Organizational Requirements

Institutions are not immune to lawsuits. If a hospital, for example, has failed to act to protect the interests of the patients admitted to its facility when it has had notice of the negligence of a physician, liability can be imposed on it through vicarious liability.69 Organizations, institutions and corporations have written policies regarding many aspects of the services provided under their auspices in part in order to avoid such circumstances.

Codes of conduct are often included in written policy manuals, as are procedures for test, medical and personnel record confidentiality, storage and retention. Conflict of interest concerns inform the policies on gifts from clients and from industry contacts, on honoraria for various professional activities, on relationships with suppliers, and on either concurrent or subsequent outside employment. Policy manuals that present these organizational requirements are available to the public.70 Organizations employ clinical professionals directly or indirectly through contractual relationships with them.

Management decisions and policies may affect the way your job is performed. Dilemmas can arise when you are expected to perform your duties in a manner that may be contrary to your professional ethos. 1 know a genetic counselor who was directed to present testing options to her clients in such a way that they would opt for one particular procedure. There was an institutional need to provide a new physician with a large number of patients. 1 had a similar experience when 1 was instructed by my organization to "Never use the 'A' word." All the many ways to say abortion were included, such as termination of pregnancy, voluntary interruption of pregnancy, change of pregnancy management plans. My Code of Ethics, however, says "Clarify alternatives" (II.4), and my Scope of Practice says "Discuss available options" (1.7). This put me in a very difficult position, both personally and professionally.

Everyone agrees that patients' questions always have to be answered honestly. In my particular case, I found that, although this organizational policy seemed to put me in a bind, I did not need to initiate that discussion very often. If the situation required such a discussion, though, I felt that I had to put the patient's needs first. Patients have a need and a right to know all of their options, whether or not they can access them at that institution. The organization changed its policy over time to one of inclusion. I was, of course, happy to comply with the new policy. If you find yourself caught in the position of having to decide between conflicting organizational requirements and professional expectations, you can seek advice from your organization's ethics committee and/or the ethics committee of the NSGC.

There are corporation compliance programs at institutions that emphasize the ways in which employees can conform to the laws and regulations that apply to healthcare. It is the responsibility of the compliance officers in those organizations to develop a program that raises the awareness of the employees with the aim of keeping them from violating any rules or regulations, either knowingly or unknowingly.

A campaign to stop employees from talking about patients in elevators is one such program designed to protect patient privacy. It is the individual provider/employee's responsibility to acquaint herself with the legal regulations and policy standards and restrictions that apply to her own assigned duties and responsibilities, and to conduct herself accordingly. In an adolescent clinic, for example, you would need to know and understand when and how a minor becomes emancipated. You would also need to know the rules about when and what you may discuss with an emancipated minor's guardian. We will discuss this, and other rules and regulations that impact genetic counseling practice, throughout this book.

2.3 Private Practice

The provision of genetic counseling is not limited to institutions. It is also offered within the private sector. A useful guide to practical strategies and recommendations for those contemplating going into private practice is available on the NSGC website.71 Many of the concerns raised for genetic counselors employed by an institution, such as the issues of privacy and confidentiality, are the same as for those in private practice. The NSGC Code of Ethics is relevant to all genetic counselors, regardless of the specific employment environment. Section II is not specific to any one genetic counseling role, but addresses the relationship with clients in general.72 The Scope of Practice for genetic counselors applies to those providing clinical services, regardless of the employment environment, private practice or employed by an organization.73

HIPAA rules apply to genetic counselors in private practice. A genetic counselor can be considered a covered entity if (1) as a professional you are certified or licensed, (2) you provide, bill or are paid for healthcare services in the normal course of your business, and (3) you transmit any health information electronically.

Patients who come to your office for the first time must be given a notice of privacy practices that is written in plain language.74 Over time, you have to be prepared to give a patient an accounting of any disclosures of personal health information you have made in the last 6 years. This includes the date, name of the person to whom you gave the information, the data that was disclosed and the purpose of the disclosure. This is all information you would want to have in the client's chart. You may also want to keep Title III of the ADA in mind when setting up your office. You want to make your office accessible to people with disabilities if it is easily accomplished.

The Security Rule of HIPAA may also apply to genetic counselors who contract with a covered entity, such as a hospital or medical group. As a business associate, you must safeguard the confidentiality, integrity and availability of the electronic health information you create, keep or transmit. Complying with HIPAA's Privacy Rule will help you satisfy the Security Rule standards.

There are some areas of concern that may apply in private practice that do not overlap with the genetic counseling practice of those employed by an institution due to the nature of private practice.

