Special Section: The Patient Self-Determination Act
The Patient Self-Determination Act: A Cooperative Model for Implementation ALEXANDER MORGAN CAPRON
In 1990, I voiced strong doubts about a bill entitled the Patient Self-Determination Act (PSDA), which had been introduced in the U.S. Senate by John Danforth (R-MO) and Daniel Patrick Moynihan (D-NY). I hoped to see it defeated.1 In 1991, after the bill had become a small part of a massive statute (the Omnibus Budget Reconciliation Act of 1990) adopted in the waning hours of the 101st Congress, I devoted countless hours to its implementation. I wanted to see it succeed. Why the change? It would be simple to explain if the bill as adopted were free of the problems that worried me. The PSD A did undergo some revisions during the legislative process. One change of particular relevance to the readers of CQ was the removal of the requirement that all healthcare provider organizations covered by the statute establish ethics committees and utilize them in resolving cases and educating the community. Yet the change in my attitude toward the Act did not arise primarily because of such changes in statutory provisions. Rather, I changed my response because once the bill became law, I felt I had a choice between standing by and watching all my worst fears come true or working to make the Act function as well as possible for the benefit of patients and providers alike. The latter was really the only honorable course. After all, I had not opposed the bill as a matter of principle but only on policy grounds; I thought that the bill placed responsibilities on the wrong parties in the healthcare system and asked them to intervene in decision-making processes at the wrong time. Once the PSDA was enacted, however, those objections were effectively moot. Even if I am right that other people and other times were preferable for achieving the Act's purpose of empowering patients to make decisions about life-sustaining medical care, the law placed certain responsibilities on healthcare provider organizations, and if patients were to be well served by the Act, those organizations would have to become as capable as possible in carrying out their responsibilities. What the Act Requires What are these responsibilities? The PSDA provides that as of 1 December 1991, every hospital, long-term care facility, hospice, and home-health agency that receives Medicare or Medicaid reimbursement and every health maintenance organization (HMO) that contracts to provide Medicare or Medicaid services— virtually every such organization in the United States — must provide adult patients with written information about their legal rights to make decisions about care, "including the right to accept or refuse medical or surgical treatment and the right to formulate advance directives." The written information must also describe the 97
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provider's policies regarding the way these rights will be implemented. Furthermore, providers are required to find out whether each patient has executed an advance directive and to document the answer in the patient's record. Finally, providers are supposed to train institutional staff and educate the community at large about advance directives. In addition to these affirmative duties placed on providers, the PSDA forbids their discriminating against patients or enrollees based on whether or not they have executed advance directives. The Act also requires that states develop a written description of the law on advance directives for providers to distribute, and it also mandates that the Secretary of Health and Human Services assist the state processes and the education of the public. Thus, the PSDA is about information: Information given by providers to patients about their rights and information given by patients to providers about what patients want done under certain circumstances —particularly what should be decided and by whom when a patient is not able to express his or her wishes about life-prolonging treatment. The federal law does not create any new substantive rights for patients to make or enforce their decisions about accepting or refusing treatment. Yet this law may still have important effects on decisions about life-support because it increases the likelihood that patients will formulate and express their wishes, and it should make institutions more sensitive to ensuring a good decision-making process. Although some of the information patients must be given involves the policies and procedures of the healthcare organization providing their care, the heart of the mandated information is the description of state law. Getting this educational effort right is, therefore, fundamental to successful implementation of the PSDA. Several groups — most notably, the American Bar Association's Commission on Legal Problems of the Elderly, Choice in Dying, Inc., and the American Hospital Association —mounted efforts nationally to help implement the PSDA. For example, in August 1991, the ABA commission produced a State Law Guide to assist groups in developing the descriptions of state statutory and decisional law on patient self-determination. The Guide helped identify the questions that such descriptions should address, which should aid the ABA group in its collateral objective of ascertaining the effects of differences in the state laws. The efforts of Choice in Dying —the organizational successor to Concern for Dying and the Society for the Right to Die — centered on distributing materials that providers could use to help patients in making decisions and making their wishes clear, as provided by state law. The hospital association produced a binder of materials to aid facilities in fulfilling their responsibilities, especially in education and training regarding advance directives. Locus of Implementation: The States All of these activities were very useful on a national level. But the PSDA, although national in scope, is local in implementation: The information that providers must give to patients will be different in each jurisdiction in the United States, and responsibilities for implementation also rest largely on the states through their Medicaid agencies. Thus, realization of the Act's purposes depended on an effective local response. Two major impediments to such a response were the diversity of the healthcare providers encompassed by the Act and their relative lack of experience with 98
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the subject matter. The first problem could develop into a "turf war/' with bad consequences for patients. If each healthcare provider developed its own description of state law (whether individually or through its state trade association), patients would likely get different and probably conflicting impressions of their rights in different settings. Besides representing an enormous duplication of effort, such a process of separate statements would stretch the relevant expertise very thin. It may at first seem improbable that organizations that provide medical care (especially those like hospitals and nursing homes with many critically ill patients) would lack in knowledge about the principles and rights relevant to decisions about terminal illness. Yet, these decisions have traditionally been the province of physicians, not facilities. In recent years —for example, since the 1976 decision of the New Jersey Supreme Court in Quinlan subjected the decisions of physicians and families to terminate life-support on an unconscious patient to review and concurrence by hospital ethics committees— healthcare providers have become more involved in such decisions. Most hospitals now have ethics committees, and many have adopted procedures for certain ethically sensitive matters, such as do-not-resuscitate (DNR) orders. Nonetheless, at many institutions, relatively few people have developed expertise on the relevant ethical principles in the context of state law; at the same time, the people who are seen as authorities on the law (legal counsel, either inside the hospital or in a firm outside) are likely to be oriented toward business and regulatory matters and to assume that good "risk management" means going to court to get judicial sanction before any decisions are made that could shorten a patient's life. The lack of knowledge about the relevant mix of law, ethics, and bedside clinical issues in this field is even more pronounced in most of the state agencies that would be drawn into the PSDA-mandated process of preparing