 Hello, everyone. Good afternoon, or I guess for those of you further out west, good morning. I'm Alan Guttmacher, the Deputy Director of the National Human Genome Research Institute at the NIH, and I'm the moderator for today's webinar. On behalf of the NHGRI, I am extremely pleased to welcome you to the very first in what will be a series of webinars about genome research and its application to health and to health care. We're picking off the webinar series now, and that its first subject is the Genetic Information Non-Discrimination Act, or GINA, is no accident. This is a historic piece of legislation that, as many of you know, took 13 years to fully gestate, but was finally passed by both Houses of the Congress and signed into law by the President. And if the system's working correctly, you should be able to see that signing on your screens now on May the 21st of this year. You could really think of no better subject to launch the NHGRI webinar series with. We're going to hear today from two speakers who are not only experts on GINA itself, but in fact are intimately involved in this consideration and its eventual passage into law. We'll hear first from M.K. Hollahan, who is a health policy analyst here at NHGRI, and then from Sharon Terry, who is the President and CEO of the Genetic Alliance. Before we get started, though, a few other logistical notes. If you have any technical problems at all, as you heard before, for instance, if you're having trouble accessing the web portion of the call, file star zero, and you can get the operator. The format for the webinar is that M.K. and Sharon will give beef presentations to start us off, and then we're going to spend most of our time asking each other questions and answering two of them. We're going to take your questions over the web. If you look on your computer screen, you should be able to see a question box and submit the questions there. You should feel free to submit questions during the presentation portion of the call. You don't need to wait until M.K. and Sharon are finished to start asking those questions. We'll keep track of the questions on this end and answer as many as we can after the opening presentations. By the way, if you should get a message that says message dismissed, that only means we're keeping things organized in our end and we've moved the question out of the queue, we haven't actually dismissed it at all. If you're having any difficulty submitting a question via the web, you can always email it to Sarah Harding on our staff here at NHGRI, who's really the person that we have to thank for organizing this. And her email address is sharding, that's S-H-A-R-D-I-N-G at mail, M-A-I-L dot N-I-H dot G-O-V. As you heard before, these are being recorded. Part of the reason why we're going to be recording this is that we hope to post the call online so that others can benefit from the conversation later. Finally, before we get started, any of you who have any blackberries or cell phones, near the phone, if you could move them away, we'd appreciate it since that can cause interference over the network. And without any further ado then, on to our first speaker, M.K. Hollahan. Thank you, Ellen. Well, thank you everyone for joining today. So we've all been talking about GINA for a number of years and the question now is, what does it mean? So the Genetic Nondiscrimination Act is a piece of federal legislation which addresses employer and health insurer use of genetic information, and it regulates that use. So as I mentioned, this has been a 13-year effort. Many of the states, I should comment now, have specific laws that are similar to GINA. Many fall far short of the protections that GINA provides. A few actually go further than the protections GINA provides. And right off the bat, I just want to make sure everyone is clear that those state laws remain in effect. The stronger state laws, those protections will still remain in effect. GINA does not preempt the state laws. So what GINA does is provide a federal baseline that everyone in the United States is protected by. If you happen to live in a state that has stronger protections, you still enjoy those stronger protections. So why was this such a contentious process and why did it take so very long? There was really entrenched opposition by employer groups and to a lesser extent, although that sort of varied over the years from the insurance industry. It sort of was perceived as more opportunities for lawsuits, as an unnecessary protection. There are really no instances of state laws, the state protection laws being utilized, for instance, discrimination. So those who opposed GINA pointed to that and said, this is a remedy in search of a problem. That is certainly not the experiences that we've heard relate to us. It's simply the process of the way laws are reported from the states. You really don't know what incidents may have never made it to court, what things may have been settled at the trial court level. If you don't have appellate decisions, it's really difficult to track the impact of a state law. And also, many of these laws we knew were untested. So how the courts would treat the state laws was still very much an open question. So GINA, this in the 110th Congress, GINA actually passed the House of Representatives on DNA Day last year, April 25th, by a vote of 420 to 3. And there was much celebration and we really thought we were looking for a fairly swift Senate passage. But that was not to be the case. GINA was blocked in the Senate for almost a full year. And then there was a series of revisions. It was finally passed by the House on May 1st of 2008. And you may wonder why it took a full year for GINA to get through the Senate. The Senate has a very different set of rules than the House does. And a single Senator has the ability to describe just putting a hold on a bill. Essentially, this is a threat of a filibuster. The Senate has a very different set of rules than the House does. And a single Senator has the ability to describe just putting a hold on a bill. Essentially, this is a threat of a filibuster. And finally passed the Senate. Then passed the House again because it was a different version than past April of 2007 