© Springer International Publishing Switzerland 2017
Lawrence Berk (ed.)Dying and Death in Oncology10.1007/978-3-319-41861-2_55. Legal Aspects of Oncology Care for Dying Patients
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Florida State University Center for Innovative Collaboration in Medicine and Law, Tallahassee, FL, USA
5.1 Introduction
A variety of potential legal issues, both personal and financial in nature, are relevant to cancer patients who are approaching the end of their lives. These include such matters as estate planning needs, attaining eligibility for public or private disability benefits, and health care insurance coverage disputes (Rodabaugh et al. 2010). However, these individuals and their families, as well as their professional caregivers, also often confront difficult decisions regarding medical care at this point and those choices must be made within the prevailing legal environment. The legal environment surrounding and shaping medical decision making and care for dying cancer patients is explored in this chapter.
The focus here is on medical-legal questions impacting dying adult cancer patients and their families and caregivers in the United States. It is noteworthy, however, that most of these same issues also have application internationally and a comparison of different national approaches may usefully inform American practice (Foster et al. 2014; Kerrigan and Ormerod 2010).
5.2 Distinguishing Living Patients from Dead Bodies
Medical decision making pertains to living patients. Postmortem rights and duties (briefly outlined in Sect. 5.7 of this chapter) apply to dead bodies. Legal definitions of death, embodying societal values, are central to distinguishing living patients from dead bodies.
Historically, permanent cessation of cardiorespiratory functioning has served adequately as a definition of death for all purposes. However, the continued utility of the heart-lung definition has been seriously called into question in the past half century as technical advances in medicine have enabled us to sustain cardiorespiratory functioning artificially in some individuals almost indefinitely. Hence, the states have had to come up with an alternative definition of death that is comprehensive (legal, ethical, and clinical) and that provides clear guidance about precisely when the duty, and the authority, to provide life-sustaining medical treatment ceases.
In 1981, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended a Uniform Determination of Death Act (UDDA), which stated the following:
The UDDA states that a “determination of death must be made in accordance with accepted medical standards.” All state statutes in this sphere agree.
An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead.
The clinical state of the art continues to evolve. The Harvard Criteria, published in 1968 and regularly updated to respond to advances in medical knowledge and technology, proposed that a permanently nonfunctioning brain (i.e., patient death) could be diagnosed accurately on the basis of four findings:
- 1.
The person is neither receptive nor responsive.
- 2.
The person has no spontaneous movements and no spontaneous breathing.
- 3.
The person has no detectable reflexes.
- 4.
As a confirmatory measure only, flat electroencephalograms are taken twice within at least a 24-h intervening period.
Because state law leaves to clinical discretion the selection of which specific tests to perform to confirm a patient’s death, individual hospitals frequently develop their own policies to guide physicians declaring death within the institution.
Either by statute of judicial decision, all the states have adopted the UDDA. Nonetheless, ethical and clinical controversies persist and threaten to disturb the prevailing consensus regarding the definition of death for all purposes and its legal consequences (Pope 2014). A thorough explication of those controversies is beyond the scope of this chapter; the point here is simply to set out the legal importance of the fundamental alive-versus-dead person dichotomy.
5.3 Informed Choice and Confidentiality
5.3.1 Informed Consent and Refusal
Adult patients have the right to make their own health care choices about the initiation, continuation, withholding, or withdrawal of various forms of medical intervention. This right is not in any way diminished because of a diagnosis of irreversible, incurable cancer.
The informed choice doctrine, encompassing both consent to and refusal of specific aspects of medical intervention, is predicated on the ethical principles of respect and autonomy or self-determination, especially regarding the physical integrity and dignity of one’s own body (del Carmen and Joffe 2005) An additional rationale for the doctrine is the belief that participating in the medical decision making process generally confers therapeutic benefit—a positive feeling of maintaining some degree of control—on the patient (Schachter and Fins 2008).
A health care provider may be held civilly liable, usually under a negligence theory but in rare cases under a battery or intentional tort theory (intentional acts that are or can be predicted to cause harm and do so) for subjecting a person to any diagnostic, therapeutic, or research-related intervention without that person’s effective consent to the intervention. The substance of the informed consent rule has evolved over time, on a case-by-case basis, as a function of state common (judge-made) law. Moreover, the majority of states have enacted statutes and regulations spelling out a jurisdiction’s specific details regarding informed consent for clinical care generally, including end-of-life care for oncology patients.
