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[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]

     THE POTENTIAL FOR DISCRIMINATION IN HEALTH INSURANCE BASED ON 
                        PREDICTIVE GENETIC TESTS

=======================================================================

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                COMMERCE, TRADE, AND CONSUMER PROTECTION

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             JULY 11, 2001

                               __________

                           Serial No. 107-46

                               __________

      Printed for the use of the Committee on Energy and Commerce

                    U.S. GOVERNMENT PRINTING OFFICE
73-729PS                    WASHINGTON : 2001

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                                 house

                               __________

_______________________________________________________________________
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                                 Office
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                    COMMITTEE ON ENERGY AND COMMERCE

               W.J. ``BILLY'' TAUZIN, Louisiana, Chairman

MICHAEL BILIRAKIS, Florida           JOHN D. DINGELL, Michigan
JOE BARTON, Texas                    HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio                RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania     EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California          FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia                 SHERROD BROWN, Ohio
STEVE LARGENT, Oklahoma              BART GORDON, Tennessee
RICHARD BURR, North Carolina         PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
GREG GANSKE, Iowa                    ANNA G. ESHOO, California
CHARLIE NORWOOD, Georgia             BART STUPAK, Michigan
BARBARA CUBIN, Wyoming               ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois               TOM SAWYER, Ohio
HEATHER WILSON, New Mexico           ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona             GENE GREEN, Texas
CHARLES ``CHIP'' PICKERING,          KAREN McCARTHY, Missouri
Mississippi                          TED STRICKLAND, Ohio
VITO FOSSELLA, New York              DIANA DeGETTE, Colorado
ROY BLUNT, Missouri                  THOMAS M. BARRETT, Wisconsin
TOM DAVIS, Virginia                  BILL LUTHER, Minnesota
ED BRYANT, Tennessee                 LOIS CAPPS, California
ROBERT L. EHRLICH, Jr., Maryland     MICHAEL F. DOYLE, Pennsylvania
STEVE BUYER, Indiana                 CHRISTOPHER JOHN, Louisiana
GEORGE RADANOVICH, California        JANE HARMAN, California
CHARLES F. BASS, New Hampshire
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska

                  David V. Marventano, Staff Director

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

        Subcommittee on Commerce, Trade, and Consumer Protection

                    CLIFF STEARNS, Florida, Chairman

NATHAN DEAL, Georgia                 EDOLPHUS TOWNS, New York
  Vice Chairman                      DIANA DeGETTE, Colorado
ED WHITFIELD, Kentucky               LOIS CAPPS, California
BARBARA CUBIN, Wyoming               MICHAEL F. DOYLE, Pennsylvania
JOHN SHIMKUS, Illinois               CHRISTOPHER JOHN, Louisiana
JOHN B. SHADEGG, Arizona             JANE HARMAN, California
ED BRYANT, Tennessee                 HENRY A. WAXMAN, California
STEVE BUYER, Indiana                 EDWARD J. MARKEY, Massachusetts
GEORGE RADANOVICH, California        BART GORDON, Tennessee
CHARLES F. BASS, New Hampshire       PETER DEUTSCH, Florida
JOSEPH R. PITTS, Pennsylvania        BOBBY L. RUSH, Illinois
GREG WALDEN, Oregon                  ANNA G. ESHOO, California
LEE TERRY, Nebraska                  JOHN D. DINGELL, Michigan,
W.J. ``BILLY'' TAUZIN, Louisiana       (Ex Officio)
  (Ex Officio)

                                  (ii)

                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Davidson, Mary E., Executive Director, Genetic Alliance, Inc.    21
    Morella, Hon. Constance A., a Representative in Congress from 
      the State of Maryland......................................    10
    Rothenberg, Karen H., Dean, Marjorie Cook Professor of Law, 
      University of Maryland School of Law.......................    38
    Slaughter, Hon. Louise M., a Representative in Congress from 
      the State of New York......................................     7
    Venter, J. Craig, President and CSO, Celera Genomics.........    35
    Young, Donald A., Interim President, Health Insurance 
      Association of America.....................................    28

                                 (iii)

  

 
     THE POTENTIAL FOR DISCRIMINATION IN HEALTH INSURANCE BASED ON 
                        PREDICTIVE GENETIC TESTS

                              ----------                              

                        WEDNESDAY, JULY 11, 2001

              House of Representatives,    
              Committee on Energy and Commerce,    
                       Subcommittee on Commerce, Trade,    
                                   and Consumer Protection,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 12 noon, in 
room 2322, Rayburn House Office Building, Hon. Cliff Stearns 
(chairman) presiding.
    Members present: Representatives Stearns, Shimkus, Bryant, 
Towns, DeGette, Capps, Gordon, and Eshoo.
    Staff present: Nandan Kenkeremath, majority counsel; Marc 
Wheat, majority counsel; Brendan Williams, legislative clerk; 
and Bruce Gwinn, minority professional staff.
    Mr. Stearns. Good afternoon, everybody. I am pleased to 
chair a hearing on the potential for discrimination on health 
insurance based on predictive genetic tests. Genetic testing 
and genetic information is but one of many new technologies 
that will advance health care, provide better preventive 
medicine and counseling, unlock the causes and factors in 
diseases, make for better treatments and improve the delivery 
of services.
    We can ensure that this new technology is a friend to 
patients and not something that they, in any way, need to fear.
    In the future, genetic information will be an indispensable 
part of a medical file. We should not by regulation force 
health care plans or providers to create separate files of 
information that have to comply with one new regulatory regime 
after another or stifle the collection, dissemination or 
research of important information. At the same time, my 
colleagues, we should be cautious regarding the potential for 
discrimination based upon genetic tests.
    There are current Federal prohibitions on discrimination 
based upon genetic information and the current privacy rules 
that already exist under Federal law. In the 104th Congress, 
during consideration of Health Insurance Portability and 
Accountability Act, Public Law 104-191, I worked to include the 
final language regarding genetic information within the 
provision prohibiting health insurance companies from denying 
coverage to an employee or a beneficiary on the basis of health 
status.
    In 1997, I chaired the Task Force on Health Records and 
Genetic Privacy in which we held a meeting to gather testimony 
and information from a variety of interested parties, including 
Dr. Francis Collins, Director of the Human Genome Project. We 
also heard from representatives of the insurance companies and 
the biotech and pharmaceutical industries and patient 
advocates. Given the technological advances in genetic testing 
we must find a way to ensure that such research is not impeded 
while also protecting the interests of the individual.
    One conclusion upon which we agree was that advancing 
medical technology is crucial. However, it is the means of its 
application that must concern us today.
    One problem we are faced with here is that science is 
beginning to realize that mapping the human genome and 
designing a predictive genetic test is a more daunting task 
than previously realized. Dr. J. Craig Venter of Celera 
Genomics whom we will hear from today was quoted as saying that 
last year ``one gene leads to many different protein products 
that can change dramatically once they are produced.'' He was 
further quoted as saying, ``that the environment acting on our 
biological steps may be as important in making us what we are 
as our genetic code.'' So one question which we will try to 
answer today is should an insurance company be able to deny 
medical coverage based on an individual's genetic profile, 
especially in light of recent information indicating we may not 
be as close to determining predictive genetic information as we 
once sought.
    Having said that, I think that there is a general consensus 
that genetic information is personal, powerful, permanent and 
sensitive. That is a fundamental statement that goes to the 
center of this debate. The most important thing we can do is be 
thoughtful and deliberative in looking at these issues. It is 
our job to understand the regulations, recognize their 
application to the industry and acknowledge our duty as 
representatives in addressing this issue.
    We had hoped to have a representative from the Department 
of Health and Human Services or the National Institute of 
Health appear before us today. However, they declined to do so 
for a number of reasons. I intend, however, to ask them 
questions, in writing, to Secretary Thompson, following this 
hearing and I invite members of this subcommittee to submit 
additional questions as well.
    I am now, my colleagues, after our opening statements, we 
will welcome Representatives Slaughter and Morella, our good 
colleagues, both leaders, strong leaders in this debate and 
whose legislation is a leading contender. With their knowledge 
and resources, we are very pleased to have them here and I 
applaud their hard work and I thank them for testifying.
    I'd also like to welcome our distinguished witnesses and 
look forward to their testimony. At this point, the ranking 
member, for an opening statement. Mr. Towns?
    Mr. Towns. Thank you very much, Mr. Chairman. I'm delighted 
that the subcommittee has chosen to take up an issue that 
affects all Americans. New technology has allowed more advances 
in health science than ever before. Our pharmaceutical and 
biotechnology industries have been able to develop therapies 
which help fight HIV and AIDS, limit the impact of multiple 
sclerosis, lower cholesterol and even allow former Senator Dole 
to make a few dollars.
    I am disturbed by the fact that hard working Americans 
across this country could be dismissed from their jobs or 
denied health coverage, solely based on genetic information 
provided through these new technologies. That is why we need to 
do something to protect our constituents from this practice. 
Genetic testing and the findings of those genetic tests can 
have many positive uses such as determining whether a person 
has a propensity for cancer, diabetes, Parkinson's disease or 
another debilitating illness, so that the patients can seek 
preventative treatment and measures to reduce their future 
risk.
    Last, let me say that I am happy that this issue is finally 
getting the legislative attention that it deserves. I would 
like to commend not only my two colleagues, the gentle woman 
from New York, of course, Ms. Slaughter and the gentle woman 
from Maryland, Ms. Morella, who will be testifying before the 
committee today for their leadership on this issue, but I also 
would like to commend you, Mr. Chairman, for holding this 
hearing and I think that you're going about this the right way 
not just by moving very quickly, but sort of hearing from 
people and talking because this is a very, very serious matter 
and I think that your approach to it is a proper one and I look 
forward to working with you, and of course, my colleagues, on 
this issue.
    Thank you again for holding this hearing and again I look 
forward to working with you and I yield back the balance of my 
time.
    [The prepared statement of Hon. Ed Towns follows:]
Prepared Statement of Hon. Ed Towns, a Representative in Congress from 
                         the State of New York
    Thank you Mr. Chairman and I am delighted that the subcommittee has 
chosen to take up an issue that affects nearly every American in this 
country; the issue of Genetic Privacy and Discrimination.
    New technology has allowed more advances in health science than 
ever before. Our pharmaceutical and biotechnology industries have been 
able to develop therapies, which help fight HIV and AIDS, limit the 
impact of multiple sclerosis, lower cholesterol, and even allow former 
Senator Dole the opportunity to make some money in his retirement. 
Technology also assisted scientists to map the human genome much more 
rapidly than initially expected. Yet these scientific gains also reveal 
information about patients that was previously either a private matter 
or impossible to discover.
    I am disturbed by the fact that hard working Americans across this 
country could be dismissed from their jobs or denied health coverage 
solely based on genetic information provided through these new 
technologies. That is why we need to do something to protect our 
constituents from this practice.
    Genetic Testing and the findings of those genetic tests can have 
many positive uses, such as determining whether a person has a 
propensity for cancer, diabetes, Parkinson's disease or another 
debilitating illnesses so that the patient can seek preventative 
treatment and measures to reduce their future risk. This, in my mind, 
is the proper use of genetic information.
    Lastly, let me say that I am happy that this issue is finally 
getting the legislative attention that it deserves. I would like to 
commend not only my two colleagues, the gentlewoman from New York, Ms. 
Slaughter, and the gentlewoman from Maryland, Ms. Morella, who will be 
testifying before the committee today for their leadership on this 
issue, but I also want to commend you Mr. Chairman for holding these 
hearings and for not being a ``Johnny Come Lately'' to this issue. 
President Clinton asked that this issue be given more of a priority 
five years ago and I'm pleased to learn that the current administration 
wants to pass legislation protecting consumers' genetic privacy and 
prohibiting discrimination based upon one's genetic information.
    I look forward to working with all my colleagues on this issue, in 
addition with members from industry to make sure that we report out a 
Commerce Committee product this session and that we enact a bill this 
congress. Thank you Mr. Chairman and I yield back the balance of my 
time.

