The Genetic Information Nondiscrimination Act (GINA): What It Does and Does Not Do and What It Means for Health Care Professionals
Maxwell Mehlman, J.D.
Within the past 12 months, Prof. Mehlman reports no commercial conflicts of interest.
Release Date: 06/03/2008
Termination Date: 06/03/2011
Estimated time to complete: 1 hour(s).
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On May 21, 2008, President Bush signed into law a measure called the Genetic Information Nondiscrimination Act, or "GINA."
GINA has had a long and tortuous history. Rep. Louise Slaughter (D-NY) first introduced a genetic nondiscrimination bill in 1995, and proceeded to reintroduce it every year thereafter. Twice before the Senate voted in favor, but the bill was rejected by Republicans who controlled the House of Representatives. In 2007, the House passed a version of the bill but it was blocked in the Senate by a single senator, Tom Coburn (R-OK). (Coburn used an informal legislative tactic called a "hold," in which a senator signals the intent to filibuster if a measure is brought up for a vote.) Coburn withdrew his opposition after the bill was amended to his liking, and after the Senate passed it unanimously in April 2008, the House approved it by a vote of 414 to 1. (The sole opponent was Ron Paul (R-Tex.), who objected to the use of federal rather than state law to prevent genetic discrimination.)
GINA's protections against genetic discrimination and against the inappropriate disclosure of genetic information are quite comprehensive but not complete. The discussion below explains what the law does and does not cover, explores its long-term implications for the future of health insurance and considers how it will affect the practice of medicine.
Why Was GINA Necessary?
All but three states (Mississippi, North Dakota and Pennsylvania) have enacted some type of statute prohibiting discrimination in employment and/or insurance on the basis of genetic information.(1) (North Carolina passed the first state genetic antidiscrimination law in 1975 to protect carriers of sickle cell and hemoglobin C trait from employment discrimination.(2) But state laws vary widely in their scope and, therefore, many people long have felt that federal legislation was necessary.
There also were some federal protections from genetic discrimination prior to GINA. The Health Insurance Portability and Accountability Act (HIPAA), enacted in 1996, prohibited providers of group health insurance from using genetic information to refuse to insure individuals within a group or to charge them higher premiums than other members of the group. A 2000 Executive Order protected federal employees from genetic discrimination. The Americans with Disabilities Act (ADA) and the Civil Rights Acts provided some limited protections. HIPAA's privacy protections also extend to genetic information.(3)
There clearly was discrimination in the early 1970s against individuals at risk for sickle cell disease...
But these federal protections were limited. HIPAA's health insurance provisions did not prevent a health insurer from refusing to sell insurance to an entire employee group or increasing premiums or limiting benefits for all members of the group on the basis of genetic information and, more importantly, HIPAA did not cover health insurance purchased by individuals rather than groups. The ADA's protections against discrimination in employment and insurance are extremely limited.(4) And HIPAA's privacy protections did not extend directly to the disclosure of genetic information to "non-covered entities," such as employers.
At the same time, there has been little more than anecdotal accounts of actual genetic discrimination in recent times. (There clearly was discrimination in the early 1970s against individuals at risk for sickle cell disease, plus the discrimination that occurred during the heyday of eugenics in this country, which was described in an earlier Cyberounds® .) A 2000 survey of employers found that only six out of 2,133 reported that they conducted genetic testing of employees and only four reported that they tested job applicants.(5) Repeated studies have failed to find any substantial evidence that health insurers require individuals to take predictive genetic tests or that they use the results of such testing in making underwriting decisions (that is, decisions about how much insurance risk is involved in a particular case, which tells the insurer whether or not to issue a policy and how much to charge in premiums).(6) However, health insurers acknowledge using genetic information, such as the results of genetic tests and family history, to identify existing or prior disease, an issue we will return to later.
If there is so little evidence of genetic discrimination, then, why was there so much support for GINA? One reason is the extensive evidence that the fear of genetic discrimination impedes people's willingness to undergo genetic testing that could improve their health. A second explanation is that genetic testing is still in its infancy and that tests in the future could achieve much greater predictive value, making their use more compelling for insurers and employers.
What Does GINA Do?
GINA prohibits health insurance discrimination based not just on the results of genetic tests but on the use of genetic services.
What Does GINA Not Do?
GINA is not as comprehensive as it might seem.
