INTRODUCTION TO MEDICAL ETHICS
Within a democracy, society tolerates a wide range of beliefs about what is moral or right and uses the democratic process to create rules and laws that regulate public behavior. This process allows for change and flexibility because laws are continually reviewed through the judiciary process.
It is important to remember that society’s beliefs about right and wrong precede laws and also influence their interpretation. Currently the rapid pace of technologic innovation and changing beliefs places considerable stress on the social structure.
There is also a wide diversity of expectations about normal, acceptable behavior, sometimes called etiquette, or manners. Breaches of etiquette pose no true threat to the integrity of an individual or society. However, individuals may have just as strong an emotional reaction to what they see as bad manners as they would have to a true ethical breach.
In the context of the medical office, a patient may feel that being rushed by the physician and treated “as a number, not a name” by the front-office staff is being treated without dignity. The patient’s emotional response to how he or she is treated may seem more important than the actual quality of care.
REASONS TO STUDY ETHICS
Although ethics is an abstract discipline and medical assisting is firmly grounded in practice and procedure, medical assistants should study ethics for a number of reasons.
First, it is an important part of an individual’s education to develop the intellectual skills to analyze complex problems and justify the choices made in particular situations. In the case of ethics, the choice is between alternative courses of action that have moral and social consequences.
Second, as society has become increasingly complex, average citizens are more aware that choices affect not only people living now, but those who will live in the future. People hesitate to allow only elected and appointed officials to deal with these choices. Learning about ethics and social issues encourages ordinary people to have input into social beliefs and expectations. There is also a greater sense of interconnections involving the whole world, sometimes called globalism. Many individuals feel some level of responsibility for all human beings, and indeed for all living beings on the earth.
Third, in the specific realm of medicine and science, more sophisticated medical treatment and new technologies are constantly becoming available. However, society does not have unlimited resources to provide everything to everyone, even in the developed world. There is a need to make informed choices about what care will be provided to whom, and when, rather than simply responding to special interests.
Fourth, every year new biomedical research makes it possible to do more things with which the world has no previous experience. Society must have informed citizens who can analyze issues and guide the future. Within the health care system, health professionals, including medical assistants, need skills in considering ethical questions in order to improve health care for individuals and society.
ETHICS AND HEALTH CARE
Current thinking about biomedical ethics identifies several rights (very strong claims) for patients and duties (requirements) for the institutions and individuals who provide health care. Sources for these ideas include religious traditions, social belief systems, and political documents such as the Declaration of Independence and the U.S. Constitution and the Bill of Rights, as well as ethical theories developed by individual philosophers.
A right is a claim that is expected to be honored. It is stronger than a wish or a need.
The early leaders of the American government believed in natural rights and the duty of any government to preserve them. Natural rights were considered to exist through the natural order or to be granted by God. These include the following:
Right to Life
One of the rights mentioned in the Declaration of Independence is the right to life.
Since the 1970s the term “right to life” has come to be associated with the movement against abortion. But in a broader context, it reflects the belief that human beings may not kill others. The belief in the right to life is found in all major religions and traditions.
The right to life has many implications for medicine. Historically, physicians and other health care workers may not harm patients because this may threaten their lives. They may not assist with suicide; this is expressly stated in the Hippocratic Oath. In the United States today, however, many individuals want some control over death, including the choice of suicide assisted by their physician.
Two important areas of conflict appeared in the middle of the twentieth century. First, advances in medical care made it possible to keep people alive who could not recover their health. Sometimes this sustaining of life came at the cost of prolonged suffering.
Second, the absolute right to life of an unborn fetus conflicts with the right of a woman to control her own reproductive capacity. Birth-control methods, artificial conception methods, and abortion, if necessary, are measures to control the size of a woman’s family. Many women and their physicians have come to believe they have a right to make decisions related to reproduction, including using available technology, as they see fit.
Right to Privacy
The Supreme Court has ruled that there is an implicit right to privacy in the Bill of Rights, specifically in the Fourth Amendment. A series of court decisions affirming a woman’s right to use mechanical birth control and to have an abortion hinged on justices’ perceiving this right to privacy.
Patient confidentiality, which has been upheld by courts, is another manifestation of the right to privacy. Patient confidentiality is discussed in detail later in this chapter.
Right to Autonomy
Currently, medical ethics takes the position that an individual has the right to autonomy, which means the right to make independent decisions about his or her health care according to individual values and concerns, without constraint or coercion by others. This right is preserved even when the individual’s decisions do not match the values of the medical community or the individual physician. The right of autonomy is the basis for informed consent. Informed consent is consent based on understanding of a medical procedure and its possible outcomes. Health care
professionals must provide complete information in order for patients to make informed decisions. The patient must have the mental capacity to reason and consider alternatives. Because of this, the law limits the autonomy of children or individuals with decreased mental capacity such as the mentally retarded or individuals whose mental capacity has been impaired by illness, those acting under the influence of drugs or alcohol, and those experiencing mental illness.
Respect for autonomy does not derive from the Hippocratic Oath. Rather, it comes from the thinking of European philosophers such as Immanuel Kant and John Locke.
Right to the Means to Sustain Life
Every society must grapple with the problem of equitable distribution of goods and services to its citizens and how to regulate that distribution over time.
This is not a problem when the supply is adequate, or when supply is greater than demand. For instance, in ordinary circumstances the supply of oxygen is more than adequate to meet the needs of the entire population.
It is when the amount of a particular resource is less than the desire for that resource that problems develop. In this case, resources are said to be scarce, and the society’s government must determine who will have access to the scarce resources.
At a minimum, every individual should have access to what is necessary to sustain life and preserve human dignity. Consideration of justice in distribution and access is especially important in social and political movements. Any society must find ways to respond to need while also rewarding contribution and providing for stability within the social system.
A duty is a commitment to act in a certain way on the basis of religious beliefs, moral principles, or a particular professional code of conduct. Traditionally five main duties of a health care professional have been identified.
Do No Harm
The concept of nonmalfeasance means, first of all, doing no harm in any treatment given. This duty is found in the Hippocratic Oath. It is not taken in a literal sense because many treatments can have adverse effects. Rather, it is taken to mean that medical benefits should outweigh adverse effects.
This concept applies especially to scientific research. Guidelines for ethical research not only require informed consent but also restrict research with possible harmful effects to those patients whose conditions are so serious that doing nothing is likely to be as dangerous as the treatment or procedure being studied.
Do the Best Possible
The concept of beneficence, doing the best possible, is seen in some systems of ethics as a separate duty, whereas in
others it is considered an extension of doing no harm. It is often difficult to pinpoint exactly what harm and good are; they may vary with a particular individual’s viewpoint.
Be Faithful to Reasonable Expectations
The concept of fidelity, being faithful, comes from the Latin term fides, which means faith. In the case of medical practice, fidelity is usually interpreted as meaning faithful to reasonable expectations. Although patient expectations vary, there is general agreement that a patient can reasonably expect to be treated with dignity, treated by individuals who honor their agreements, and treated by competent providers. Patients can also expect that they will be cared for by individuals who adhere to the ethical standards of their profession, to statutory law, and to accepted medical and scientific practice.
Be a Patient Advocate
The concept of fidelity includes the expectation that patient needs come first. An advocate is a person who intercedes on behalf of another person. A medical assistant functions as an advocate for patients by suggesting appropriate community referrals to the physician, by making sure that all insurance claims are complete, by following up to help patients receive insurance coverage if additional information will make that possible, and generally by working to protect patients’ rights (see Highlight on Patient’s Bill of Rights later in this chapter).
