Dale Halsey Lea, MPH, RN, CGC, FAAN
Human genome research is creating new opportunities for a more individualized approach to the screening, diagnosis, and treatment of rare and common diseases. Concerns about insurance discrimination, however, have led many people who could benefit from genetic testing to choose not to have it. Other individuals have chosen to pay for genetic testing on their own. In May 2008, the Genetic Information Nondiscrimination Act, known as GINA, was signed into law. GINA is a federal law that protects United States citizens from health insurance and employment discrimination based on their genetic information. Nurses, who are on the frontlines of healthcare delivery, need to become familiar with the scope and limitations of GINA. This article describes the need for GINA, the scope and limitations of this law, and health provider resources relating to this law. Case studies that illustrate typical situations nurses and their clients may face with regard to genetic and genomic information are provided. Activities that nurses can carry out in their own institutions to facilitate GINA compliance are outlined.
Citation: Lea, D. H., (May 5, 2009) "The Genetic Information Nondiscrimination Act (GINA): What it Means for Your Patients and Families" OJIN: The Online Journal of Issues in Nursing, Vol. 14, No. 2.
Key Words: employment discrimination, ethics, Genetic Information Nondiscrimination Act (GINA), genetic information, genomic information, genetic testing, insurance discrimination, nursing roles
Human genome research is creating new opportunities for a more individualized approach to the screening, diagnosis, and treatment of rare and common diseases. Increasingly, genetic tests are being used for the diagnosis of rare and common disorders (Hudson, Holohan, & Collins, 2008). Genetic testing is also being used to determine whether a person will respond to a particular medication, and to specify the most appropriate dose of the medication so as to prevent side effects (National Human Genome Research Institute, 2008a). Concerns about insurance discrimination, however, have led many people who could benefit from genetic testing, to choose not to have it. Others have chosen to pay for genetic testing on their own, because they feared they would be denied health insurance based on their genetic information if that information were made available to their health insurer (Genetics and Public Policy Center, 2008c).
In May 2008, then President George W. Bush signed the Genetic Information Nondiscrimination Act, often known as GINA. GINA is a groundbreaking federal law that protects United States (US) citizens from health insurance and employment discrimination based on their genetic information. As noted by Francis Collins, former head of the National Human Genome Research Institute:
This bill could just as well be known as the bill to protect people with DNA, and that would be all of us! Since each of us has dozens of genetic variations that may put us at risk for disease, we all would have had a reason to be concerned about the possible misuse of genetic information. With this act, Americans won't have to worry about their jobs or their health insurance being taken away because of the genes they inherited. (National Human Genome Research Institute, 2008d, paragraph 6).
This act provides safety for all of us.
The passage of GINA has important implications for patients and their families. Nurses are on the frontlines of healthcare delivery and need to become familiar with the scope and limitations of GINA so that they can educate patients and families about this new law. This article describes the need for GINA, the scope and limitations of this law, and health provider resources relating to the implications of this law. Efforts to inform the public and healthcare providers about GINA are described. Case studies that illustrate typical situations nurses and their clients may face with regard to genetic and genomic information are provided. Activities that nurses can carry out to make sure that accurate information about GINA and its protections is communicated to patients are discussed.
Before GINA: The Need
It has long been recognized that genetic information has unique characteristics that set it apart from other medical information. Genetic information, such as a family history of early onset colorectal cancer or results of genetic testing for the genes BRCA1/2 (genes that can cause hereditary breast/ovarian cancer), can give information about an individual’s future health risks, as well as that of their family members. Prior to GINA, there was some federal attention to the privacy of genetic information. In 1996, the Health Insurance Portability and Accountability Act (HIPAA) was passed to address concerns about discrimination based on a person’s health information. HIPAA set standards for protecting the privacy of individually identifiable health information so as to prevent inappropriate use and disclosure of this information. HIPAA was the first step toward restricting the use of genetic information by limiting its use in setting insurance premiums and determining a person’s eligibility for benefits in group health plans.