a description of state law on advance directives. The attorney general's office would know the law but probably would not be familiar with the nuances about advance directives that have emerged in the bioethics literature much less with relevant medical concerns. The agencies that oversee Medicaid providers have seen some of the same issues in the context of nursing home regulations, but that adversarial experience is not the best preparation for the task at hand. Further complicating the picture is the PSDA itself, which provides that each state must prepare a "written description of the law of the state (whether statutory or as recognized by the courts of the state) concerning advance directives,"2 whereas healthcare providers must give patients a document that describes not only advance directives but patients' rights "to make decisions concerning medical care, including the right to accept or refuse medical or surgical treatment."3 Thus, if a state carried out its obligation without coordinating with healthcare providers, patients would get disjointed statements in which rights to make treatment decisions (basically, informed consent—including the right of "informed refusal") would be segregated from rights to have one's wishes respected after one has lost the ability to speak for oneself. The California Consortium To overcome these potential problems, the Pacific Center, in February 1991, invited a number of healthcare provider organizations, the relevant state agencies, 99
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healthcare professionals, representatives of patients/consumers, and several bioethics centers to join together to mount a comprehensive response to the PSDA in California. Initially, we were met with some reluctance. The organizations that represent the various providers were either (in the case of the hospital association) already beginning to put together a response to the PSDA and apprehensive of losing control of the process to an unwieldy coalition or (in the case of the HMO association) largely unaware of the responsibilities imposed by the PSDA on their members and hence uncertain why any special effort was even needed. Also, representatives of the state, although willing to participate, were understandably wary of delegating any authority to a self-constituted body. By the end of the first meeting in March, these concerns had begun to evaporate. Over the succeeding months, they ceased to play any part in the deliberations of what came to be the California Consortium on Patient Self-Determination, a 25-member organization with expertise across all the topics touched by the PSDA.4 Although never dull, the Consortium's meetings were marked by goodwill and a strong sense of mission; people argued strongly for their beliefs about the best way to proceed —down to arguments about word choice and punctuation in the patient brochures — but always with respect for their fellow participants and with the hope of finding common ground that truly met the concerns of all. In addition to its monthly meetings, the Consortium's work was also carried out through a number of meetings and conference calls of its four task forces, which dealt with legal and regulatory issues, patient information, policies and procedures, and education and training. Before describing the work of these groups, I will summarize the Consortium's overall accomplishments: production of The PSDA Handbook in five editions to supply guidance to all types of providers in implementing the Act; development of a basic brochure for patients (see Appendix 1), required by the state for use by all covered healthcare providers, and a second brochure that providers may make available to patients who want more information about how to execute advance directives in California; and a series of workshops throughout the state in November to educate staff from provider organizations about the PSDA. With the federal regulations on the PSDA still not released as this article goes to press, activities undertaken by the day the Act went into effect will probably represent only the beginning of local efforts to comply with the PSDA. Therefore, California's experience may prove illustrative for those who do not wish to "reinvent the wheel" in refining their own responses. Developing California's Response Regulatory and Legal Issues
The PSDA is in many ways a modest piece of legislation. When the Consortium began working, inquiries were made to the Health Care Financing Administration (HCFA) about the regulations that it would be issuing, and we learned that the people who were working on this at the HCFA regarded the Act as so straightforward as to be virtually "self-executing." Once the legal task force got to work, however, it quickly concluded that the Act contained many important ambiguities and even potential contradictions. Working under the leadership of Alice
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Mead of the California Medical Association, the task force prepared a letter to the HCFA that soon became an underground classic in bioethics circles. In the absence of the regulations, it is impossible to know whether the HCFA has lived up to its promise that all the issues raised in that letter will be adequately resolved in the regulations, but the task force's concerns have already been influential in the way the facilities are being instructed about the PSDA in California and elsewhere. With the regulatory issues in suspense, the legal group devoted itself to two other tasks. First, a summary of law had to be prepared for inclusion in the PSDA Handbook. This task involved much more than merely paraphrasing California statutes because the state has a large body of court decisions that go far beyond the areas covered in the state's two major statutes in this field— each the first of its type in the Nation: the Natural Death Act (first adopted in 1976) and the Durable Power of Attorney for Health Care (DPAHC) Act (first adopted in 1983). The second area of activity for the task force (and for all the lawyers who participated in the Consortium, including those who did not participate in this particular task force) was to check the rest of the Consortium's work, particularly the patient brochures, for their legal accuracy. This was, of course, an important and necessary function. Yet it was also one that engendered some tension for the group as a whole. In the end, that tension was amicably resolved, but there were moments when the view of some lawyers that certain language was needed to be "legally accurate" seemed irreconcilable with the wish of other participants for documents that would be understandable by people other than attorneys! Patient Information
The PSDA requires that written information be given to patients; perhaps the most important single concern in implementing the PSDA is that this information be accurate and understandable to the broadest range of potential patients. Chaired by Judith Ross of the Center for Healthcare Ethics at St. Joseph Health System, Orange, the task force on patient documents collected existing materials from hospitals and bioethics centers and developed a single, uniform description both of patients' common law rights and of the legal instruments available for patients to express their wishes and to appoint a healthcare agent. The task force decided to present the information in a question-and-answer format that would be easier for laypeople to understand (see Appendix 2). In the task force's reading of the PSDA, the opportunity to make an advance directive was the major message the Act intended people to receive. But these directives were specifically impeded (as they should be) in patients' broader rights to give or withhold consent to any medical or surgical procedure. Therefore, the basic patient brochure begins with the broad question of "who decides about treatment?" before focusing on the statutory means to plan for the decision-making process a patient wants to have followed when illness or mental incapacity makes it impossible to participate directly. Several impending changes in state law complicated the work of this task force on both the basic and the second brochures. One change was a minor amendment to the DPAHC law to make the power permanent until revoked rather than having it cease automatically in 7 years. The major change was a total amendment to the Natural Death Act to replace the existing ineffectual "Directive to Physicians" with a much more usable "Declaration," in effect, a statutory living will.
