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  • 1. Webcast: Employment Law Provisions of the Genetic Information Nondiscrimination Act of 2008 (GINA). >> JACQUIE: Good afternoon everybody. Welcome to today's webcast, Employment Provisions of the Genetic Information Nondiscrimination Act of 2008 with Mark Rothstein. Your moderator today is going to be Lex Frieden. I'm Jacquie Brennan, and now I'll turn it over to Lex. >> LEX: Thank you, Jacquie. We've got an exceptional webcast planned today, and I know many of you have tuned in before and you know the drill. Those of you who are new today who joined us for this special occasion, we'll review some -- some of the issues that involve this webcast. Let me say first of all if you have a computer that's interconnected available, I suggest you go to www.ilru.org and look on the left side for the webcast calendar. Click that and then go to the top of the page and you'll see the note about today's webcast. If you'll dial in there you can get a number of follow along materials, materials that our presenter will be discussing as well as a great bio on our presenter. It's a real pleasure for me today to welcome our presenter who is Mark Rothstein. Professor Rothstein is a dear friend of mine, someone with whom I have worked closely over a number of years, not so much recently. Mark used to be the director of the Health Law Policy Institute at the University of Houston. He's moved on to lead the Institute on Bioethics, Health Policy and Medicine at the University of Louisville. Mark Rothstein is, I believe, considered by many authorities to be one of the world's leading experts on the subject matter that we'll discuss today, genetics and the law. He has served on many panels and advises on a routine basis members of Congress and their staffs and Mark is certainly the most knowledgeable person we could have or hope to have join us on a program of this nature. Our webcast today is sponsored by the National Institute on Disability and Rehabilitation Research, NIDRR. They fund the programs that we offer over irlu.org and are the operating unit of ILRU that operates these webcasts. I'll be your moderator. I know many of you and hope to meet the rest at an early opportunity. And at this point if you have questions during today's webcast, it's important that you mail them to swdbtac@ilru.org. You may have questions now. You're welcome to mail them in now, but during the course of the program we'll be monitoring that E-mail, swdbtac@ilru.org. And we'd love to have your questions. We will try to direct as many of those questions as we can to our speaker.
  • 2. If you have technical difficulties during today's call, please phone (713)520-0232 and we'll try to fix you up. And again, if you'll go to the website, www.ilru.org, look at the webcast calendar and today's presentation page. You'll find the PowerPoint slides and other materials to support today's presentation available there. Again, we want to thank you for joining us and we look forward to your questions and now it's a pleasure for me to turn the program over to our presenter, Professor Mark Rothstein. Mark, before you begin your presentation, I wonder if you would say a few things about what you're doing at the University of Louisville now in general. >> MARK: Certainly. Good afternoon, everyone. And Lex, it's my pleasure to be joining you on this program. As you mentioned and as some of the folks on the webcast may know, I was at the University of Houston from 1985 to 2000. So I had an opportunity for 15 years to work with Lex and others on a wide range of issues and so it's great to be on this program. Here at the university I'm based at the medical school and I direct something called the Institute for Bioethics, Health Policy and Law which I know is a mouthful. And what we do is to do research on a wide range of bioethics and health policy issues. As for myself, the issues I'm working on involve genetics as well as public health and health privacy and related issues. We teach medical students. I also teach at the School of Public Health and at the law school and a variety of places around town. So they are keeping me busy. And we're just waiting for the NCAA tournament to begin and see how the Louisville Cardinals do. >> LEX: That's great. Mark, thanks a lot. We surely wouldn't want to understate the role that you played in advising many of us and others in the process of developing the ADA. You and Laura Rothstein have been real contributors to the disability movement. So we want to thank you for that. But today's program is about genetics and law and disability and ethics. And we're going to turn it over to you now to give us a briefing. >> MARK: Thank you, Lex. Good afternoon again. I'm going to be talking about the new Genetic Information Nondiscrimination Act of 2008, which is referred to as GINA and I'll be talking about what GINA does, what it doesn't do, how it works, how it relates to the ADA, how it relates to other laws and perhaps we'll talk about some of the things that still need to be done to protect individuals against genetic discrimination in employment and breach of their privacy with regards to genetic information. So if those of you who have my PowerPoint slides ready to go, I'm going to move to the first slide which should say life before GINA and GINA was enacted last year, but that was certainly not the first time that we saw legislation in the United States dealing with genetic discrimination. The starting point was in the early 1970's when there were widespread reports of irrational discrimination in health insurance and also employment against individuals who were tested for sickle cell disease and were shown to be carriers. Sickle cell disease is a recessive order and to be affected you have to inherit the mutation from both parents. Individuals who only inherit a mutation from one parent are unaffected and yet
  • 3. throughout the south there were reports of discrimination against people who had this carrier state. And so laws were enacted initially in Florida and Louisiana and North Carolina, but then this kind of legislation continued and other recessive traits added. So it was an effort to combat irrational discrimination. On the next slide you'll see that the real turning point in genetic privacy and nondiscrimination legislation was the launch of the Human Genome Project in 1990. This was the supposed 15 year project to map and sequence all of human genes and all of the genetic code. It turned out to only take 13 years to do that, but as soon as this project began, people got concerned about, all right, we're going to count all this information. How is this going to be used? Is there a possibility that people will be subject to discrimination on the basis of the information? So the next slide talks about what is discrimination? And sometimes the word is used in a nonpejorative sense as to say he has a discriminating palate or whatever. As I'm using the term and as we use it in the law, it really means socially unacceptable or invidious or unfair discrimination. On the next slide, there are the two concerns about genetic discrimination and these may seem sort of odd, but let me explain what they are. First, people are concerned that employers will get genetic information and then not know how to react to it, not know what it means and as a result engage in sort of unfair, irrational, inaccurate use of the predictions. And the sickle cell example from the early 1970's will be an example where the information was misused. On the other hand, there is also the possibility that employers will accurately use the information, but people don't like the way they are likely to use that information. So, for example, an employer might accurately read genetic information to conclude that one employee or an applicant is more likely to get a genetic-related disease and not want to hire them. Well, even though that may be accurate in a scientific sense, there are policy reasons why we could argue that an employer ought not to be able to use that information even though it's being used accurately. Now, the next slide looks really complicated. It's this chart or table and I want to explain it and I think for the nonlawyers on the call, it is going to be especially helpful. What I want to do is try to clarify the relationship between the law and practices that employers might engage in that are rational or irrational. When I use those terms, I'm referring to whether there is some sort of legitimate reason or economic justification for the employer's action. So let's begin with the upper left quadrant which is legal and rational. So the employer who selects people based on job-related abilities, their experience, their education, their productivity, or even their medical assessment of whether they are capable of performing certain functions like