In order to protect patient safety, it may even be necessary for a medical assistant to report unsafe or illegal behavior to proper authorities. The first step is always to follow up within the organization by reporting to the supervisor any incident or situation that could cause potential harm. If no action is taken after a reasonable amount of time, the situation should be documented in writing (as a memory aid) and reported to the next person in the chain of command. If a medical assistant has followed up within the organization without resolution of an unsafe or illegal situation, he or she should report the incident to the appropriate government agency. For example, if unsafe or illegal behavior is being exhibited by a physician or nurse, the medical assistant should report the behavior to the state authority that licenses that individual. These agencies have different names in different states—for example, Board of Registration (Massachusetts), Board of Medical Practice (Minnesota, Delaware, and Vermont), or Board of Medical Examiners (Oregon, Louisiana, New Jersey, Nevada, and others). Any type of report must be based on firsthand evidence. In most states, reports can be made online, and these reports can usually be made anonymously. Information about professionals whose licenses have been revoked or suspended is also available online in many states.
Tell the Truth
The concept of veracity has increased in importance since the nineteenth century. Veracity is not found in the Hippocratic Oath. It has developed with the evolution of the scientific tradition. Today it is seen as a proactive duty— physicians and other health care professionals must provide truthful information without having to be asked. It is a tenet of modern science that scientific knowledge belongs to all. Results of experiments must be accurate and reviewed by other scientists to see if the results can be replicated, then published for the benefit of all.
Give Each Person a Fair Share
The concept of justice requires that each individual be given his or her due and implies that he or she deserves a fair share of resources. However, there is often an underlying belief that an individual must contribute or bear a portion of the burden before being allowed to get certain resources. Justice in the context of medical practice appears not only in terms of distribution of medical resources, but also in the belief in the right to compensation if a mistake is made.
Deciding what is “fair” is difficult because different situations may require different guidelines. In the United States, the tendency is to believe in “first come, first served.” But in an emergency department, serious conditions must take precedence.
What Would You Do? What Would You Not Do?
Case Study 1
Denise Fitzgerald is a 16-year-old girl who has come to the office with complaints of a sore throat and fever. While Vicki is taking vital signs, she notices a circular wound on Denise’s arm that looks like a cigarette burn. It is red and has some crusted areas. When she asks Denise about it, the patient blushes and says in a low voice that her boyfriend burned her a few days ago to teach her a lesson. Then Denise says, “Please don’t tell the doctor because he will tell my mother, and I’m afraid she will make me break up with my boyfriend.” ■
Many issues become controversial when there is a disagreement within society about the relative hierarchy of certain rights and duties.
Conflict surrounds the issues of contraception, abortion, and other issues related to reproduction. With regard to pregnancy, some people feel that the duty to follow divine law or natural measures takes precedence over an individual’s right to autonomy. This results in differing beliefs about how appropriate it is to use contraception and artificial measures to become pregnant. There has been controversy about the “morning-after pill” (marketed under the name Plan B). Because it has been found to be relatively safe, it was approved as an over-the-counter medication for women older than age 18 by the Food and Drug Administration (FDA) in 2006.
Another controversial issue is abortion. Some argue that the fetus’s right to life outweighs the woman’s right to privacy in determining—with her physician—the proper course of her medical care. Since the original U.S. Supreme Court decision in 1973 upholding a woman’s right to obtain an abortion in any state (Roe v Wade), the Court has been called on to rule many times on various state laws that seek to limit this right. The Partial-Birth Abortion Ban Act of 2003, which prohibits a specific abortion procedure that can be done in the second trimester of pregnancy, is an example of a federal law that restricts a woman’s right to abortion in some cases. It was upheld in the Supreme Court case of Gonzales v Carhart in 2007.
Stem Cell Research
A promising area of research for medical treatment involves the use of embryonic stem cells. These cells, taken from fetal tissue, are able to mature into different types of tissue. Embryonic cells may be found to be able to reduce, or possibly even reverse, the symptoms of Parkinson disease and other diseases.
The ethical conflict arises because the cells of live human embryos may be killed during research activities. In addition, a possible source of embryonic cell tissue is from aborted fetuses or fertilized ova not used for in vitro fertilization. Researchers who use fetal tissue stress that they use only tissue from spontaneous abortions (miscarriages). Antiabortion advocates argue that if there is an increased need for fetal tissue, a time may come when women might be influenced in their decision whether or not to have an abortion if they could sell their fetus’s tissue for research and/or treatment. In 2001 the federal government introduced a policy that federal funding would be available only for research using the 64 then-existing stem cell lines. This policy was reversed in 2009, and federal funding is now available for additional stem cell lines.
Genetic Engineering and Cloning
A number of ethical issues surround the practices of genetic engineering (making, altering, or repairing genetic material) and cloning (reproducing genetically identical cells or individuals).
One is the issue of genetically engineered crops and other food products. This encompasses practices as diverse as injecting milk cows with growth hormones in order to get them to produce more milk to incorporating material from bacteria into plant seeds. Opponents argue that we cannot predict all of the possible effects of manipulating genetic material and are likely to see unexpected and unwanted consequences to ourselves or other species.
Gene therapy is a term used for experimental treatments that attempt to treat or cure disease by giving patients new genes or parts of genes that may have been synthesized in the laboratory, taken from human tissue, or engineered from genetic material of animals or other species. Research efforts are overseen by the Recombinant DNA Advisory Committee of the National Institutes of Health (NIH). A clinical study of a gene therapy treatment for arthritis was suspended in July 2007 after the death of a patient.
Human cloning is prohibited by several states, but efforts to pass legislation on the federal level have not succeeded to date. Experiments in animal cloning continue, although critics claim that it results in unhealthy animals and needless suffering. There are serious concerns about safety and health if cloned animals were introduced into the food supply chain.
Refusing or Withholding Treatment and Physician- Assisted Suicide
The right to refuse treatment is well established for adults. The 1990 Patient Self-Determination Act establishes the duty of hospitals, nursing homes, and health maintenance organizations (HMOs) to inform patients or new subscribers of their right to express their wishes related to health care and to refuse treatment. The act also establishes the right of an individual to prepare an advance directive that specifies what treatments he or she would like to receive, and what ones he or she would not wish to receive, if the individual were to become incapable of making those decisions at a later time. Courts have held an individual’s right to refuse treatment in such high regard that they have allowed mentally ill patients to refuse treatments for their mental illness.
When an individual requires resuscitation or life support to stay alive, there may come a point where it seems that the treatment is resulting in more suffering (harm) than benefit. This is especially true if it is unlikely that the person can recover his or her health or normal function. If there is a written document expressing the person’s wishes, life support may be removed or discontinued. In the absence of an advance directive, an individual’s family may bring to court a petition to remove life support. Such a petition must be supported by witnesses other than those who file the petition, stating that the incompetent individual expressed a desire to avoid being kept alive by artificial means. Life support has been interpreted to include ventilators, antibiotics, and even tube feedings.
Physician-assisted suicide and euthanasia (literally, “good death”), sometimes called mercy killing, evoke fears that the power to take life will be abused—that it will be used more for the convenience of others than for the well-being of those who are dying. Advocates for the disabled have argued that allowing physician-assisted suicide or euthanasia could be the first step in society’s determining that the severely disabled are too much of a financial and physical burden and having them euthanized.
Throughout the 1990s, an individual physician named Jack Kevorkian provided patients with degenerative, terminal illness a machine that provided an injection of lethal drugs. He was sentenced to 10 to 25 years in prison in 1999 and was released after 8 years in 2007 after he promised not to assist in any additional deaths.
In 1997, Oregon became the first state to legalize physician-assisted suicide, allowing physicians to write a prescription for a patient of a lethal dose of pain killer or other medication. The physician is not allowed to administer the medication. The U.S. Supreme Court upheld a challenge to the Oregon law in 2006. The discussion about physician-assisted suicide occurs in every state, but to date similar legislation has failed to pass in any other state.