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Versions of such a bill had been passed twice before by the legislature but had been vetoed by the former Governor; the legislature was expected to pass the bill, but the new Governor had not announced whether he would sign it. The patient task force and the Consortium as a whole wanted to finish work on the brochures in time to have them distributed to providers well before the PSDA went into effect on 1 December. By September, it became apparent that the bills would pass, and the Consortium took the calculated risk to revise the brochures (and all other materials, such as the Handbook, in which California law is discussed) on the expectation that the bills would be signed into law. Once they were, the only remaining issue was whether the State Department of Health Services would mandate the use of the brochure that the Consortium had labored so hard to produce. The decision by the Department (late in September) to do so probably has many roots, not the least was the active participation of its representatives in the Consortium. However, one important factor was the administrative simplicity: Had the state allowed institutions to develop their own descriptions of patients' rights, the state would have had to review and approve each version. Institutional Policies and Procedures
The task force that dealt with institutional policies and procedures also had to contend with the pending changes in state law —and with the state's wavering on whether to require the use of the Consortium's brochure. This group, led by Gail Catlin of the California Association of Hospitals and Health Systems, began by generating a list of issues about patient choice and advance directives that healthcare institutions needed to address then prepared model policies and procedures for various kinds of institutions represented in the consortium. The initial focus of these models was on the process of informing patients and recording their responses. The group concluded that providers should go beyond the strict language of the Act. For example, the PSDA requires only that the provider record in the patient's medical record whether the person has an advance directive. But the content of such documents, not their mere existence, is needed for medical decisions. Thus, although recognizing that it is the patient's responsibility to produce the document, the model procedure encourages institutions to request the actual document rather than just ask about it. The policies and procedures—along with other advice to institutions about the necessity of involving medical, nursing, and other healthcare personnel in their implementation efforts — form a major component of the PSDA Handbook. To have the Handbook prepared in time for necessary educational activities from September through November, the Consortium decided to leave several more complex and contentious matters to be considered by institutions developing policy rather than as subjects for model guidelines. As set forth in Appendix A in the Handbook, these issues principally include the implementation of patients' directives that might involve institutional policies and procedures for writing and reviewing DNR orders, for deciding when a patient has lost decision-making capacity, or for resolving disputes among healthcare professionals and family members. These issues are plainly of major importance if the true purpose of the PSDA is to be achieved, but they seemed secondary to the immediate need to have a method of communicating to patients beginning on 1 December 1991.5
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Training
A final but indispensable function of the Consortium was to respond to the PSDA's least well-explained requirement: that providers train their staff and educate the community about advance directives. How well these functions are carried out will ultimately determine how well the PSDA is implemented. This task force identified existing resources and methods for education and training, drawing particularly on the grass roots experiences of California Health Decisions (CHD) both in educating people at a grass roots level and in "training the trainer" who will lead institutions in communicating to patients about advance directives. Rather than limiting itself to general advice, the task force, under the leadership of Treacy Colbert of CHD, built on existing models to provide outlines for staff training programs and for community forums.
Notes 1. Capron AM. The PSDA: not now. Hastings Center Report 1990;(Sep/Oct):35-6. 2. Pub. Law 101-508, Sec. 4751(a) (1990), codified at, 42 U.S.C. 1396(a) (58) (Suppl 1991). 3. Pub. Law 101-508, Sees. 4206(a) (2) and 4751(a) (2) (1990), codified at, 42 U.S.C. 1395cc(a) (1) (f) and 1396a(w) (1) (A) (Suppl 1991). 4. The Consortium consists of the following groups: California Association for Health Services at Home; California Association of Catholic Hospitals; California Association of Health Facilities; California Association of Health Maintenance Organizations; California Association of Homes for Aging; California Association of Hospitals and Health Systems; California Association of Public Hospitals; California Commission on Aging; California Department of Health Services; California Dialysis Council; California Health Decisions; California Medical Association; California Nurses Association; California State Hospice Association; Center for Healthcare Ethics, St. Joseph Health System; College of Chaplains, California Chapter; Hospital Council of Southern California; International Bioethics Institute; Kaiser Permanente Medical Care Program; LACMA-LACBA Joint Committee on Biomedical Ethics; Pacific Center for Health Policy and Ethics, University of Southern California; Society for Hospital Social Work Directors; Stanford University Center for Biomedical Ethics; United Hospital Association; University of California Office of General Counsel. A further several dozen individuals served as informal reviewers and consultants for the Consortium. 5. The Consortium is continuing to meet, and the development of model or sample policies on these additional issues is a major task.
APPENDIX 1 Your Right to Make Decisions about Medical Treatment
This brochure explains your rights to make health care decisions and how you can plan what should be done when you can't speak for yourself. A federal law requires us to give you this information. We hope this information will help increase your control over your medical treatment.
Who decides about my treatment? Your doctors will give you information and advice about treatment. You have the right to choose. You can say "Yes" to treatments you want. You can say "No" to any treatment you don't want —even if the treatment might keep you alive longer.