For a patient’s decision about whether to accept or reject a suggested medical intervention to be considered legally valid, three separate but interrelated elements must be present. First, the patient’s participation in the decision making process and the final decision(s) regarding intervention must be voluntary, rather than unduly influenced by force, fraud, duress, or any other actual or perceived form of constraint or coercion. Second, the patient’s agreement or disagreement with recommended interventions must be adequately informed. The professional is obligated to disclose sufficient information about the proposed intervention to empower the patient to give or withhold a knowledgeable, intelligent consent or refusal. The third essential element of legally effective medical decision making is adequate cognitive and emotional capacity on the part of the patient to appreciate and manipulate relevant information about his or her medical care.
Regarding the informed part of the informed consent doctrine, there are two competing standards for determining how much information about a proposed medical intervention must be disclosed to the patient in advance. The medical custom or reasonable professional standard mandates the sharing of such information that a reasonable, prudent professional would disclose under similar circumstances. In other words, the health care professional’s disclosure behavior is judged against the customary disclosure behavior of that person’s professional peers. By comparison, the materiality or patient orientation standard compels the sharing of information that might make a difference (i.e., might be “material”) to the decision making of a reasonable, average (in other words, objectively determined) patient in the same or similar circumstances. The different states are approximately evenly split between these two competing standards of information disclosure.
Under either the materiality or the reasonable professional standard, certain basic items of truthful information disclosure emanate from the professional’s fiduciary or trust obligations to the patient (Tabak et al. 2012). These include the following: diagnosis or nature of the patient’s medical problem; prognosis; nature and purposes (expected benefits) of the proposed interventions; reasonably foreseeable risks associated with the intervention, specifically, the probability of a risk actually occurring and the severity if it does materialize; and reasonable alternative interventions and their anticipated risks and benefits. The professional also must explain the reasonably foreseeable risks and benefits of foregoing available interventions. For example, a patient possesses the right to voluntarily stop eating and drinking (VSED) (Pope and Anderson 2011), but needs to be properly informed of the likely consequences (namely, death) of that action.
Other pieces of information that a health care professional should carefully consider disclosing to the patient are: complementary and alternative medicine alternatives; cost ramifications to the patient of proposed alternatives; professional-specific information pertinent to the particular intervention (for instance, the professional’s own individual track record with the particular intervention or any financial incentives that professional has regarding the patient’s course of care); and the level of uncertainty within the medical community concerning the particular intervention being contemplated.
This latter piece of the decisional puzzle—medical uncertainty—is particularly important in the oncology arena, where “clinical equipoise” between multiple alternatives often is present (van Laarhoven et al. 2014). Frequently, there is no clear, definitive clinically “correct” answer and competing quality of life considerations are attached to different choices, enhancing the wisdom of patient-centered shared decision making (Ellor et al. 2014) rather than the traditional physician-dominated paternalistic approach.
The patient’s informed consent to a medical intervention may be implied or expressed. There are many situations in which a patient’s permission to proceed with a medical intervention does not need to be put into words but, instead, may be implied from the circumstances. This happens when, through demonstrative actions or passive compliance, the patient indicates a wish (or at least willingness) to undergo a specific intervention by voluntarily submitting to it in a manner that the health care professional can reasonably rely on to conclude that the intervention has been authorized. Implied consent is appropriate for most routine, noninvasive, relatively low risk kinds of medical interventions such as taking a patient’s blood pressure or listening to the heart. Implied consent is not an exception to the general informed consent requirement, but instead a different (created by behavior instead of words) form of permission.
Express consent (put into spoken or written words), by contrast, is more appropriate when the proposed medical intervention is intrusive and/or significantly more risky than ordinary, everyday life. With a small number of exceptions created by particular state statutes for designated kinds of interventions (such as testing for the HIV virus), implied consent in the form of spoken rather than written patient words is legally adequate, so long as the consent is given voluntarily, competently, and on the basis of sufficient information being disclosed. However, for particularly intrusive or risky interventions, the provider should consider documenting the patient’s decision to consent or refuse by asking the patient to sign a separate written form, in addition to the professional always completing a thorough, timely progress note in the patient’s medical record (Treleaven et al. 2012). Also, voluntary accreditation standards with which the provider complies, such as those of the Joint Commission, may require the use of separate written consent forms for particular sorts of medical interventions.