Terminally ill patients and their families are often looking for a trusted advisor with whom they can discuss their fears and concerns. Even when a physician is not morally willing or legally able to provide a means for a patient to end his or her life, there is increasing recognition of the value of frank discussion and reassurance that patients will not be left to cope alone.
On the basis of personal beliefs, patients can formalize their decisions about treatment in terminal or end-of-life situations in a number of ways. These include do-not- resuscitate (DNR) orders, living wills, health care proxies, and organ donor cards, all of which fall under the heading of “advance directives” (Box 3-1). An advance directive may specify care to be given or avoided and name a person to make medical decisions for the individual should he or she become incompetent. This is usually a spouse, child older than age 18, member of the clergy, or close friend. Medical advance directives should always name a single individual
BOX 3-1 Advance Directives
DO-Not-Resuscitate (DNR) Order
Requested by either patient or health care agent. A written order from the physician in the patient’s medical record that allows medical staff to not resuscitate in the event of cardiac or respiratory arrest.
Executed by an individual before or during illness. Identifies the patient’s wishes about which life-prolonging actions should or should not be taken. In states that accept it, it provides instructions to health professionals about treatment to be provided and may include instructions to a health care agent as to which treatments he or she should authorize. Provisions for organ donation, autopsy, or donation of remains to a medical school are also usually included in a living will.
Health Care Proxy
Executed by an individual before or during illness. Names a health care agent who has the ability to make decisions about care, including signing a DNR order. It may also outline the types of care that the individual does or does not wish to receive. It becomes effective only when the individual becomes incapable of making his or her own decisions.
Durable Power of Attorney
A written authorization to act on the behalf of another, especially in business affairs. An ordinary power of attorney expires when a person becomes incapacitated, but a durable power of attorney remains in effect, even if the grantor does become incapacitated. An authorization limited to health care decisions only is called a durable power of attorney for health care decisions or a medical durable power of attorney.
Organ Donor Card
A card stating that an individual wishes to donate organs. Many states have done away with a separate organ donor card, preferring to place the organ-donor designation on an individual’s driver’s license.
to make decisions, with an alternate if possible. This is often a difficult choice, especially for an elderly person with several children (Figure 3-1). In addition, the patient may want to provide for donation of any organs that are useful. Organ donation (or donation of one’s entire body) and procedures for determining who may give permission if the patient has not left a directive are outlined in the Uniform Anatomical Gift Act.
Signed originals rather than photocopies of the advance directives should be held by the named surrogate, and the patient should keep copies with his or her important papers. It should also be noted in the primary care physician’s records with a copy if possible so that the surrogate can be contacted if necessary.
DNR orders should be in the medical record, and the staff should be informed of the patient’s wishes. If the patient is at home, the family must have a copy of the DNR order to show emergency personnel, who otherwise will be legally obligated to resuscitate the patient.
Removal of life support means that no form of support, including mechanical breathing, feeding, or medications to prolong life, should be given. Pain medication and sedation are continued if necessary after removal of life support.
A living will is a document executed by an individual that gives medical professionals instructions about how that person wishes to be treated in the event he or she becomes incompetent. A living will may also give instructions regarding organ donation, autopsy, or donation of the remains to a medical school for anatomy dissection. Many states allow an individual’s wishes to donate organs to be noted on his or her driver’s license or on an organ donor card that can be carried in the wallet. In the event of a fatal auto accident, the police—who usually use the license or other documents to make identification—can notify ambulance personnel that the deceased is an organ donor.
A person usually names an agent to carry out his or her wishes if he or she is unable to do so. A health care proxy names the person who is charged with this responsibility and may also give specific instructions to the designated person concerning medical issues. Laws regulating living wills and health care proxies vary from state to state, and it is important for patients to use forms that will be valid where they live. This may require the assistance of an attorney.
Personal and Professional Ethics
It is important to distinguish between personal and professional ethics. In the work situation, professional ethics usually takes precedence over personal beliefs and morals. For example, a medical assistant may believe that a parent who is paying the medical bill should be given the results of laboratory tests done on his or her child. Legally, however, after age 18, information about a patient can be given only with the patient’s consent. In this case, professional ethics requires that the medical assistant follow the law, no matter what he or she believes personally, and maintain the patient’s confidentiality.
Acting according to professional ethics means that the medical assistant cannot ethically withhold from the physician information given by the patient related to the medical condition. Even if the medical assistant does not agree with how the physician is managing a patient’s care, the medical assistant cannot ethically (or legally) suggest another treatment plan for the patient.
It is important to clarify one’s personal set of moral values and beliefs and identify areas where there may be potential conflict with professional ethics to avoid having to make a difficult decision on the spot. Using the process outlined in the following section, the medical assisting student should determine his or her own personal beliefs related to issues of potential ethical conflict. Then he or she should decide what professional ethics requires in those situations.
An individual or medical practice can look to a professional organization for guidance related to ethical questions. Medical associations publish guidelines related to medical ethics. Professional associations for medical assistants can be a source of information and guidelines. For problems affecting the medical office, a discussion by all office staff may assist in decision making (Figure 3-2).
Process Used to Make Ethical Decisions
Making ethical decisions involves measures to respond to conflict between different values and their relative importance. In order to decide on a course of action, it is helpful to clarify the conflict and make a thoughtful choice. A six- step process can be used to make these decisions. Actions should be well considered and in accordance with beliefs about what is right and wrong, rather than simply impulse reactions.
Information that needs to be gathered includes (1) background about the situation; (2) facts related to the specific
Figure 3–2 A staff meeting may be helpful to discuss problems affecting the medical office.
problem; (3) information about the people involved, such as their knowledge of the situation or their mental capacity; and (4) the laws or institutional policies that relate to the situation.
Identifying Conflicting Values
A conflict does not always involve lofty values. It may be as simple as one person’s wish to not cause problems, to save time, or to avoid a hassle. However, this desire may conflict with professional duties or with another individual’s right.
If a medical assistant is working in a facility where individual staff members do not always follow established procedures (e.g., do not always run controls for laboratory tests), the desire to go along with co-workers and avoid conflict may be strong; however, the duty to act with fidelity is not being met. The medical assistant may be personally performing the needed controls, but the knowledge that others are not doing so creates a conflict between personal reluctance to violate the autonomy of a co-worker and the professional duty of fidelity to patients.
Determining Relative Importance of Conflicting Claims
To determine the relative importance of conflicting claims, an individual needs to clarify his or her goals and weigh the conflicting values. It is important to remember that when values conflict, an individual or group makes a decision about importance that is valid within its own context but may not conform to the values of other individuals or groups.
For example, in the case of abortion, some people believe that the right of a fetus to life outweighs all other rights. Others believe that a woman’s right to autonomy in medical decisions about her body, and the consequences to a child of being unwanted, diminish or outweigh the absolute right to life in the early stages of a pregnancy.
Once it has been established which values are more important, it is important to consider the possible outcomes of possible actions. It is helpful to identify as many courses of action as possible, predict the consequences of each action, and project how different goals would be met or not met by following each possible course of action.
Choosing and Justifying One Alternative
Conflicting claims require choices. By analyzing hypothetic situations in detail, a person can construct some sort of personal framework for ethical decisions; once on the job, there is often little time to analyze each situation individually.
In the end, there are four ways to justify a decision:
Implementing the Decision
The final step in this process is to put the ethical decision into action. This does not have to be a permanent solution. The decision can be reconsidered and another solution can be tried, or the question can be reconsidered at intervals to see if circumstances, beliefs, or knowledge has changed.