and had to go back to the House. And then as Alan pointed out, it was signed by the President on May 21st. So what does this law actually do? GINA will prevent healthcare insurers and employers from discriminating based on an individual's genetic information. And it is really our hope that this will allow Americans to take advantage of the benefits of genetic testing without being afraid that they're going to subject themselves to risks of losing their health insurance or their children or their other family members will be at risk of losing insurance or that this will affect them in their employment. Getting a job, keeping a job, being promoted. So what GINA does specifically is prohibits health insurers from requesting or requiring genetic information of an individual, of their family members, or of using it for any decisions regarding coverage, rates, pre-existing conditions. They simply can't use it for underwriting whatsoever. It's very important that the definitions have been crafted in a way that is broad enough that this includes not only genetic test results but includes genetic services, participation in a clinical research trial, and it also protects family history, which is obviously a very important genetic indicator. So some of the core protections are for tests such as those that reveal a risk of a future disease, like BRCA 1 and 2 variant testing, testing for gene variants associated with Alzheimer's disease, for colon cancer, for Huntington's. As I mentioned, it protects family history. It would protect tests based on DNA or RNA-based pharmacogenomics. Any test that measures human DNA or RNA, those are protected by GINA. So as I mentioned, the genetic information is a pretty broad definition. It includes family history, which is incredibly important. Many of the state definitions do not include family history. And this was really, I think, a significant conceptual battle because health insurance companies, the individual policies which allow underwriting based on a specific application, specific health information, they always look to family history. It's a very important indicator for them, and this is not something that, after GINA takes effect, it's not going to be allowed to be used. So genetic services means a genetic test, genetic counseling, genetic education, and this includes participating in any sort of research study. That has genetic services, of course. What GINA does not cover. GINA is about the information, the genetic information. It is not about a genetic disease. So GINA would protect and preclude use of information about, for example, a woman who had BRCA 1 or 2 variant, predisposing heart and breast cancer. It would protect that information. It does not protect a woman with breast cancer because that has manifest disease. That information can be used for underwriting purposes. It does not protect the use of any genetic information in regard to life insurance, long-term care insurance, or disability insurance. It only protects relation to health insurance. GINA also does not cover members of the military. It's something that is conceptually difficult to accept. The military is an entirely different employment in health insurance system, and GINA does not and cannot reach that. So other limitations that are important to understand about GINA, because GINA uses definitions that are, it references other statutes, other employment statutes. It does not cover very small employers. So the definition of employer only relates to employers of 15 or more employees. So for very small companies, the protections of GINA do not extend. There is some argument as to whether smaller companies would still want to at least be aware of compliance with GINA and hopefully strive to not use information in this way. But that's an open question, and these are also companies who may be most at risk of, you know, increasing health care costs, health insurance costs. So there is a vulnerability there. Also it's going to be difficult to prove violations of GINA, particularly in the employment context. So we are hopeful that we will get strong regulations which really will be critical to GINA having impact that it's hoped for. So what happens now? GINA was signed into law, as we said, May 21. So the agencies who are drafting regulations have 12 months to complete those regulations. The insurance protections, which is Title I of GINA, go into effect May of 2009. The employment protections, which is Title II of GINA, those go into effect six months later in November of 2009. So research implications. This is a question we've gotten from several different areas. What does this mean about the informed consent process for genetic research? Many informed consents relating to studies that collect genetic information have one or two sentences that describe possible uses or abuses of genetic information. At this point, there's really nothing that can be communicated or should be communicated in the research context until the law takes effect, which hasn't happened yet, until the regulations are final. It's not clear what the message should be. The challenge at this point is to fairly describe the important protections that will be afforded by GINA, but not to oversell in terms of, yes, someone will be protected and will have a remedy if there's a health insurance violation and misuse of this information. But that doesn't mean that if they apply for long-term care or disability insurance down the road, that this information couldn't be used in that context. So the primary concerns really have been about health insurance because I think for most people that seems to be a much more immediate concern, but GINA does not address any other type of insurance product and that's important to understand. So until the regulations are finalized, the true significance of GINA in terms of what we can communicate to patients and what we can communicate to research subjects will remain unclear. So I just wanted to end with a little bit of information about the rulemaking process. So when we talk about regulations being issued, that's essentially you can think of the law as sort of the skeleton and the regulations are sort of the flesh. It explains how a law will be