In communicating information to a patient, and in interpreting a patient’s response to information provided, the health care provider should be attuned to cultural aspects of the patient’s background that might contribute to a tension or even outright conflict between the patient’s underlying values and those embodied in predominant American society and law. Especially in the end-of-life context, the culturally influenced attitude of patients and their families regarding such matters as the role of individual autonomy, advance medical planning (see Sect. 5.4, below), and the propriety of literal and transparent medical communication should be factored into planning precisely how the provider’s legally required fact disclosures will be sensitively broached with the patient, family, and/or surrogate (Chew 2012). In a similar vein, the structural aspects (the where, when, and how aspects of presenting choices to the patient) of decision making guide the effective degree of patient participation determining a particular decision (Salloch et al. 2014); health care providers are obliged to manipulate those structural aspects as creatively as possible to maximize the patient’s contribution to shared decision making.
5.3.2 Right to Control Medical Information
The right of cognitively and emotionally capable adult individuals or their surrogates to make personal medical decisions is paralleled by a right to exercise control over distribution of the patient’s personal medical information. In other words, the medical decision maker in the specific situation ordinarily is the one with authority to dictate details regarding the keeping or disclosure of personally identifiable information concerning the patient.
In the course of providing care, health care professionals routinely come into the possession of very private information about patients and their families. Professionals owe patients a fiduciary or trust responsibility to hold in confidence all sensitive patient information entrusted to them through the professional/patient relationship. This is both an ethical obligation, based on the patient’s important autonomy interest in protecting personal privacy and avoiding the social stigma and potential discrimination that breach of one’s medical privacy might entail (particularly in the oncology context), and a legally enforceable duty.
5.3.2.1 State Law
Every state, both within its various state professional Practice Acts and in separate statutes pertaining to particular health care delivery settings, has enacted provisions pertaining to the confidentiality duties of health care professionals, institutions, and agencies. Administrative regulations often are published to spell out how those duties will be implemented at the ground level. Moreover, a strong common law health care confidentiality doctrine has evolved through state court decisions delivered over time. Violation of state common law or relevant statutory or regulatory requirements regarding the confidentiality of patient information may expose transgressing health care providers to civil damage suits, brought by or on behalf of the patient whose privacy was improperly infringed; additionally, violation of state Practice Act provisions may subject the violator to administrative sanctions by the state, including license suspension or even revocation.
However, there are numerous exceptions to the general confidentiality rule. Several of these exceptions are not really relevant to the oncology context, but a few do apply to the current discussion. The most pertinent exception in the oncology context occurs when a patient voluntarily and knowingly waives, or gives up, the right to assert the confidentiality of particular information. These waivers take place daily, either expressly or by implication, through which patients make their information available to third-party payers (for instance, Medicare claims processors and private health insurers), quality of care auditors (such as Joint Commission surveyors), and other public and private entities like health care surrogates authorized to make medical decisions on behalf of decisionally incapacitated patients. Also, because the modern delivery of oncology care is a team effort, each patient implicitly gives permission for the sharing of certain otherwise private pieces of information among the members of the care team. Internal information sharing of this nature is essential to optimal patient care. Indeed, failures in communication among the multiple providers involved in the care of a dying cancer patient who needs such coordination and continuity may lead to negligence liability claims when harm results.
Further, a health care professional may be compelled to reveal otherwise confidential information about particular patients by the force of legal process, namely, when a judge issues a court order requiring such release. This is a possibility in any civil or criminal lawsuit involving a factual dispute about a patient’s physical or mental condition, for instance, in a personal injury suit stemming from an automobile accident. A court order (as opposed to a subpoena or subpoena duces tecum, which is issued simply as an administrative, nondiscretionary matter by the court clerk rather than by a judge) may overrule the state’s professional/patient testimonial privilege statute. That statute ordinarily would prohibit the provider from testifying in a legal proceeding regarding private patient information, but a court order could require the professional to produce personally identifiable patient information. Every state testimonial privilege statute provides for judicially compelled testimony on the part of the health care professional when, for example, the patient has placed his or her own health condition and medical treatment in issue in a lawsuit.