INTRODUCTION TO LAW
Difference between Public Law and Private Law
The legal system in the United States is primarily divided into two parts, public law and private law. Public law refers to laws that define the relationship between the individual and society as a whole. The term criminal law is used to refer to the set of laws that protect society. Examples include laws against robbery, rape, and operating a motor vehicle while under the influence of alcohol or a controlled drug. Private law, also called civil law, is the set of laws that deals with disputes between individuals and/or groups of people. This may involve two individuals or groups of people; individuals and corporations, government, or other organizations; or one corporate, government, or organizational entity and another such entity. Contracts are considered a part of civil law, and disputes about contracts that go to court are tried as part of the civil court system.
Both civil and criminal action disputes can lead to lawsuits that are tried in the court system. In any court proceeding, there is a plaintiff, the person or entity that makes the complaint, and a defendant, the person or entity against whom a lawsuit is brought. In a criminal lawsuit, the plaintiff is the district or state’s attorney, a representative of the government. In a civil lawsuit, the plaintiff is the injured party.
In criminal law the criminal activity itself is held to be harmful or potentially harmful to society or individual members of society. The act itself is punishable, regardless of whether anyone was actually harmed by the act. In civil law, an injury or damage must result because of someone’s wrongful act for liability (legal responsibility) to arise. The same misdeed can provoke both a criminal charge and a civil lawsuit. The criminal suit will determine if the person is guilty of committing a crime punishable by an imprisonment or fine paid to the government. The civil suit will determine what liability the person has to the injured party, if any.
A well known example of this dual legal picture is the
O. J. Simpson case. Simpson was found not guilty by a jury of the murder of his ex-wife, Nicole, and her friend, Ronald Goldman. However, her estate filed a civil suit against him on the grounds of “wrongful death.” In the civil case, he was found liable for their deaths, and more than 30 million dollars was awarded in damages. In a criminal case the charge must be proven “beyond a reasonable doubt,” but in a civil case the burden of proof is only to a level at which the supporting evidence is more convincing than the opposing evidence (“a preponderance of the evidence”).
Specialized Areas of Public Law
Specialized areas of public law include constitutional law, international law, and administrative law. Constitutional law is the study of law of countries and other political organizations. International law concerns the relationships among countries and includes maritime law and regulations applying to ocean-going vessels. Administrative law arises from the actions of federal government agencies, such as the Social Security Administration and the Internal Revenue Service.
Creation of Laws
Law was created by tradition through accepted social practices and decisions of the courts. This type of law is called common law or case law. Today most laws are created through a vote by a legislative body. The term for this is statutory law. Legislators are elected by popular vote to serve either in the state or federal legislature. One of their important duties is to draft new legislation, which is called a bill while it is under consideration. Once passed by either the House of Representatives or the Senate, a bill that contains several parts becomes an act. Once passed by both houses, the act is signed into law by the President (for a federal law) or a state governor (for law applicable to one state). Cities and towns can also enact laws, called ordinances; these usually have to do with local issues, such as smoking in public places, parking, leash laws for pets, and curfews at parks.
All employees of the medical office must be aware of the federal and state laws that regulate the provision of health care and insurance reimbursement, as well as those related to the operation of a business.
The branch of law that describes offenses against the public welfare is called criminal law. A crime is an offense in violation of a law that prohibits or requires certain behavior. When a person is convicted of a crime (or pleads guilty to a crime), punishment is imposed. A felony is a serious crime, punishable by death or imprisonment in a state or federal penal institution for more than 1 year. A misdemeanor is a less serious crime, punishable by a fine or imprisonment for less than 1 year, often in a local or county penal institution. Another term sometimes used to describe a criminal act is malfeasance—a wrongdoing that is illegal or contrary to official obligation.
Occasionally a physician is charged with manslaughter or criminal negligence if a patient dies or sustains serious injury as a result of incorrect or negligent treatment. This is usually in addition to a civil lawsuit brought by the patient or family for wrongful death (see the discussion of professional malpractice later in this chapter). Euthanasia and assisted suicide (except for physician-assisted suicide in Oregon) are usually considered murder whether performed by a health professional or family member.
Two or more people who have joined together to commit an unlawful act may be accused of conspiracy; this may be applied to actions that are illegal in and of themselves, or actions to prevent detection of a prior crime.
Stealing another person’s property (without violence) is called larceny. In the medical office, this may take the form of embezzlement—appropriating funds from a client, customer, or employer.
A growing problem in the health care industry is fraud— deliberate deception carried out to secure unfair or unlawful gain. Billing for services not provided, billing for services provided to imaginary patients, performing unneeded services, and even deliberately using codes from a higher level of service than that provided are all forms of insurance fraud. Every instance of such a billing can be considered a separate act. If the fraud involves the use of mail (mail fraud) or electronic resources (wire fraud), it becomes a federal offense.
In the mind of an office employee, there may be a difference between billing an insurance company using a code for more complex service than was actually provided, “because they pay us so little anyway,” and billing for procedures that were never performed. But from a legal perspective, both are considered fraud and, if proved, both carry serious penalties.
Insurance companies and agencies of the federal and state government are victims of billions of dollars in fraudulent claims each year. They have increasing incentives to investigate health care facilities they suspect of fraudulent billing.
The branch of law that regulates interactions among individuals, groups, organizations, and the government is civil law. Disputes arise when one individual or group believes that the actions of another individual or group have caused personal injury or damage to property. In medical offices these usually relate to the actual care received by the patient and/or the relationship between the patient and the physician or office staff. Two types of obligations that may give rise to civil lawsuits are contracts and torts.
Contracts involve agreements between two or more parties and are discussed in detail later. If a contract exists, failure to meet the terms of the contract by either party is called a breach of contract. A tort is an injury or wrong against a person or property that does not involve breach of contract. If a person knows, or should know, the
BOX 3-2 Intentional and Unintentional Torts
Abandonment Failure to continue to provide medical care to a patient without proper notification.
Assault Threat to touch another person or his or her property without permission in a way that will cause pain, injury, or damage or is offensive.
Battery Touching of another person or his or her property without permission in a way that will cause pain, injury, or damage or is offensive.
Defamation Making a false claim that may harm a person’s reputation, business, or group. If the claim is made verbally, it is called slander. If the claim is made in writing, it is called
False imprisonment Confining a person without legal authority, such as using restraints without a proper physician order.
Invasion of privacy Public disclosure of private information, such as releasing medical information or photographs without consent of the patient.
Misrepresentation Providing information with knowledge that it is incorrect or reckless disregard for the truth.
Negligence Failure to act with reasonable prudence in a situation. Negligence by a professional is also called malpractice.
Strict liability Responsibility for injury, even if there was no negligence. This is often applied when individuals are injured by products or equipment.
consequences of his or her action, the wrong is called an intentional tort. If the action is a mistake or has unintended consequences, it is called an unintentional tort. See Box 3-2 for a list of torts. Keep in mind that intentional torts may also be prosecuted as criminal acts if they are performed with specific intent to cause injury.
Two other terms may be used for acts that can result in civil lawsuits. The term misfeasance refers to a legal act performed in an improper way, especially if it causes injury or damage. The term nonfeasance means failing to perform an act that should have been performed to prevent injury or damage.
LAW AND PROFESSIONAL LIABILITY
The physician-patient relationship is a contractual relationship. Each party has certain rights and responsibilities under the relationship.
Several elements must be present in order for there to be a contract:
A contract does not have to be written or sometimes even discussed in detail. When clothes are left for dry cleaning, it is assumed that there will be an obligation to pay for the service. The same is true if a patient makes a visit to a medical office. Written contracts are used when there is a considerable amount of money at stake (such as a car loan or mortgage), and in the medical office a patient may be asked to sign a statement confirming that payment will be made for any charges not covered by insurance.
