited health care resources by passing the National Organ Transplant Act.(5) Under this legislation, Congress charged a private contractor, the United Network for Sharing Organs (UNOS) with developing a patient selection process which would allow for the rationing and allocation of harvested organs.(6) The current system emplaced by UNOS involves a three-stage process.(7) Under the first stage, private physicians serve as the gatekeeper, playing an individual role in the patient selection process.(8) The private physician must refer the patient she feels is a good organ donation candidate to a regional transplant center. This stage is laden with inequities, as a single physician may limit a patient's access because of her individual medical, social, or prejudicial beliefs. The second stage of the UNOS selection process involves the development of patient selection criteria by the regional transplant center.(9) The criteria are developed by evaluation committees comprised of physicians from within the community surrounding the center.(10) The major problem with this practice is that these patient selection criteria are not uniform across the country. Such discrepancies often lead to a patient being rejected by one transplant center only to be accepted by another.(11) The final stage in the UNOS system of organ allocation, is the selection of the recipient from a candidate waiting list.(12) This stage works on a point system where points are awarded for blood-type matching, length of time on the waiting list, degree of urgency, and patient proximity to the transplant center.(13) The patient awarded the highest point value, receives the available organ.

It is imperative that readers of this annotated bibliography understand the current UNOS selection process because it is the best example of government involvement and explicit rationing within the American healthcare system. Each stage of the system has the potential for influences of social and individual prejudices. Therefore, the pertinent question becomes, how to implement a system, which exercises the explicit rationing of limited resources, that is efficient, successful, and equitable. In order to answer this question, one must consider: 1) Who is best situated to make patient selection decisions, (doctors, administrators, the legislature, courts, HMO's); 2) On what basis should these decisions be made, (need, ability to pay, likelihood of success, likelihood of compliance with treatment); and 3) What biases may arise, (selections made on age, race, gender, and class).

The general theme of this bibliography is that physicians should have the maximum level of input in deciding questions regarding patient selection. Physicians take an oath to put the care of the patient first and foremost in their practice. The medical profession is rooted in long-standing ethical guidelines. The physician, by the nature of her profession, is best situated to make the difficult, life or death decisions involved in the rationing of limited resources. Therefore, patient selection decisions, involving the limited availability of treatment or services, should be made by a council, consisting primarily of doctors from the relevant hospital or community.

The following articles are included in this bibliography:

 Annotations

Allen v. Mansor, 681 F.Supp. 1232 (E.D. Mich. 1986)

Subjective assessment of a patient's suitability to receive limited services must be a factor in developing patient selection criteria. Such issues normally arise in the context of individuals who abuse drugs or alcohol, and are in need of an organ transplant. Because substance abuse directly affects the success rates of organ transplantation, it must constitute a factor when making organ allocation decisions. To ensure the validity of such selection criteria, experts in the field of drug and alcohol abuse must be included on physician panels charged with developing rationing criteria.

In Allen v. Mansour, a Federal District Court struck down a Michigan Medicaid patient selection criteria which required candidates for liver transplants to provide documentary proof of abstinence from alcohol for a period of two years. In the case at hand, the Department of social services denied the Petitioner's Medicaid request because the he had not been alcohol-free for at least two years prior to requesting the transplant. The Federal District Court struck the waiting period as being arbitrary and capricious. Because the patient selection criteria in this case was developed by a panel of doctors without input from alcohol abuse experts or the use of statistical analysis relating to alcohol abuse, the two year alcohol abstention period was arbitrary. Since the Petitioner's liver transplant was medically necessary and the two-year abstention period was unreasonable, the court struck down the Michigan Department of Social Service's Medicaid selection criteria.

The affects of drug and alcohol abuse on the success of organ transplantation are undeniable. Therefore, it is necessary to account for drug and alcohol abuse in crafting patient selection criteria. In order to create rationing criteria which are not arbitrary, the physicians who develop these standards must utilize expert input regarding the affects of substance abuse on the body. Since substance abuse is an illness, treatment options and a patient's willingness to seek treatment must be incorporated into the patient's eligibility for selection. Selection criteria which account for the patient's substance abuse problems while not indiscriminately punishing patients for their illness are not arbitrary or unreasonable.


Babara A. Noah, Racial Disparities in the Delivery of Health Care, 35 San Diego L. Rev. 135 (1998).