    Mr. Stearns. I thank Mr. Towns. Mr. Shimkus, you're 
recognized for an opening statement.
    Mr. Shimkus. Thank you, Mr. Chairman, and I want to commend 
my colleagues for being here and look forward to the testimony 
and appreciate their leadership on this issue. I know they 
would appreciate the visit I had from some breast cancer 
survivors in my District Office a couple of months ago and 
they've been very blessed in their clinical trials, but their 
concern was what about their children and their grandchildren 
and the safeguarding of data being conducted on these trials 
and the possible challenges to their future generations should 
the data and the genetic information fall into other hands.
    So this is a challenging issue that we have to address and 
there should be an appropriate balance for science, but also 
for confidentiality and we all know that our biggest problem is 
health care coverage of all our citizens and we want to make 
sure that while we can continue using an employer-based health 
care system to provide insurance, that we don't scare them away 
by a lot of things that we plan and try to do here in 
Washington.
    So I applaud your efforts. It is relevant to my 
constituents and I look forward to your testimony and the rest 
of the panel and with that, Mr. Chairman, I yield back my time.
    Mr. Stearns. The gentleman yields back the balance of his 
time. The gentleman from Tennessee, Mr. Gordon, is recognized 
for an opening statement.
    Mr. Gordon. Thank you, just very quickly, let me add my 
welcome to our colleagues. I know that I joined Ms. Morella as 
her ranking member for a few years and know that she has a real 
interest in this subject and certainly my colleague and good 
friend, Louise Slaughter, we sat next to each other for several 
years, talked about these sorts of things and if anything, she 
is our in-house specialists by virtue of advanced degrees and a 
lot of work experience in this area and I think it has been 
demonstrated by the fact that you have gotten 252 co-sponsors, 
maybe even more than that by today, in a good bipartisan effort 
and so I look forward to hearing your testimony. Again, 
congratulate you for bringing this important issue to us.
    Ms. Slaughter. Thank you.
    Mr. Stearns. Ms. Capps for an opening statement.
    Ms. Capps. Yes, thank you, Mr. Chairman. And I'm so honored 
to have our expert witnesses and our wonderful colleagues here 
today to testify. As we move further into the 21st century, 
scientific breakthroughs hold tremendous promise for the future 
of medicine. New advances that have cured previously fatal 
diseases, extended lives of millions of Americans and enhanced 
a quality of life. But unfortunately, as you two know very 
well, there's a danger involved with this progress and as 
medical science advances it, it is accompanied by greater 
threats to rights and civil liberties of patients.
    New and better technologies also lead to new and better 
ways to take advantage of people. Superior understanding of 
life sciences lead to innovative ways to deprive individuals of 
their right to privacy and their access to care. I am an active 
supporter of medical research, but I believe at the same time 
we have to balance promoting medical research against 
protecting the most important aspect of health care, sacred 
trust between patients and health care providers. As a nurse, I 
know that good medicine depends on a patient's willingness to 
seek out and share their personal health information with their 
doctors, nurses and therapists. No diagnosis or treatment is 
completely reliable without this kind of trust. But if they're 
not sure that this sensitive information will be kept 
confidential and will not be used against them, they're not 
going to be forthcoming. The success of the human genome 
project has added a very new element to this problem. The 
project allows us to better understand and predict some of the 
most intractable diseases that we face and this information can 
also be misused to cut costs, reduce financial liabilities and 
increase profit margins. It is possible that unscrupulous 
insurers and employers could use this information to avoid 
paying the higher costs for the health care of an individual. 
In fact, these institutions could deny coverage to a person 
based on the mere possibility that he or she might develop a 
costly condition and this would mean that while we may be able 
to help someone to avoid cancer or heart disease, that person 
might be denied all their basic health care so that a company 
can avoid the risk of potential paying for that treatment.
    So I'm proud to be an original co-sponsor of the Genetic 
Nondiscrimination Health Insurance and Employment Act offered 
by Representatives Louise Slaughter and Connie Morella. This 
bill would protect Americans from possible discrimination if 
genetic tests show they are predisposed to diseases like ALS, 
Parkinson's or cancer. Advances like the mapping of the human 
genome should bring powerful new tools to fight against 
disease, not become a source of fear for patients. If patients 
believe the results of their genetic tests will hurt them, they 
will be unwilling to take those very tests and this would 
ultimately block us from achieving the potential of 
breakthroughs like the human genome project. And so, Mr. 
Chairman, I appreciate your willingness to hold these hearings 
and hope that the Congress is going to pass swiftly H.R. 602. I 
yield back my time.
    [Additional statements submitted for the record follow:]
Prepared Statement of Hon. Ed Bryant, a Representative in Congress from 
                         the State of Tennessee
    I also thank the chairman for this hearing, and I thank the 
witnesses for coming today. I am glad that this subcommittee will be 
looking into this issue. I am also a member of the Health Subcommittee, 
and as a member of that subcommittee, I have learned a great deal about 
the health care industry.
    I have been amazed by the treatment available to people today to 
fight illnesses and diseases. The development of Genetic testing is an 
example of one these improvements. Over the next few decades genetic 
testing will become an integral part of health care, and I look forward 
to hearing from the witnesses about the benefits of this technology in 
regard to research, preventive care, and the delivery of care.
    There are numerous benefits of genetic technology; however, a 
doctor's possession of this personal information, also brings into play 
a patient's privacy.
    Included in HIPAA and the recently enacted medical privacy rule, 
there is a ban on genetic discrimination in determining the eligibility 
and rate setting in health insurance. Today, I look forward to hearing 
about the implementation of these bans. We need to look into these laws 
and see if there are any gaps in regulatory authority to address 
problems that may arise in discrimination in health insurance based on 
genetic tests.
    However, in acting on this issue, the government should not 
hamstring the health care industry in a way that prevents it from 
taking advantage of this new technology. I have had the opportunity to 
look into the issue of Medicare reform, and I've seen many examples of 
instances when the government has made a process unnecessarily 
complicated. We should be sure that this does not happen while we work 
to insure that genetic discrimination in health insurance does not 
occur.
    Again, I thank the Chairman for holding this hearing and our 
witnesses for coming today. I yield back the rest of my time.
                                 ______
                                 