implemented and what it really means and where someone would turn if they think there's a violation of the law. What's the process? So federal rulemaking is the next part. Congress passes a law that's designed to address some sort of social or economic meter problem like the risk of genetic information, of genetic information being used to discriminate. They pass a law like GINA, specific agencies that have jurisdiction over areas relevant to this bill have to study it. They have to look at sort of the existing systems and come up with regulations necessary to implement the law and there has to be a period of public comment. So and this is all laid out in a variety of formats and a federal law called the Administration Procedures Act. So regulations are, they're not the law itself, but they have the force of law and it's very, very important that these are done thoughtfully and with appropriate input. So for GINA, there's a few agencies drafting regulations. There's the Department of Health and Human Services, the Office of Civil Rights. There's the Department of Labor and there's the Equal Opportunity Employment Commission, the EEOC. So some of the critical issues for the regs to consider are what is genetic information? What are the definitions? What kind of examples are we going to use? What is manifest disease? When does a genetic condition with signs and symptoms but no clinical illness equate to manifest disease? So some of these don't have perfectly simple answers, but they're important that we get them right. So for the public comment period, there'll be a notice published in the Federal Register that will solicit comments. We anticipate public comments to come from a variety of parties, from insurers and employers certainly, possibly from pharmaceutical companies, from genetic testing companies, from privacy advocates, and from disease groups. For GINA, this process will be controversial as the whole process of getting the law passed was. And in this case, there's also a complication because we're looking at a presidential election in November. So the timeline involved is very likely to be that the career staff who are making recommendations to the leadership of the agencies who are working on these regs will actually be submitting the final draft to a new administration. So that just complicates things a little bit from their perspective. So finally, I'd just like to urge people who work in genetics and genetic testing and work with patients and work in advocacy to get involved, and it's very important to pay attention when the draft GINA regs are released and to contribute comments in whatever way, whatever area your expertise is in and whatever the concerns are because it is really to the benefit of all of us who have really vigorous and broad public comments on GINA. Thanks very much, and I'll turn it over to Sharon Terry now. Thanks very much, MK, for giving us this great overview of where GINA stands. I thought I'd just say a word or two about the process, not so much in the kind of history that MK just gave us, but instead in terms of looking at how many groups were involved to get us this far and to go to MK's last point that we really do want broad input as we go forward. So I think as many of you know from very different points of view since this audience is quite diverse, we have seen genetic discrimination in many forms in many ways, and certainly the fear of discrimination has been overwhelming, especially in the realm of clinical trials and the research enterprise, but also for persons. And so during the process of bringing this bill forward over these 13 years, there's been a very good and active engagement from a very broad stakeholder community. So certainly the Coalition for Genetic Fairness with which many of you are familiar, and in fact many of you are members, was very active in working with the organizations that MK mentioned, the Chamber of Commerce, the National Association of Manufacturers, and then more specifically the various committees in the House that had difficulty with this bill. And as our champions in the Congress are fond of saying, all of this work together created a better bill that was certainly more clear about many of these very controversial issues that MK pointed out at the end of her talk. I think really significant for this process is that each of the stakeholder groups, be they providers, researchers, actual patients, patient groups, policymakers has a stake in this endeavor. And while it is thrilling and wonderful that we've come to a point where we can say the law has passed, the time that we're looking forward to ahead of us is important in the sense of both making sure that the regs are right as well as making sure the community is educated. And while the reg writing will happen with the agencies that are federal that MK posted there, really what an important thing for all of us on the phone to understand is that our input is important. And while, again, most of us will not be in those meetings and sort of dickering over the various points like what's the definition of genetic information or exactly how far should a reg be pushed in order to afford the right protection, all of us in our various positions will have a say in it through the kind of active engagement that we've had with these agencies overall. And so whether it's HHS or whether it's EOC or another agency, they certainly want to hear what you have to say and the practical questions that you're facing. And I think the important thing going forward is what implication does this have on both the regular practice of medicine as genetics gets integrated as well as the broader issues around clinical trials and that sort of thing. So what I think we will be looking for, so the Coalition for Genetic Fairness, as well as I'm sure NHGRI will be looking for is input from stakeholders to say, here's the rubs, here's the things we're coming up with. And we've certainly begun to get a lot of those questions. I know NHGRI's website offers you some answers to those kinds of questions. The Genetics and Public Policy Center has a nice section in the Coalition website as well. So what does it mean practically? And as MK said, we don't know what