The implementation of HIPAA provided some protection from discrimination, but important gaps remained. The implementation of HIPAA provided some protection from discrimination, but important gaps remained. For example, HIPAA did not prevent health insurers from charging a higher insurance rate for a group by raising a company’s insurance premium when it learned that the business employed several individuals who had a genetic disease or disorder, such as early onset breast cancer. HIPAA did not limit insurance companies from collecting genetic information, nor did it prevent insurers from requiring that an individual take a genetic test before issuing health insurance coverage (U.S. Department of Health and Human Services, 2008). Until GINA was passed, most states had some laws in place to protect individuals against discrimination based on their personal genetic information. However, these laws differed greatly in the type and amount of protection that they offered (Hudson et al., 2008).
The need for federal genetic-information-nondiscrimination legislation was underscored by research describing individuals’ choices regarding genetic testing. Recent clinical research has shown that both patients and genetics health professionals have concerns about the potential for discrimination by insurance companies based on their genetic test results. Hadley’s study of families who had a history of hereditary nonpolyposis colorectal cancer (HNPCC) found that many family members had a significant amount of apprehension about genetic testing. Their primary concern was the potential for genetic discrimination by insurance companies (National Human Genome Research, 2008a; 2008c). In another study the Genetics and Public Policy Center conducted a survey of members of the general public regarding privacy of their genetic information. Survey results showed that 93% of respondents thought employers should not have access to their genetic test results and opposed giving insurance companies access to their results (Genetics and Public Policy Center, 2008c).
Healthcare professionals share these fears. Matloff et al. (2000) conducted survey research with cancer genetics specialists to examine what they thought they would do personally if they had a 50% risk of carrying a mutation that predisposed them to hereditary breast/ovarian cancer (BRCA1/2) and/or HNPCC. Results of their survey showed that 68% of those who responded to the questionnaire would not bill their insurance company for genetic testing due to the fear of discrimination. Twenty-six percent indicated that they would use an alias when undergoing testing (Matloff et al.).
GINA: Scope and Limitations
The passage of GINA in May 2008 has now set in place a national level of protection against discrimination based on a person’s genetic information. The passage of GINA in May 2008 has now set in place a national level of protection against discrimination based on a person’s genetic information. In this act, genetic information refers to information about a person’s genetic tests, the genetic tests of a person’s family members, and the incidence of diseases or disorders in a person’s family (“family history”). It also includes information about any person’s or family’s request for, or receipt of, genetic services or their participation in clinical research that involves genetic services. Genetic services include genetic testing and/or receiving genetic counseling. Genetic counseling involves obtaining, interpreting, and/or assessing genetic information. GINA specifically defines the term “genetic test” as the analysis of human genes, chromosomes, proteins, or metabolites to determine a person’s genotype and whether the person has one or more gene mutations or chromosomal changes (Genetics and Public Policy Center, 2008d).
GINA requires regulations interpreting the law to be available by May 2009. GINA’s health insurance provisions will begin to take effect in May 2009, while the employment provisions take effect in November 2009. The period of implementation for the health insurance protections will continue up until May 2010. As these protections and provisions come into effect, nurses will need to become familiar with the protections that GINA offers. GINA does not allow the following behaviors: (a) individual and group health insurers to use an individual’s genetic information to determine whether they are eligible for health insurance, (b) an insurer to ask for or mandate that a person have a genetic test, (c) employers to use an individual’s genetic information to make decisions about job assignments, whether to hire or fire an individual, or any other terms of employment, or (d) employers to ask for, require, or buy genetic information about an individual or his or her family members (Genetics and Public Policy Center, 2008c; Hudson et al., 2008).
GINA will be enforced by several federal agencies. GINA will be enforced by several federal agencies. These agencies include: the Department of Health and Human Services, the Department of Labor, the Department of the Treasury, and the Equal Opportunity Employment Commission. Corrective actions will be taken and financial penalties issued for those insurers and employers who violate GINA (Genetic and Public Policy Center, 2008d; Hudson et al., 2008).
With the passage of GINA, it is hoped that people will be less reluctant to participate in genetic and genomic research. Genetic and genomic research that involves linking gene variants to health outcomes generally requires large numbers of people in the study. However, researchers have reported that many people who could participate have chosen not to because they were concerned about the potential for discrimination against them based on their genetic information. The new GINA legislation prohibits insurers and employers from using research participants’ genetic information against them (Genetic and Public Policy Center, 2008e).