 Prepared Statement of Hon. W.J. ``Billy'' Tauzin, Chairman, Committee 
                         on Energy and Commerce
    Thank you Mr. Chairman.
    I commend you for holding this important hearing. This Committee 
has important expertise to contribute to addressing the evolving nature 
of health care, health insurance, and the privacy and use of medical 
information. Today's hearing combines many of these cutting edge 
concerns. As a general matter, our overall objective is improving the 
health of Americans. In this regard, genetic testing holds great 
promise. It will provide important information both for the counseling 
and treatment of individual patients and for research to identify the 
causes and factors in diseases. In the future, genetic information will 
be an indispensable part of a medical file.
    We can protect privacy and assure that genetic information is used 
on behalf of patients. We must encourage, however, the free flow of 
general medical knowledge that will be derived from genetic tests. 
Also, whatever we may do to enhance protection from discrimination in 
eligibility or rate setting for insurance, we must take great care not 
to create an unnecessary bureaucracy that will chill the collection and 
use of genetic information on behalf of patients and for research. 
Moreover, it is important to evaluate the current Federal prohibitions 
on discrimination based on genetic information and the current privacy 
rules that already exists under Federal law. Federal regulation of 
health insurance and health care is already too complicated to add 
redundant provisions. We must make sure that what we do in this area 
doesn't add to the complexity.
    Finally, we must always recognize that our private sector health 
insurance is a significant part of what helps provide Americans with 
great health care. Let's not take steps that will increase premium 
rates for small employers and, thus, unintentionally increase the 
number of uninsured Americans.
    I am pleased that this hearing will begin a careful evaluation of 
the issues pertaining to genetic non-discrimination in health 
insurance. I look forward to hearing from today's witnesses to assist 
the Committee in these deliberations.
                                 ______
                                 
Prepared Statement of Hon. Bobby L. Rush, a Representative in Congress 
                       from the State of Illinois
    Mr. Chairman, thank you for holding this important hearing on the 
potential for discrimination in the health insurance market based on 
predictive genetic tests.
    With major scientific breakthroughs occurring everyday in the field 
of biotechnology and genetics, such as the mapping the human genome, we 
in Congress have the awesome responsibility of ensuring that this new 
technology is not misused. Clearly, genetic tests offer a way for modem 
medicine to pinpoint preventive care to those who may be genetically 
predisposed to certain medical conditions. By targeting preventive care 
we can improve the quality of life for many Americans who would 
otherwise suffer needlessly.
    However, if Americans are afraid to use genetic tests due to the 
fear of genetic discrimination by either employers or insurers, the 
gains from this new technology may never be fully realized. This would 
be similar to having a cure to a common disease and simply throwing it 
away.
    Clearly, perception is key. It is true that there is a patchwork of 
laws in place prohibiting the discriminatory use of genetic information 
in some circumstances. However, unless Americans clearly believe their 
genetic information is protected from prying eyes and discrimination, 
there will continue to be apprehension regarding the use of this new 
technology.That is why I want to commend the hard work of both 
Representatives Louise Slaughter and Connie Morella on this topic. This 
session, Representatives Slaughter and Morella reintroduced H.R. 602, 
the Genetic Nondiscrimination in Health Insurance and Employment Act, 
which would clearly ban discrimination in the workplace and in health 
insurance on the basis of genetic information. This bill unambiguously 
tells Americans that their genetic information will not be used against 
them. I am proud to be one of 252 cosponsors of this bipartisan 
legislation and hope to see it passed this year.
    I am also pleased to hear that President Bush has recently endorsed 
the concept of a ban on genetic discrimination. Representative 
Slaughter and Morella's bill is the best legislative vehicle for 
ensuring the passage of such a ban and I hope the President and the 
Republican leadership will work with Representatives Slaughter and 
Morella to ensure its passage this year.

    Mr. Stearns. I thank my colleagues and at this point we are 
pleased to welcome our two colleagues and ask them for their 
opening statement and we'll start with our distinguished 
colleague from New York. I always go left to right, but I'd be 
glad to go right to left.

  STATEMENTS OF HON. LOUISE M. SLAUGHTER, A REPRESENTATIVE IN 
  CONGRESS FROM THE STATE OF NEW YORK; AND HON. CONSTANCE A. 
    MORELLA, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF 
                            MARYLAND