Certain groups of people are not legally able to be a party to contracts, including most medical care contracts. These people are also not able to give informed consent. Such groups include the following:
All consent forms should be signed and all implied contracts made with a competent party acting as a willing health care decision maker for the child or incompetent person. In some circumstances, adult rights, including the right to consent to medical treatment, are given to individuals younger than the age of 18. Such an individual is called an emancipated minor. In most states, an individual between 14 and 18 years old can obtain a court order from a judge to become free of control of a parent or guardian after proving the ability to be financially independent.
Within the physician-patient relationship, the physician provides skillful care to the patient and continues to treat the patient unless he or she informs the patient that the relationship will be terminated. In this case the physician must give the patient time to make other arrangements for care. The physician arranges for someone else to treat the patient if the physician is unavailable (such as on nights, on weekends, and during vacations). The physician informs the patient about treatments or procedures and carries out only those treatments and procedures to which the patient consents. The physician informs the patient of test results, diagnoses, and medical conditions and gives the patient instructions for follow-up care and procedures to follow at home.
A physician has the following rights:
size or certain specialty
Decisions not to treat particular patients must be based on general principles (such as limiting a practice to urology) rather than arbitrary decisions (based on a whim or subjective judgment).
The patient agrees to keep appointments, give accurate information about his or her medical condition, provide an accurate medical history, follow directions, and pay for service.
The patient has the following rights:
Patients’ rights may be legally defined by the state or an institution. The Patient’s Bill of Rights is a name that is often used to refer to the Consumer Bill of Rights and Responsibilities, which was adopted by the Presidential Advisory Commission on Consumer Protection and Quality in the Health Care Industry in 1998 (see Highlight on the Patient’s Bill of Rights). This document was created to improve consumer trust in the health care system by defining the rights and responsibilities of consumers, health care professionals, health care institutions, and insurance plans. The Bipartisan Patient Protection Act (also known as the McCain-Edwards-Kennedy Patients’ Bill of Rights) was an attempt to enact the findings of this commission into federal law. It failed in the U.S. House of Representatives in 2002. In the next decade, most individual states did pass legislation defining what was commonly called a “patient’s bill of rights,” although the focus varies from state to state. Some concentrate primarily on rights of patients in residential facilities, whereas others have a broader scope. The federal Patient Protection and Affordable Care Act, which became law in March 2010, has shifted focus somewhat from merely defining patients’ rights to ensuring that all Americans will have access to affordable, high-quality health care and preventative care.
Terminating the Physician-Patient Relationship
To end a relationship with a patient, a physician must notify the patient in writing. It is recommended that such a letter be sent using certified mail with return receipt requested. The letter needs to be dated, must state the reasons for termination of care, and should describe how medical records will be made available. Copies of any correspondence regarding termination and receipts should be kept in the medical record. If the patient notifies the physician by telephone that he or she wishes to terminate the
Highlight on the Patient’s Bill of Rights
Eight areas of consumer rights and responsibilities were emphasized in the Consumer Bill of Rights and Responsibilities that was adopted by the President’s Advisory Commission on Consumer Protection and Quality in the Health Care Industry in 1998.
their health care. If they cannot make their own decisions, they have a right to be represented by parents, guardians, family members, or others.
relationship, the physician should send a similar letter as documentation.
Common reasons for a physician terminating care of a patient include the following:
If a patient can convince a court that he or she was under the belief that a physician-patient relationship still existed and because of such belief did not seek out another practitioner, and sustained injury, a successful case can be made for abandonment. This is rare and should never happen if the physician keeps good written records about any termination notification.
Personal and Professional Liability
A person is responsible for his or her actions and may be held liable if those actions injure another person. In daily life we are required to act as a reasonable person would act in the same circumstances. The failure to act—or refrain from acting—as a reasonable person would act in similar circumstances is called negligence.
A common example of negligence relates to a wet floor. If someone washes the floor or spills water on the floor and does not wipe it up, the floor becomes slippery. When an unsuspecting person comes along and is not aware that the floor is wet, that person could slip and be injured. The person responsible for making the floor wet would be expected to know that the wet floor would be slippery and could cause someone to fall. A person who notices the spill would also be expected to know that the wet floor could cause a fall.
If a person falls, is injured, and files a lawsuit, the person who washed the floor, or another person with responsibility for public safety who noticed the spill, could be found to be negligent and be responsible (liable) to pay for the injured person’s medical care, lost wages, and any other costs caused by the fall on the wet floor.
Standard of Care
A person without any special training is held only to the standard of a “reasonably prudent person.” The term prudent means careful or using common sense. For instance, any reasonably prudent person is expected to realize that an infant or unconscious person will not be able to remove a heating pad that is too hot. If an infant or unconscious person is burned by a heating pad, the person who placed it will be considered liable and will be responsible for medical bills as well as compensation for pain and suffering.
A medical assistant is generally held to a professional standard, especially when performing procedures that are often done by a licensed health professional. The medical assistant must be especially careful to avoid offering advice or making decisions that may be interpreted as diagnosing illness or prescribing treatment.
If the medical assistant administers medication, he or she must do so correctly and must follow proper procedures and precautions to protect the patient from injury. A physician must be on the premises (not necessarily in the room) any time medication is given by a medical assistant, because in most states the medical assistant can perform the procedure only under the authority and supervision of a physician. It is important for medical assistants to find out what they are legally allowed to do in the state where they work.
In emergency situations, when no qualified professional is available, health care practitioners are expected to give care for which they have been trained but at which they may not be proficient. For instance, any physician would be expected to initiate emergency care for a patient who suddenly goes into cardiac arrest, even a specialist such as an ophthalmologist. Patients make an assumption that in a medical office they will receive medical treatment, even in the event of an emergency. All medical office personnel are expected to be able to give advice in an emergency or to activate the local emergency medical system if they cannot handle the situation.
Many, if not most, medical offices train all of their personnel in cardiopulmonary resuscitation (CPR) and first aid. If a medical assistant, secretary, or receptionist tells any patient that a problem is not serious, and it is, then he or she may be liable if there is injury to the patient caused by delay of treatment. Failure to respond correctly to an emergency can be considered a “breach of contract” because there is an implied contract between a patient and a medical office that any emergency will be handled by competent staff.
Health professionals are generally held to a high standard of care. For physicians and other health professionals, the term standard of care defines the level of appropriate care legally required of any other practitioner with the same education and training providing the same care in the same geographic region. In general, if a legal question arises, a medical assistant will be held to the standard of care of the professional who would normally perform the care in question.
For example, if a family practice physician prescribes blood pressure medication, he or she has to do it as competently as another family practice physician in the same area. If a nurse practitioner prescribes blood pressure medication, he or she has to meet the same standard as the family practice physician. If a patient sustains injury from taking the medication, in either case, the court would look at the appropriateness of the medication for the particular patient, the dose, and the follow-up to see whether either practitioner has acted at an acceptable level.
Consent can be implied by a patient’s actions. If a medical assistant says, “Would you please roll up your sleeve so that I can give you an injection?” and the patient does so, the patient has given implied consent to the medical assistant to administer the injection. Even though the patient has not verbally agreed, the act of preparing for the injection suggests that the patient is willing to undergo the procedure.
Expressed consent can be verbal or written. We know, however, that simply expressing consent does not always represent understanding. Patients today have the legal right to completely understand what will be done to them or for them. For this reason, many medical offices now use written consent forms to obtain informed consent.
Written consent forms are now always used for surgery, for procedures involving entry into a sterile body cavity, for procedures that carry a risk to the patient’s health, and for testing for human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). Written consent forms are increasingly being used as well for immunizations; treatment with birth control pills; transfusions of blood or blood products, such as plasma; and other treatments and procedures.