In the first place, the law does not prohibit health insurers from taking into consideration a person's health in determining whether or not to issue them insurance or what rates to charge. As a result, issuers of individual insurance policies can refuse to insure someone or charge them higher premiums because they are or are expected to become ill, and group health insurers can continue their practice of "experience-rating" -- deciding whether or not to issue a policy and what premiums to charge on the basis of the size and number of insurance claims filed by members of the group in the past, which indirectly measures their health status. (For example, an insurer may decide not to insure a group of employees because they were so sick that they needed a lot of expensive health care the previous year.) In addition, the law allows a group insurer to consider the costs of genetic tests and other services incurred by members of the group.
GINA allows a health insurer to make people take genetic tests to determine whether or not they have a "manifested" disease.
The law also permits a health insurer to refuse to write or renew an individual insurance policy, or to set premiums for an individual policy, based on the fact that the individual is afflicted with a genetic ailment. In an op-ed piece in the L.A. Times , UCLA law professor Russell Korobkin asks us to imagine three people: "Amy carries the BRCA1 gene, which is associated with an elevated risk of breast cancer. Beth has an aunt and a sister who had breast cancer. Five years ago, Cindy had breast cancer, which is now in remission." As Korobkin points out, all three share a higher-than-average risk of some day developing breast cancer. But although GINA makes it illegal for a health insurer to refuse to cover Amy or Beth, or to charge them higher rates, the law does not stop an insurer from refusing to insure Cindy, cancelling her insurance upon the next open enrollment period, or raising her rates to unaffordable levels, despite the fact that, as Korobkin emphasizes, "[s]he's not any more at fault for the possibility that she will suffer a relapse than Amy and Beth are responsible for their risk profiles."(8)
In addition, GINA allows a health insurer to make people take genetic tests to determine whether or not they have a "manifested" disease, disorder or pathological condition. The Senate committee report on GINA gives the following example:
Mr. Jackson holds a family health insurance policy with Consolidated Mutual that covers Mr. Jackson, his wife and his young son, Steven. Steven suffers from severe difficulties in breathing that are symptomatic of cystic fibrosis. Steven undergoes a "sweat test," a commonly performed analysis to detect abnormal levels of sodium and chloride ions in sweat. Steven's test reveals significant abnormalities in the levels of these ions. The definition of "genetic information" in the legislation includes an exception for metabolic tests that are "directly related to a manifested disease, disorder or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved." The sweat test is a metabolic test that directly relates to a manifested disease, cystic fibrosis. Thus, the results of the sweat test are not considered "genetic information" under section 101. Consolidated Mutual is thus not barred by this section from taking the results of the sweat test, or the fact of Steven's manifested cystic fibrosis, into account in setting premiums for a policy under which Steven is covered, even if such policy also includes Steven's parents.(9)
This leaves open the possibility that an insurer could take an overly broad view of what constituted a disease, disorder or pathological condition and require someone to undergo genetic testing to see if they had a genetic mutation that was associated with a condition that many would not regard as a morbidity. Furthermore, the law does not define "manifested," so an insurer might be able to force someone to take a genetic test to detect an extremely early stage of an illness. In either case, the insurer would be making underwriting or rate-setting decisions on the basis of the likelihood of having to pay future health care expenses for genetic conditions, which seems to be what GINA was intended to prevent.
GINA provides much less comprehensive protection against discrimination than a number of state laws.
Moreover, despite its broad definition of "genetic information," GINA does not bar all use by insurers of information about a person's genetic endowment. An insurer can still make decisions based on a person's physical attributes ("phenotype"), which can reveal a great deal about his or her genetic makeup ("genotype"). Stanford Professor Henry Greely notes, for example, that "[a] family practitioner, on seeing a twenty-five-year-old patient with a cholesterol level of 650, should suspect the genetic disorder, familial hypercholesteremia"(10) and GINA permits an insurer to take cholesterol level into account in underwriting.
In this respect, GINA provides much less comprehensive protection against discrimination than a number of state laws. New Jersey's law prohibiting discrimination based on "genetic information," for example, defines it as "the information about genes, gene products or inherited characteristics that may derive from an individual or family member."(11) In New Jersey, therefore, unlike under GINA, it is illegal to base insurance decisions on the fact that an individual is afflicted with a genetic disease or condition. Moreover, GINA explicitly allows insurers to take into account age and sex, which of course are genetic characteristics.
Furthermore, GINA does not cover disability, long-term care insurance or life insurance, all of which may be difficult or impossible for individuals to obtain on the basis of their genetic risk factors.
As for employment discrimination, although GINA forbids an employer from requesting or requiring an individual to take a genetic test, or purchasing genetic information about an employee or an employee's family member, the law contains an explicit exception for an employer who "inadvertently requests or requires family medical history of the employee or family member of the employee." The question is what is meant by "inadvertent."