it means practically until the regs are written. We know what it means generally in our engagement as we go forward to understand exactly what this is going to mean is going to be important. And meanwhile, I think the stakeholder community, communicating with one another through this process is going to be really important. And we look forward to sort of that continued discussion and continued refinement of what this will mean for those people that we know either haven't been tested or have been tested anonymously or have not entered into clinical trials because of their fear. And I think I'll stop there because I think the most important thing to look at this webinar is hearing the discussion and the questions that you have. Indeed, Sharon. Thank you very much for that and thank you, MK, as well. Just remind folks while we do have some questions already queued up and I'll start any one of those in just a minute. If you have other questions you want to submit, go ahead and put them in the question box on your screen or if you're having problems with that, remembering you can email them to fharding at mail.nih.gov. Because we probably won't be able to get to all the individual questions, we have a couple of hundred people on the line today. We are going to group similar questions as much as we can and get to as many as the time allows. So let's get started. And this question I'll throw out to both of our speakers. What were the changes that were made to the bill that allowed for Senate passage, finally? Sharon, do you want me to take that? Sure. Well, the answer is it depends who you talk to. There were nuanced changes that really did not lessen the protections that were contained in the bill that passed the House. There were some clarifications of language that made things a little bit more clear from the insurer perspective. For example, insurers are not allowed to request or require genetic tests. However, if someone who has, for example, a BRCA variant wants to have prophylactic surgery to lessen their risk of developing breast cancer, the insurance company is allowed, in that case, to require the genetic test result for a coverage decision. And so that was always the intent. The language of the earlier bill was never intended to preclude insurers from making reasonable requirements of medically necessary and coverage determinations. But that was something specific that they wanted made very clear for their purposes. So I think the consensus was that was a reasonable thing to do, and so that language was changed. There was some clarification about under what circumstances manifest disease could be considered. In manifest diseases, for one person, it is legitimate or it's open game. Gina doesn't preclude it from being used for underwriting. However, if the manifest disease is of a family member who might be also uninsured with the same company, possibly on the same policy, that complicates things. It's one person's genetic information. It's another person's manifest disease information. One is fair game, one is not. So there was some language added to clarify that as well. And then from the employer perspective, a real sticking point for some time was this concept described as a firewall, which would keep, in a nutshell, would keep employers, limit employers' liability to only employer violations as opposed to insurance violations that many employers are self-insured, so they wear both hats. They're health plan administrators as well as employers. And so there was some kind of nuanced language agreed upon probably at the 11th hour that gave some sense of comfort to people on both sides that to limit the liability to instances of abuses of information and that tried to clarify situations where employers who were also health plan administrators could sort of delineate which hat they were wearing and which title they would be liable under. Good. Thank you. Sharon, anything you wanted to add to that? No, I think that's fine. Okay, good. So Sharon, this one I'll throw at you. And that is, is there any interest in Congress or in other communities in addressing discrimination based on genetic information and life insurance disability or long-term care insurance? The answer to that is yes. And we saw even during the hearings for Gina in various committees on the Hill various members of Congress get quite excited by, for example, long-term care insurance, which lots of Americans are going to be facing. And so there, Anna Eshoo from California has said she will take up that issue. And certainly the Coalition for Genetic Fairness has not left those issues to the side. Neither has Genetic Alliance. And we're just looking at how practical is it to consider those apart from healthcare reform generally and whether or not some integrated approach might be better. And I might just add a number of people are particularly interested in this for a couple of reasons. One is that it is very rare that any states have laws having to do with genetic information and life insurance disability or long-term care insurance. Only a couple of states that approach that. So there's no even floor there. And also, of course, the nature of genetic information that's predictive is less likely, in fact, to be used against an individual on health insurance since most health insurers assume that they'll only be insuring a given individual for a few years. That is, since our health insurance is employer-based, large in the United States, health insurers assume that any individual covered life will go to some other insurance company within a few years, either because the individual will change jobs or the health insurer will stop covering that specific employer. Whereas, of course, lifelong term care and disability insurers care very much about more predictive information. Health insurance tends to have a very short time horizon. Lifelong term care and disability insurers often care very much about will somebody be well for 10 years or will they be well for 17 years, and that's where they really do their underwriting, et cetera. So that's a good question and will be a lively issue to keep attention to. Okay, and this one for MK. How would people know that an insurance company denied them