  • 4. climbing a telephone pole or running after fleeing suspects, using those criteria in certain circumstances would be certainly rational and also legal. Now, if we go diagonally to the bottom right quadrant where we have irrational and illegal, Title VII of the Civil Rights Act of 1964 prohibits discrimination on the basis of race, color, religion, sex and national origin, and it's not only irrational to exclude someone from a secular job, let's say working at a department store or an office somewhere; but it's also illegal. So discrimination on the basis of religion or in the other example using national origin would be both irrational and illegal. Now we'll get to the two hard cases. If we go straight up to the upper right, this box surprises a lot of people because it illustrates that just because an employer engages in irrational conduct does not make it illegal. So technically it would be lawful in the private sector if an employer chose employees based on their Zodiac sign, or if two employees applied and the employer flipped a coin to decide which one to hire. That's legal, even though it's irrational. So the law presumes that employer conduct is legal except when it falls under certain categories. The five under Title VII, race, color, religion, sex, national origin and two main other ones, age being 40 or over, and disability and now we've added on to that genetic information. Under state laws they include other categories like marital status and sexual orientation. And now the final category, rational and illegal, bottom left, an employer might want to not hire someone with cancer or some other illness because they would be concerned about higher health care costs. They also might not want to hire someone who had a dependent with some serious disease. It's also rational for an employer not to want to hire a pregnant woman because he would think that, well, she's going to have to go on maternity leave shortly and I'll have to replace her temporarily or perhaps even permanently. The fact that there is some short term, individual, economic justification does not make this practice legal because Congress has said we are prepared to impose on employers some inefficiencies because it's more important to us to have a society that is open and fair than that it's operating all the time on optimum efficiencies. And we're living -- and this is me speaking, not Congress -- we live in a society not in an economy. And there are other values that are often much more important than some company's bottom line. So moving to the next slide, I want to review for you the state genetic nondiscrimination laws. GINA was enacted in 2008, but the state law started in the 1970's and kicked off in the 1990's with the start of the Human Genome Project. So about two-thirds of the state and DC prohibit genetic discrimination in employment. 25 states prohibit employers from requiring genetic information. 18 states prohibit employers from requesting genetic information or a genetic test, and continuing on the next slide, there are 16 states that prohibit employers from performing a genetic test on their own, although that's increasingly unlikely because the testing is so expensive that employers would more likely get the results that already had been run and then you just use
  • 5. that information. 14 states provide specific penalties for genetic discrimination in employment. The other 20 states that have these laws simply use the remedies and penalties in their basic employment discrimination statutes. And 11 states prohibit employers from obtaining information about a genetic test result. There was a statute in Texas that was enacted in the 1990's prohibiting genetic discrimination on employment and I had the privilege of working on that one. On the next slide, Executive Order 13145 is listed, and this was signed by President Clinton in 2000, and the purpose of this was not only to prohibit discrimination in employment by the federal government but also politically it was an attempt to sort of nudge the Congress along into enacting the -- what we now call GINA because it was sort of delayed and stalled in Congress. So it prohibits federal employers from discrimination on the basis of genetic information or requiring the genetic information and requiring them to keep it private, but federal government use of genetic information was never really a problem. So as I say, this executive order was signed primarily for other reasons. Now, on the next slide I take up the issue of whether we've really needed to enact GINA. There is another provision that is less known in the Health Insurance Portability and Accountability Act, HIPAA, that applies to employer-sponsored group health plans. And it prevents discrimination on the basis of health information and health information is specifically defined to include genetic information. So already since 1996 it's unlawful to discriminate on the basis of genetic information in fashioning an employer-sponsored group health plan. Well, before GINA was passed, in addition as I said earlier, there were laws enacted that prohibit genetic discrimination in employment in about 35 states and 47 states enacted laws prohibiting genetic discrimination in individual health insurance policies. So the first question is did we need GINA? Well, on the next slide, you'll see the reasons for enacting GINA. Number one, the law was pending for so long it was actually introduced in Congress in 1995 before HIPAA was enacted. So at the time that GINA was first proposed, although it wasn't called GINA at that time, we had no HIPAA law dealing with employer-sponsored group plans. And second, GINA was intended to improve upon the confusing and inadequate patchwork of state and federal laws. So when the justification was first enacted there weren't any other laws and now the justification is there are too many laws that are too confusing. On the next slide, reason No. 3, GINA was intended to add protection in states without genetic laws. So in Kentucky there was no law prohibiting genetic discrimination in employment. But the most important reasons for enacting the statute was number four, there has never been a serious problem of genetic discrimination in employment in the sense that people who take genetic tests are fired in great numbers or people who have genetic family history of higher risk are denied employment in great numbers. The problem is that individuals who might want to