Both explicit and implicit racial discrimination exist in the current system of health care rationing within the United States. Unconscious treatment decisions often result in racially unequal rationing practices.(14) Physicians and health care providers have traditionally written off these systemic inequities, within the rationing of services, as a result of cultural differences.

The author of this article specifically points out racial inequities in patient selection criteria for organ transplants. Potential for discrimination in the organ allocation process at the individual level exists when physicians first evaluate potential transplant candidates to determine whether they meet medical and other criteria to be placed on a waiting list. It is at this stage where selection criteria, such as limiting organ allocation on the basis of drug or alcohol abuse, disparately impacts the African-American patient. The author also points out that the organ allocation process also has systemic factors which result in biases in the rationing of organs. The current kidney allocation system, as established by the United Network for Organ Sharing (UNOS), operates on a point system. The current system awards a high number of points for a perfect antigen match. African-Americans as a group make up a relatively small portion of organ donors. Racial inequity in the current point system exists because the likelihood of a perfect antigen match is very low when white donors are matched with African-American Donors.

Both individual and systemic discrimination within the organ allocation process must be stopped. While the author advocates for the abolishment of favoring antigen matches, the likelihood of a successful transplant must be considered in the organ allocation process. However, with the implementation of highly effective anti-rejection drugs, reliance on a perfect antigen match is unnecessary. Alone, increased donation rates among minorities, will not meet the organ transplant needs of African-American patients. Therefore, the point system which places heavy emphasis on a perfect antigen match should be replaced by a system which not only considers the likelihood of a successful transplant, but also results in less racial disparity in organ allocation.


Chris Ham, Tragic Choices in Health Care: Lessons from the Child B Case, 319 British Medical Journal, 1258 (Nov. 6, 1999).

In the English system of health care, great deference is given to the public health authority in making resource-rationing decisions. English courts review patient selection cases focusing only on the health authority's decision-making process. In the mid-1990's, a case arose in England which brought to light many questions regarding the country's resource rationing criteria.

Child B was a six-year old girl diagnosed in 1993 with a potentially terminal form of leukemia. . The pediatricians charged with Child B's care felt that she was unlikely to benefit from further intensive care. However, child B's father, David Bowen, found two Doctors from California who recommended that the child should receive a second bone marrow transplant. Mr. Bowen contacted the public health authority and requested that they finance the treatment. The public health authority declined the request stating that the pediatricians charged with treating the child were in the best position to assess her treatment options. The authority further stated that they were unwilling to use health care resources on invasive procedures with limited chances of success. In response to the health authority's denial of his request, Mr. Bowen turned to the English courts. The Court of Appeals ruled that the decision making process utilized by the health authority was valid, therefore there was no reason for the authority's decision to be reviewed. After receiving some further care, funded by private donation, Child B succumbed to her illness in 1996.

The author of this article correctly asserts that in a system that seeks to ration services, while still respecting patients' needs, the procedural methods utilized must be sound. The author correctly points out that in this case, the decision making process was valid. The Director of Public Health correctly followed the recommendations of Child B's personal physicians. Although these recommendations may have caused a quicker death for Child B, the doctors were best situated to make this difficult decision. Patient selection decisions which are made under a process which is fair, and based on criteria which are known and accessible to the public make these tough choices much more palatable to the individuals they affect.


 

David Orentlichter, Destructing Disability: Rationing of Healthcare and Unfair Discrimination Against the Sick, 31 Harvard Civil Rights-Civil Liberties L. Rev. 49, (1996).

America can no longer afford all medically necessary care. Although implicit rationing based on ability to pay already exists within our system, the author of this article asserts that explicit, government controlled, rationing of healthcare services is inevitable. It is likely that patient selection criteria within this explicit system of rationing will discriminate against the mentally ill as well as the physically disabled. The focus of this article is to suggest a process of service allocation which operates efficiently while still including the sick and disabled.

The author suggests that in order to avoid discrimination against the disabled in a healthcare system that practices explicit rationing of services; the reasonable accommodation standard should be applied. The author looks to the Americans with Disabilities Act and the Rehabilitation Act in asserting that physicians must take an individual's disability into account and make reasonable accommodations before excluding them from the resource allocation process. Under this system, a physician would only be able to deny a person a limited resource after determining that the person's disability seriously compromises their ability to benefit from the service. The author goes further in suggesting that once the physician has made a reasonable accommodation for the individual's disability, that person would be put in a lottery with everyone else in need of the limited resource. Such a lottery process would remove the social and political discrimination against the disabled, and increase equality within our system of rationing.