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How do I know what I want? Your doctor must tell you about your medical condition and about what different treatments can do for you. Many treatments have "side effects." Your doctor must offer you information about serious problems that medical treatment is likely to cause you. Often, more than one treatment might help you —and people have different ideas about which is best. Your doctor can tell you which treatments are available to you, but your doctor can't choose for you. That choice depends on what is important to you. What if I'm too sick to decide? If you can't make treatment decisions, your doctor will ask your closest available relative or friend to help decide what is best for you. Most of the time, that works. But sometimes everyone doesn't agree about what to do. That's why it is helpful if you say in advance what you want to happen if you can't speak for yourself. There are several kinds of "advance directives" that you can use to say what you want and who you want to speak for you. One kind of advance directive under California law lets you name someone to make health care decisions when you can't. This form is called a DURABLE POWER OF ATTORNEY FOR HEALTH CARE.
Who can fill out this form? You can if you are 18 years or older and of sound mind. You do not need a lawyer to fill it out. Who can I name to make medical treatment decisions when I'm unable to do so? You can choose an adult relative or friend you trust as your "agent" to speak for you when you're too sick to make your own decisions. How does this person know what I would want? After you choose someone, talk to that person about what you want. You can also write down in the DURABLE POWER OF ATTORNEY FOR HEALTH CARE when you would or wouldn't want medical treatment. Talk to your doctor about what you want and give your doctor a copy of the form. Give another copy to the person named as your agent. And take a copy with you when you go into a hospital or other treatment facility. Sometimes treatment decisions are hard to make and it truly helps your family and your doctors if they know what you want. The DURABLE POWER OF ATTORNEY FOR HEALTH CARE also gives them legal protection when they follow your wishes. What if I don't have anybody to make decisions for me? You can use another kind of advance directive to write down your wishes about treatment. This is often called a "living will" because it takes effect while you are still alive but have become unable to speak for yourself. The California Natural
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Death Act lets you sign a living will called a DECLARATION. Anyone 18 years or older and of sound mind can sign one. When you sign a DECLARATION it tells your doctors that you don't want any treatment that would only prolong your dying. All life-sustaining treatment would be stopped if you were terminally ill and your death was expected soon, or if you were permanently unconscious. You would still receive treatment to keep you comfortable, however. The doctors must follow your wishes about limiting treatment or turn your care over to another doctor who will. Your doctors are also legally protected when they follow your wishes. Are there other living wills I can use? Instead of using the DECLARATION in the Natural Death Act, you can use any of the available living will forms. You can use a DURABLE POWER OF ATTORNEY FOR HEALTH CARE form without naming an agent. Or you can just write down your wishes on a piece of paper. Your doctors and family can use what you write in deciding about your treatment. But living wills that don't meet the requirements of the Natural Death Act don't give as much legal protection for your doctors if a disagreement arises about following your wishes. What if I change my mind? You can change or revoke any of these documents at any time as long as you can communicate your wishes. Do I have to fill out one of these forms? No, you don't have to fill out any of these forms if you don't want to. You can just talk with your doctors and ask them to write down what you've said in your medical chart. And you can talk with your family. But people will be more clear about your treatment wishes if you write them down. And your wishes are more likely to be followed if you write them down. Will I still be treated If I don't fill out these forms? Absolutely. You will still get medical treatment. We just want you to know that, if you become too sick to make decisions, someone else will have to make them for you. Remember that: is A DURABLE POWER OF ATTORNEY FOR HEALTH CARE lets you name someone to make treatment decisions for you. That person can make most medical decisions—not just those about life-sustaining treatment—when you can't speak for yourself. Besides naming an agent, you can also use the form to say when you would and wouldn't want particular kinds of treatment. ^ If you don't have someone you want to name to make decisions when you can't,, you can sign a NATURAL DEATH ACT DECLARATION. This declaration says that you do not want life-prolonging treatment if you are terminally ill or permanently unconscious.
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How can I get more information about advance directives? Ask your doctor, nurse, or social worker to get more information for you. The California Consortium on Patient Self-Determination prepared the preceding text, which has been adopted by the California Department of Health Services to implement Public Law 101-508.
APPENDIX 2 PSDA Handbook Table of Contents. Section 1 IMPLEMENTING THE PATIENT SELF-DETERMINATION ACT Section 2 POLICIES TO COMPLY WITH THE PATIENT SELF-DETERMINATION ACT Model Policy on Advance Directives Annotated Model Policy on Advance Directives Section 3 PROCEDURES TO IMPLEMENT POLICIES Model Procedures on Advance Directives Annotated Model Procedures on Advance Directives Section 4 QUESTIONS AND ANSWERS ABOUT ADVANCE DIRECTIVES Section 5 Informational Brochures for Patients Your health care choices are in your hands (Basic Brochure for Patients) Making an Advance Directive (Brochure for Patients Who Want More Information about Advance Directives) Section 6 TRAINING FACILITY STAFF AND EDUCATING THE COMMUNITY ABOUT THE PSDA Section 7 LAW ON HEALTH CARE DECISIONMAKING Summary of California Law on Medical Decisionmaking Patient Self-Determination Act of 1990 California Durable Power of Attorney for Health Care Act Sample Durable Power of Attorney for Health Care (DPAHC) form California Natural Death Act (NDA) Sample Directive to Physician under the NDA Section 8 GLOSSARY OF TERMS Section 9 CONSORTIUM MEMBERS AND PARTICIPATING REPRESENTATIVES Section 10 Appendix A: POINTS TO CONSIDER IN DRAFTING POLICIES AND PROCEDURES TO IMPLEMENT PATIENT DECISIONS
Section 11 Appendix B: PATIENT RIGHTS CHAPTER FROM THE 1992 JCAHO STANDARDS FOR ACCREDITATION OF HOSPITALS
Section 12 THIS FACILITY'S DOCUMENTS AND POLICIES
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The Patient Self-Determination Act: A Cooperative Model for Implementation ALEXANDER MORGAN CAPRON