  • 6. undergo genetic testing are in great numbers often dissuaded from doing so because they're afraid of the consequences of the social and economic consequences including discrimination in employment, but also discrimination in health insurance and other areas. So the key purpose of GINA was to allay the concerns of these individuals who are afraid to undergo genetic testing. That's the main purpose of GINA. Now on the next slide where you see the picture of the capital, we have the three main titles of GINA, Title I being health insurance. My focus is going to be on Title II, prohibiting employment discrimination on the basis of genetic information. And the next slide has the signing ceremony where President Bush in May of last year signed the law and there are just a couple of people I want to point out on the picture. On the far left is Senator Snow who was the lead Senate sponsor and standing next to her on our right is Representative Louise Slaughter who was the original House sponsor of the bill in 1995 and was one of the lead sponsors. One a Republican and the other a Democrat. On the next slide I have the section 2 slide which is the quote from the statute that sort of confirms what I said just a minute ago, that the purpose of the law is to fully protect the public from discrimination and allay their concerns and let them have the advantages of these new technologies that have come down the pike. And this reason explains why in addition to genetic advocacy groups, genetics researchers, biotech companies, pharmaceutical companies and many other similar groups pushed for this legislation so much because no one would want to take their tests if they were afraid of the discriminatory consequences. The next slide has the definition under GINA of genetic information and it's a three-part definition. It includes the individual's genetic test results; number two, the genetic tests of family members of the individual. So, for example, if in my medical record there was the genetic test result of a parent that showed that they were affected by some disorder, I would be at risk. They wouldn't even need to know -- that is an employer wouldn't even need to know if I was tested to know that I was at risk. There is another term I want to explain in number two where it says the genetic tests of family members. The Equal Employment Opportunity Commission was assigned the responsibility for promulgating regulations interpreting this new statute and they did so on March 2§nd, and they interpreted the term "family members" as meaning anyone who is a fourth degree relative or closer, which means a great-great grandparent. And number three, the other way you can have genetic information is the manifestation of a disease or disorder in a family member. So it's your genetic test, a family member's genetic test or if a family member has a disease or disorder. On the next slide it's mentioned that the term also includes any requests for or receipt of genetic services or tests or undergoing -- or enrolling in clinical research by the individual or a family member.
  • 7. Now, the statute refers to genetic tests. The next slide talks about the definition of a genetic test. And it says it includes the analysis of human DNA, RNA, chromosomes, proteins or metabolites that detect genotypes, mutations or chromosomal changes. And on the next slide it does not include an analysis that is directly related to a manifested disease that could reasonably be detected by a health care professional. So what this means is any test to identify if an individual is already affected is not a genetic test. An individual under GINA is not covered if they already have a genetic disorder. The statute only protects people who are asymptomatic. And that's a very important thing to know and I would argue -- and I'll talk about this later -- a major shortcoming of the statute. It only applies to people who are asymptomatic. Now, on the next slide and the ones immediately thereafter, we talk about what are some of the substantive provisions of GINA, Title II which applies to employment, and here the first -- the coverage and remedies are the same as Title VII of the Civil Rights Act of 1964 which also means that they are the same as the ADA. So the coverage and remedies are the same as the ADA. It applies to employers with 15 or more employees as well as employment agencies, labor organizations and training programs. Now, Congress gave the EEOC one year from the date on which the act was signed to issue final regulations and the proposed regulations as I mentioned were issued on March the 2§nd, and there is a comment period, so if you want to submit comments to the proposed regs, you can do so. On the next slide it indicates that the remedies are the same as for Title VII and the ADA, but there is no disparate impact liability under the statute. So, in other words, for laypeople, you have to prove that the employer intentionally discriminated against you. And the third bullet on this slide, state laws are not preempted. So you can sue under one of those 35 state laws, as well as GINA. You basically can sue under both or take your pick. The reason why this is important is that in some states the unfair practice laws apply to employers with fewer than 15 employees, and in some states it goes down all the way to one employee or more. Others, it's two or five or ten, so if you're in one of those states, you may not have the ability to sue under GINA if you're working for a small employer, but you may have the ability to use one of the existing state laws. On the next slide are some of the prohibitions under Title II. It's unlawful to discriminate on the basis of genetic information in hiring or firing or job assignments or to limit or segregate or classify in ways that adversely affect an employee. This language is identical from Title VII. On the next slide, there are some ways that are unique to GINA. It's unlawful to request, require or purchase genetic information about employees, and let me point out that the term employees not only includes applicants, it includes former employees. So employees means current employees, applicants and former employees. It's also illegal under GINA to retaliate against an employee who wants to exercise his or her rights under the statute and all of the federal
  • 8. antidiscrimination laws have anti-retaliation provisions. And if you think about it, here is why it's important: No one would exercise their rights or attempt to if their employer would fire them for doing so. So on the next slide are some ways that acquiring genetic information is lawful. I said earlier you can't request, require or purchase genetic information, but employers may inadvertently obtain genetic information sometimes through voluntary disclosures, other times through the water cooler as the EEOC says in the regs. Because you learn that someone's father has Alzheimer's disease or you learn that somebody's child is sick with cystic fibrosis or some genetic disorder and learning that information is acquiring genetic information, but if it's inadvertent, there is no liability. Under the statute, it's not unlawful if the employer acquires information through a voluntary workplace wellness program. And another way is through certification under the Family and Medical Leave Act. If you're seeking family or medical leave, you can be asked to document why you're doing so and turning in that documentation might be giving the employer some genetic information. On the next slide, the statute lists permissible disclosures by employers when they have genetic information and it's okay to give it to the employee if the employee files a written request, in response to a court order in some public health emergency. There is an interesting provision discussed on the next couple of slides that deal with genetic monitoring. And this involves employees who are working with exposure to toxic substances that may cause damage