5.3.2.2 Federal Law
Federal confidentiality regulations are codified at Title 45, U.S. Code of Federal Regulations Parts 160 and 164.These regulations implement the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (Public Law No. 104–191, title XI, Part C). These regulations, published in the form of a Privacy Rule and a Security Rule, impose on covered health care entities (defined as, among certain others, any health care providers who transmit any patient-related information electronically) an extensive set of requirements regarding the handling of personally identifiable medical information contained in patient records. These regulations authorize significant criminal and civil sanctions for unauthorized disclosures of personal health information. Substantively, HIPAA and its implementing regulations in essence codify pre-existing state statutory and common law protections for patients, with some additional provisions clarifying that patients have a right to access the information recorded in their own medical records. (Previously, state law had varied or was unclear regarding the issue of patient access to records.) HIPAA contains provisions authorizing covered entities to transmit personal health information to certain others for purposes of “treatment, payment, and health care operations” such as quality assurance or marketing. These and other exceptions explicitly contained in HIPAA are consistent with pre-existing state statutes and common law precedent.
5.4 Advance Health Care Planning
5.4.1 Decisional Capacity Issues
The law begins with a presumption that all adults are able to make and communicate autonomous decisions about their own medical care. Sometimes, though, a patient is not mentally and/or emotionally capable of assimilating pertinent information and taking an active part in a rational, voluntary decision making process about medical interventions. Oncology patients approaching end-of-life situations may become (or already may be) so impaired that they fall into this category. When the patient personally lacks adequate decisional capacity, the health care professional is not relieved of the duty to obtain informed consent but, instead, must work with someone else who is willing and available to act as a surrogate on the patient’s behalf.
Assessing decisional capacity entails a functional inquiry. The basic questions to be posed are the following: (1) Can the person make and communicate any decisions at all? (2) Is the person able to offer reasons for the choices made, indicating any degree of reflection and consideration? (3) Are the reasons given based on logical reasoning proceeding from factually accurate suppositions? (4) Can the patient appreciate the probable consequences (i.e., the likely risks and benefits) of the alternatives outlined and the choices expressed, and comprehend that these consequences apply to that particular patient? (5) Does the individual actually understand the practical implications of his or her choices?
A patient’s cognitive and emotional capacity should be evaluated on a decision specific, rather than a global or all-or-nothing, basis. A patient may be capable of making some kinds of decisions, but not others; partial or limited capacity is possible even when total capacity is not. Moreover, capacity may fluctuate within a specific patient according to variables such as time of day, day of the week, physical location, acute and transient physical problems, other persons available to support or coerce the patient’s choice, and medication reactions. Some of these factors may be susceptible to manipulation by caregivers (e.g., through changes in the timing of drug administration) so that discussions with the patient (rather than or in addition to discussions with the surrogate) about the care plan can take place under the most lucid circumstances possible.
5.4.2 Advance Health Care Planning Opportunities
A number of legal instruments have evolved over the past several decades and are available to empower a patient who presently is decisionally capable to plan ahead for a future time when medical decisions regarding the initiation, continuation, withholding, or withdrawal of life-sustaining medical treatment may need to be made but that person will then lack sufficient capacity to exercise autonomous choice (Sabatino 2014). A recent report of the Institute of Medicine (2014), Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life, confirms the observations of many health practitioners and legal commentators (Sico 2013) that current methods of advance health care planning are hardly a panacea for difficulties that may arise in this arena. Nonetheless, advance planning does help patients who have the foresight and wherewithal to look ahead to maintain some degree of prospective medical autonomy. Advance planning also may help individuals and their families avoid court involvement in medical decisions, conserve limited health care resources in a way that is consistent with patient self-determination, and reduce emotional stress on families in crisis circumstances. Thus, health care professionals have an obligation to assist patients to be aware of and take advantage of available planning opportunities.
Although an advance directive (AD) may be oral, it is much more likely to be followed if it is a written document. An instruction (living will)–type AD contains an individual’s instructions about wanted, limited, or unwanted interventions in case that person subsequently becomes incapacitated. These instructions may be detailed (e.g., relating to specific medical treatments in specific situations), general (for instance, requesting “no extraordinary measures”), or phrased in terms of a patient’s personal values and goals (like “keep me alive forever no matter what pain or expense” or “avoiding suffering is my main concern”).
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