    Ms. Slaughter. Mr. Chairman, I thank you for the 
opportunity to testify at the hearing entitled ``The Potential 
for Discrimination of Health Insurance Based on Predictive 
Genetic Tests.'' I'm pleased to be here, of course, with my 
good friend, Connie Morella. We were elected at the same time 
and we've been pretty much a matched set ever since, but she's 
a wonderful colleague and has been incredibly helpful on this 
bill and we're happy to discuss this with you.
    Two hundred and twenty-five years ago, Thomas Jefferson 
drafted our Nation's Declaration of Independence to include the 
phrase ``all men are created equal.'' He could scarcely have 
known that this statement would turn out to be a literal truth 
as well as a figurative one. With the completion of the mapping 
of the humane genome, science has revealed to us the fact that 
human beings are 99.9 percent the same, regardless of race, 
gender or nationality.
    The remaining 0.1 percent of the human genome accounts for 
all the human variation we see around us, from eye color to 
major disability. And while some of us may appear to have been 
blessed with better genes, none of us has perfect ones. Every 
person carries between 5 and 50 genetic flaws that predisposes 
him or her to a range of disorders.
    Over the past few years, entire newsletters, medical 
journals, and on-line services have sprung up to cover the 
advances in genetic medicine. Along with these discoveries, we 
are seeing a corresponding increase in the number of genetic 
tests available to Americans. People can now take advantage of 
genetic tests that will help gauge their risk for breast 
cancer, colon cancer, and Huntington's Disease. In all, over 
800 genetic tests are now available. In time, we expect that 
new therapies will be developed to target disorders based on 
our knowledge of the genetic information involved. Scientists 
will be able to focus treatment on diseases at the molecular 
level, alleviating side effects and other unintended 
consequences. We can anticipate a new way, an entirely new way, 
to provide health care at less cost and with fewer long 
hospital stays.
    All of this great promise can only come to pass if genetic 
research can proceed forward unimpeded. Today, the greatest 
threat to genetic research comes from the potential for genetic 
discrimination: the misuse or abuse of genetic information. 
Indeed, many people are reluctant to go into clinical trials 
because that information is not protected.
    Today's hearing proposes to address the ``potential'' for 
genetic discrimination. Unfortunately, genetic discrimination 
is not just a theoretical possibility. It is already a reality. 
For example, in 1997, the New York Times reported the story of 
a woman who took a genetic test for early onset breast cancer. 
It came back positive. As a result, she decided to undergo a 
prophylactic double mastectomy. When she petitioned her insurer 
to cover this procedure, her request was denied. She then re-
submitted her request, sending with it the results of her 
genetic test, which indicated a dramatically increased risk of 
cancer. Upon receiving the information, her insurer denied the 
request again, and canceled her policy. This is just one of 
dozens of cases.
    This story encapsulates Americans' worst fears about the 
potential abuse of genetic information. As policymakers, 
however, we must look beyond the anecdotal stories to the 
fundamental policy issues at hand. In my judgment, genetic 
discrimination is grossly unfair for three key reasons.
    As I stated above, every single human being is born with 
genetic flaws. As a result, we are all potentially uninsurable 
and potentially unemployable. By allowing discrimination to 
persist, we are simply punishing those people with the bad luck 
to have had the genes that were discovered first.
    Having a given gene does not necessarily mean one will ever 
get sick. A genetic mutation only confers a higher or lower 
level of risk.
    Our understanding of genetics is in its infancy. In most 
cases, we do not have a solid grasp of what it means to have a 
particular genetic mutation or how much risk is elevated. As a 
result, this information is useless as a basis for decisions 
about insurance coverage or premiums.
    By banning genetic discrimination, we are simply asking 
insurers to continue covering the exact same people, under the 
exact same conditions that they are covering today. We're not 
asking them to insure a population with bad genes. I want to 
really enforce again that all of us are in that category.
    Any congressional effort to ban genetic discrimination 
should adhere to four fundamental principles.
    No. 1. It should ban discrimination in both health 
insurance and employment. If our goal is to make the American 
people comfortable in taking a genetic test, we cannot ban 
genetic discrimination in just one area or the other.
    No. 2. It should contain strong provisions prohibiting the 
collection and disclosure of predictive genetic information 
without informed consent. Predictive genetic information should 
be a matter of privacy, not a matter of commerce.
    No. 3. It should protect all forms of predictive genetic 
information, including family history. Much of our predictive 
genetic information comes from our knowledge of the disorders 
that run in our family. People need to be comfortable 
discussing this information with their health care providers 
and having it in their medical records without fear that 
someone else will see it and that they will be harmed by it.
    No. 4. It should contain meaningful enforcement and 
remedies. It is not enough for Congress to pass a law but not 
punish violations. It's not good enough to say we wish you 
wouldn't do this. The abuse of genetic information represents a 
fundamental violation of an individual's person. It should be 
treated as such.
    Representative Morella and I believe we have the 
legislative solution to genetic discrimination. We are proud to 
sponsor H.R. 602, along with 250 of our colleagues, the Genetic 
Nondiscrimination in Health Insurance and Employment Act. This 
bill has the support of well over a majority of the House of 
Representatives, as well as hundreds of outside organizations 
that I like to think represent anywhere from a quarter to a 
third of all of the people in the United States. We hope that 
your committee will act soon to pass H.R. 602 as quickly as 
possible.
    Once again, Mr. Chairman, I thank you for the opportunity. 
Representative Morella and I both look forward to the day when 
social policy can keep pace with science. We hope that would 
have happened 5 years ago when we introduced this bill. We're 
kind of lagging behind. But Congress needs to pass a strong, 
meaningful, genetic nondiscrimination law and they need to pass 
one now.
    Thank you.
    [The prepared statement of Hon. Louise M. Slaughter 
follows:]
  Prepared Statement of Hon. Louise M. Slaughter, a Representative in 
                  Congress from the State of New York
    Mr. Chairman, I thank you for the opportunity to testify at this 
morning's hearing, ``The Potential for Discrimination in Health 
Insurance Based on Predictive Genetic Tests.'' I am delighted to be 
here this afternoon with my dear friend and distinguished colleague 
from Maryland, Rep. Constance Morella, to discuss this pressing health 
issue.
    Two hundred twenty-five years ago, Thomas Jefferson drafted our 
nation's Declaration of Independence to include the phrase, ``All men 
are created equal.'' He could scarcely have known that this statement 
would turn out to be a literal truth, as well as a figurative one. With 
the completion of the mapping of the human genome, science has revealed 
to us the fact that human beings are 99.9 percent the same, regardless 
of race, gender, or nationality.
    The remaining 0.1 percent of the human genome accounts for all the 
human variation we see around us, from eye color to major disability. 
And while some of us may appear to have been blessed with better genes, 
none of us has perfect ones. Every person carries between five and 
fifty genetic flaws that predisposes him or her to a range of 
disorders.
    Over the past few years, entire newsletters, medical journals, and 
online services have sprung up to cover the advances in genetic 
medicine. Along with these discoveries, we are seeing a corresponding 
increase in the number of genetic tests available to Americans. People 
can now take advantage of genetic tests that will help gauge their risk 
for breast cancer, colon cancer, and Huntington's Disease. In all, over 
800 genetic tests are now available. In time, we expect that new 
therapies will be developed to target disorders based on our knowledge 
of the genetic information involved. Scientists will be able to focus 
treatment on diseases at the molecular level, alleviating side effects 
and other unintended consequences.
    All of this great promise can only come to pass, however, if 
genetic research can proceed forward unimpeded. Today, the greatest 
threat to genetic research comes from the potential for genetic 
discrimination--the misuse or abuse of genetic information.
    Today's hearing proposes to address the ``potential'' for genetic 
discrimination. Unfortunately, genetic discrimination is not just a 
theoretical possibility; it is already a reality. For example, in 1997, 
the New York Times reported the story of a woman who took a genetic 
test for early onset breast cancer. It came back positive. As a result, 
she decided to undergo a prophylactic double mastectomy. When she 
petitioned her insurer to cover this procedure, her request was denied. 
She then re-submitted her request, sending with it the results of her 
genetic test, which indicated a dramatically increased risk of cancer. 
Upon receiving this information, her insurer denied the request again, 
and canceled her policy.
    This story encapsulates Americans' worst fears about the potential 
abuse of genetic information. As policymakers, however, we must look 
beyond the anecdotal stories to the fundamental policy issues at hand. 
In my judgement, genetic discrimination is unfair for three key 
reasons:
    As I stated above, every person has genetic flaws. As a result, we 
are all potentially uninsurable. By allowing discrimination to persist, 
we are simply punishing those people with the bad luck to have the 
genes that were discovered first.
    Having a given gene does not necessarily mean one will ever get 
sick. A genetic mutation only confers a higher--or lower--level of 
risk.
    Our understanding of genetics is in its infancy. In most cases, we 
do not have a solid grasp of what it means to have a particular genetic 
mutation, or how much risk is elevated. As a result, this information 
is useless as a basis for decisions about insurance coverage or 
premiums.
    By banning genetic discrimination, we are simply asking insurers to 
continue covering the exact same people, under the exact same 
conditions, they are covering today.
    Any Congressional effort to ban genetic discrimination should 
adhere to four fundamental principles:

1. It should ban discrimination in both health insurance and 
        employment. If our goal is to make the American people 
        comfortable in taking a genetic test, we cannot ban genetic 
        discrimination in just one area or the other.
2. It should contain strong provisions prohibiting the collection and 
        disclosure of predictive genetic information without informed 
        consent. Predictive genetic information should be a matter of 
        privacy, not a matter of commerce.
3. It should protect all forms of predictive genetic information, 
        including family history. Much of our predictive genetic 
        information comes from our knowledge of the disorders that run 
        in our family. People need to be comfortable discussing this 
        information with their health care providers and having it in 
        their medical records.
4. It should contain meaningful enforcement and remedies. It is not 
        enough for Congress to pass a law but not punish violations. 
        The abuse of genetic information represents a fundamental 
        violation of an individual's person. It should be treated as 
        such.
    Representative Morella and I believe we have the legislative 
solution to genetic discrimination. We are proud to sponsor H.R. 602, 
the Genetic Nondiscrimination in Health Insurance and Employment Act. 
This bill has the support of well over a majority of the House of 
Representatives, as well as hundreds of outside organizations. We hope 
the Energy and Commerce Committee will act to pass H.R. 602 as quickly 
as possible.
    Once again, Mr. Chairman, I thank you for the opportunity to 
testify here today. Representative Morella and I look forward to 
working with you ensure that social policy keeps pace with science, and 
Congress passes a strong, meaningful genetic nondiscrimination law.