to the genes or the chromosomes of individuals and can the employer monitor to see if those things are happening. And the answer is yes if these conditions are met: Number one, you have to supply as an employer written notice to the employees. Number two, the employee voluntarily agrees to undergo testing and signs a written authorization unless the statute says if the monitoring is required by law, but at the moment, there is no law that so requires. On the next slide, number three, if the employee is informed of his or her individual results. Number four, the monitoring must be in compliance with any applicable regulations such as OSHA regulations which don't currently exist, but conceivably might in the future. And number five, the employer doesn't receive any individual results. The employer receives the results only in aggregate form. So if you have 100 workers who take this test, the employer might get information that seven tested positive, but that's it. It doesn't identify any of the seven. I think one of the shortcomings of the bill or of the law is that GINA makes no provision for similar examinations and genetic testing of applicants and employees before they are exposed. And in many instances, individuals with a certain genetic makeup are at much greater risk and they would be well served by having a genetic test and then deciding on the advice of their own physician whether they want to accept that job. And so basically what I would urge and have for
  • 9. many years is that these type of provisions also apply to the pre-placement stage, but as yet it does not. Okay, as I suggested at the very top of the webcast, GINA has many limitations and I started to go through them on the next slides. First, GINA applies to health insurance and employment. It does not apply to life insurance or disability insurance or long-term care insurance or other uses of genetic information. And these areas are also very important to individuals and will GINA sufficiently allay the concerns of the public if they only are protected in these narrow ways? The answer is I don't know; but people are concerned about their ability to get life insurance and disability insurance and I think increasingly this is going to be an issue for long-term care insurance because long-term care for people who have Alzheimer's disease is much more expensive to provide. And now there are genetic tests that can show an increased risk of Alzheimer's disease and I think it's a matter of time before there is pressure to have genetic information before a company decides to write you such a policy. Okay, second, on the next slide, GINA does not apply to nongenetic predictive testing and the example I would use is called epigenetics and the next slide has a definition. They are alterations in the chemical makeup of DNA that did not involve modifying the DNA sequence. So, in other words, the same number and orders of the A's and T's and C's and G's, the base pairs of DNA are not changed, but what happens is sometimes there is exposure and there are chemical changes on these DNA sequences, one for the scientists out there is referred to as methylation and these changes of an epigenetic nature determine whether the genes are going to be expressed. And that is very important and I would add as an aside, one of the scary things about these epigenetic changes is that they can be acquired by individuals and then be passed on to their children and their grandchildren. But at any rate, the question that I raise on this slide is because GINA doesn't account for epigenetics, and there may be many other of these kinds of factors developed by scientists over the next several years, is GINA stuck in today's or yesterday's science? Okay, number three on the next slide, GINA adopts the approach known as genetic exceptionalism. So instead of making it unlawful to use predictive health information, or making it unlawful for an employer to acquire nonjob-related health information, GINA focuses on, quote, genetic information. And one of the concerns that many people have is that by isolating and calling special attention to genetics, it may have the effect of increasing the stigma of genetic conditions and genetic tests and services, and if that happens, I'm afraid GINA may be making matters worse. Number four, next slide, and this is very important for Title II, GINA's employment provisions are unlikely to limit the disclosure of genetic information and there is an error on this slide. I meant to say to employers. GINA's employment provisions are unlikely to limit the disclosure of genetic information to employers.
  • 10. Section 202 (b) which I mentioned earlier makes it unlawful for an employer to request or require or purchase genetic information, et cetera. But on the next slide, those of you familiar with the ADA know that under section 102 (d) (3) of the ADA, after a conditional offer of employment, an employer is permitted to require as a condition of employment that the individual sign an authorization for the disclosure of all of that individual's health records, regardless of the job in question, the job the individual is applying for, or the individual's health status. So now the question arises, how can you square section 202 (b) of GINA which says you can't get genetic information with section 102 (d) (3) of the ADA that says you can get everything? Well, here is the problem: Under the ADA you can get all this stuff. Under GINA you can get everything but genetic information. At the present time we do not have any technical capability in electronic health records or even in paper records to filter out genetic information and send just nongenetic information. I wish we did. In fact, one of my current projects is working with computer scientists to try to figure out how to do this, but we don't. And there are two states that are I think good examples of the problem. California and Minnesota have enacted laws that prohibit employers from gaining access to nonjob-related health information at any time. So it goes beyond the ADA and says no employer can get nonjob-related health information about an individual at any time. The problem is there is no way of limiting it, and when employers in California and Minnesota send requests to hospitals and doctors, the hospitals and doctors send everything. And until we work that out, until that becomes a priority to protect the privacy of individuals, we're going to be faced with unbelievable problems no matter what the law provides. And you see on the next slide that each year there are at least 10 million authorizations signed at the pre-placement stage and that's just the employment stage. A study that I did in 2007 showed that there were 25 million compelled authorizations every year, and employment was the first where you want this job, sign here. Number two on the list at 6.8 million was individual life insurance applications. You want to apply for life insurance? Sign here. And 6.8 million of those go out and there are many other types of releases as well that I won't mention the millions here and the millions there. And even if they wanted to, there is no way of preventing the disclosure of this information. So on the next slide, you'll see one of my concerns is that GINA does not address the issue of using what are called contextual access criteria to limit the scope of these disclosures. Okay, number six -- or I'm sorry, number five on the next slide is that GINA's employment provisions create a gap with the ADA's protections and if you go to the next slide, I'll try to explain this bar chart. On the left you see GINA and the ADA, and on the top going left to right are health conditions from the least severe to the most severe. So let me start with the ADA first.