on the basis of what Genick does cover? Wouldn't the insurance company try to hide that fact? Well, I don't think they're going to be very honest about the reason, so that is an inherent problem in any sort of legislation that would address something like this, because insurance companies are not required to explain to you, and you can't prove what the underwriting process was, what the decisions were based on. I think the general thought on this is that an individual who has genetic information that may predispose them to a disease, they're going to be aware of it. They're going to be somewhat more hyper-vigilant about a process like applying for individual insurance and an underwriting process. So if they suspect that they've been denied or if they've been rated at some incredibly high level of premiums, or the terms are somehow really not comparable to what they would have expected or what other companies might have offered, I think the expectation is that those people would complain. It's going to be made very clear in the regs where they complain to. Do they go to HHS? Do they go to the state regulators? Is there a dual notification system where they would trigger some sort of evaluation of what the process was? And in that case, if the insurer couldn't point to something specific other than genetic information, which, remember, they're not supposed to possess. So first of all, they need to have access to it. They need to have, I guess, gleaned it from a medical record or in some way gotten access to it. For example, family history might be in a medical record. They may request medical records. Then there's going to be some review process. I assume that they'll probably have like a preliminary Q&A between a regulatory agency and an insurance company if there's a suspected case of discrimination based on genetic information. Very good. Thanks. In answer to a question that several people have asked about accessing more information that the webinar is based on, et cetera, for those of you who don't know it, there is an NHGRI webpage about the webinar series that includes, for instance, the full text of HR 493, some other articles about gene, et cetera, an overview of the law's timeline, et cetera, and you can get that either by going to, just probably the best thing is to type into your search engine, NHGRI webinar, and you will come up with a page, but for those of you who are more obsessive than that, it would be www.genome.gov slash 275-27023. Okay. So here's a question, and I'll throw it out to either one of our speakers. Would you recommend waiting until the regs are passed before getting genetic testing? I'll give a people answer, and then I'm kicking, but give a lawyer answer. I think that one has to consider a number of things and the example of the other data, someone in fact is, you know, a 68-year-old mother is diagnosed with breast cancer and is CRCA1 positive. Her 45-year-old daughter and 43-year-old daughter, whatever, might consider testing sooner than waiting either 12 or 18 before the law actually takes effect because of health concerns. If somebody is much younger and has some time after work, has a condition for which there are either nose treatment or less serious iterations than one might want to wait, one does have the protections afforded by this law. Yeah, I agree with Sharon. I think the individual situation is what would make that determination and in particular what the individual's insurance information is. If someone is covered under a group health plan and they're contemplating getting a genetic test for whatever, I think that if they feel they have a real health concern, I would go ahead and get the test. In terms of our concerns about the lack of protection for life, long-term care, and disability insurance, I can just say that although we do see, we've just actually recently seen some data about individuals getting tested for genetic variants related to Alzheimer's disease and that understandably one consequence of learning that information is speaking out long-term care insurance. And I'm sure the long-term care insurance companies are paying attention to this fact. It is my understanding that currently none of the application procedures for those insurance products or for the individual insurance market require genetic testing. Many of the math questions about family history, typically not specifically about genetic diseases, but as I'm sure most of you know, really all diseases have some genetic component, whether it's established at this point or not is a different matter. But I think that if someone feels they have a pressing need for health information based on a genetic test, they should proceed. And if you're undercovered under a group health insurance plan, your risk is very minimal. I would just add as well that it is also probable, and this is completely speculation on my part, that in fact because we now have heightened sensitivity around these issues that employers and insurers will not be trying to tread in this area and there'll be less potential for discrimination, although again that would be just speculative. Okay, now we have a series of questions that are about maybe sort of technical aspects of law in terms of what does this really mean, et cetera, et cetera. So maybe M.K., you'll take the lead on these, but Sharon may want to play in. The first is, you mentioned that junior does not cover members of the military. Does that limitation also extend to family members who are covered under the military policy that is the dependence of the military person? As far as I understand, no. That does not extend to dependence who are getting cares through their active duty family member. It is strictly about the service member. Is that one of those things that the regs might define further? You know, I actually, I'm not sure, I doubt it. Because there is no trigger for that and because the employment agencies, Department of Labor and EOC, who are going to be drafting these regs, their jurisdiction does not extend to the military either. So I don't think they're going to be addressing that. I think you should look actually for some work. I know that Genetics and Public Policy Center has been actively engaged