    Mr. Stearns. Thank you.
    Ms. Morella.

             STATEMENT OF HON. CONSTANCE A. MORELLA

    Ms. Morella. Thank you, Mr. Chairman. I want to thank you 
and members of the subcommittee for this hearing. I want to 
particularly thank you for scheduling this hearing. I do think 
it's very important and it shows your continued interest in 
this particular issue.
    I associated myself with the comments that you just heard 
from my colleague and good friend, Louise Slaughter. Actually, 
she's been tenacious in her dedication to this issue, having 
crafted this bill 5 years ago and being unrelenting in moving 
it forward and now more than ever we realize how important it 
is. But I am also pleased that you have invited J. Craig Venter 
from Celera to be here also who is a friend of mine and has his 
company in my District.
    As you may recall, last summer in a special ceremony at the 
White House, the completion of the so-called ``rough draft'' of 
the human genome was announced. This was a significant 
milestone and has been compared to the incredible discoveries 
of Galileo.
    The Human Genome Project, with its goal of producing 
detailed maps of the 23 pairs of human chromosomes and 
sequencing the DNA that make up the human genome, has 
identified genes responsible for diseases such as glaucoma, 
colon cancer, and cystic fibrosis.
    With the identification of these genes, millions of 
Americans are renewed with hope for promising genetic therapies 
to cure their disease, or that of a loved one. We have 
witnessed in recent years the rapid pace of medical discoveries 
and growing optimism for a future with less human suffering.
    However, in order to fulfill the promise that the mapping 
of the Human Genome holds, we do need to address the issue of 
genetic discrimination. For example, the presence of a cancer 
causing gene may indicate a predisposition, but it doesn't 
guarantee that the person will contract the disease. How should 
an employer or insurer respond?
    The ethical, social and legal implications of genetic 
advances have been the subject of intense scrutiny and concern. 
As scientific knowledge about genetics advanced, many 
researchers have expressed concerns about how this information 
will be used. While genetic information and genetic technology 
hold great promise for improving human health, they can also be 
misused.
    Genetic information can be used as the basis for insidious 
discrimination. The misuse of genetic information can be a 
serious problem in terms of people's access to employment and 
health insurance and the continued ability to undertake 
important genetic research. I believe, as do many others, that 
the misuse of genetic information has the potential to impede 
medical research. We know for a fact, it does.
    Privacy and discrimination are two critical issues 
regarding genetics. The privacy interests of an individual and 
his or her genetic information is important and fundamental to 
all Americans and the protection of privacy can make 
discriminatory actions less likely. However, the approach would 
be to prohibit this potential misuse of the information by 
prohibiting discrimination.
    These concerns have encompassed fears of discrimination in 
many aspects of life, including employment and health and life 
insurance. A study on discrimination found that a number of 
institutions, including health and life insurance companies, 
health care providers, blood banks, adoption agencies, the 
military and schools were reported to have engaged in genetic 
discrimination against asymptomatic individuals. The 
discriminatory practices alleged included treating a genetic 
diagnosis as a preexisting condition for insurance purposes, 
refusal by an adoption agency to allow a woman at risk for 
Huntington's Disease to adopt based on the woman's genetic risk 
and termination from employment after disclosure of a risk of 
Huntington's Disease. Similarly, another study reported that 22 
percent of the respondents indicated that they or a family 
member were refused health insurance as a result of a genetic 
condition.
    Mr. Chairman and members of the subcommittee, I've had the 
honor for the past 15 years to represent Montgomery County, 
Maryland. We call it the Human Genome Alley. My District is 
home to the National Institutes of Health and hundreds of 
biotechnical companies such as Celera. As a member of the House 
Science Committee, I chaired the Subcommittee on Technology for 
6 years. Mr. Gordon was my ranking member for a number of those 
years and we held hearings on the Human Genome Project. The 
pace of discovery was rapid. The project is moving forward, but 
I've always had that concern about the possible misuse of 
genetic information and my colleague, Congresswoman Slaughter 
has moved ahead on that.
    I've come to the conclusion that we need legislation that 
will, first of all, cover all genetic information, including 
family history, that predicts future health risks in healthy 
individuals, that it should prohibit both health insurers and 
employers from collecting predictive genetic information and 
from using it to discriminate in the health care system and the 
work place, that it should provide individuals who experienced 
genetic discrimination the right to seek redress through legal 
action with access to meaningful remedies and that it should 
ensure that those entities holding genetic information about 
individuals will not disclose it to third parties without the 
permission of the individual.
    In closing, Mr. Chairman, and members of the subcommittee, 
I just want to bring to the attention of the committee 
something that you already know. It's what President Bush said 
about genetic discrimination in his radio address of June 23. 
``Genetic discrimination is unfair to workers and their 
families. It is unjustified--among other reasons, because it 
involves little more than medical speculation. A genetic 
predisposition toward cancer or heart disease does not mean the 
condition will develop. To deny employment or insurance to a 
healthy person based only on a predisposition violates our 
country's belief in equal treatment and individual merit.'' It 
couldn't have been better said.
    Again, I want to express my appreciation to the committee, 
to you, Mr. Chairman, for establishing this hearing and for 
allowing myself and Congresswoman Slaughter to testify. I do 
realize that this is, in part, because I am the Republican 
sponsor for the Genetic Nondiscrimination Health Insurance And 
Employment Act, H.R. 602. It is a solid, bipartisan bill. I 
want to commend Congresswoman Slaughter again and hope that 
this wonderful subcommittee under your leadership, Mr. 
Chairman, will move such legislation ahead. Thank you.
    [The prepared statement of Hon. Constance A. Morella 
follows:]
 Prepared Statement of Hon. Constance A. Morella, a Representative in 
                  Congress from the State of Maryland
    Mr. Chairman, Members of the Committee, I am delighted to be here 
today and joined by my good friends Congresswoman Louise Slaughter and 
Dr. Craig Venter. I appreciate the opportunity to testify on The 
Potential for Discrimination in Health Insurance Based on Predictive 
Genetic Tests.
    As you may recall, last summer in a special ceremony at the White 
House, the completion of the ``rough draft'' of the human genome was 
announced. This was a significant milestone and has been compared to 
the incredible discoveries of Galileo.
    The Human Genome Project, with its goal of producing detailed maps 
of the 23 pairs of human chromosomes and sequencing the DNA that make 
up the human genome, has identified genes responsible for diseases such 
as glaucoma, colon cancer, and cystic fibrosis.
    With the identification of these genes, million of Americans are 
renewed with hope for promising genetic therapies to cure their 
disease, or that of a love one. We have witness in recent years the 
rapid pace of medical discoveries and growing optimism for a future 
with less human suffering.
    However, to fulfill the promise the mapping of the Human Genome 
holds, we do need to address the issue of genetic discrimination. For 
example the presence of a cancer causing gene may indicate a 
predisposition but does not guarantee that the person will contract the 
disease: How should an employer or insurer respond?
    The ethical, social and legal implications of genetic advances have 
been the subject of intense scrutiny and concern. As scientific 
knowledge about genetics advanced, many researchers have expressed 
concerns about how this information will be used. While genetic 
information and genetic technology holds great promise for improving 
human health, it can also be misused.
    Genetic information can be used as the basis for insidious 
discrimination....the misuse of genetic information can be a serious 
problem, in terms of people's access to employment and health insurance 
and the continued ability to undertake important genetic research. I 
believe, as do many others that the misuse of genetic information has 
the potential to impede medical research.
    Privacy and discrimination are two critical issues regarding 
genetics. The privacy interests of an individual and his or her genetic 
information is important and fundamental to all Americans, and the 
protection of privacy can make discriminatory actions less likely. 
However, the approach would be to prohibit this potential misuse of the 
information by prohibiting discrimination.
    These concerns have encompassed fears of discrimination in many 
aspects of life, including employment, and health and life insurance. A 
study on discrimination found that a number of institutions, including 
health and life insurance companies, health care providers, blood 
banks, adoption agencies, the military and schools, were reported to 
have engaged in genetic discrimination against asymptomatic 
individuals. The discriminatory practices alleged included treating a 
genetic diagnosis as a preexisting condition for insurance purposes, 
refusal by an adoption agency to allow a woman at risk for Huntington's 
disease to adopt based on the woman's genetic risk, and termination 
from employment after disclosure of a risk of Huntington's disease. 
Similarly, another study reported that twenty-two percent of the 
respondents indicated that they or a family member were refused health 
insurance as a result of a genetic condition.
    Mr. Chairman I have had the honor for the past 14 years to 
represent Montgomery County in Maryland, Genome Alley. My district is 
home to the National Institutes of Health and hundreds of biotechnology 
companies such as Celera. As a member of the House Science Committee, I 
Chaired the Subcommittee on Technology for 6 years. We held hearings on 
the Human Genome Project, the pace of discovery was rapid, the Project 
is moving forward., but I was always concerned with the possible misuse 
of genetic information.
    I have come to the conclusion that we need legislation that will:

 cover all genetic information--including family history--that 
        predicts future health risks in healthy individuals.
 prohibit both health insurers and employers from collecting 
        predictive genetic information and from using it to 
        discriminate in the health care system and the workplace.
 provide individuals who experience genetic discrimination the 
        right to seek redress through legal action, with access to 
        meaningful remedies.
 ensure that those entities holding genetic information about 
        individuals will not disclose it to third parties without the 
        permission of the individual.
    Mr. Chairman, in closing I would like to bring to the attention of 
the Committee what President Bush said about genetic discrimination in 
his radio address on June 23.
          ``Genetic discrimination is unfair to workers and their 
        families. It is unjustified--among other reasons, because it 
        involves little more than medical speculation. A genetic 
        predisposition toward cancer or heart disease does not mean the 
        condition will develop. To deny employment or insurance to a 
        healthy person based only on a predisposition violates our 
        country's belief in equal treatment and individual merit.''
    Again I would like to express my appreciation to the Committee to 
be able to testify today. I do realized this is in part because I am 
the lead Republican sponsor for the Genetic Nondiscrimination in Health 
Insurance and Employment Act, H.R. 602, a solid bipartisan bill. I hope 
as part of this oversight hearing that the many good merits of this 
bill will be recognized.
    Thank you.

    Mr. Stearns. I thank the gentlelady.
    We have someone, Ms. Eshoo from California, who was not 
here for the opening statements, but I'd like to give her an 
opportunity to have one.
    Ms. Eshoo. Thank you, Mr. Chairman, I appreciate it. First, 
the warmest of welcome to my two, our two fabulous colleagues. 
I think they are part of the permanent women's hall of fame in 
the Congress for your work and I'm proud to support the bill.
    To Representative Slaughter, this has been a 5-year effort, 
my colleagues, and she has been absolutely, totally, 
unswervingly on this for 5 years and we're going to pay 
attention to it. We have to.
    And to Congresswoman Morella, of course you bring your 
credibility on a whole host of issues as the Republican sponsor 
of this.
    I'd like to ask, Mr. Chairman, that the Washington Post 
article of Saturday, July 7, 2001 be made part of the record. 
It's ``Keeping Genes Private.'' I think it's a very important 
piece that should be part of our record. And I also want to 
especially welcome Dr. Venter, The New York Times Y2K Man of 
the Year. Dr. Venter has distinguished himself in so many ways.
    I'd also like to say something else in addition to what 
I'll submit for the record and that is when we had our 
bipartisan retreat earlier this year, and as one of the co-
chairs of the effort, we turned to some of the leaders in our 
Nation to speak to us on three key top issues facing the 
American people. And one of them was this very area. Dr. 
Francis Collins was at the dinner that evening and as I sat 
next to him and he spoke of the overwhelming need for the 
Congress to address this, not a future Congress, we should stop 
this 5-year roll that we're on and not go into the sixth and 
seventh year and make it a decade where we're trying to catch 
up with the science that's already there for us to take 
advantage of. At any rate, I said to Francis Collins, come with 
me because at the table next to us was seated the Speaker and 
the Minority Leader and I said you have to be very succinct, 
you have to say in 1\1/2\ or 2 minutes to each one of them what 
you just told me. If there's anything to come out of this 
bipartisan conference, it should be the commitment of the 107th 
Congress to get this bill done. And both the Speaker shook his 
head. He asked very good questions of Francis Collins as did 
the Minority Leader. So we have the makings, the ingredients, 
Mr. Chairman, that right from this subcommittee where we set 
the original table for this legislation, we should distinguish 
ourselves on a bipartisan basis to move this bill. The American 
people will be forever grateful. Our great grandparents and 
great, great grandparents and great great grandparents should 
not become the sin of the present generation. Whatever we are 
predisposed to or of should remain in the realm of scientists, 
medical scientists, biotechnology professionals to help bring 
about how we address those thing, but it should not be held 
against us in the work place or any other place. So I want to 
thank these two great women for their faith in this issue and 
they are dogged and we should match it with what we can do 
here. Let's get this thing done.
    So thank you, great members. The American people owe a 
great deal of gratitude to you. I couldn't mean it more. I 
respect you. I admire you and thank you to the scientific 
community for the work that you've done in not only advancing 
America's best interests, but how proud we are of you that 
you're Americans and the best.
    Thank you, Mr. Chairman. Let's do this.
    Mr. Stearns. Okay, and by unanimous consent, so ordered, to 
put in the record.
    Ms. Eshoo. Thank you.
    [The article follows:]

             [Saturday, July 7, 2001--The Washington Post]

                         Keeping Genes Private
    President Bush surprised longtime advocates of a law against 
``genetic discrimination''--the use of genetic tests to deny people 
access to jobs or health insurance--by joining their cause last week. 
The president addressed the need for protection from abuses of this 
information, saying it amounts to ``medical speculation'' because a 
genetic predisposition to a condition does not mean it will develop: 
``To deny employment or insurance to a healthy person based only on a 
predisposition violates our country's belief in equal treatment and 
individual merit.''
    If this reasoning sounds familiar, it's because Mr. Bush's 
predecessor made the same arguments, issuing an executive order that 
barred the use of predictive genetic information in employment 
decisions throughout the federal workforce. That good policy remains in 
force, but it needs to be expanded to non-federal employees, something 
only Congress can do. The Republican House leadership, though, has 
declined for nearly five years to hold hearings on any of several 
genetic privacy bills, including one, written by Rep. Louise Slaughter 
(D-N.Y.), which has the high-profile endorsement of scientists Francis 
Collins and J. Craig Venter, the decipherers of the human genome.
    The Slaughter bill would bar employment discrimination based on 
gene tests and forbid insurance companies from using genetic 
information to deny coverage or adjust premiums. More important, no one 
could be forced to take a genetic test for either employment or 
insurance purposes--abuses that already are starting to be seen. It's 
true that insurers already set premiums based partly on guesses about 
future, not present, health; but genetic information at this stage adds 
little to such guesswork except an air of certainty that remains 
spurious. Some insurers are reported to have denied coverage merely 
because someone took a genetic test, the sort of overreaction that 
drives people away from taking the tests at all.
    The president has not said exactly what he wants to see in a bill. 
But a law he signed in Texas overlaps significantly with what privacy 
advocates say they want, diverging mostly in how narrowly ``genetic 
information'' is defined. There's room here for a bipartisan bill that 
would extend significant protection to millions of people. Will House 
leadership unbottle the topic?