  • 11. Under the ADA, individuals who are asymptomatic are not covered. And I'm talking about the first prong of the definition. I'm not talking about whether people are regarded as having a condition; just whether they have a substantially limiting impairment. So asymptomatic, not covered by the ADA. If they have a biomarker that is sort of a subclinical effect of exposure, let's say, or the early signs of cellular changes that are leading to disease, or mild symptoms, the ADA does not apply. Of course it must be substantially limiting, but if you are affected, in the third column, yes -- the green, yes, the ADA protects you. GINA is just a mirror image of that. GINA says that if you are asymptomatic you are covered. And on the far right if you have manifested disease, you are clearly not covered. The EEOC has not answered specifically the question of what about biomarkers or mild symptoms? I think that box is going to be red as well, that it's not going to be covered. So there is this gap between the coverage for people who are affected versus people who are asymptomatic and this I think reflects somewhat the policy unsophistication of Congress to enact law -- a law that seems to have a dichotomy between your unaffected and your affected. In the science world, it's well known that that's not the case. There is this continuum and this bar is supposed to reflect that. Okay, on the next slide, I talk about genetic predisposition and the ADA. There was a ruling of the EEOC in 1995 that if an employer discriminated against an individual on the basis of genetic information, that is an asymptomatic individual, that the employer would be regarding that individual as having a disability. On the next slide the infamous Sutton decision of the Supreme Court in 1999 seemed to throw that out the window, but then we have the ADA Amendments Act of 2008 that overturns Sutton in most respects, and so if you want to know what the bottom line is, I think the issue under the ADA is moot because as we remember maybe from that bar, asymptomatic people are specifically and expressly covered by GINA. And that's where they will be protected. So in the next slides I want to present you with my own evaluation of the new law, GINA. Is this going to be a good law? Does it work? Et cetera. So number one, I think it's very important despite the fact that I'm a vocal critic of GINA to acknowledge that GINA does have symbolic value and that may be important. If you think about the ADA, before last year when the act was amended, the ADA, Title I, dealing with employment was not a very good law. 95 percent of the cases that were brought were won by defendants mostly because the plaintiffs couldn't prove that they had a disability under the statute. Nevertheless, there were great number of employers who notwithstanding the fact that they might be able to escape liability if they challenged the case, they voluntarily complied with the statute and they undertook reasonable accommodations for their employees. And it was just a recognition that we are adding disability to the class of other
  • 12. criteria on which it's unlawful to discriminate. So I think symbolically it's important that GINA says, okay, we're adding genetic information to that list. Okay, number two, and this is my biggest criticism of Title I of GINA dealing with health insurance. GINA avoids the underlying societal problem. I would argue and have at the expense of many trees that genetic discrimination in health insurance is not about genetics. Genetic discrimination in health insurance is not about genetics, and if you go to the next slide, the elephant in the room is that it's all about health care finance and access to health care. That's what it's about. And as I explain on the next slide, the question is should we as a country allow individuals who are sick or more likely to get sick for whatever reason, genetic or infectious disease or trauma or anything else, should we allow them access to the economic mechanism by which they can get health insurance coverage? Should they be able to obtain that coverage without medical underwriting which would have the effect of basically bouncing the amount. That's the issue. So it's a broader issue. It's not about genetics. And then the rest of the slide, should there be a universal right of access to health care coverage? That's what this issue is all about. And as you can see, GINA is just a tiny part of that. On the next slide, number three, the other problem is GINA does not resolve the broader issue of the relative rights of employers vs. employees to control access to health information, including predictive health information. So it's still the law under section 102 (d) (3) of the ADA that employers can get all this information about individuals. Number four, GINA does not address the issue of genetic privacy or health privacy for that matter. And I want to -- in the context of this slide I want to talk to you about the growing threat posed by electronic health records and networks. These are very valuable in providing efficient, effective care, saving money in terms of nonduplication of services, providing clinical decision support and doing all sorts of other good things; but these records -- the things that make them good, also make them a threat to privacy. They are comprehensive. In other words, they include all clinical encounters. They are longitudinal. They cover a wide path in a person's lifetime, conceivably even cradle to grave. And they are interoperable which means that any health care provider will have ultimately access to all of this information. And so more information is going to be out there about individuals and their health conditions including health conditions dealing with genetics and more health care providers who don't need all of this information where there may not be any clinical utility, they are going to get this information. And all those third parties like the life insurers that I mentioned and the disability insurers and so forth, people who can require that you sign a release to apply, they are going to get much more information than they ever got in the past. And then that brings us to the next slide that's going to spin on to your screens. To what extent, if any, should individuals be able to exercise control over their health records to sequester sensitive information, which includes not just genetic information but maybe
  • 13. reproductive health information or substance abuse information or mental health information or a variety of other things that are considered to be particularly sensitive? And then when the information is released to these third party requesters for a workers' comp claim or a personal injury lawsuit or a Social Security disability application, what information are these people going to get? Are they going to get everything? Are they going to only get some of the things that they requested? So I think that there are many issues still to resolve. So on the next slide going forward, I want to deal with sort of the political side of GINA. Does GINA represent my first metaphor, a foot in the door to more comprehensive and effective legislation so the people who would say yes to that would say we couldn't get anything better than GINA this go round, but now we've got something and we'll go back later and amend the statute and have it deal with all these other better things that should be addressed. Or, my second metaphor on the next slide, is GINA the one bite of the apple in enacting genetic nondiscrimination law? Are we going to be stuck with GINA with all of its flaws, all of its gaps, all