in this area for some time, and I think we'll be seeing some more exploration of these issues from that center. But I wouldn't expect that to be resolved in the regs. It's simply not implicated by the language of Gina. Great. And here's a question. What are the enforcement mechanisms in Gina? So the specifics will be defined in the regs. The enforcement mechanisms in terms of the remedies available. Under Title I, really the remedies are equitable relief, which essentially means if you were denied coverage wrongfully based on, you know, based on Gina, then you would be covered. If your premiums were inflated based on genetic information in violation of Gina, then your premiums would be adjusted to an appropriate level. There's not punitive damages available under Title I. However, in Title II, there actually are damages for an employer who acts illegally in using genetic information in terms of hiring, firing, promotion, et cetera. There are monetary penalties which follow a typical structure from other employment statutes. It's consistent with other employment statutes that are determined on the size of the employer. So the largest-sized employer I think can be $300 or $350,000 for employers of, I think, $500 or more. So there are actual monetary remedies. But even though for the health insurance context, you don't have the same type of remedy, health insurers are not going to want the bad publicity that will come from being identified as intentionally violating people's civil rights under Gina by using their genetic information to screen them out to drop them from insurance to rate their rates. So there's sort of a more powerful disincentive than that simple equitable relief may suggest. Great. Thank you. A couple of questions about to what degree is the law retroactive. That is, for instance, someone asks, is there a timeframe as to when the law takes effect on an individual basis? For example, BRCA results from someone who had testing in 2006. Are they covered? Or is it only if the testing is done after the law goes into effect that they're covered? So the law does not provide for retroactive application. And I don't think there's actually any language that addresses timing of the test. The standard sort of legal interpretation would be it would be timing of the illegal act, the timing of the violation under Gina. So it really wouldn't matter when you obtained the genetic information. What would matter is when was the illegal action by the insurer or the employer. And it wouldn't actually be an illegal action if it occurred prior to the law taking effect, which as I mentioned was May 09 for the health insurance and November 09 for the employment protections. So that would be really the start. Right. So just underline that even if this information was somehow known to the insurance company prior to May of 2009, let us say, but they took no act upon it, but then in 2010 did something which was discriminating based on that information, even though they had prior access to that information which was legal, they are now a use of that information in a way that is illegal would subject them to the law. Right. Right. Exactly. I mean they can't be held liable for something that wasn't illegal when they, you know, obtained that information and filed it away. It's their actions after the law takes effect that they would be liable for. Okay. Another sort of technical question. Can you go over again the differences in coverage of the law between group health and individual insurance policies? Okay. So Gina relates to all health insurance policies, all types of health insurance policies, but in actuality its major effect will be to protect people who are covered under individual health insurance policies. That's because HIPAA, which went into effect in the 90s, already protected these type of actions of underwriting and pre-exing conditions and excluding people based on several types of information, one of which was genetic information. So for those of us who were under group health insurance plans, we already had some measure of protection against discrimination based on our genetic information under HIPAA, but HIPAA did not and does not cover individual insurance plans. So this was really a very important gap to be filled. And Gina also amends HIPAA to sort of broaden and clarify some of the protections to make those consistent with what will be available for people in the individual health insurance market who weren't covered at all. Thanks. And now questions for maybe both of you about several questions that have to do with this idea of the rulemaking process. And folks are asking first of all during the public comment period of the rulemaking process, will there be any particular efforts to create strategies for getting a broader representation of the general public involved in the discussion beyond the stated stakeholders? And then perhaps related to that, there's a question whether genetics professionals will be involved in any way in the rulewriting process. So I certainly could answer the first part and comment on the second part. And yes, we will still play a very active role as we did throughout the crafting of the bill itself. So the coalition for genetic fairness, which again is now 500 organizations and they span the whole spectrum of healthcare providers and that includes genetic specialists as well as the more general practitioner groups and the medical specialties, the research community, the stakeholder community in terms of the various disease organizations and then individuals within those organizations, hospitals, universities, et cetera. So we will undertake a process whereby when the public comment period opens, we'll be both doing webinars, putting things on our website, et cetera, to help prepare people to make comments as well as sharing our comments so that if people want to sign on to those, that can happen. And then the comment I'd make on whether or not genetic specialists will be involved, I believe they are already involved because HHS itself of course has some of those specialists in the various agencies under HHS and they have been involved in definitions and in the kind of finer points of the actual genetics and then