In 1990, I voiced strong doubts about a bill entitled the Patient Self-Determination Act (PSDA), which had been introduced in the U.S. Senate by John Danforth (R-MO) and Daniel Patrick Moynihan (D-NY). I hoped to see it defeated.1 In 1991, after the bill had become a small part of a massive statute (the Omnibus Budget Reconciliation Act of 1990) adopted in the waning hours of the 101st Congress, I devoted countless hours to its implementation. I wanted to see it succeed. Why the change? It would be simple to explain if the bill as adopted were free of the problems that worried me. The PSD A did undergo some revisions during the legislative process. One change of particular relevance to the readers of CQ was the removal of the requirement that all healthcare provider organizations covered by the statute establish ethics committees and utilize them in resolving cases and educating the community. Yet the change in my attitude toward the Act did not arise primarily because of such changes in statutory provisions. Rather, I changed my response because once the bill became law, I felt I had a choice between standing by and watching all my worst fears come true or working to make the Act function as well as possible for the benefit of patients and providers alike. The latter was really the only honorable course. After all, I had not opposed the bill as a matter of principle but only on policy grounds; I thought that the bill placed responsibilities on the wrong parties in the healthcare system and asked them to intervene in decision-making processes at the wrong time. Once the PSDA was enacted, however, those objections were effectively moot. Even if I am right that other people and other times were preferable for achieving the Act's purpose of empowering patients to make decisions about life-sustaining medical care, the law placed certain responsibilities on healthcare provider organizations, and if patients were to be well served by the Act, those organizations would have to become as capable as possible in carrying out their responsibilities. What the Act Requires What are these responsibilities? The PSDA provides that as of 1 December 1991, every hospital, long-term care facility, hospice, and home-health agency that receives Medicare or Medicaid reimbursement and every health maintenance organization (HMO) that contracts to provide Medicare or Medicaid services— virtually every such organization in the United States — must provide adult patients with written information about their legal rights to make decisions about care, "including the right to accept or refuse medical or surgical treatment and the right to formulate advance directives." The written information must also describe the 97
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provider's policies regarding the way these rights will be implemented. Furthermore, providers are required to find out whether each patient has executed an advance directive and to document the answer in the patient's record. Finally, providers are supposed to train institutional staff and educate the community at large about advance directives. In addition to these affirmative duties placed on providers, the PSDA forbids their discriminating against patients or enrollees based on whether or not they have executed advance directives. The Act also requires that states develop a written description of the law on advance directives for providers to distribute, and it also mandates that the Secretary of Health and Human Services assist the state processes and the education of the public. Thus, the PSDA is about information: Information given by providers to patients about their rights and information given by patients to providers about what patients want done under certain circumstances —particularly what should be decided and by whom when a patient is not able to express his or her wishes about life-prolonging treatment. The federal law does not create any new substantive rights for patients to make or enforce their decisions about accepting or refusing treatment. Yet this law may still have important effects on decisions about life-support because it increases the likelihood that patients will formulate and express their wishes, and it should make institutions more sensitive to ensuring a good decision-making process. Although some of the information patients must be given involves the policies and procedures of the healthcare organization providing their care, the heart of the mandated information is the description of state law. Getting this educational effort right is, therefore, fundamental to successful implementation of the PSDA. Several groups — most notably, the American Bar Association's Commission on Legal Problems of the Elderly, Choice in Dying, Inc., and the American Hospital Association —mounted efforts nationally to help implement the PSDA. For example, in August 1991, the ABA commission produced a State Law Guide to assist groups in developing the descriptions of state statutory and decisional law on patient self-determination. The Guide helped identify the questions that such descriptions should address, which should aid the ABA group in its collateral objective of ascertaining the effects of differences in the state laws. The efforts of Choice in Dying —the organizational successor to Concern for Dying and the Society for the Right to Die — centered on distributing materials that providers could use to help patients in making decisions and making their wishes clear, as provided by state law. The hospital association produced a binder of materials to aid facilities in fulfilling their responsibilities, especially in education and training regarding advance directives. Locus of Implementation: The States All of these activities were very useful on a national level. But the PSDA, although national in scope, is local in implementation: The information that providers must give to patients will be different in each jurisdiction in the United States, and responsibilities for implementation also rest largely on the states through their Medicaid agencies. Thus, realization of the Act's purposes depended on an effective local response. Two major impediments to such a response were the diversity of the healthcare providers encompassed by the Act and their relative lack of experience with 98
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the subject matter. The first problem could develop into a "turf war/' with bad consequences for patients. If each healthcare provider developed its own description of state law (whether individually or through its state trade association), patients would likely get different and probably conflicting impressions of their rights in different settings. Besides representing an enormous duplication of effort, such a process of separate statements would stretch the relevant expertise very thin. It may at first seem improbable that organizations that provide medical care (especially those like hospitals and nursing homes with many critically ill patients) would lack in knowledge about the principles and rights relevant to decisions about terminal illness. Yet, these decisions have traditionally been the province of physicians, not facilities. In recent years —for example, since the 1976 decision of the New Jersey Supreme Court in Quinlan subjected the decisions of physicians and families to terminate life-support on an unconscious patient to review and concurrence by hospital ethics committees— healthcare providers have become more involved in such decisions. Most hospitals now have ethics committees, and many have adopted procedures for certain ethically sensitive matters, such as do-not-resuscitate (DNR) orders. Nonetheless, at many institutions, relatively few people have developed expertise on the relevant ethical principles in the context of state law; at the same time, the people who are seen as authorities on the law (legal counsel, either inside the hospital or in a firm outside) are likely to be oriented toward business and regulatory matters and to assume that good "risk management" means going to court to get judicial sanction before any decisions are made that could shorten a patient's life. The lack of knowledge about the relevant mix of law, ethics, and bedside clinical issues in this field is even more pronounced in most of the state agencies that would be drawn into the PSDA-mandated process of preparing a description of state law on advance directives. The attorney general's office would know the law but probably would not be familiar with the nuances about advance directives that have emerged in the bioethics literature much less with relevant medical concerns. The agencies that oversee Medicaid providers have seen some of the same issues in the context of nursing home regulations, but that adversarial experience is not the best preparation for the task at hand. Further complicating the picture is the PSDA itself, which provides that each state must prepare a "written description of the law of the state (whether statutory or as recognized by the courts of the state) concerning advance directives,"2 whereas healthcare providers must give patients a document that describes not only advance directives but patients' rights "to make decisions concerning medical care, including the right to accept or refuse medical or surgical treatment."3 Thus, if a state carried out its obligation without coordinating with healthcare providers, patients would get disjointed statements in which rights to make treatment decisions (basically, informed consent—including the right of "informed refusal") would be segregated from rights to have one's wishes respected after one has lost the ability to speak for oneself. The California Consortium To overcome these potential problems, the Pacific Center, in February 1991, invited a number of healthcare provider organizations, the relevant state agencies, 99