of its inadequacies because we had this one opportunity in 2008 and we now no longer have the political will? It took 13 years to get a flawed, inadequate law enacted. How many more years is it going to take to get something better? And then the last slide, if we were to attempt to amend GINA, one of the things that we would need to overcome is so-called legislative fatigue. If I proposed a law or an amendment to GINA this year or even if the president did, can you imagine what the reaction would be on Capitol Hill? They are worried about the economy. They are worried about the environment. They are worried about education and all these other issues and we solved genetic discrimination last session of Congress. Come back to me later. So that is sort of the practical political obstacle to amending the statute and making it better. So time will tell. I don't know that we can pass judgment on whether GINA, Title I or Title II, is going to be successful. How are we going to know if it's successful? That is going to be determined by how comfortable people feel about undergoing genetic testing. I think as a public policy in this country, we need to do two things: Number one, we don't want to discourage people who want to undergo genetic testing from doing so. And that was the purpose of GINA. But, number two, we don't want to coerce people into genetic testing who don't want to be tested. And the decision on whether to undergo genetic testing is extremely difficult and personal and we need to have policies in place that respect the wishes of individuals and respect their autonomy to make these kinds of very difficult decisions for themselves and for their families. So with that, that concludes my formal remarks and I look forward to hearing some of your questions. >> LEX: Mark, thank you very much. That was an outstanding presentation and wonderfully organized for those of us who are not technicians or experts in the area. Some of that I must admit was a bit over my head, and I'm sure a lot of the folks on the call are much more familiar
  • 14. with some of the genetic issues than I am. Nonetheless, you've raised issues for everyone and I'm sure there are a number of questions which will come into our E-mail for those of you who are out there and wish to send questions, please do so at our Southwest Disability and Business Law Technical Assistance Center. We'll be glad to have your questions and get to them shortly. Mark, a couple of questions that I had based on your presentation, one of them it's clearly illegal to discriminate based on familial information, but is family defined to include cohabitants in a household? >> MARK: No, it is not. >> LEX: Okay, that's an interesting distinction with the ADA I think. Another question that I had, Mark, pertains to the whole issue of employers having information. On the one hand, it's not legal for them to have certain information. On the other hand, it's not legal for them to practice based on that information. So if they have it inadvertently, they are still not allowed to operate on it, is that correct? >> MARK: That is correct. That's a very good point, Lex. It's interesting that in employment law we always run this question of should we ban acquisition or should we ban use? And different laws take different positions, you know, on the topic. Here all use of genetic information is unlawful and noninadvertent access is also illegal under the GINA. >> LEX: Mark, as you point out, there is -- among the priorities that President Obama has set, one of them is personal health information, electronic health information and there will be action on that, are there advocates of privacy who are engaged in the discussions about electronic health information that you're aware of at the current time? >> MARK: Yes, the economic stimulus bill, the American Recovery -- and I forget what the other R is -- Reinvestment Act of 2009 contains a specific provision dealing with privacy issues and one of the specific items in the law addresses or seeks to address the area that I mentioned about segmented medical records. So section 3002 appoints this new health information policy committee and says that the number one thing for them to consider is the following: Technologies that protect the privacy of health information and promotes security and a qualified electronic health record including for the segmentation and protection from disclosure of specific and sensitive individually identifiable health information. So that is on the radar screen of Congress as well as the Executive Branch, but technically it's going to be very difficult to do. >> LEX: Well, I mean you've raised a whole lot of issues. I thought things were fairly simple once we passed the law, but obviously it leaves a lot of questions remaining, and I'm sure that our listeners have many questions. And so at this point what I'd like to do is turn the Q&A's over to Studio B and we have Jacquie Brennan as the DBTAC - Southwest ADA Center.
  • 15. >> JACQUIE: I prefer to think of this as Studio A. Never mind. So we do have some questions. Here is the first one: Several years ago the Chicago Bull's benched a player due to fears that he had a congenital heart condition which had already killed two other basketball players on the court. Doctors couldn't confirm the condition through regular exam and the Bulls demanded that he take a DNA test to confirm the condition or else they would not play him. He refused to take the genetic test and he was traded to a team that played him anyway. Would GINA prohibit what the Bulls did, and is there a direct threat exemption to GINA like there is in the ADA? >> MARK: That's a great question. For those of you who want more information, the name of the player was Eddie Curry and they were suspicious that he had hypertrophic cardiomyopathy which can result in sudden death on exercise. And the Bulls wanted him tested and he refused. And so they did, I suppose, the worst thing that can happen to a basketball player. They traded him to the Nicks. So he was forced to play for the Nicks at only $5 million a year. GINA has no direct threat provisions in there. The only thing that's different about the Curry situation is he had undergone other tests and so the diagnosis might have been made on the basis of nongenetic information. For example, off stress tests or some other heart tests, so what I think the statute is trying to do is to place on the individual the option of deciding whether to undergo genetic testing and I don't really think that he -- turns out that he had hypertrophic cardiomyopathy. >> JACQUIE: Okay, how does GINA apply -- and we've had this -- actually we have like six of this same question in one form or another -- how does GINA apply to insurance companies and then sort of bringing in another part to that, can the protected genetic information be used by insurance companies to make coverage determinations and are there any remedies for that if insurance companies engage in that kind of practice? >> MARK: Well, Title I of the statute of GINA makes it unlawful for a health insurer to use genetic information with the same definition that we mentioned with regard to employment for underwriting purposes. So they can't decide insurability based on a genetic test, but here is the problem with health insurance companies, they really don't need to do this because suppose I apply today for an individual health insurance policy. And somewhere in my record it says that I am at increased risk of colon cancer because I took a genetic test. It would be unlawful to refuse to hire -- I'm sorry, I've been talking about employment too long -- it would be unlawful to deny coverage under Title I of GINA. But the problem that I try to mention is what happens a year from now or two years from now or three years from now if I actually develop colon cancer? If I get colon cancer, then all bets are off. The statute doesn't protect me anymore. It only protects people who are asymptomatic. And then whether the insurance company could refuse to renew my policy or to renew it at greatly increased rates or to exclude colon cancer and renew my policy -- that would depend on state health insurance law. And state health insurance law in virtually every state allows the insurance company to adjust the policy based on new medical
