The law regulates human relationships, both prospectively and retrospectively, in a wide variety of ways. To a large extent, the legal implications of medical practice are generic, in the sense that these apply to patients of all ages. Rules developed to deal with the care of younger adults apply with full force to older persons, whose rights do not diminish just because of advanced chronological age. However, a patient’s advanced years may sometimes raise issues demanding particular attention by the involved participants in the professional/patient relationship. This chapter concentrates on several selected aspects in which the law influences the delivery of geriatric services through its impact on the recognition and enforcement of the respective rights and responsibilities of the parties, within the specific dynamics of an older patient/health care provider relationship.

The U.S. Constitution establishes a federal system of government, under which health care delivery and other matters are regulated at the national (federal), state, and local levels. Under separation of powers principles, such regulation takes the form of constitutional (federal, state, and local) provisions, statutes enacted by elected legislatures, rules or regulations promulgated by executive branch administrative agencies like health or social service departments on the basis of authority conferred on the agency by the legislature via a statute, and common law doctrines created by the courts as a matter of public policy and prior case precedent. These various forms of regulation may impose specific or general duties on parties, may authorize but not require parties to act in specific ways, or may prohibit parties from engaging in particular conduct. Health care regulation may be directed at individual health professionals or at health care facilities, agencies, institutions, and other organizations.

Regulation of Health Professionals

One primary mechanism for regulating individual health professionals to assure adequate qualifications and acceptable conduct is licensure, which entails the requirement that an individual satisfy—on both an initial and a continuing basis—certain enumerated standards to be permitted to practice a particular profession. Professional licensure ordinarily occurs at the state level through statutes (such as state Medical Practice Acts or Nursing Practice Acts) and regulations promulgated by a state’s licensing body (such as the Medical Board or Nursing Board) to implement the Practice Act. Licensure statutes and regulations limit certain activities to licensed professionals; engaging in those activities without prior state approval (in other words, practicing medicine or nursing without a valid license) subjects the wrongdoer to potential civil fines and even criminal sanctions.

Many statutory and regulatory requirements or prohibitions imposed on health professionals occur as conditions attached to payment for professional services under government insurance programs, especially Medicare and Medicaid. Professionals who treat patients covered by these government programs must satisfy the positive (e.g., “Thou shalt” maintain adequate patient records) or negative (e.g., “Thou shalt not” engage in self-referral) “strings” placed on the payment of public dollars to receive compensation for services rendered.

Another significant manner of health professional regulation under the civil law is tort liability in private lawsuits claiming malpractice; this form of regulation is discussed below. Particularly egregious behavior (such as patient abuse or billing fraud) may subject a health professional to criminal law punishments.

Regulation of Health Care Facilities and Agencies

Besides regulating individual health professionals, government additionally regulates provider facilities and agencies through licensure requirements, conditions attached to the receipt of compensation under public insurance programs including Medicare and Medicaid, criminal prohibitions on specific behaviors such as the filing of false claims, and civil liability for malpractice claims brought by or on behalf of individual patients. For example, Congress enacted the Nursing Home Quality Reform Act, codified at Title 42 U.S. Code §#1395i-3(a)-(h), as part of the Omnibus Budget Reconciliation Act (OBRA) of 1987, Public Law No. 100-203. This act, which has been amended several times subsequently, contains many of the recommendations proposed in a 1986 Institute of Medicine report that Congress had directed the Department of Health and Human Services to commission. OBRA 1987 amended the Social Security Act, Titles 18 (Medicare) and 19 (Medicaid), to require substantial upgrading in nursing home quality and enforcement. To implement this legislation, Department of Health and Human Services published a series of regulations, which have been codified at Title 42 Code of Federal Regulations Part 483. Violation of these regulations subjects nursing homes to a range of sanctions, up to decertification from participation in the Medicare and Medicaid programs.

Overview of Malpractice Liability

In a private civil lawsuit predicated on a theory of professional negligence, the plaintiff is required to establish four distinct elements by a preponderance of the evidence (Table 32-1). First, the patient/plaintiff has the burden of proving that the professional/provider defendant owed the patient an obligation defined by the appropriate standard of care. The existence of this duty ordinarily is established by showing that there existed, within the relevant time frame, a professional relationship between the patient and provider; that is, that the plaintiff was a patient of the provider for diagnostic and/or therapeutic purposes.

Second, the plaintiff must present sufficient evidence that the professional/provider breached or violated the appropriate standard of care within the professional relationship. The professional/provider does not guarantee particular results, let alone perfection. By the same token, however, it is not enough for professionals/providers to “do their best” if their conduct does not rise to the applicable level of care, even when the errors or omissions were unintentional (i.e., negligent). How the law determines the applicable level of professional care is discussed in the following section.