With the passage of GINA, it is hoped that people will be less reluctant to participate in genetic and genomic research. It is important to understand not only what GINA does, but also what it does not do. GINA does not prevent healthcare providers from recommending genetic tests to their patients. Nor does it mandate coverage for any particular genetic test or treatment. GINA does not prevent insurance companies from considering an individual’s current health status in determining eligibility or setting premiums when an individual applies for or renews his or her coverage. GINA relates only to genetic information; it does not provide protection for individuals with manifested disease. GINA’s protections are limited to health insurance and employment. It does not cover long-term care, life, or disability insurance. GINA does not apply to members of the military or the Tricare military health system. It also does not cover the veterans’ healthcare that is administered by the Veterans’ Administration, the Federal Employees Health Benefits Plan, or the Indian Health Service. It is important for nurses to be aware of these limitations (Genetic and Public Policy Center, 2008d). Table 1 provides a summary of situations GINA does and does not cover.
Resources to Assist in Understanding the Implications of GINA
Since GINA’s passage, there have been a number of nation-wide efforts to inform nurses, healthcare providers, and the general public about the scope and limitations of GINA. Several of these efforts will be described below.
For the past 15 years the American Nurses Association (ANA) Center for Ethics and Human Rights has participated in efforts to make sure that all nurses are prepared to provide competent and ethical genetic and genomic healthcare. The ANA Center for Ethics and Human Rights, with the support of the ANA Government Affairs Department, has lobbied the U.S. Congress regarding confidentiality protections for those requesting genetic testing. In 2009, the ANA and International Society of Nurses in Genetics (ISONG) published a new book edited by Rita Black Monsen (2009) entitled Genetics and Ethics in Health Care: New Questions in the Age of Genomic Medicine. Monsen’s book provides nurses with comprehensive information on ethics and genomics, including information about GINA (Badzek, Turner, & Jenkins, 2008; Monsen).
The National Human Genome Research Institute (NHGRI) has been able to provide detailed information about GINA on the Policy and Ethics pages of its web site (National Human Genome Research Institute, 2008b). NHGRI has also created a new webinar series that presents the latest topics in genomics, health, and society, including a session on GINA. The goal of the webinars is to engage public health communities, advocacy groups, health providers including nurses, and members of the public in discussion about the latest topics in genomics (National Human Genome Research Institute, 2008e).
The Genetic Alliance is another group that has created resources about GINA to reach out to the general public. The Genetic Alliance is a network of many organizations that offers space for shared resources, creative tools, and multiple timely programs. The Policy Section of the Genetic Alliance website offers a GINA guide that informs members of the general public about what GINA means for them (Genetic Alliance, 2008; 2009). All of the Genetic Alliance’s policy work regarding genetic discrimination can be found on their website in the Policy Section. www.geneticalliance.org/policy.discrimination This is a good GINA resource for nurses to share with their patients, families, and communities.
Because nurses are on the frontlines of healthcare delivery, they need to become familiar with...resources regarding GINA so that they can remain up-to-date, and direct patients and families to reliable information about GINA. The Genetics and Public Policy Center has created and widely distributed a fact sheet that summarizes GINA (Genetic and Public Policy Center, 2008b; 2009d). The Center has also co-hosted a series of webinars with the Bureau of National Affairs, the first of which highlighted the scope and limitations of GINA. The Center will continue developing GINA educational materials for patients, clinicians, health insurers, employers, researchers, and ethics boards (Genetic and Public Policy Center, 2008a).
Bilingual resources relating to GINA are not available as of the date of publication of this article. It will be important to develop such resources to better serve the diverse populations in the US today.
Because nurses are on the frontlines of healthcare delivery, they need to become familiar with these and other resources regarding GINA so that they can remain up-to-date, and direct patients and families to reliable information about GINA. Case Studies 1 and 2 (found at the end of this article) provide examples of patient questions and concerns about genetic discrimination and nursing responses to these concerns. Nurses also need to make sure that accurate information about GINA and its protections is communicated to patients considering genetic testing. Table 2 provides GINA-related resources that nurses can share with their patients. Table 3 outlines steps that nurses can take in their institutions to make sure that patients and families are informed about GINA.