  • 16. information. And so that's why I try to focus on the fact that the issue is, you know, less genetics and more about can you still get coverage if you're sick? >> JACQUIE: All right. Okay, another one is HR professionals will probably be devising policies regarding GINA. Can an employer face a problem when an FMLA form extracts genetic information derived from a treatment that an employee might have received? Or would FMLA in this case protect that information nonetheless? I think you touched on that on a slide, but maybe -- >> MARK: Well, let me clarify. If the employer in evaluating an FMLA claim gets genetic information, that would be considered an inadvertent receipt of genetic information and, therefore, would not violate Title II of GINA. And in the proposed regs that just came out a couple of weeks ago from the EEOC, that specific example was used. >> JACQUIE: Okay. Do you foresee any greater use of information gleaned from amniocentesis or other in utero testing in terms of sharing genetic information? >> MARK: I'm not sure that I would see that in the context that we are talking about because we're talking about employment and the kind of in utero genetic testing that's done is mostly for, you know, childhood onset disorders. And people would in most instances already be affected by the time they would enter the workforce. So the answer is probably not from, you know, prenatal genetic testing, but as the price comes down for genetic testing, it's going to be much more common to do sort of multiplex testing which is testing for maybe 10,000 mutations at one time and, in fact, there are a handful of companies now that offer the so-called genome wide association studies where for anything ranging between $400 and $1,000 you can have your entire genome probed for genetic information. >> JACQUIE: This person wants to know if you can elaborate a little more about the intersection of GINA and the ADA or where something becomes more of an ADA issue vs. GINA? For example, in the case of an employee who undergoes some sort of genetic testing and then that information is either given to other employees or is let go, the person is let go, would that be a GINA issue or would that fall under the ADA or both? >> MARK: Well, it could be both, but keep in mind that bar that I had with the red and the green. If someone is asymptomatic, they are not likely to be covered by the ADA unless you can make a claim that they are being regarded as having a disability, and conversely if you're on the GINA line, if they are already affected, they are no longer covered by GINA. So there is probably very little overlap unless you get into either the regarded as situation or the retaliation situation simply based on the exclusionary criteria used in the definitions. >> JACQUIE: Okay. As a small employer I have only seven employees and I am not covered by the ADA. Am I still covered by GINA?
  • 17. >> MARK: The answer to that is no. The coverage is going to be the same, 15 or more employees for GINA. >> JACQUIE: And do you think that's going to be effected -- some states sort of lower that. Do you think states will pass analogous laws like they have for Title VII or the ADA? >> MARK: 35 states already do have state law. >> JACQUIE: That's right. And somebody did ask that, where they could get a list of which states -- >> MARK: There is a very good website that is from the National Conference of State Legislatures, so if you go on ncsl.org and you have to go to a few more links, it's health and genetics and programs and whatever, you can find a very good table that lists all the state genetic nondiscrimination laws in employment and health insurance and there is also another table dealing with the 12 states that have genetic privacy laws. >> JACQUIE: Okay, great. As an HR person, I know that I have to keep a person's medical records separate from their personnel files. If I come in to possession of genetic information, do I keep that separate from both files or can I put it with the medical records? >> MARK: Well, certainly you could always put it with the medical records. The question is whether you could do it in reverse. You could put anything you want in the medical record, the question is whether you can put medical information in the personnel record. And to the extent that you can put information that has been developed for another purpose, such as workers' compensation or Family Medical Leave Act or short-term disability claims, to the extent that that information can be kept separately, even if it does contain genetic information, that's not going to violate GINA. GINA does not have a provision like section 102 (d) of the ADA that requires that information be stored separately. And the reason for that is you're not supposed to have any information to begin with. And so that anything you obtain inadvertently can remain in the file of wherever you obtained it. >> JACQUIE: Do you think that there is going to be any one or two genetic diagnoses that would be discriminated against more than others? >> MARK: That's a great question. I don't know. What we have so far is that there are -- you can count on one hand the number of cases of genetic discrimination that we've seen so far. That means where asymptomatic individuals were subject to discrimination. My hunch is that it may be in the behavioral genetics area where employers are afraid that somebody is going to have a meltdown while they are driving the company truck, or they are going to have some sort of behavioral problem with a customer that could not have been anticipated but for some genetic test that shows a greater predisposition to sudden violence or loss of control or something like
  • 18. that. So I think it might be in the behavioral genetic area, but that's just a guess because we don't have a big track record of discrimination on the basis of predictive genetics. >> JACQUIE: All right. In your experience, have you seen a lot of cases where discrimination at this level has happened as far as employment, a lot of cases of genetic discrimination in employment or are there only a handful of those kinds of cases? >> MARK: There are only a handful of those cases. There are surveys that ask individuals if they have been subject to discrimination, and many more people claim that they have been subject to discrimination, but it turns out that the people who say they have been subject to discrimination are people who are already affected by disorders, and so I'm not saying they haven't been subject to discrimination, it's not genetic discrimination as defined by GINA and other statutes. They might be subject to discrimination that is more properly considered under the ADA because it's disability discrimination as opposed to genetic discrimination because they are asymptomatic. So it's very hard to assess those cases and it's very hard to prove those cases. And even as a result of surveys, the