    Mr. Stearns. Just briefly, I'd like to--I don't have so 
much questions for the two of my colleagues, but I would like 
to make a note that Ms. Eshoo has talked about that nothing has 
been done in this area and I would remind members that the 
Health Insurance Portability and Accessibility Act, HIPAA of 
1996 added provisions specifically prohibiting discrimination 
based on genetic information for private group health plans and 
insurers offering coverage in connection with private group 
health plans.
    This particular act was in the 104th Congress, so it 
already prohibits discrimination based on certain health 
information, including genetic information in the private group 
health market. In fact, in the first paragraph of this code it 
says ``a group health plan and a health insurance issuer 
offering group health insurance coverage in connection with a 
group health plan may not establish rules for eligibility 
including continued eligibility of any individual to enroll 
under the terms of the plan based on any of the following 
health status related factors in relation to the individual or 
a dependent of the individual.'' And right out off the bat is 
genetic information.
    So I call my colleagues' attention to the provisions in 
HIPAA of 1996 that say that a lot of the things you were 
talking about have been put in place with policy. Now the 
problem was the Department of Health, we tried to get a 
representative here to see how this policy is working and we 
were not able to do so for a number of reasons, but we intend 
to pursue this because this goes to the heart of the question. 
We have passed legislation. We have said that individuals and 
group individuals cannot be dismissed based upon genetics and 
in fact, they can't even be, their premiums cannot be adjusted 
because of genetic information that is revealed.
    So we have that in place. Is it working? If it's not 
working, then obviously Congress needs to do something, but 
with that in mind I would like to say to both my colleagues 
that in looking at your legislation I think we have to see what 
is working first and continue to take the provisions of your 
legislation and move forward.
    Now in my committee we can deal with the health insurance, 
but of course, on the employment side which I believe you have 
employment discrimination would go on John Boehner's 
chairmanship on his committee. So I'm hoping that you'll work 
with us on the discrimination on the health and perhaps you 
would work with Chairman Boehner on the aspect dealing with 
employment.
    But I guess my only question to you folks are have you seen 
specific examples, not necessarily statistical and not 
something from 1997 or 1998, but has there been a proliferation 
of genetic discrimination out there enough for us to do an 
omnibus bill and if so, then why isn't the HIPAA Act of 1996 
working and I'd be glad to----
    Ms. Slaughter. I'd like to respond to that, if I may. HIPAA 
in my estimation was somewhat misleading because it talked 
about the portability of insurance which was the main theme 
there. But it didn't mean that if you went from one job to 
another you took your insurance with you. It meant that if you 
were eligible at the job you had, and if your next employer 
offered insurance, which was not guaranteed, and if you could 
afford it, then you were eligible to have it. But it also said 
that you have to exhaust your COBRA coverage before you can get 
it and you had to have had 18 months of prior coverage. And 
people who didn't have any coverage prior are not covered at 
all. So they're still out there being discriminated against and 
as far as do we know that discrimination is taking place, yes, 
we do.
    I'm sure you're aware of the Burlington Northern-Santa Fe 
case that just recently--in the news.
    Mr. Stearns. I've read that case.
    Ms. Slaughter. We've had numbers of cases.
    Mr. Stearns. But wouldn't you agree that they have due 
course process through the HIPAA Act? Just the paragraph I 
read----
    Ms. Slaughter. I wouldn't, no.
    Mr. Stearns. So you're saying that you don't think----
    Ms. Slaughter. I don't think that covers it at all. I don't 
think the genetic provision in there is nearly good enough and 
I really believe the fact that most people--which I thought was 
really the serious error on this bill--believed that if they 
were insured at one time they were going to be insured the rest 
of their lives. It's not the case. If you left your job, you 
left your insurance there, and if you went to another job and 
if they offered it, which was not certain, if they offered it, 
and second, if you could afford it, then you could be eligible 
because you had exhausted COBRA and you had been insured for 18 
months.
    Ms. Morella. I'd like to reiterate what you said, actually, 
because we looked into this. The law still only guarantees 
coverage if the individual can afford the plan being offered, 
which in some cases it can be astronomically marked up with 
that concept in mind.
    Ms. Slaughter. Because of genetics.
    Ms. Morella. Yes. And if that person has already exhausted 
COBRA coverage and if the individual has had, as has been 
mentioned, 18 months of prior coverage, so people who had no 
coverage previously, had insurance through the individual 
market would be basically unprotected and there's no promise or 
provisions in HIPAA preventing insurance companies from 
requesting or requiring that an individual give up genetic 
information or protecting the privacy of genetic information.
    Mr. Stearns. I'm not an expert on this.
    Ms. Slaughter. There are a lot of loopholes.
    Mr. Stearns. And I'm just saying----
    Ms. Slaughter. I'm not either, but I mean on the surface, 
it looked great.
    Mr. Stearns. It says here group health plan and a group 
insurance issuer offering these plans, you can't change the 
premiums, based upon genetic information. You cannot dismiss 
anybody because of their genetic information and it's against 
the law. So I'm reading right from the statute, paragraph 
1182(b)(1). So I'm saying that on the health side now that the 
law is in place and what we need to understand is it working. 
If it's not working, why not?
    But I bring those to your attention because as you know 
both of us have been here a long time. We pass bills every year 
and we don't know how they're working and I think one of the 
things we have to do is find out the bills that we've passed, 
if they're working first, before we put new ones and that's, I 
was hoping in this hearing that would do this and I assure my 
colleagues that when I get these questions to the Department of 
Health and Labor, I'm going to provide them to you too.
    Ms. Morella. Good, because this is the information that we 
were, we have been given.
    Mr. Stearns. I understand. Mr. Towns?
    Mr. Towns. Thank you very much, Mr. Chairman. Mr. Chairman, 
let me request that all statements be made a part of the 
record.
    Mr. Stearns. By unanimous consent, so ordered.
    Mr. Towns. Thank you. Let me first commend both of you on 
the outstanding work that you have done. But I do have a couple 
of questions. Why would you not divide it up in terms of health 
insurance and employment? The more committees that you have to 
refer a bill the more constraint it will have. Why wouldn't you 
break it up and leave health and insurance one place and of 
course, the education and work force in terms of the employment 
part in another?
    Ms. Slaughter. Well, we thought that both were equally 
important and that you couldn't do one without the other and 
really give full protection to people.
    Also, there is one little item there that the Senate bill 
which is co-sponsored in chief by Mr. Daschle is the same bill 
that we have and has numerous co-sponsors and we understand 
that will be coming forward this year. So it took years of 
writing and perfecting this bill to get it where we thought we 
could really give the right protection to Americans.
    Look, I'm a former scientist. The last thing in the world I 
would ever do is anything that would chill research. I see this 
whole new way of providing health care. As Connie said, since 
Galileo, at least since the germ theory of disease, we have not 
had anything as revolutionary as this.
    The human suffering that can be alleviated with this 
research is overwhelming. The least we can do is not stop it in 
its tracks by having people so afraid, as they are now, that 
they will not be part of clinical trials. And the public's 
perception of it is that they are in for some trouble and let 
me give you one statistic here if I may. In June 2000 a Harris 
Poll said that 88 percent of Americans believe that people 
shouldn't pay higher or lower premiums on their predictive 
discrimination information. Ninety-four percent surveyed said 
insurance companies shouldn't have access to it. And a study 
conducted--this is one that I think is important--a study 
conducted by Northwestern National Life found that by the year 
2000, which was last year, 15 percent of employers planned to 
get the genetic status of prospective employees and their 
dependents before making employment offers.
    Mr. Towns. Right.
    Ms. Slaughter. So we saw them as equally important.
    Ms. Morella. I don't see how you can separate the health 
discrimination from the employment when you think about the 
particular cases and how it overlaps. Dr. Francis Collins who 
is in charge of that Human Genome Project at NIH did appear at 
a news conference on this issue and he attested to the fact 
that clinical trials have been in trouble because of this 
concept of the shroud of discrimination.
    Mr. Towns. Right. I don't want you to think for a moment 
that I'm saying they're both not important. I think the only 
thing I'm saying is that sometimes when you craft it in a way 
that you keep it from other areas, it has a tendency to move a 
lot faster. That's all that I was saying. I think that both of 
them are extremely important and no question about it. And I 
support that.
    I guess the other thing though that I would sort of have, 
in terms of when it comes to penalties or damages awarded, I 
think that in your bill it goes to the Treasury. Why not to the 
individual?
    Ms. Slaughter. We thought that was the better thing to do. 
Actually, the individual has a right of recourse on there and I 
think that the Labor Department would be in charge of the 
arbitration to see where discrimination has taken place, but I 
don't know that it goes to the Treasury. I don't have any sense 
that it went to the Treasury. I think it went to the individual 
for damages.
    Mr. Towns. No. My understanding is that it's the same as 
the Daschle bill.
    Ms. Slaughter. It is the same as the Daschle.
    Mr. Towns. Then it goes to the Treasury? That's what I was 
wondering.
    Ms. Slaughter. Okay, civil penalties as Cindy points out go 
to the Treasury. Individual penalties go to the individuals if 
they are awarded.
    Mr. Towns. Okay, I will do everything I can to try and help 
into moving this legislation. You can be assured of that.
    Ms. Slaughter. Thank you.
    Mr. Towns. These are just questions that I have that----
    Ms. Slaughter. Right. We wanted to make sure that there was 
a penalty involved because we know without one, it's just 
useless.
    Mr. Towns. Right.
    Ms. Slaughter. We worked to refine that several times and I 
worked with Senator Daschle's office on having the same bill 
that we could have before the House and Senate.
    Mr. Towns. Right. Thank you. I understand that part because 
we can avoid a conference if we get it through.
    Ms. Slaughter. We sure could.
    Mr. Towns. Thank you very much.
    Ms. Slaughter. If I could just get it on suspension, it 
would go through like a hot knife through butter.
    Mr. Towns. Thank you very much.
    Ms. Slaughter. You're welcome.
    Mr. Towns. Thank both of you.
    Mr. Stearns. Ms. Capps.
    Ms. Capps. Thank you, and again, it's a true pleasure to be 
here and have this discussion going on today. I was very eager 
to be an original co-sponsor of this legislation precisely for 
the kind of discussion that's coming off today. We need to 
educate our colleagues, first, about the limitations of the 
HIPAA plan and its frailty. I understand it's being reviewed 
even now by the Secretary of HHS and the dramatic discoveries 
that have occurred with the genome project underscore the 
imperative nature of the legislation like this and perhaps just 
because it's also new it won't be the last piece, but surely, 
surely we can allow it to go unmarked up. It's got to come to 
the floor. This is an historic day I think today. I believe we 
should just push it through. We should keep it in concert with 
the Senate version and then begin to give, to empower our 
constituents and to empower patients.
    I want to engage you in a discussion, a little bit, in the 
area of research because I think there is a fear by some 
research institutions that privacy sanctions that patients can 
hold on to will maybe on that side block research, so if you 
could comment a little bit on that we could add that to the mix 
of things because we need to have everybody on board with this. 
We need to have insurers aware that they're not saving money by 
withholding employment this way because as you pointed out, 
there is no one who doesn't have weak genes.
    Ms. Slaughter. Including the president of the insurance 
company.
    Ms. Capps. Exactly. It's a matter of knowledge and being 
able to--we're actually going in the direction that is going to 
equip better, people better, to become better part of the work 
force, to be better employees because they'll have more 
knowledge and be able to do the planning and the proactive work 
and it will lead us in that direction, but to the area of 
medical research.
    Ms. Slaughter. Medical researchers like to go through 
records, obviously, to find things that they want to research 
or information that they need. We don't want to stop that. It 
is our firm belief that they do not need to know, as they look 
through that record, who you are, where you live and where you 
work and who insures you.
    Ms. Capps. So can we make assurances to----
    Ms. Slaughter. That's what the citizenry is worried about, 
that that's the kind of information that will get out. That's 
what we want to protect, their privacy, so that their name is 
not attached to that record so that they could lose their job 
or have other repercussions.
    I mean I'm sure that a lot of people have been dismissed, 
not even understanding the reason why. But we have had some 
tragic cases of people who have gotten wonderful reports at 
work, progressing right along, highly thought of, who suddenly 
found that they had a disposition to a disease and they were 
suddenly fired. And that's not uncommon. I'm afraid it's 
getting even more common. And we do have the power here in 
Congress to stop that and I think we owe it to people to do it.
    Ms. Capps. And I think it goes without saying that we have 
two women, members of--colleagues who are women that this is 
not--that men don't face these same limitations, but many of 
the issues that are being discussed in terms of characteristics 
that might be discriminated against happen to be those that 
women carry and that we need to do this for all the population, 
but sometimes it has to do with offspring and the role that 
women bear in caring for children and those that depend on 
them.
    Ms. Morella. I've often said that if you knew that your 
grandmother, you had your grandmother's blue eye genes, do you 
want to know that you also have her cancer gene and that your 
employer knows and your neighbor knows and your health care 
provider knows and that's your concern----
    Ms. Slaughter. And your mother-in-law.
    Mr. Towns. Will the gentlelady yield?
    Ms. Capps. I will be happy to.
    Mr. Towns. We're for this because, of course, you live 
longer than we do. We're for it.
    Ms. Slaughter. This could even the score. We might make 
that better for you.
    Ms. Capps. I yield back.
    Mr. Stearns. I thank you and I thank our distinguished 
colleagues very much for taking your time and now we'll have 
the second panel. Ms. Mary Davidson, Executive Director of 
Genetic Alliance, Inc.; Dr. Donald Young, Interim President, 
Health Insurance Association of America; Dr. J. Craig Venter, 
Celera Genomics on behalf of Biotechnology Industry 
Organization; and Dr. Karen Rothenberg, Dean, Marjorie Cook 
Professor of Law, University of Maryland School of Law.
    Let me welcome each of you to our second panel and we'll 
probably move from right to left.
    Ms. Mary Davidson, if you are--at your convenience, we'll 
look forward to hearing your opening statement and welcome. 
Thank you very much for taking your time to be here to testify.