certainly American Society of Human Genetics, American College of Medical Genetics, National Society of Genetic Counselors all have been very active in the coalition and in the various discussions that have happened so far and they will continue to be so. Yeah, I would agree with all of that and certainly we at NHGRI have been and continue to be available to our sister agencies in their work here and our own department is working on these and we're in close contact with them. We are providing technical information wherever and whenever appropriate and in terms of the solicitations that will go out for public comment, those are open to any parties. So the sort of organized effort that the coalition, that Sharon will be working on is really fantastic because these are going to be kind of involved and lengthy documents to have people who are very familiar with some of the underlying issues helping to understand what the main points are that need comment are very helpful but anyone separate from those organized groups can make their own comments and I think that's actually a really important part of the rulemaking process and one that shouldn't be overlooked. Thanks. Now a couple of questions that get at the same kind of essential issue and that is, once Gina becomes fully effective, will it be permissible for employers to use genetic information in the workplace to protect workers from exposure to agents that might result in work-related illness? So again, the absolute specifics will be clarified in the rags. From what I understand from my colleagues at the EOC, the only circumstances under which an employer can require genetic testing from an individual in the framework of there's a necessity that we notice information because you'll be at risk for working in this, the example that's always given is someone working in a chemical plant is if they give them notice they want them to be tested for X or Y variant related to sensitivity if they ask for their informed consent, if they make it clear the testing is voluntary and only if the employee agrees to be tested can an employer do the testing. So they're not able to requirement as a term of employment. I expect that this will receive a very intricate regulation and a very specific regulation with examples of what perhaps was permitted in the past that will no longer be permitted regardless of the circumstances. Good, thanks. Here's one about again the sort of technical aspects. What will the penalties be for violation of GINA? So they're different for Title I and Title II. There are monetary penalties and there are equitable relief which are really remedies for the person aggrieved for insurance. There it would be what's called equitable relief which would be restoring coverage if it was denied, adjusting rates to the appropriate level if they were inflated based on this information. There's also penalties for the administrators of the healthcare plans for intentional violations of GINA and for employers there's monetary penalties. And one thing that really can't be underestimated here is that if a pattern or a specific intentional violations of GINA are brought to light, the actual publicity of that is going to be something insurers are not going to want to be tainted with and certainly employers wouldn't either. But the regs are going to spell out very specifically what the remedies slash penalties are for both Title I and Title II. Great, thanks. Are there states that currently have on their books regulations or laws about genetic discrimination that are stronger than GINA's? Yes. And those will remain intact. GINA provides a baseline protection. It does not preempt states that go further than GINA does. For example, there are some, very few but some states that include protection for life insurance, long-term care, and disability. It does not. Good, thanks. What about GINA's effect on Medicaid and Medicare coverage? Will it have any? Not to my knowledge, but I think the HHS portion of the regulations will spell that out. All right. So in terms of coverage, GINA doesn't affect coverage of any health insurance plan. It doesn't mandate coverage for genetic tests. It doesn't mandate coverage for treatment of genetic disorders. There's not a real coverage. The only coverage issue is a person cannot be denied for health insurance policy based on their genetic information. So I know that part of the Metagap program is implicated by GINA, but that's simply a result of where different statutes are amended to enact GINA. But that will be clarified in the HHS regs. Thanks. Will GINA have any impact on medical records release? I don't think GINA will have any impact on any otherwise authorized medical records release. However, I think specifics... I mean, I don't even actually know whether there'll be ancillary sections to regulations. I think that's a legitimate question for someone during the comment period to pose to HHS to ask about that. But I don't see anything in the language of GINA that would change any pre-existing law. So I think my understanding is whatever was authorized before in terms of release of medical information is unchanged by GINA. Okay, what about an individual who has some... We're here to describe his variant disease, but something that's picked up a newborn screen but which is completely asymptomatic. So in other words, it's a biochemical abnormality but no symptom at the time that the newborn testing is done. Technically, or would they be somehow subject to GINA this information? Well, if the screening picked up a genetic variant and it was testing human DNA or RNA, then it's genetic information. So it's protected under GINA. Now, when and if that person were to develop a manifest disease related to that genetic variant, that disease information would be fair game, but the genetic information never would be fair game. So the fact they had a disease, if they developed a disease, that would be something that could be used for underwriting or anything otherwise allowed by law, but the fact of the genetic variant would be protected not only up until the time they got the disease, it would be protected thereafter as well. This is where this question of manifest disease will get very