2.3.1 Partnerships

You may decide not to practice alone, but to form or join a partnership. You need to be aware of your liability. Common partnerships are formed when two or more individuals or co-owners (general partners) provide a business for profit. There is full personal liability for the debts of the partnership which may be unlimited. Your share in the profits will be consistent with the partnership agreement. A limited partnership is formed with at least one general partner and one or more limited partners. Limited partners contribute to the partnership and obtain an interest from it, but may not be co-owners. The liability for partnership debts for limited partners is only to the extent of their contribution. As an individual or as a partnership you may employ someone who provides genetic counseling services for you. Employers could be found responsible for the negligent acts of their employee counselor through indirect liability.

2.3.2 Billing

Fees for services provided by an institutional employee are usually set by the institution. As a private practitioner, you decide what services you will provide, you set your own fees, and you locate your office where you want to see clients. You may find yourself in competition with other private practitioners and with institutions offering genetic counseling services. You should be aware of some potholes that may involve people in business. Although not strictly a billing issue, federal and state laws prohibit a physician from referring a Medicare or Medicaid client to a healthcare service in which she has a personal financial interest. The federal laws75 regarding self-referral are complex and have a long list of exceptions.

Another issue is the manipulation of the market. One form of competition can be eliminated by fixing your fee at a level that can control the market. Price-fixing can be avoided by not agreeing with any of your competing providers on any term of price, quantity or quality. When competitors agree to divide geographic markets or customers, the outcome is called market allocation. This can even take the form of agreeing where to locate your office.

Payments from others or from third parties should be easily justified. If you receive payments in the form of rebates and referral fees that are used as business inducements, these qualify as kickbacks. Most kickbacks are illegal. As a private practitioner, you will most likely do your own billing. Knowingly filing a false or fraudulent claim for payments from Medicaid, Medicare or other third-party payers is prohibited by state and federal laws. If you offer group counseling sessions, you cannot bill each participant for an individual consultation.

Institutions and physicians have been charged with, for example: performing surgeries that were not necessary, billing for additional services and add-ons that were not provided, billing out-patient services as if they were provided to an inpatient, double billing, physician billing for services provided by interns, forging physician or patient signatures, and billing for cancer treatments that were covered by research grants.

After finding in 1995 that the University of Pennsylvania Health System had fraudulently billed the Medicare program, the DHHS instituted a nationwide audit program of attending physicians and physician groups at other institutions. Thomas Jefferson University in Philadelphia was the subject of the first audit and paid a $12 million settlement. More recently, St. Barnabas Health Care System in New Jersey agreed to pay $265 million to settle a False Claims Act lawsuit for overcharging Medicare.76

2.4 Industry/Technology

Industry, as we use the term, refers to the production and sale of medical devices, tests, and pharmaceuticals. Genetic counselors work in industry in a number of capacities, such as clinical coordinators or educators. Many are guided by the role definition of the industry. The issues for genetic counselors working in industry encompass client privacy/confidentiality as well as truth-telling and conflict of interest. There are also potholes at the boundaries of those roles and services, with the possibility of crossing over into a clinical role.

Clients can experience injuries that are caused by a medial device or a drug. People who are injured by a device or a technology can sue a company under product

Table 2.3 Example of warning created to protect manufacturer

Caution: Using this medication alone, with other medicines or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Do not drive, operate machinery or do anything else that could be dangerous until you know how you react to this medicine.

liability laws for defective products. A product is considered defective if it is not "reasonably" safe. This standard can also be applied to pharmaceutical products. A drug is considered to be defective if the foreseeable risk from using the drug was so great in relationship to its benefits that no reasonable physician would ever prescribe it for any patients. Needless to say, this is very difficult to prove.77

The Food and Drug Administration (FDA) does not usually require suppliers of medical technologies to communicate risk information directly to patients. Drug manufacturers provide warnings and instructions to the physician. These warnings create an intervening level of protection for the companies (Table 2.3).

Prescription drug inserts serve to reinforce and augment the information given by a doctor to the patient.78 Providers, however, are expected to fulfill a separate duty to exercise good judgment particularly when applying new technologies and procedures (Jones v. Karrker).19 In a case in which a woman used Accutane in the first trimester,80 the court ruled that the manufacturer's warnings about the dangers of Accutane therapy were adequate. The company had developed a Pregnancy Prevention Program for physicians to use which included patient information and a consent form that patients signed. The defendants were shown to have complied with the prevention program protocol.

2.5 Reproductive Technology

People have many technological options available to them for family planning. The legal requirements for such technologies begin with the duty to exercise good judgment when applying new technology or procedures.81 Organizations offering preimplantation genetic diagnosis (PGD) have been sued for failure to perform proper testing.82 Efforts to plan technologically assisted reproduction involve the law of contracts, which has threatened to supplant family law in determinations of parentage. When couples divorce, property, contract and family law have all been brought into the conflict over what to do with stored frozen embryos.83

2.6 Research

Genetic counselors fill many different roles in research. Some are the principle investigators, while others act as project coordinators. Some of us have participated as subjects. As a graduate student, 1 was a subject in a project that looked at the levels of hexosaminadase A over a defined period of time. Because of questions that came up in the course of the testing process, both my parents were conscripted to be tested!