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healthcare professionals, representatives of patients/consumers, and several bioethics centers to join together to mount a comprehensive response to the PSDA in California. Initially, we were met with some reluctance. The organizations that represent the various providers were either (in the case of the hospital association) already beginning to put together a response to the PSDA and apprehensive of losing control of the process to an unwieldy coalition or (in the case of the HMO association) largely unaware of the responsibilities imposed by the PSDA on their members and hence uncertain why any special effort was even needed. Also, representatives of the state, although willing to participate, were understandably wary of delegating any authority to a self-constituted body. By the end of the first meeting in March, these concerns had begun to evaporate. Over the succeeding months, they ceased to play any part in the deliberations of what came to be the California Consortium on Patient Self-Determination, a 25-member organization with expertise across all the topics touched by the PSDA.4 Although never dull, the Consortium's meetings were marked by goodwill and a strong sense of mission; people argued strongly for their beliefs about the best way to proceed —down to arguments about word choice and punctuation in the patient brochures — but always with respect for their fellow participants and with the hope of finding common ground that truly met the concerns of all. In addition to its monthly meetings, the Consortium's work was also carried out through a number of meetings and conference calls of its four task forces, which dealt with legal and regulatory issues, patient information, policies and procedures, and education and training. Before describing the work of these groups, I will summarize the Consortium's overall accomplishments: production of The PSDA Handbook in five editions to supply guidance to all types of providers in implementing the Act; development of a basic brochure for patients (see Appendix 1), required by the state for use by all covered healthcare providers, and a second brochure that providers may make available to patients who want more information about how to execute advance directives in California; and a series of workshops throughout the state in November to educate staff from provider organizations about the PSDA. With the federal regulations on the PSDA still not released as this article goes to press, activities undertaken by the day the Act went into effect will probably represent only the beginning of local efforts to comply with the PSDA. Therefore, California's experience may prove illustrative for those who do not wish to "reinvent the wheel" in refining their own responses. Developing California's Response Regulatory and Legal Issues
The PSDA is in many ways a modest piece of legislation. When the Consortium began working, inquiries were made to the Health Care Financing Administration (HCFA) about the regulations that it would be issuing, and we learned that the people who were working on this at the HCFA regarded the Act as so straightforward as to be virtually "self-executing." Once the legal task force got to work, however, it quickly concluded that the Act contained many important ambiguities and even potential contradictions. Working under the leadership of Alice
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Mead of the California Medical Association, the task force prepared a letter to the HCFA that soon became an underground classic in bioethics circles. In the absence of the regulations, it is impossible to know whether the HCFA has lived up to its promise that all the issues raised in that letter will be adequately resolved in the regulations, but the task force's concerns have already been influential in the way the facilities are being instructed about the PSDA in California and elsewhere. With the regulatory issues in suspense, the legal group devoted itself to two other tasks. First, a summary of law had to be prepared for inclusion in the PSDA Handbook. This task involved much more than merely paraphrasing California statutes because the state has a large body of court decisions that go far beyond the areas covered in the state's two major statutes in this field— each the first of its type in the Nation: the Natural Death Act (first adopted in 1976) and the Durable Power of Attorney for Health Care (DPAHC) Act (first adopted in 1983). The second area of activity for the task force (and for all the lawyers who participated in the Consortium, including those who did not participate in this particular task force) was to check the rest of the Consortium's work, particularly the patient brochures, for their legal accuracy. This was, of course, an important and necessary function. Yet it was also one that engendered some tension for the group as a whole. In the end, that tension was amicably resolved, but there were moments when the view of some lawyers that certain language was needed to be "legally accurate" seemed irreconcilable with the wish of other participants for documents that would be understandable by people other than attorneys! Patient Information
The PSDA requires that written information be given to patients; perhaps the most important single concern in implementing the PSDA is that this information be accurate and understandable to the broadest range of potential patients. Chaired by Judith Ross of the Center for Healthcare Ethics at St. Joseph Health System, Orange, the task force on patient documents collected existing materials from hospitals and bioethics centers and developed a single, uniform description both of patients' common law rights and of the legal instruments available for patients to express their wishes and to appoint a healthcare agent. The task force decided to present the information in a question-and-answer format that would be easier for laypeople to understand (see Appendix 2). In the task force's reading of the PSDA, the opportunity to make an advance directive was the major message the Act intended people to receive. But these directives were specifically impeded (as they should be) in patients' broader rights to give or withhold consent to any medical or surgical procedure. Therefore, the basic patient brochure begins with the broad question of "who decides about treatment?" before focusing on the statutory means to plan for the decision-making process a patient wants to have followed when illness or mental incapacity makes it impossible to participate directly. Several impending changes in state law complicated the work of this task force on both the basic and the second brochures. One change was a minor amendment to the DPAHC law to make the power permanent until revoked rather than having it cease automatically in 7 years. The major change was a total amendment to the Natural Death Act to replace the existing ineffectual "Directive to Physicians" with a much more usable "Declaration," in effect, a statutory living will.