While the process introduced by the author increases equity within the system, it decreases efficiency. Physicians and other medical specialists are best situated to make the difficult life and death decisions involved in rationing limited services. Removing the physician input and putting everyone in need of limited services in a lottery eliminate the advice and counsel of those closest to the patient. Although a lottery system may appear to be more equal on the surface, in all actuality it is not. It would allow patients who have less life expectancy, have made poor lifestyle decisions, and who would benefit less from the resource, to triumph over those who are more likely to benefit from the resource. Therefore, a lottery or any other "chance" method of allocating limited resources is inappropriate in our healthcare system.


 

George P. Smith II, Our Hearts Were Once Young and Gay: Health Care Rationing and the Elderly, 8 University of Florida Journal of Law and Public Policy, 1, (1996).

A system, which must explicitly ration the allocation of limited healthcare resources, encompasses thousands of difficult decisions involving who lives and who dies. Because of the implicit beliefs that the disabled, the elderly, and the poor are less able to positively contribute to society, these groups are likely to bear the burden of societal prejudices. Therefore, whoever is charged with making patient selection decisions must be insulated from such beliefs.

The author of this article asserts that the tool, which will allow society to undertake such critical selection decisions, is a rigid adherence to ethics.(15) Mr. Smith believes that ethics serve as a regulator for value-based decision making within the healthcare system. Rigid adherence to the ethical foundations of medicine and the treatment of patients shields decision makers from social prejudices. Uniform patient selection criteria, based on standards such as those expounded by the American Medical Association's Principle of Ethics, would allow all patients to stand on equal footing within the healthcare system.(16)

Based on the reasoning of this article, the physician, or a counsel of physicians is best situated to make patient selection decisions. Concern for the care the patient receives is the physician's first concern.(17) Idealistically, from a pure ethical point of view, the physician is best situated to make life or death decisions regarding the patient. Furthermore, it is highly unlikely that elected politicians, who are influenced by interest groups, will ever be shielded from social biases. Therefore, the government is too removed from the individual patient and relevant medical community to establish patient selection criteria. If ethics are to be the foundation on which patient selection criteria are built, the physicians must have the most influence in making resource allocation decisions.


 

Ingrid Kinkopf-Zajac, Assessing Patient Compliance in the Selection of Organ Transplant Recipients, 6 Health Matrix: The Journal of Law-Medicine 503, (1996)

The most visible element of explicit rationing within our current healthcare system is the selection process for allocation of organs transplantation. Assuming that the goal of organ transplantation is the successful outcome of the procedure, then the likelihood of patient compliance must be a factor in determining selection criteria. The author of this article makes a well-reasoned assertion that patient non-compliance must be factored into the organ selection process. Although such an assertion is controversial, Ms. Zajac recommends establishing uniform guidelines for assessing the willingness or ability of a patient to comply with post-transplant treatment.

The author begins by suggesting that the UNOS three-stage process of candidate selection remain in place, but recommends several changes. Ms. Zajac points out that the private referral system utilized in the first stage of the UNOS selection process is discriminatory against poor people who have no private physician. Ms. Zajac advocates that the system should require physicians to refer all patients at end-stage organ failure to regional transplant centers. This way, physicians would no longer serve as gatekeepers, and all potential candidates would have equal initial access. Ms. Zajac argues that patient selection criteria are really developed in the second stage of the UNOS process by the regional transplant centers. Under the current system, the various regional centers implement a wide variety of differing criteria in determining how to rank the potential candidates. The lack of uniformity within this system allows a patient to be rejected at one regional center, while being accepted by another.(18) Ms. Zajac argues that it is at this point that a person's likelihood of compliance should be assessed. She asserts that these centers should establish standardized criteria that include: A psychiatric evaluation, drug and alcohol screening, and the patient's past record of compliance with treatment. Ms. Zajac further argues that patient compliance could be a factor in the final stage of the UNOS process by taking points from candidates who have previously rejected a transplant due to non-compliance with treatment.