The Senate Report on GINA refers to what it calls "the water cooler problem," where "conversations among co-workers about the health of a family member" reveal genetic information about the family member or employee. The architects of GINA do not want an employer who acquires this information to be in violation of the act. But how does the employer acquire the information? Can the employer seek it out, for example, by having supervisors mingle with employees and requiring the supervisors to report back what they overhear? In addition, employees and job applicants may reveal information about genetic illness, for example, in explaining that they were late because they had to take a sick relative to the doctor. GINA prohibits the employer from discriminating against the employee or applicant on the basis of the information but how often will an employer admit to individuals that that is why they did not get the job or were fired?
This raises another serious limitation of GINA: it expressly prevents employers from being held liable for "disparate impact." In employment law, it is understood that people may not be able to prove that they suffered unlawful discrimination by pointing to an explicit statement by an employer about the basis for the employer's adverse action. As a result, the law allows discrimination to be proven on the basis of "disparate impact" -- a showing that a group of employees or prospective employees with certain characteristics routinely are subject to adverse employment actions. If this doctrine applied to genetic discrimination, individuals could obtain redress by proving, for example, that the employer had never hired anyone with a certain genetic risk factor. Yet GINA does not permit employees to assert this type of disparate impact claim. According to the Senate Report, this is due to "the unique nature of genetic information and our current understanding of this developing area of science." It is hard to understand what this means.
Finally, GINA permits employers to request, require or purchase genetic information in order to monitor biological effects of toxic substances in the workplace. While this is a loophole that enables employers to obtain genetic information about employees, it is not a very large loophole, since the law says that the monitoring information must be transmitted to employers in an aggregate manner so that it cannot be linked to individual employees.
Why Did the Insurance Industry Not Try to Block the Legislation?
Although some industry groups remained opposed to GINA, chiefly the U.S. Chamber of Commerce (which objected that the legislation would complicate medical practice and increase litigation(12)), the health insurance industry lined up in support. One of the major health insurance trade associations, America's Health Insurance Plans (AHIP), testified on behalf of the bill,(13) as did the National Association of Health Underwriters,(14) and AHIP issued a congratulatory press release when the bill passed the Senate.(15)
Given the lack of insurance industry opposition, it is ironic that GINA may spell the beginning of the end for private health insurance.
How can this be explained? One possibility might be that the law is so weak and filled with so many loopholes that health insurers do not view it as a threat to their profitability. The industry stance might have been less accommodating, for example, if GINA barred, not just genetic test results and family history, but the use of genetic information that was revealed in the course of routine physical examinations. But even in that case, insurers may have viewed passage of GINA as unstoppable, and wanted to reserve their political clout for bigger, more winnable battles to come, such as over the push for a single-payer national health system that would eliminate the role of private health insurance altogether.
What Are the Policy Implications of GINA?
Given the lack of insurance industry opposition, it is ironic that GINA may spell the beginning of the end for private health insurance. To understand why, bear in mind that, while the law prohibits health insurers from using genetic information to decide whom to insure or how much to charge in premiums, it allows individuals to use genetic information about themselves in making health insurance purchasing decisions. This creates the risk of a phenomenon known as "adverse selection." As The Economist describes it: "If genetic information is kept secret from insurers, but individuals have the freedom to add or drop insurance coverage, then...[p]eople will be tempted to 'game' the system. Those who test negative for a serious and costly disease may drop coverage, while those who test positive may add or increase coverage."(16) Over time, those who buy insurance will tend to be those who are at a higher risk for genetic illnesses, while those at lower risk will tend to take their chances without insurance. Since the high risk individuals are likely to be more costly to insure than those at lower risk, insurers will have to raise their premiums. This will cause more people to drop out of the pool of insureds, which will lead to even higher premiums, and so on. In the insurance industry, this is referred to as a "death spiral," because eventually, insurance stops being insurance and instead becomes a health-care equivalent of the old-fashioned "Christmas Club": an account into which people deposit money that they later withdraw to pay for their health care. In short, the insurance industry disappears and is replaced by savings banks.
For a long time, there was no evidence that adverse selection occurs as a result of genetic information being accessible to insurance purchasers but not to sellers. Proponents of legislation like GINA pointed to this to lull the fears of insurers and economists. But a study published in 2005 on how people respond to the results of genetic testing for increased susceptibility to Alzheimer's disease found that those who tested positive were 5.7 times more likely than those who tested negative to purchase or increase their amount of long-term care insurance.(17)
It is likely that some employers who now provide health benefits will no longer be able to do so.