The decision to have a genetic test to learn of one’s risk for developing a disease...may be a very challenging and emotional experience for a patient. Another important component of nursing care related to GINA and genetic testing is an understanding of the decision-making process for patients and their families. The decision to have a genetic test to learn of one’s risk for developing a disease, such as hereditary breast/ovarian cancer, may be a very challenging and emotional experience for a patient. Patients may have fears about how they will cope with knowing their risk of disease and/or preventive interventions, such as surgery. Nurses need to be aware of their own feelings and beliefs about whether or not a patient should have a genetic test, so that they can provide the most unbiased and supportive care. Nurses also need to be able to identify cultural, religious, and societal issues that may be related to how patients think about and consider genetic testing (Consensus Panel, 2009). Stories that illustrate patient concerns regarding genetic testing and decision making can be found at the National Genetics Education and Development Centre’s ‘Telling Stories’ web site (National Genetics Education and Development Centre, 2008).
The nursing role today includes talking with patients about the protections from insurance and employment discrimination that are now provided by GINA. The Genetics and Public Policy Center provides information about GINA that is designed for the general public in the form of frequently asked questions and answers. Examples of patient questions regarding genetic testing decisions and also concerns about health and employment discrimination are provided. Nurses can refer patients and families to this web site for more information about GINA (Genetics and Public Policy Center, 2008b). The Center also provides a resource page including an e-mail address that provides for responses to specific questions submitted by individual patients (Genetics and Public Policy Center, 2008b).
Human genome research is creating new opportunities for a more individualized approach to the screening, diagnosis, and treatment of rare and common diseases. Until recently, many people were concerned that information resulting from their genetic testing would be used against them by their insurers and/or employers. With the passage of GINA in May 2008, U.S. citizens now have federal protections against insurance and employment discrimination based on their genetic information. Nurses need to know what GINA does and does not cover so that they can communicate this information effectively to their patients and families. Nurses can take a leading role in their institutions to assure that patients and families have accurate information about GINA and the protections GINA provides. Nurses can also take advantage of the multiple educational resources about GINA to learn about this new act and to share these resources with their patients.
Dale Halsey Lea, MPH, RN, CGC, FAAN
Dale Halsey Lea is a registered nurse and a Board Certified genetic counselor with more than 20 years experience in clinical and educational genetics. She is currently the Health Educator with the Education and Community Involvement Branch and the Genomic Healthcare Branch, National Human Genome Research Institute. As Health Educator, Ms. Lea develops consumer and health professional genetics and genomics health education and community involvement programs and resources; translates genetic and genomic research results into terms understandable by lay audiences; conducts genetics research for the Education and Community Involvement Branch; and provides administrative support for public and health professional education and community involvement programs. Ms. Lea is widely published in the nursing and genetics/genomics literature in the area of integrating genetics into nursing practice. In 2001, Ms. Lea was inducted as a new Fellow in the American Academy of Nursing, and serves on their Expert Panel on Genetics.
Badzek, L., Turner, M., & Jenkins, J.F. (2008). Genomics and nursing practice: Advancing the nursing profession. OJIN: The Online Journal of Issues in Nursing, 13(1). Retrieved on March 10, 2009, from www.nursingworld.org/MainMenuCategories/ANAMarketplace/ANAPeriodicals/OJIN/TableofContents/vol132008/No1Jan08/GenomicsandAdvancingNursing.aspx.
Consensus Panel, June 2008. (2009). Essentials of genetic and genomic nursing: Competencies, curricula guidelines, and outcome indicators (2nd Edition). Silver Spring, MD: American Nurses Association.
Genetic Alliance. (2008, November). What does GINA mean? A guide to the genetic information nondiscrimination act. Retrieved January 21, 2009 from www.geneticalliance.org/GINAResource
Genetic Alliance. (2009). Genetic discrimination. Retrieved January 21, 2009 from www.geneticalliance.org/policy.discrimination
Genetics and Public Policy Center. (2008a). Center launches new GINA resource. Retrieved March 12, 2009 from www.dnapolicy.org/news.release.php?action=detail&pressrelease_id=101
Genetics and Public Policy Center. (2008b). Frequently asked questions. Retrieved March 16, 2009 from www.dnapolicy.org/gina/faqs.html#insurance2
Genetics and Public Policy Center. (2008c). Genetic privacy and discrimination. Retrieved March 12, 2009 from www.dnapolicy.org/policy.privacy.php
Genetics and Public Policy Center. (2008d). Information on the genetic information nondiscrimination act (GINA). Retrieved March 12, 2009 from http://www.dnapolicy.org/resources/WhatGINAdoesanddoesnotdochart.pdf
Genetics and Public Policy Center. (2008e). The genetic information nondiscrimination act. Retrieved March 12, 2009 from www.dnapolicy.org/policy.issue.php?action=detail&issuebrief_id=37.