The third element that a medical malpractice plaintiff is required to prove is the occurrence of some financially compensable injury or damage. Besides special or economic damages that include such quantifiable items as lost income and past and future health care–related costs, plaintiffs may be awarded general or noneconomic damages for such things as pain and suffering, mental anguish, grief, and other emotional complaints. In recent years, juries have become much more willing to award substantial noneconomic damages to older patients claiming medical negligence. In very rare circumstances, punitive or exemplary damages may be awarded over and above compensatory damages, where the defendant’s conduct has been not merely negligent, but actually reckless or malicious. For example, a jury might award punitive damages when it finds that a patient has developed serious pressure ulcers because of a hospital’s or nursing home’s demonstrated ongoing pattern of neglect.

The final component of proof in a professional malpractice lawsuit is the element of causation. To succeed, a plaintiff must persuade the jury, to a reasonable (not absolute) degree of medical certainty, that his or her injuries were the result of the defendant’s negligence. A plaintiff must prove not only that the defendant’s negligence was a “substantial factor” in bringing about the injury or that “but for” (sine qua non) the defendant’s negligence the injury would not have happened, but further that there were no intervening, superceding (i.e., not reasonably foreseeable) forces that acted to break the chain of proximate or direct causation between the defendant’s negligence and the patient’s injury. For example, a physician might negligently fail to diagnose cancer in an older patient in a timely manner and the patient, on learning that cancer is at such stage that it cannot be treated effectively, commits suicide. Assuming the availability of effective treatment if the cancer had been properly diagnosed in a timely manner, representatives of the deceased patient may argue that “but for” the physician’s negligence the death would not have taken place; however, the physician would respond that the patient’s act of committing suicide was an intervening, superceding (i.e., not reasonably foreseeable) factor that disrupted the chain of proximate causation between the physician’s negligence and the patient’s injury.

Developing and Disseminating Standards of Care

Legal standards of care have been established mainly by the courts as a matter of common law on an incremental, case-by-case basis. State statutes, such as those containing professional licensure requirements, also help to define the required standards of care.

Under the traditional formulation, a professional who is accused of negligent acts or omissions in a medical malpractice claim is usually held to a standard requiring the professional to have and exercise that level of knowledge and skill ordinarily possessed and exercised by competent, reasonable professional peers (determined on a national rather than a local basis) in similar circumstances. Put differently, under long-standing tort principles of negligence, professionals have been judged legally according to the prevalent practice or custom of peer professionals in clinical circumstances like the situation that confronted the particular defendant in the case immediately before the court.

However, there is a significant current trend in many states to deviate from the traditional customary professional standard of care in favor of imposing more objective, external standards of “reasonableness” against which the professional’s behavior is to be evaluated by the jury. An objective, evidence-based standard of reasonableness may exceed (i.e., require more knowledge and sophistication than) the prevailing customary practice within the professional community at the time in handling a specific clinical challenge presented by a patient. Thus, the state of the art in a particular area of care, required under a reasonableness standard, frequently may not be synonymous with and reflected in the current customary practice within the practitioner community. Courts adopting a reasonableness standard often recite the famous maxim of Judge Learned Hand: “Courts must in the end say what is required; there are precautions so imperative that even their universal disregard will not excuse their omission.”

When a reasonableness standard is imposed on malpractice defendants, expert witnesses may be allowed to testify, and thereby educate the lay jurors, regarding the appropriate professional conduct under the circumstances. To establish what conduct would have been reasonable, the parties may also introduce other kinds of evidences to supplement the testimony provided by the expert witnesses (Table 32-2). Additional forms of evidence introduced for this purpose may include professional codes of ethics, medical journal literature, textbooks (learned treatises), the Physician’s Desk Reference (PDR) and pharmaceutical package inserts (PPIs) pertaining to the correct use and dosage of prescription drugs, pertinent statutes or regulations, voluntary accreditation standards such as those of the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), and, of increasing importance, pertinent clinical practice guidelines or parameters.

Leaders in health care delivery and financing acknowledge (although frequently not in public) that a good deal of routine medical practice has long been predicated more on habit and inertia than on solid empirical evidence establishing clinical efficacy. Out of a concern about both the wasteful resource usage and the quality of patient care, in the last couple of decades professional organizations and specialty societies including the American Geriatrics Society and the American Medical Directors Association, governmental agencies led by the federal Agency for Healthcare Research and Quality (AHRQ), and individual institutions and agencies in the United States and elsewhere have engaged in a concerted movement to develop, collect, and disseminate to practicing clinicians a variety of evidence-based clinical practice guidelines or parameters to educate practitioners about whether a particular diagnostic or therapeutic intervention actually has been demonstrated to produce desired health benefits for patients. The Institute of Medicine has defined clinical practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”