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Versions of such a bill had been passed twice before by the legislature but had been vetoed by the former Governor; the legislature was expected to pass the bill, but the new Governor had not announced whether he would sign it. The patient task force and the Consortium as a whole wanted to finish work on the brochures in time to have them distributed to providers well before the PSDA went into effect on 1 December. By September, it became apparent that the bills would pass, and the Consortium took the calculated risk to revise the brochures (and all other materials, such as the Handbook, in which California law is discussed) on the expectation that the bills would be signed into law. Once they were, the only remaining issue was whether the State Department of Health Services would mandate the use of the brochure that the Consortium had labored so hard to produce. The decision by the Department (late in September) to do so probably has many roots, not the least was the active participation of its representatives in the Consortium. However, one important factor was the administrative simplicity: Had the state allowed institutions to develop their own descriptions of patients' rights, the state would have had to review and approve each version. Institutional Policies and Procedures
The task force that dealt with institutional policies and procedures also had to contend with the pending changes in state law —and with the state's wavering on whether to require the use of the Consortium's brochure. This group, led by Gail Catlin of the California Association of Hospitals and Health Systems, began by generating a list of issues about patient choice and advance directives that healthcare institutions needed to address then prepared model policies and procedures for various kinds of institutions represented in the consortium. The initial focus of these models was on the process of informing patients and recording their responses. The group concluded that providers should go beyond the strict language of the Act. For example, the PSDA requires only that the provider record in the patient's medical record whether the person has an advance directive. But the content of such documents, not their mere existence, is needed for medical decisions. Thus, although recognizing that it is the patient's responsibility to produce the document, the model procedure encourages institutions to request the actual document rather than just ask about it. The policies and procedures—along with other advice to institutions about the necessity of involving medical, nursing, and other healthcare personnel in their implementation efforts — form a major component of the PSDA Handbook. To have the Handbook prepared in time for necessary educational activities from September through November, the Consortium decided to leave several more complex and contentious matters to be considered by institutions developing policy rather than as subjects for model guidelines. As set forth in Appendix A in the Handbook, these issues principally include the implementation of patients' directives that might involve institutional policies and procedures for writing and reviewing DNR orders, for deciding when a patient has lost decision-making capacity, or for resolving disputes among healthcare professionals and family members. These issues are plainly of major importance if the true purpose of the PSDA is to be achieved, but they seemed secondary to the immediate need to have a method of communicating to patients beginning on 1 December 1991.5
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Training
A final but indispensable function of the Consortium was to respond to the PSDA's least well-explained requirement: that providers train their staff and educate the community about advance directives. How well these functions are carried out will ultimately determine how well the PSDA is implemented. This task force identified existing resources and methods for education and training, drawing particularly on the grass roots experiences of California Health Decisions (CHD) both in educating people at a grass roots level and in "training the trainer" who will lead institutions in communicating to patients about advance directives. Rather than limiting itself to general advice, the task force, under the leadership of Treacy Colbert of CHD, built on existing models to provide outlines for staff training programs and for community forums.
Notes 1. Capron AM. The PSDA: not now. Hastings Center Report 1990;(Sep/Oct):35-6. 2. Pub. Law 101-508, Sec. 4751(a) (1990), codified at, 42 U.S.C. 1396(a) (58) (Suppl 1991). 3. Pub. Law 101-508, Sees. 4206(a) (2) and 4751(a) (2) (1990), codified at, 42 U.S.C. 1395cc(a) (1) (f) and 1396a(w) (1) (A) (Suppl 1991). 4. The Consortium consists of the following groups: California Association for Health Services at Home; California Association of Catholic Hospitals; California Association of Health Facilities; California Association of Health Maintenance Organizations; California Association of Homes for Aging; California Association of Hospitals and Health Systems; California Association of Public Hospitals; California Commission on Aging; California Department of Health Services; California Dialysis Council; California Health Decisions; California Medical Association; California Nurses Association; California State Hospice Association; Center for Healthcare Ethics, St. Joseph Health System; College of Chaplains, California Chapter; Hospital Council of Southern California; International Bioethics Institute; Kaiser Permanente Medical Care Program; LACMA-LACBA Joint Committee on Biomedical Ethics; Pacific Center for Health Policy and Ethics, University of Southern California; Society for Hospital Social Work Directors; Stanford University Center for Biomedical Ethics; United Hospital Association; University of California Office of General Counsel. A further several dozen individuals served as informal reviewers and consultants for the Consortium. 5. The Consortium is continuing to meet, and the development of model or sample policies on these additional issues is a major task.
APPENDIX 1 Your Right to Make Decisions about Medical Treatment
This brochure explains your rights to make health care decisions and how you can plan what should be done when you can't speak for yourself. A federal law requires us to give you this information. We hope this information will help increase your control over your medical treatment.
Who decides about my treatment? Your doctors will give you information and advice about treatment. You have the right to choose. You can say "Yes" to treatments you want. You can say "No" to any treatment you don't want —even if the treatment might keep you alive longer.