Legally, it is not the form, but the understanding by the person on whom the treatment or procedure will be performed, that truly represents consent. It is the responsibility of the person performing the procedure, prescribing the medication, or performing the test or examination to inform the patient about the potential risks of the action, the discomfort it may cause, the common side effects, the importance of the procedure, and the probable results if the test or procedure is not done (Figure 3-3).
Often the medical assistant is asked to obtain the signature on the consent form and witness that signature. If the
medical assistant believes that the patient does not fully understand what he or she is consenting to, the matter should be referred back to the physician. This is a good example of the medical assistant acting as a liaison between the patient and the physician and being an advocate for the patient.
Depending on state law, there may be special consent forms for the release of information about HIV test results and/or treatment, drug and alcohol rehabilitation, services for mental health, or other health-related information.
A patient can rescind (withdraw) the authorization to release information at any time by notifying the medical office in writing.
Case Study 2
Howard Morton is a 72-year-old patient who has come to the office for an office visit for severe back pain. After examining him, the physician referred him to an orthopedic surgeon for evaluation. While Vicki is preparing the referral form for Mr. Morton, he says, “If I see an orthopedic surgeon, he is probably going to want to do surgery. Do you think surgery is the best treatment for my kind of problem? What else could I try? Should I see a chiropractor? Or do you think acupuncture might help?” ■
anesthesia). In such a case a lawsuit may be allowed under the doctrine of res ipsa loquitur, whereby the court assumes that negligence must have occurred because of the type of injury. An example would be if the gallbladder was removed when the patient was scheduled for a hysterectomy.
A physician who gives casual medical advice at a party may not consider the person a patient he or she has a duty to take care of. But if the person fails to seek medical treatment on the basis of the physician’s casual words, a court may have to decide if the physician owed a duty to the person.
If a professional does exactly what any other professional would have done and the patient has a poor outcome, the physician is not necessarily negligent. For example, even with the best sterile technique it is possible to get a wound infection. A person with a wound infection must show that proper technique was not used. If the injured person does not follow directions to keep the wound dry and the wound gets infected, the infection might have occurred because the patient did not follow directions.
If someone makes a mistake but there is no injury, the person who makes the mistake will not be liable and will not have to pay any damages. Many mistakes can be corrected if they are reported promptly.
Professional negligence is often called malpractice. To avoid lawsuits for malpractice, a health professional must be sure that he or she is acting within the limits of his or her profession and must act (or refrain from acting) in a given situation as a reasonable and prudent person of the same profession would. When the medical assistant performs procedures that are usually performed by other professionals, such as nurses, the medical assistant will be held to the same standard as the professional who usually performs the procedure. No one always does everything perfectly, and both negligence and malpractice are assumed to be mistakes and unintentional.
Requirements to Prove Professional Negligence
To prove that a professional is guilty of professional negligence and liable for the outcome, four things must be proved by a preponderance of the evidence. This means that they are more likely than not. Sometimes these things are called the 4 Ds of malpractice:
In some instances the plaintiff has no direct knowledge of the incident (e.g., if the plaintiff is under general
Professional Liability Insurance
To protect against financial loss if the patient sues, physicians usually have professional liability insurance (also called malpractice insurance). This is for two reasons. One is to protect physicians for their own negligent actions. The second is to protect physicians if they are sued for the negligent actions of their employees while on the job.
If an injury occurs, the law allows the injured person to sue both the person responsible for causing the injury and that person’s employer, provided that the incident occurred at work. This occurs under what is known as the doctrine of respondeat superior. The English translation of this Latin term is literally “let the master answer,” meaning let the person at the head of the organization answer for the injuries caused by his or her employees.
This legal doctrine provides an incentive for employers to be sure that their employees are careful and gives the injured person a better chance of collecting damages for any injury. Even if the employee does not have insurance to cover such an incident or enough money to pay the amount received in judgment, the employer ought to have liability insurance. As the number of lawsuits for outpatient care increases, it is recommended that medical assistants carry their own malpractice insurance.
Laws that protect health professionals from being sued for giving emergency care at the scene of an accident are called Good Samaritan Acts. They vary from state to state and may cover physicians, nurses, emergency medical technicians, anyone certified to perform CPR, and other professionals.
Litigation (the process of taking a lawsuit or criminal case through the courts) is complex. Having a general understanding of the process is important, even though less than 5% of all lawsuits brought against medical professionals or medical institutions ever reach the stage of going to trial.
Initiating a Lawsuit
A person who believes he or she has received inappropriate medical care consults an attorney, who obtains information from the patient and usually tries to obtain copies of the relevant medical records. A letter containing a patient’s authorization to send a copy of medical records to a lawyer may be the first indication to the medical office that the patient is actively contemplating a lawsuit.
After receiving written authorization from the patient, the medical office provides a copy of the record to a lawyer. Under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), health care facilities, including physicians’ offices, are allowed to charge a reasonable copying fee for records sent to an attorney or requested by a patient.
At the time a lawsuit is actually filed, the patient signs a document releasing the physician from the requirements of patient confidentiality. This is necessary because information about the patient’s medical record becomes part of the public record in the litigation process.
When he or she obtains the patient’s medical records, the attorney has them reviewed by physicians or other health professionals uninvolved in the patient’s treatment to determine if a case can clearly be made for malpractice. Appropriateness of care is clearly the major issue in a suit for malpractice. However, incomplete, illegible, or altered records decrease the medical record’s credibility, even if the care actually given was appropriate.
Most malpractice suits are accepted by attorneys on a contingency basis. In such a case the individual filing the lawsuit pays for the attorney’s time and effort only if he or she collects an award from the party being sued. This is usually a percentage of the settlement or judgment amount. Contingency payments to the attorney are usually from 20% to 40% of the amount collected.
Response to a Possible Lawsuit
The first thing a physician should do on receiving a request for patient records by an attorney or on being served with notice of a lawsuit is to inform the company that provides his or her professional liability insurance. If a suit is filed, the malpractice insurance provider will appoint an attorney to represent the physician as a policyholder. The physician may also wish to hire an independent attorney because the physician’s interests are not always the same as the malpractice insurance carrier’s. If other staff members are named in the lawsuit, it may be in their best interest to hire their own attorneys as well.
As the legal process continues, the attorneys usually negotiate a settlement in order to avoid the time and expense of going to court, as well as the possibility of a large damage award. Because juries are unpredictable, the attorneys appointed by the insurance provider will hesitate to risk a jury trial, even if there does not appear to be any negligence in the care provided to the plaintiff. If there is a lawsuit, the court may issue a subpoena, a court order that requires an individual to be present to testify during some part of the trial process. In order to require that the original medical record is present, the court will issue a subpoena duces tecum, a court order requiring that documents (or other material evidence) be made available. An employee of the health care facility should bring the original medical record to court each day that it is required and be present wherever the medical record is at all times.
Alternative Dispute Resolution
Instead of a trial, both parties may agree to have their dispute decided by a neutral third party. This process can reduce time, expense, and publicity of a dispute. Such a process may take the form of mediation or arbitration.
Mediation uses a facilitator to help two parties in conflict settle their differences. This can be done in different ways, and if no settlement is reached, either party may find recourse in the court system.
Arbitration is a process whereby a neutral party settles the dispute. The arbitration can be either binding or nonbinding.
In nonbinding arbitration, the parties do not have to accept the decision and one party can proceed with a court case. In binding arbitration, the parties agree at the beginning to be bound by the decision of the arbitrator(s).
Various organizations provide lists of arbitrators, and depending on the circumstances and applicable state law, the parties in arbitration either select a mutually acceptable arbitrator or are assigned one from a list prepared during the arbitration process.