The idea of holding patients accountable for non-compliance with treatment is very controversial.(19) In this article, Ms. Zajac makes a well-reasoned argument as to why patient compliance must be considered in the allocation of scarce resources. By removing the private physician as the gatekeeper for transplant referrals, she eliminates the individual biases and social prejudices that keep many from even being considered as transplant candidates. Furthermore, Ms. Zodiac's suggestions at how patient compliance can be implemented into organ donation selection criteria always puts the goal of successful transplantation first. In a system which must ration limited resources, such an approach is both logical and efficient.


John F. Kilner, Who Lives? Who Dies? Chapter 3, 1990

Whether implicitly or explicitly, the perceived value that an individual has within society plays a role in determining whether the person is selected to receive limited healthcare resources. Social value criteria are based on the idea that limited healthcare resources should be allocated to those individuals who, if saved, will be the greatest benefit to society. One of the fundamental bases underlying the social value doctrine is that society as a whole has invested thousands of dollars and limited resources into an individual's treatment. Therefore, these resources should be allocated to those individuals who, in the future, will most contribute back to society. This allows the country, as a whole, to get a return on its investment.

Although Mr. Kilner appears to favor the use of social value concepts in developing patient selection criteria, he does an excellent job at pointing out the weaknesses of the social value doctrine. The most important weakness in a system that rations on the basis of a patient's perceived social value is the potential for bias. More than likely the people charged with making such patient selection decisions would come from the upper strata of the social spectrum. It is conceivable that these decision makers would favor patients who are most like themselves, believing that the services they provide are highly valued by society. Such personal biases of these individuals would lead to the exclusion of the poor and minorities. Furthermore, it is also likely that social biases would pervade the initial development of the patient selection criteria.

Mr. Kilner correctly points out the implicit factors of social value that underlie healthcare rationing decisions. However, social value criteria should not be explicitly used as a basis for rationing healthcare. Although these economic classifications, on the surface, are not "suspect" for the purposes of Constitutional analysis, government sanctioned use of these factors would result in unequal protection under the law. Since social value criteria would disproportionately exclude minorities from allocation of limited healthcare services, a strong argument could be made that such criteria should be subject to strict scrutiny. Therefore, explicit use of the social value criteria in patient selection decisions should not be considered.


 

-Micheal Terry: When Did We Decide To Execute Our Old and Our Frail, The Express; World Reporter at 1, (Dec. 7, 1999).

Mr. Terry presents a vigorous assertion that age should not be considered in rationing health care services. The central theme throughout the article is that elderly people have paid into the system for the longest period of time and therefore are entitled to the best care the system can provide. However, the elderly are repeatedly denied access to expensive care, such as chemotherapy and treatment by specialists. Mr. Terry goes further in pointing out that not only are elderly patients being denied limited resources, but in many cases are deprived of basic care so that physicians may concentrate their time, (also limited), on younger patients. Under such conditions termed "involuntary euthanasia", elderly patients in need of limited care are often given high doses of pain- killers as a substitute for disease fighting antibiotics. These high doses of sedatives obscure the patient's mental ability to question the treatment being administered and the patient eventually succumbs to the otherwise treatable illness.

Although the article presents a graphic view of the affects of health care rationing on the elderly, the author fails to acknowledge the reality that rationing of services and treatment within medicine is a necessary evil. Notwithstanding the fact that the elderly have made the longest contribution into the healthcare system, a patient's age cannot be disregarded in a system which must ration its limited resources. The elderly as a group create incredible strain on limited resources. There is a sum-total of certain specialized treatments within a nation's health care system. Patient-selection criteria which does not account for age allows people who are at, or past the age of life expectancy, the same access to limited treatment as people who have enjoyed only a small percentage of their life expectancy.

While this author does not advocate summarily casting aside the needs of the elderly in a limited resource system which only caters to the young, age must be a factor when deciding what patients receive rationed care. Although the older patient may have contributed into the health care system for a much longer period of time than the younger patient, selection-criteria which denies the older patient limited resource treatment because of age does not rise to the level of euthanasia.


 

Ole Frithjof Norheim, Health Care Rationing--Are Additional Criteria Needed For Assessing Evidence Based Clinical Practice Guidelines? 319 British Medical Journal 1426, (Nov. 27, 1999).

Rationing decisions, which result in the withholding of potentially beneficial treatment from patients in need, cannot be made based on guidelines developed behind closed doors. Any system, that rations limited resources, must be legitimate. The guidelines on which patient selection decisions are based must be available to the patients and public whom these criteria affect. Such legitimacy and accountability cannot exist when patient-selection criteria are developed in a closed-forum setting inaccessible to the public.