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How do I know what I want? Your doctor must tell you about your medical condition and about what different treatments can do for you. Many treatments have "side effects." Your doctor must offer you information about serious problems that medical treatment is likely to cause you. Often, more than one treatment might help you —and people have different ideas about which is best. Your doctor can tell you which treatments are available to you, but your doctor can't choose for you. That choice depends on what is important to you. What if I'm too sick to decide? If you can't make treatment decisions, your doctor will ask your closest available relative or friend to help decide what is best for you. Most of the time, that works. But sometimes everyone doesn't agree about what to do. That's why it is helpful if you say in advance what you want to happen if you can't speak for yourself. There are several kinds of "advance directives" that you can use to say what you want and who you want to speak for you. One kind of advance directive under California law lets you name someone to make health care decisions when you can't. This form is called a DURABLE POWER OF ATTORNEY FOR HEALTH CARE.
Who can fill out this form? You can if you are 18 years or older and of sound mind. You do not need a lawyer to fill it out. Who can I name to make medical treatment decisions when I'm unable to do so? You can choose an adult relative or friend you trust as your "agent" to speak for you when you're too sick to make your own decisions. How does this person know what I would want? After you choose someone, talk to that person about what you want. You can also write down in the DURABLE POWER OF ATTORNEY FOR HEALTH CARE when you would or wouldn't want medical treatment. Talk to your doctor about what you want and give your doctor a copy of the form. Give another copy to the person named as your agent. And take a copy with you when you go into a hospital or other treatment facility. Sometimes treatment decisions are hard to make and it truly helps your family and your doctors if they know what you want. The DURABLE POWER OF ATTORNEY FOR HEALTH CARE also gives them legal protection when they follow your wishes. What if I don't have anybody to make decisions for me? You can use another kind of advance directive to write down your wishes about treatment. This is often called a "living will" because it takes effect while you are still alive but have become unable to speak for yourself. The California Natural
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Death Act lets you sign a living will called a DECLARATION. Anyone 18 years or older and of sound mind can sign one. When you sign a DECLARATION it tells your doctors that you don't want any treatment that would only prolong your dying. All life-sustaining treatment would be stopped if you were terminally ill and your death was expected soon, or if you were permanently unconscious. You would still receive treatment to keep you comfortable, however. The doctors must follow your wishes about limiting treatment or turn your care over to another doctor who will. Your doctors are also legally protected when they follow your wishes. Are there other living wills I can use? Instead of using the DECLARATION in the Natural Death Act, you can use any of the available living will forms. You can use a DURABLE POWER OF ATTORNEY FOR HEALTH CARE form without naming an agent. Or you can just write down your wishes on a piece of paper. Your doctors and family can use what you write in deciding about your treatment. But living wills that don't meet the requirements of the Natural Death Act don't give as much legal protection for your doctors if a disagreement arises about following your wishes. What if I change my mind? You can change or revoke any of these documents at any time as long as you can communicate your wishes. Do I have to fill out one of these forms? No, you don't have to fill out any of these forms if you don't want to. You can just talk with your doctors and ask them to write down what you've said in your medical chart. And you can talk with your family. But people will be more clear about your treatment wishes if you write them down. And your wishes are more likely to be followed if you write them down. Will I still be treated If I don't fill out these forms? Absolutely. You will still get medical treatment. We just want you to know that, if you become too sick to make decisions, someone else will have to make them for you. Remember that: is A DURABLE POWER OF ATTORNEY FOR HEALTH CARE lets you name someone to make treatment decisions for you. That person can make most medical decisions—not just those about life-sustaining treatment—when you can't speak for yourself. Besides naming an agent, you can also use the form to say when you would and wouldn't want particular kinds of treatment. ^ If you don't have someone you want to name to make decisions when you can't,, you can sign a NATURAL DEATH ACT DECLARATION. This declaration says that you do not want life-prolonging treatment if you are terminally ill or permanently unconscious.
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How can I get more information about advance directives? Ask your doctor, nurse, or social worker to get more information for you. The California Consortium on Patient Self-Determination prepared the preceding text, which has been adopted by the California Department of Health Services to implement Public Law 101-508.
APPENDIX 2 PSDA Handbook Table of Contents. Section 1 IMPLEMENTING THE PATIENT SELF-DETERMINATION ACT Section 2 POLICIES TO COMPLY WITH THE PATIENT SELF-DETERMINATION ACT Model Policy on Advance Directives Annotated Model Policy on Advance Directives Section 3 PROCEDURES TO IMPLEMENT POLICIES Model Procedures on Advance Directives Annotated Model Procedures on Advance Directives Section 4 QUESTIONS AND ANSWERS ABOUT ADVANCE DIRECTIVES Section 5 Informational Brochures for Patients Your health care choices are in your hands (Basic Brochure for Patients) Making an Advance Directive (Brochure for Patients Who Want More Information about Advance Directives) Section 6 TRAINING FACILITY STAFF AND EDUCATING THE COMMUNITY ABOUT THE PSDA Section 7 LAW ON HEALTH CARE DECISIONMAKING Summary of California Law on Medical Decisionmaking Patient Self-Determination Act of 1990 California Durable Power of Attorney for Health Care Act Sample Durable Power of Attorney for Health Care (DPAHC) form California Natural Death Act (NDA) Sample Directive to Physician under the NDA Section 8 GLOSSARY OF TERMS Section 9 CONSORTIUM MEMBERS AND PARTICIPATING REPRESENTATIVES Section 10 Appendix A: POINTS TO CONSIDER IN DRAFTING POLICIES AND PROCEDURES TO IMPLEMENT PATIENT DECISIONS
Section 11 Appendix B: PATIENT RIGHTS CHAPTER FROM THE 1992 JCAHO STANDARDS FOR ACCREDITATION OF HOSPITALS
Section 12 THIS FACILITY'S DOCUMENTS AND POLICIES
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