Indeed, some supporters of laws like GINA admit that they view the prospect of increased genetic testing as an important catalyst for national health insurance. Karen Politz, director of the Health Policy Institute at Georgetown University, states for example: "Ultimately, unlocking all these genetic secrets will make the whole idea of private health insurance obsolete."(18)
What Are the Policy Implications of GINA for Employers?
To the extent that genetic information can identify individuals who are at a higher risk than others for illnesses requiring costly medical treatment, an effective ban on the use of this information by employers means that employers will be unable to avoid employing these individuals. This in turn will increase the cost of employment-based health insurance. It is likely that some employers who now provide health benefits will no longer be able to do so, especially smaller employers who have less cushion against rising premiums. Employers who continue to help pay for insurance will likely have to reduce the amount of coverage, shifting more costs onto individual employees.
Given that the U.S. relies primarily on employment-based health insurance, it may sound fair to make employers bear the cost of insuring workers with genetic susceptibilities for high cost ailments. Spreading the costs of insurance for these workers across all of a company's employees certainly is better than leaving the costs entirely on individuals such as Amy and Beth in Professor Korobkin's op-ed piece, mentioned earlier. But employers still are much less capable of spreading risks than society as a whole. One therefore has to question the fairness of imposing high costs on specific employers, especially smaller firms, as opposed to converting to a national health insurance system where the costs are borne by all.
When GINA was enacted, Sharon Terry, the president of the pro-GINA interest group Genetic Alliance, said: "Just like we've begun to mitigate discrimination in race and gender in this society we're going to have to go through the same thing for genetics."(19) But prohibiting discrimination on the basis of genetic information is very different from prohibiting discrimination on the basis of race, religion, national origin and even, in many cases, gender. The latter prohibitions are based on the premise that factors like race, religion and national origin do not affect an individual's ability or job performance. Genetic information that accurately identifies a risk for illness, on the other hand, especially serous illnesses that are expected to manifest themselves in the nearer term, may well have a bearing on how productive a person will be or how much it will cost to provide them with future health benefits. A law requiring employers to ignore these genetic risk factors thus resembles laws that prohibit discrimination on the basis of disability, since there too, there may be real costs to the employer which the individual employer must bear, and there too, it would be fairer if the extra costs of employing persons with disabilities were borne instead by society as a whole.
Supporters of laws like GINA like to argue that genetic risks are different from disabilities in that we all have genetic risks for something. Rep. Slaughter comments, for example: "People know we all have bad genes, and we are all potential victims of genetic discrimination."(20) But then why would there be any reason to discriminate on the basis of genetic risk factors? One reason could be that genetic information is easily misunderstood by insurers, employers and the people to whom the information applies. When public health programs began screening people for sickle cell in the 1970s, many people who had inherited only one malfunctioning gene, and therefore were not at risk for the disease (although they could pass the gene on to their offspring), mistakenly thought they had the disease.(21) But this is not what Rep. Slaughter means. She is talking about genetic information correctly understood, and on that basis, the implication that we all need protection because we are all in the same genetic boat is simply incorrect. We do not all have the same degree of genetic risk. My father's family has a genetic risk for heart disease. My mother's family does not. The women on my wife's mother's side have a heightened risk for breast cancer but the women on her father's side do not. Both the men and women on my mother's side and the women on my wife's father's side live much longer and relatively disease-free lives than their counterparts on the other side of the family. In short, GINA's protections are needed by some people more than others. To deny this is to ignore the real justice that GINA can help achieve.
What GINA Means for Health Care Professionals
Although there is little objective evidence that genetic discrimination in insurance or employment occurs, this is not what most people believe to be the case. Surveys consistently report widespread fear that genetic discrimination is or will be taking place. This dissuades health care professionals from recommending genetic testing to their patients, and discourages patients from agreeing to be tested, thereby depriving society of the increasing health benefits that the testing can provide.(22) GINA can help to dispel some of these concerns and thus received strongly endorsements from organized medicine (as well as from the genetic testing industry). The law also explicitly allows health care professionals to request that a patient or family member undergo genetic testing,(23) even if the health care professional is employed by or affiliated with a health plan. However, GINA does prohibit a health care professional from requiring that someone undergo genetic testing.(24)
As medicine makes increasing beneficial use of genetic information, society has to come to grips with the potential "collateral damage" from the information. GINA takes an important step toward addressing one set of concerns, but many challenges remain.