Hudson, K.L., Holohan, M.K., & Collins, F.S. (2008). Keeping pace with the times – The genetic information nondiscrimination act of 2008. The New England Journal of Medicine, 358 (25), 2661-2663.
Junglen, L.M., Pestka, E.L., Clawson, M.L., & Fisher, S.D. (2008). Incorporating genetics and genomics into nursing practice: A demonstration. OJIN: The Online Journal of Issues in Nursing, 13(3). Retrieved on March 16, 2009, from www.nursingworld.org/MainMenuCategories/ANAMarketplace/ANAPeriodicals/OJIN/TableofContents/vol132008/No3Sept08/ArticlePreviousTopic/IncorporatingGeneticsandGenomicsintoPractice.aspx
Matloff, E.T., Shappell, H., Brierley, K., Bernhard, B.A., McKinnon, W., & Peshkin, B.N. (2000). What would you do? Specialists’ perspectives on cancer genetic testing, prophylactic surgery, and insurance discrimination. Journal of Clinical Oncology, 18(12), 2484-2492.
Monsen, R.B., (Ed.). (2009). Genetics and ethics in healthcare: New questions in the age of genomic health. Silver Spring, MD: Nursebooks.org
National Genetics Education and Development Centre. (2008). Telling Stories: Understanding real life genetics. Retrieved on March 12, 2009 from www.geneticseducation.nhs.uk/tellingstories/
National Human Genome Research Institute. (2008a). Frequently asked questions about genetic testing. Retrieved on March 12, 2009 from www.genome.gov/19516567.
National Human Genome Research Institute. (2008b). Genetic discrimination. Retrieved on March 12, 2009 from www.genome.gov/10002077
National Human Genome Research Institute. (2008c). Genomics in action: Getting ahead of the curve on genetic tests. Retrieved December 4, 2008 from www.genome.gov/15015000.
National Human Genome Research Institute. (2008d). Statement from Francis Collins, M.D., Ph.D. Retrieved December 4, 2008 from www.genome.gov/27026482.
National Human Genome Research Institute. (2008e). Webinar series Retrieved December 4, 2008 from www.genome.gov/27527023.
U. S. Department of Health and Human Services. (2008). Office of civil rights – HIPAA. Retrieved March 16, 2009 from www.hhs.gov/ocr/hipaa
Table 1. GINA – Important Points for Nurses and their Patients
What GINA Does
- Prevents health insurers from denying health insurance coverage, adjusting premiums, and discriminating against a person based solely on his or her genetic or family history information
- Prevents health insurers from requesting that a person have a genetic test
- Prevents employers from using a person’s genetic information to make decisions about hiring, firing, compensating, or promoting
- Places limitations on health insurers’ and employers’ rights to require, request, or purchase a person’s genetic information
What GINA Does Not Cover
- Individuals with “manifest disease”
- Long-term care insurance, life insurance, and disability insurance
- Members of the United States military (and Tricare military health system)
- Veterans’ healthcare administered by the Veterans’ Administration
- Federal Employees Health Benefits Plans
- Indian Health Services
GINA does not prevent healthcare providers who desire to recommend genetic tests for their patients from doing so.
Definitions Related to Genetic Information
- GINA defines genetic information as any information about a person’s genetic tests, family members’ genetic tests, and family history of a genetic disease or disorder.
- Genetic information also includes referral of a person or family for, or use of, genetic services and participation in clinical research that involves genetic services.
- Genetic test: GINA defines the term ‘genetic test’ as the analysis of human genes, chromosomes, proteins, or metabolites to determine a person’s genotype.