best we could get is a listing of the number of people who feel they've been subject to discrimination. And in most of those cases no lawsuit has ever been filed. We don't know whether in fact the employer even knew that the individual had a genetic test. All we have are genetic tests, person loses job, they think it's discrimination. And as I say, there are relatively few of those situations. >> JACQUIE: In terms of third parties who may store or transmit this genetic information, do you see a high possibility for the likelihood that information gets into the wrong hands and thus winds up in the hands of an employer or anyone else for that matter who might be able to act on the information? >> MARK: Well, employers do have a right under current law to get an individual's entire medical record and post GINA, but not genetic information, assuming that could be done which is a major assumption. So employers already get lawfully lots of information. I don't think that there is -- I mean, I have many concerns, but one of them is not necessarily that the people who get authorizations for genetic information are then going to turn around and sell them somewhere else. So I'm not concerned that a life insurance company who gets medical information lawfully is going to figure out where this applicant is working and then try to sell that information to the employer. I think that would be incredibly stupid and against their long-term interests even if they could sell that. >> JACQUIE: Yeah. You know, I know you went over how employers can get medical information. And so you know they have a right to request your medical records and so they just request from the doctor your medical records and the doctor will likely not go into those records to ferret out any genetic information, right? So it would just all get turned over in that way. >> MARK: Yes, and when you think about the definition of genetic information that I mentioned to include family health histories --
  • 19. >> JACQUIE: Right. >> MARK: -- you understand how difficult that is. So it's not just the results of a genetic test, it could be, you know, when you go to the doctor, a new doctor, they often ask are your parents living? What did they die from? Do you have brothers and sisters? Are they in good health, and so forth and all this information. So there is no generally recognized place -- certainly a paper record where that information would appear. And so it's just a mess. If I were a large hospital where I had a foot high stack of paper and somebody said send all the information, but don't send genetic information, it would take a committee of ten all afternoon to go through somebody's file with a gallon jar of Wite-Out to try to figure out what to send and they are not going to do it. >> JACQUIE: Yeah, I think that's exactly right. I wonder if it will be -- but you're right, I can't even think how you could word a medical request to actually have all of that information. Because like you said it's just on everything. It's on what you fill out that first day you go. It may be on doctor's notes where they just make notes about what you say in an office visit. That would be really -- you're right -- next to impossible to do that. Well, that is all the questions I have on my end. Lex may have thought of a couple more while we've been chatting. So I want to thank everybody who sent in questions because they definitely make it a lot easier -- wait a minute. They just brought me another one. How does GINA delineate the language that only asymptomatic folks are protected? I mean, is this not the issue that someone might actually have a symptomatic genetically related condition? >> MARK: Well, they obviously could have a symptomatically-related genetic condition, but GINA doesn't cover that. GINA explicitly says that once a condition is manifested, and that's the language, what is manifested and the regs go into how a condition manifests itself, basically if it's diagnoseable by a health care provider using regular techniques, once it's manifested, GINA is out of the picture. The ADA may then apply, but GINA doesn't. >> LEX: Mark, we could also add there that there are many conditions that are manifested that are symptoms representing any number of underlying conditions. >> MARK: Exactly. >> LEX: One question that I do want to add before we conclude today, has to do with this question of medical records that your employer receives. What would you say about a person who when they applied for a job -- I mean, is there anything illegal if I make a job application about leaving the space where they ask me to specify who my physician is blank? Maybe I'm between physicians. Maybe I don't have a health care provider. Is there anything that prohibits me from doing that?
  • 20. >> MARK: There is nothing that prohibits you from doing that, but you might not get the job because an employer is permitted under the ADA under conditional offer of employment to make submission to a medical examination if they want to conduct it themselves or I should say and/or the supplying of medical records a condition of employment. And so they might legitimately say we can't hire you unless you come up with your medical records. >> LEX: Interesting. I mean there are a lot of questions here. You've actually made some very good points. You've raised a lot of issues and you've been good enough to tell us that many of these are questions that were not resolved by GINA. They have not been addressed. We can assume on the basis of the conversation that you're working with others to help continue identifying those issues and addressing them and we really appreciate it, Mark. >> MARK: Thank you, Lex. I'm doing what I can and one of these days we may have some results. >> LEX: Any other concluding comments you'd like to make before we wind up today's presentation? >> MARK: No, it was my pleasure to talk with you again and I want to wish all my friends in Houston all the best. >> LEX: Well, we certainly want to thank you for joining us today, for giving us this time and taking the trouble to put together this fine presentation. For those of you who are watching, much of the information that has been discussed today here is on the website. The complete discussion will be archived and available to you on the website perhaps as early as tomorrow. We will also try to add some additional information that Dr. Rothstein mentioned in the course of his presentation. We'll try to dig up that list of states that already has coverage and post that on our website. We want to thank all of you very much for joining today. For those of you who asked questions, they were good questions. We appreciate that. We look forward to receiving further feedback from you and perhaps it's necessary to have a whole series of discussions about these matters. Mark, you might consider joining us at a later date to discuss personal health records and electronic health information. >> MARK: Sure. >> LEX: We want to thank the National Institute on Disability and Rehabilitation Research, NIDRR, for sponsoring today's program. And we again hope all of you join us again. The opinions and views expressed today are those of the presenters and no endorsement of the sponsoring agencies should be inferred from the presentations.
  • 21. And finally, this webcast would not have been possible without the fine efforts of our webcast team at ILRU, Rob Dickehuth provides the technical expertise for these broadcasts and Marie Bryant does the fine job of captioning. Thank all of you again for joining us. Please join us next time on the ILRU DBTAC webcast. Bye-bye.