Arbitration is not common in malpractice cases; it is far more common in commercial contract and labor contract disputes.
Privilege is a special right or permission granted to a certain group of individuals. For example, a health care facility’s policy and procedure manual may give physicians the power to order soft restraints or leather restraints for a patient in certain circumstances. With such an order, other health professionals may legally apply the restraints. A patient who is placed in restraints according to established procedures could not make a case for false imprisonment, an intentional tort.
Consent has been already discussed in detail. A patient may be asked to sign a consent form allowing photographs to be taken and published in a medical journal or textbook, or used as a slide in a lecture (without personal identifying information) for the purpose of providing education. If informed consent was obtained, especially if it is in writing, the patient cannot make a case for invasion of privacy.
Self-Defense or the Defense of Others
Self-defense or the defense of others is another defense against intentional tort. When physical contact occurs, a person accused of assault and/or battery may assert that he or she was defending against contact initiated by another person.
Expiration of the Statute of Limitations
Several defenses can be used against a charge of negligence or malpractice. The statute of limitations is the law that limits the time period during which a person can sue. The period varies from 1 to 3 years, depending on the laws of the particular state and whether the suit is for negligence or malpractice (negligence usually has a shorter statute of limitations than malpractice).
Although state law can vary slightly, the statute of limitations usually begins at one of three points:
Contributory or Comparative Negligence
If the injured person has played a part in causing the injury, some states regard this as a complete defense (contributory negligence). Other states determine comparative
negligence—how much of the negligence was caused by the professional and how much was caused by the injured individual. Judges and juries are asked to assess damages to the injured party depending on the percentage of the injury caused by the health care professional.
For example, after minor surgery a patient developed a wound infection that required additional surgery and resulted in an unsightly scar. The physician’s attorney brought out that the patient had failed to seek medical attention for several days after noting swelling, drainage from the wound, and a fever of 102° F. Prompt medical attention, the attorney argued, would have prevented the second surgery and minimized scarring.
In a state using contributory negligence, establishing that the patient contributed to the injury would be a complete defense and the patient would not collect any damages. In a state using comparative negligence, the judge or jury would determine a percentage for the amount of negligence on the part of the physician and award the patient that percentage of the total damages established by the court.
Assumption of Risk
A patient who does not follow medical advice becomes responsible for any problems that occur as a result of his or her decision. This is called assumption of risk. This is easier to establish if the patient has signed a waiver, such as a form acknowledging that a patient is leaving the hospital against medical advice. In the medical office, there is usually no form for the patient to sign, so a complete note should be written in the patient’s medical record if he or she refuses to follow medical advice. This note should include the patient’s exact words if possible, and the name of any staff or family member who was present during the discussion. If a patient frequently misses appointments, it is also an example of disregarding medical advice. By documenting all missed appointments, the medical assistant can provide evidence that the patient, not the physician, is responsible for any problem that may arise.
What Would You Do? What Would You Not Do?
Case Study 3
While walking down the hall to call the next patient, Vicki notices a large wet area on the linoleum floor of the hall. She gets several dry paper towels and goes to clean up the spill. Just as she bends over to wipe up the water, the physician comes out of examination room 4. He looks at the open door of his other examination room, and noticing that it is empty, he says, “Where’s my next patient? And can you take an ECG on the patient in room 4 right away?” ■
FEDERAL AND STATE LAWS AFFECTING THE MEDICAL OFFICE
Controlled Substances and Prescriptions
The Drug Enforcement Administration (DEA) enforces the Controlled Substances Act of 1970. A controlled substance is a drug that has a potential for addiction and/or abuse. Physicians who prescribe controlled substances must register with the DEA and renew their registration every year, but the physician’s DEA number should not be preprinted on prescription forms. The DEA updates the five schedules of controlled substances annually. Schedule I controlled substances have the highest potential for abuse and currently have no accepted medical use in the United States, whereas Schedule V controlled substances have the lowest potential for abuse. The specific medications are discussed in more detail in Chapter 26.
Federal law requires that controlled substances be stored away from other medications, in a sturdy, locked cabinet. It is recommended to use a double-locked box or drawer—a box or drawer with an outer lock or key and an inner compartment that also has a lock or key. A physician may not legally obtain Schedule I controlled substances unless participating in an authorized experiment. Schedule II controlled substances are ordered from a manufacturer or a distributor using federal triplicate order form DEA Form 222. Schedule III through V controlled substances do not
require the special triplicate form; however, they do require that invoices and packing slips be kept for 2 years.
If controlled substances are kept in a medical office, an inventory sheet must be maintained. The controlled substance stock should be counted daily and verified by a second person. The two people must sign the inventory sheet. Every 2 years, a record of daily inventory of controlled substances must be submitted to the DEA. If controlled substances need to be wasted or destroyed, two witnesses must sign the inventory sheet. If any controlled substances are stolen, local police must be alerted immediately.
Prescribing, dispensing, and/or administering controlled substances also requires documentation. States vary on what paperwork is necessary; some require a special narcotic prescription form for Schedule II prescriptions. Any physician copies of controlled substance prescription forms should be kept in a secure, fireproof safe or other storage. If controlled substances are administered or dispensed only rarely, records can be kept in the patients’ records and made available to DEA investigation.
A medical assistant must know the legal requirements regarding controlled substances that have been set by the DEA and the state in which he or she works. A medical assistant will often be responsible for flagging the physician’s DEA registration renewal date, as well as for providing security and inventory record keeping for all controlled substances. A medical assistant may also be responsible for properly disposing of expired controlled substances and keeping records. In some states medical assistants are not permitted to administer controlled substances, although they are allowed to administer other medications.
Federal law also identifies drugs that require a prescription. A prescription is an order from a physician or other licensed health care provider to a pharmacist to dispense a supply of medication. Individual states have different regulations within a set of federal guidelines. The medical assistant must know the laws of the state in which he or she works.
In order to prevent theft or alteration of prescriptions, it is recommended that physicians adhere to the following recommendations:
The physician may also write on the prescription whether a generic substitute may be provided. Different states have different laws regarding substitution of a generic preparation for a brand-name drug.
Federal and State Laws Protecting Employees
Hiring and Firing
A person who works for an organization that has more than 15 employees is protected by federal Equal Opportunity Employment laws (Title VII of the Civil Rights Act of 1964) and the federal Age Discrimination in Employment Act of 1967. These laws make it illegal for a company to discriminate in hiring practices on the basis of race, sex, religion, national origin, or age. Some states also have legislation making it illegal to discriminate on the basis of sexual orientation. Complaints about discrimination in hiring are submitted to the federal Equal Employment Opportunity Commission (EEOC).
Employment policies must treat employees equally and cannot discriminate against any category of employees by paying one group (such as men) more than another group for the same duties.
Preemployment testing is allowed only to determine if the potential employee has the skills and abilities to perform a specific job. If keyboarding is included in the job description, the employer may administer a keyboarding test to test a candidate’s qualifications for the position. This also applies to any testing done before an individual with a disability is hired.
The Americans with Disabilities Act (ADA) discusses the need for employers to make “reasonable accommodations” for any individual with a physical or mental disability who is otherwise qualified to perform the tasks necessary in the job. The law also deals with the necessity of making public accommodations accessible to disabled individuals. The EEOC also hears complaints about possible failure to comply with the workplace portions of the ADA.
Preemployment drug tests have been ruled legal for any position. However, random drug tests while on the job are usually legal only if the demands of public safety outweigh the employee’s right to privacy. Some health care facilities perform drug tests on all new employees.