Answers to Questions about GINA
Go to the Genetics and Public Policy Center to contact someone who can answer your questions about GINA www.dnapolicy.org/gina/resources.providers.html
This information was adapted from: Genetics and Public Policy Center. (2008b). Frequently Asked Questions about GINA. www.dnapolicy.org/gina/faqs.html
Table 3. Steps Nurses Can Take to Make Sure That Their Patients and Families are Fully Informed about GINA
- Create a nursing education and practice team in your institution that will oversee the education of nurses in the areas of genetics, genomics, and GINA.
- Create educational programs that introduce the Essential Nursing Competencies (Consensus Panel, 2009) as the foundation for current nursing practice, including knowledge of ethical issues of privacy of genetic/genomic information and GINA.
- Support the GINA nursing education and practice team’s collaboration with the medical genetics department and staff to develop educational programs for nurses about genetics, genomics, and GINA.
- Conduct annual conferences and continuing education programs on genetics, genomics, and GINA for nurses.
- Require all new nurses hired in your facility to take a basic course on genetics, genomics, and GINA.
- Create a short DVD presenting information about genetics, genomics, and GINA that can be viewed when convenient by nursing staff and other healthcare providers in your facility.
- Create posters for nursing and healthcare staff and display them throughout your facility.
- Meet with your nursing manager and your institution’s clinical researchers, research administrators, and institutional review boards to ensure that they are fully informed about GINA and that research participants are made aware of GINA.
Appreciation is expressed to Hudson et al. (2008) and to Junglen, Pestka, Clawson and Fisher (2009) for many of these Table 3 suggestions.
Case Study 1. Genetic Testing and Insurance Discrimination
You are an oncology nurse working in a hospital oncology clinic. Today, you are seeing Mrs. M, a 40 year old patient who has been diagnosed with breast cancer and is now undergoing treatment. Mrs. M tells you that she has a family history of early onset breast and ovarian cancer in two of her sisters and that her mother died at an early age from breast cancer as did two maternal first cousins. Mrs. M has received genetic counseling and tells you that the genetic counselor talked with her about genetic testing for hereditary breast/ovarian cancer, called BRCA1 and BRCA2. Mrs. M tells you that she is very nervous about having the genetic test because she is applying for new healthcare insurance and is “scared that this health insurance company will deny me coverage if I take the test.” Your response to Mrs. M is based on the guidelines found in Essentials of Genetic and Genomic Nursing (American Nurses Association, 2009) indicating your responsibility to provide her, as your client, with credible, accurate, appropriate, and current genetic and genomic information, resources, and services to facilitate her decision making. You explain to Mrs. M that a new federal law, called GINA, has recently been passed that prevents insurance companies from discriminating against individuals based on their genetic information. Unfortunately, you inform her, GINA does not prevent discrimination based on her history of breast cancer disease. Since she already has breast cancer, the health insurance company may refuse to sell her a policy. You tell her that she should check with her state insurance department as she may have other options. Her state insurance laws may give her additional protection, because in some states, the health insurance companies are not allowed to discriminate against a person based on his or her current health status. You provide her with resources about GINA from the Genetics and Public Policy Center, and encourage her to contact her state insurance department. Mrs. M tells you that she is very grateful for the information and care you have given her.
Case Study 2. Family History Concerns and Employment Discrimination
As a family practice nurse, one of your responsibilities, as outlined in the Essentials of Genetic and Genomic Nursing (American Nurses Association, 2009) is the collection of a three generation family history from your patients. Today you are seeing Mr. S for the first time in your clinic. Mr. S is a 30-year-old African American male. While collecting his family history he tells you that his maternal grandmother died from early onset Alzheimer disease when she was in her 50’s, and his mother recently passed away from the same disease. She was 58. He says that he is worried about giving you this information that will go in his medical record. He adds, “What if my employer gets a hold of this information? I am applying for a new job and I am scared that this employer might find out about this family history and not hire me.” You inform Mr. S. that there is a new federal law called GINA – the Genetic Information Nondiscrimination Act – that was just passed. GINA does not allow an employer to ask for or use a person’s family history information to make any decisions about hiring that person. Mr. S breathes a sigh of relief and asks you where he can get more information about GINA. You refer him to the Genetics and Public Policy Center’s web site that has information about GINA for the general public.
© 2009 OJIN: The Online Journal of Issues in Nursing
Article published May 5, 2009
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