There are controls on the research community from different sources. For genetic counselors participating as coordinators or investigators in research projects, the institution that sponsors the work will have oversight responsibilities about which you need to be aware. There are also federal regulations that may apply. The boundaries between medical research and clinical practice or accepted therapy are not always clear.

In 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued a report that addressed this subject. Known as the Belmont Report,84 it defines "practice" to include interventions that are designed to improve the well-being of an individual patient and that have reasonable expectations of success. "Research" is considered an activity that is designed to test a hypothesis, permit conclusions to be drawn, and to develop or contribute to universal knowledge. Formal protocols describe the objective of the research and the procedures that will be used.

2.6.1 Human Subjects

Research with human subjects is invaluable when it results in benefits that can be applied to the understanding and treatment of disease. History has taught us, however, that the abuse and misuse of human subjects, both adults and children, has been more common than we would like to think. Plutonium exposure studies were conducted in the 1940s on men, women and children who were thought to be terminally ill. The subjects were not told what the substance was with which they were injected. They were not told that they were be given 2 to 14 times the dose that was the standard at the time.

In the 1950s, women were given diethylstilbestrol (DES) during pregnancy as part of a research protocol without having been told and without having given consent to participate in the project (Miller v. University of Chicago).85 In Ahem v. Veterans Administration^ the patient received doses of radiation to treat his cancer that were much higher than the dose that was the accepted standard of care at the time. The court in that case ruled that a patient must always be fully informed of the experimental nature of a treatment.

The foundation of the guidelines for research with human subjects is the Nuremberg Code.87 The ten-point Code begins with the need for the informed consent of the participant: The voluntary consent of the human subject is absolutely essential. The Code serves as the core of all the standards that have been written since, including the Belmont Report. The Belmont Report was a response to the ethical problems in research projects such as those cases mentioned above. It developed basic ethical principles to govern research with human subjects.

Consent is required in all cases in which an investigational drug is administered for either scientific knowledge or to patients who are receiving medical treatment.

Federal regulatory agencies, such as the FDA and the DHHS, mandate extensive disclosures to subjects who are enrolled in clinical trials. Consent forms that are employed should use words that make the project understandable.

Some people argue that the standards for consent should be higher in research than in regular medical care. Their reasons include the greater uncertainty about the therapeutic benefit, the heightened concerns about conflict of interest, and greater uncertainties about the risks of the interventions.88 Although some courts recognize a duty to simply reveal the experimental status of a treatment to the patient, others impose heightened requirements. In nontherapeutic research, that is, research that involves healthy volunteers or studies on patients that are not designed to test potential treatment, some courts have required higher requirements for informed consent.89 This consent may include information about whether a drug used for treatment had FDA approval. An informed consent to research participation does not preclude lawsuits based on perceived poor outcomes.

h\ Ancle v. Rock,90 parents of a child with cystic fibrosis sued for failure to timely disclose the results of cystic fibrosis testing, claiming the child suffered health consequences due to a two-year delay in treatment. The child had been in the control group of a research project, and the parents claimed that they were not told that she was tested for and had cystic fibrosis. A second child was born with cystic fibrosis during the time period of the research.

If a court finds that the decision to continue a patient in a test group was negligent, serious questions may arise about the validity of exposing such groups of patients to potentially dangerous agents or environments. Monetary or other inducements to encourage enrollment in clinical trials could bias the sample or coerce continued participation, and is usually considered inappropriate.

2.6.2 Gene Transfer

Clinical trials of human gene transfer, a cutting-edge biotechnology, involve the therapeutic or experimental administration of genetic material to human beings. Gene transfer raises concerns that are different from those raised in conventional drug research. These include the threshold toxic effects, hazards of viral recombination and accidental gene transfer to personnel, poorly characterized risks of insertional mutagenesis, and the possibility of inadvertently affecting the germline of trial participants.

Human gene transfer therapy may need special safety and ethics reviews. Problems that arise can have life-threatening consequences. Recently, three cases of children who had undergone treatment for adenosine deaminase-severe combined immunodeficiency and who had developed leukemia were reported.91 The Recombinant DNA Advisory Committee recommended the continuation of retroviral human gene transfer studies, because of the lack of data to warrant stopping them.92 The case of Geisinger v. University of Pennsylvania (Pa. 1999), which settled out of court, raised questions of informed consent, conflict of interest, and ethics violations in the gene therapy phase one safety clinical trial for ornithine transcarbamylase (OTC) treatment.

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