Occupational Safety and Health Act of 1970
The Occupational Safety and Health Administration (OSHA) was created in 1970 to be the federal agency responsible for the physical protection of employees in the workplace. OSHA regulates all workplace environments but has two specific functions related to the medical office. The Bloodborne Pathogens Standard relates to preventing exposure to pathogens that cause disease. This standard is discussed in detail in Chapter 17. OSHA also regulates the exposure of employees to hazardous chemicals in the workplace and requires employers to inform employees of the hazards of any chemicals used. See Chapter 18 for a discussion of the Hazard Communication Standard. The 1988 Clinical Laboratory Improvement Amendments, which regulate office laboratories, are discussed in detail in Chapter 29.
Family and Medical Leave Act
The Family and Medical Leave Act of 1993 (FMLA) applies to employers with 50 or more employees. Under FMLA, employees are entitled to up to 12 weeks of unpaid leave to accommodate a serious health crisis of any family member or the birth or adoption of a child. The employee must notify the employer before the beginning of the leave how much of the leave he or she intends to take. After the employee returns, he or she must be given former job and seniority status.
Sexual harassment is defined as any unwanted physical or verbal sexual attention from anyone an individual interacts with on the job that causes that individual to fear reprisal if the attention is refused. Sexual harassment is not flirting. Flirting occurs when both parties engage in actions or verbal exchanges intended to attract or compliment the other. Harassment occurs when one party (most often a man) engages another party (most often a woman) in unwanted comments or physical contact of a sexual nature. If a comment or attention is unwanted, it should be clearly stated to the offending party. Sometimes individuals hesitate to “hurt the other person’s feelings” or are uncomfortable speaking out, and communication is unclear.
Minimum Wage and Overtime
The federal Fair Labor Standards Act regulates the minimum wage, although some states have a higher minimum wage than that set under federal law. The Fair Labor Standards Act also requires overtime pay of one-and-one-half the employee’s regular rate of pay for time worked beyond 40 hours in 1 week. Professional and supervisory employees are exempt from the law. Registered nurses and office managers are considered professional employees, but medical assistants are not and are covered by the overtime rules.
Employee Retirement Income Security Act
The Employee Retirement Income Security Act of 1974 (ERISA) regulates employee benefit plans, including managed care health plans, pension plans, and other employee benefits. ERISA sets minimum standards for pension plans to prevent unfair denial of pension rights. Under ERISA, employee health plans cannot use health status or medical condition to deny certain employees the right to insurance.
Health Insurance Portability and Accountability Act of 1996
HIPAA provides legislation related to several aspects of health insurance, privacy of patient information, and standards for filing health insurance claims electronically. This act has several sections.
Health Insurance Availability and Coverage
The first part deals with health insurance availability and coverage. It provides specific regulations for group health insurance plans to prevent eligibility rules that exclude patients with certain diagnoses or genetic conditions or require them to pay higher premiums. It also regulates the length of time that group health plans can refuse to pay for preexisting conditions, especially if the new subscriber had other health insurance before enrolling in the group insurance plan.
The HIPAA Privacy Rule (one part of the law) went into effect in 2003. This rule provides patients with control over the use and disclosure of their health information. The Privacy Rule contains provisions that describe how personal health information may be used, stored, maintained, or transmitted electronically. In addition, it describes how patients must be informed of their right to control their health information.
Transaction and Code Set Rule
The Transaction and Code Set Rule prescribes electronic data interchange standards for structuring information that must be used for Medicare and Medicaid insurance claims. As of July 1, 2005, almost all providers that file Medicare claims electronically must adhere to these electronic data interchange standards.
The Security Rule complements the Privacy Rule by setting standards to maintain security of personal health information that is transmitted electronically. It identifies administrative, physical, and technical security safeguards for electronic protected health information (EPHI). The final compliance date was April 21, 2006.
The Unique Identifiers Rule established a new provider identification number called the National Provider Identifier (NPI), a 10-digit identification number issued to each provider by the Centers for Medicare and Medicaid Services (CMS). The NPI replaces other physician insurance identification numbers but not the DEA number or state physician license number.
The final part of HIPAA is the Enforcement Rule, which describes penalties for violating HIPAA rules.
Health Information Technology for Economic and Clinical Health Act
The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009, includes incentives to encourage adoption of electronic medical records by physicians and health care facilities and to create a national health care infrastructure. This act also includes a 1% reduction in the Medicare fee schedule if an electronic medical record has not been adopted by 2015.
In order to continue to protect the individual’s right to privacy in the face of increased sharing of health care data, this act also increases the security provisions of HIPAA and adds increased financial penalties for privacy violations. It requires notification of patients for unauthorized use and unencrypted disclosure of PHI; breaches involving more than 500 patients must be reported to federal agencies and sometimes local media. Privacy requirements are imposed directly on business associates, whereas formerly, health care providers were required to have contracts with business associates. Business associates also become liable for financial penalties for privacy violation.
For public health reasons and the good of society as a whole, physicians are required to make certain reports, usually to a state or local agency. Some are required by law and cannot be refused because the patient does not want the information released.
Failure to make a mandated report is a crime. When a report is required by law, the patient should be informed why the report is required and to whom the report will be made.
State Regulation of Health Occupations
The laws that regulate the practice of medicine are called medical practice acts, and they generally contain the following two elements:
Physicians can also be licensed in most states if they have held a medical license in another state for more than 5 to 10 years. This is called reciprocity or reciprocal licensing. Usually this is simply a matter of requesting a license if a physician is moving from one state to another. In states with many physicians, reciprocal licensing is more difficult to obtain. Florida severely limits reciprocal licensing in an effort to keep older physicians from “retiring” to Florida and then opening practices or taking hospital or clinic jobs.
The physician licensing board approves the original application for a license then renews the license yearly or biannually (every 2 years).
Revoking or Suspending a Physician’s License
A physician licensing board can revoke or suspend a physician’s license for conviction of a crime, unprofessional activity, and physical or mental incapacity, including alcoholism, drug abuse, and senility. If the physician is convicted of a crime, the seriousness and nature of the crime will influence the physician licensing board’s decision about the length of time a person’s license may be suspended.
Similar laws govern the licensure and revocation of licenses for such professionals as registered nurses, nurse practitioners, and physician assistants. These laws clarify what the member of the profession can and cannot do.
BOX 3-3 List of Health Care Facilities That May Be Licensed by the State
Facility Licensing and Accreditation
Each state requires certain types of health care facilities to obtain a license. This gives the state oversight into the activities of the facility and allows for on-site surveys to maintain quality standards. A list of these types of facilities can be found in Box 3-3. Physician offices are usually not included, but if laboratory testing is done in the office, it may be necessary to get a license or certificate of waiver for the laboratory depending on the type of testing being done. Health insurance companies and HMOs are also licensed by the state, which sets certain requirements for their business operations.
In addition to state licensure, health care facilities that bill Medicare and Medicaid for services fall under CMS oversight and are responsible for meeting all regulatory standards.
The CMS also participates with state and private agencies to regulate clinical laboratories and determine compliance with regulations for quality assurance. This is discussed in more detail in Chapter 29.
Many health care facilities, including hospitals, ambulatory surgical centers, clinical laboratories, health clinics, and physician offices, seek accreditation by independent accrediting agencies as a means to improve health care and maintain high standards. Accreditation may also be a means to comply with regulations for state licensure and regulations of the CMS.
The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations [JCAHO]) was originally established in 1951 to accredit hospitals, rehabilitation centers, and nursing homes. In recent years it has expanded its activities to accredit almost all kinds of health care facilities, including clinics and physician offices. In order to become accredited, the health care facility must prepare a report demonstrating compliance with all standards of the Joint Commission. This is followed by a survey visit with follow-up to improve in any areas of weakness that might be found during that visit.
The Accreditation Association for Ambulatory Health Care (AAAHC) performs a similar type of accreditation for most types of ambulatory health care facilities.