The author asserts that the best way to achieve legitimacy in rationing medical resources is to establish strict guidelines involving not only the closed medical community, but also the patients and the public. Instead of providing substantive examples of what these guidelines should be, this article focuses on the process used to develop and implement patient-selection criteria. The first consideration in forming rationing guidelines is that physicians charged with developing patient-selection criteria must represent a broad spectrum of medical disciplines. Such diversity secures the representation of competing interests and allows for a variety of professional perspectives. The next consideration is that the process of developing rationing guidelines must involve the views of patients and the public at large. Although the author recognizes that public participation in developing selection criteria is difficult to implement, guidelines for rationing that reflect only the values of doctors or those who have a financial stake at risk cannot be considered legitimate. The final consideration in developing patient selection criteria is that the guidelines must be explicit and accessible. Establishing explicit criteria available to the individual citizens of a community allows for public assessment and legitimacy.

The strongest aspect of this article is the author's insistence on public accountability. A system of health care rationing which is based on firm guidelines, which are known to the public, increases the acceptability of difficult patient-care decisions. Such a system reduces the likelihood that rationing decisions will be based on self-serving reasons, or discriminatory criteria such as race, religion, or sexual orientation. Guidelines of health care rationing developed in an open, public forum are much more legitimate than those developed behind the closed doors of a communities' hospital.


Robert H. Blank, Regulatory Rationing: A Solution to Health Care Resource Allocation, 140 U. Pennsylvania L. Rev. 1573 (1992).

In the current American health care system, maximum consumption of limited resources is quickly leading towards a national crisis. Rationing criteria within this system has resulted in inequitable distribution of resources based solely on social and medical considerations. The author of this article asserts that all resources within the nation's health care system are to some extent limited. In order to ease the tension upon the system, the author suggests that the federal government must accept responsibility for the allocation and use of medical resources and develop an explicit system of rationing.

The author suggests that in a system where the rationing of resources is regulated by the federal government, individual responsibility must be stressed. Individuals who make preventative lifestyle changes, which positively affect their health, should be rewarded by patient selection criteria which favors such decisions. By establishing such positive criteria, individuals are encouraged to take an active role in maintaining their health levels. Educating the population and encouraging individual responsibility will lessen strain on limited health care resources. The author argues that the federal government is in the best position to implement such a policy. The author asserts that private providers and physicians are not in an ideal position to implement rationing policies because many times they are required to act purely out of self interest or in the best interest of their individual patients.

The author does a fantastic job of pointing out how the federal government is in the best position to implement educational programs and suggest national guidelines for rationing services. However, he incorrectly asserts that the federal government is in the best position to develop specific selection criteria which affect individual patients. An enlightened corps of physicians charged with not only acting on behalf of their patients, but also acting to reduce strain on limited resources are in the best position to develop patient selection criteria. These physicians, by virtue of their profession, are best situated to make the painful choices involved in limiting certain services to people in need.

 

1.Robert H. Blank, Regulatory Rationing: A Solution to Health Care Resource Allocation, 140 U. Pa. L. Rev. 1573, (1992).

2. Chris Ham, Tragic Choices: Lessons from the Child B Case, British Medical Journal, vol. 319 1258, 1259 (Nov. 6, 1999).

3. Robert H. Blank, Regulatory Rationing: A Solution to Health Care Resource Allocation, 140 U. Pa. L. Rev. at 1573.

4. George P. Smith II, Our Hearts Were Once Young and Gay: Health Care Rationing and the Elderly, 8 U. Fla. J. L. & Pub. Pol'y at 11.

5. Ingrid Kinkopf-Zajac, Assessing Patient Compliance in the Selection of Organ Transplant Recipients, 6 Health Matrix at 509.

6. Id at 510.

7. Id.

8. Id. at 511.

9. Id. at 512.

10. Id. at 513.

11. Id.

12. Id at 518.

13. Id.

14. Babara A. Noah, Racial Disparities in the Delivery of Health Care, 35 San Diego L. Rev. at 136.

15. George P. Smith II, Our Hearts Were Once Young and Gay: Health Care Rationing and the Elderly, 8 U. Fla. J. L. & Pub. Pol'y at 20.

16. Id.

17. Id at 21.

18. Id at 513.

19. Id. at 505.

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