interesting because one can take a various kinds of examples where the question is at what stage exactly in the process of the disease to come, quote-unquote, manifest? No, that's going to be a very sticky issue, and I think one that was really of all of the things that were explored ad nauseam during the many years that it took to pass GINA, this was one that I think is yet to really be explored in the depth to which it's going to need to be for the regs to make sense and be useful. Sharon, did you have something to add there? I was just going to add that I recall, and I'm sure that MK will know the detail better than I... The issues around newborns are a little different in that newborns have no pre-existing condition even if they're born with something, obviously, or maybe not so, obviously, and that insurance companies treat the newborns and their information somewhat differently than someone who comes into a plan later on. Well, that's a good point, actually. In terms of coverage, so the information would be, as I said, as that person went through their life, that genetic information would certainly be protected under GINA. However, I think what Sharon's referring to is the fact that all 50 states have laws that prohibit an insurance company, you know, they can't deny coverage to a newborn. They can't impose pre-existing condition restrictions on a newborn born with a genetic disorder or any other kind of disorder. So this is not... There's sort of a special legal treatment of that area. Right. So the question... Is there any concern that insurers will raise rates based on genetic information now in order to avoid being prosecuted once the law does take full effect? I think that's very unlikely. You know, if there would be a legal argument to be made after the law takes effect that the continued imposition of this higher rate, which was justified by perhaps it's legal to do that today, if they continue to charge that rate in May or June of 2009 after Title I of GINA takes effect, that that continued imposition of that rate was a violation because the law changed. And certainly in this case you could argue the insurer knew the law was changing. I mean, it would not look very good for that to be the strategy employed. A question about the state coverage is not about GINA per se, but the state law is the coverage genetic information. For such state legislation, does jurisdiction fall into the person's place of residence or the company's place of business? Well, if a company... So I'm not an expert on this area. My general legal sense here is that if a company is doing business in your state and you live in the state and they're insuring people... So wherever Aetna is headquartered, if they're doing business in Maryland and insuring people in Maryland, they're subject to the laws of Maryland for those insurers. So it doesn't make sense that... If an insurer didn't want to do business in the state of New York because they felt their insurance laws were too restrictive, they could decide to do that. A large insurance company probably wouldn't. But it would be where they were... You're supposed to be protected by the laws of the state in which you reside. So if a company is reaching into your state and doing business there, would it be covered by the laws of that state? That's my... I think it may also... It could have come from the way the state law is crafted, but my experience, at least in a couple of states that I was well aware of, was very much what you described. And since health insurance is in different states governed by different state agencies, et cetera, most of them define these things. But in fact, as long as you're offering your product in the state, it comes under that law. It really does sort of follow the residents of the individual. Yeah. Another question makes... I probably have to bear next to the last one. Does GINA cover genetic information of fetuses? That is before delivery. Yes, it does. And is that explicit in the law, or is that simply because it covers the mothers, or how does that happen? It was actually made explicit in the law based on some concerns that Senator Coburn had. During the... When it was passing the House, and language was added during the energy and commerce hearings to clarify. This was... And really, this was thought to be implicit in the bill, that if the mother was protected, that an embryo or fetus would be protected. The language actually extends to an embryo or fetus. Because GINA relates to employment or insurance information, and fetuses and embryos don't have their own insurance and don't have their own jobs. It was thought to be implicit, but the agreement was that the language would... We thought, I think, as an observer, working with the coalition, my sense was that the advocates thought, this was fine to agree to, because it just clarified something we believe was already implicit, and that Senator Coburn had expressed some concerns in this area. This did not ameliorate his concerns overall about the bill, but that language was added specifically for that purpose in spring of 2007. Thanks. Well, unfortunately, the hours passed didn't even get time to get to that. One more question I'd hope to get to. There are a number that we didn't get to, unfortunately. But our time's up. On behalf of NHGRA, I'd like to thank all of you for participating in the webinar. We certainly enjoyed hearing your questions, our NHGRA staff, particularly Sarah Hardy, for organizing the webinar, and certainly both of our expert speakers, M.K. Hollahan and Sharon Terry. We will be holding the second of these webinars in two months, on September 11th at 1 p.m. Eastern Time. The title of the webinar is Family History of the Next Generation. Please do join us to hear about what's going on in the field of family history and upcoming NIH stages of science, meeting of family history and how your own organization or group might get involved with Family History Day on Thanksgiving Day, 2008. You'll be receiving more information from Sarah Hardy as we get closer to that date. But again, feel free to join us, and thanks a lot for participating in this. If you have any comments or questions about the way this worked, we'd like to...