  STATEMENTS OF MARY E. DAVIDSON, EXECUTIVE DIRECTOR, GENETIC 
  ALLIANCE, INC.; DONALD A. YOUNG, INTERIM PRESIDENT, HEALTH 
 INSURANCE ASSOCIATION OF AMERICA; J. CRAIG VENTER, PRESIDENT 
   AND CSO, CELERA GENOMICS; AND KAREN H. ROTHENBERG, DEAN, 
 MARJORIE COOK PROFESSOR OF LAW, UNIVERSITY OF MARYLAND SCHOOL 
                             OF LAW

    Ms. Davidson. Thank you very much. Good afternoon. My name 
is Mary Davidson and I'm Executive Director of the Genetic 
Alliance and I want to thank you for the invitation to present 
today on a topic that is very and near and dear to the hearts 
of everyone in my organization and I think to tremendous 
numbers of American public out there. And I'm here today to 
really talk about the urgent need for comprehensive genetic 
nondiscrimination legislation in health insurance as well as in 
employment.
    Mr. Chairman, I request that my longer written testimony be 
added to the----
    Mr. Stearns. By unanimous consent. So ordered.
    Ms. Davidson. Thank you. I have two major points. New 
genetic discoveries offer an amazing potential for healthier 
lives, but Americans are afraid to use these tests and 
technologies because of their concerns about genetic 
discrimination. Congress has the authority and I hope the 
compassion and the will to create comprehensive legal 
protections that will give us the confidence we need to 
continue participating in research and to obtain testing and 
treatments for ourselves and for our families.
    I'm here today representing consumers, individuals like 
you, me and our families and also on behalf of the Genetic 
Alliance, the largest international coalition of more than 350 
genetic disease organizations and their millions of members.
    Genetics is about all of us. Genetic diseases affect us all 
from cancer to sickle cell disease to heart disease to diabetes 
to Alzheimer's to the rare diseases. No one is untouched. This 
is the central message of the Human Genome Project.
    However, the same genetics that connects us as one human 
family can also be misused by insurance companies and employers 
to deprive us of health care and jobs. We need a real safety 
net, not the haphazard, protective patchwork currently provided 
by HIPAA, the ADA and various State and Federal laws and 
regulations.
    Let's put a personal face on this problem. Gail is a doctor 
with a family history of breast and ovarian cancer and she knew 
that she should have BRCA1 and 2 testing. These are predictive 
tests that indicate risk of breast and ovarian cancer in women 
of her background. Very genetic discrimination. She not only 
concealed her history from her doctor, but she took the tests 
under an assumed name and in the subsequent weeks a routine 
gynecological exam picked up a possible abnormality. Unaware of 
Gail, a doctor, Gail's family history, her doctor let it go, 
but had her doctor known about her history, a very different 
course of action would have taken place. Unlike many, this 
story has a happy ending. Gail took charge of her medical care. 
She requested a follow-up study. Her genetic tests came back 
negative and everything turned out okay. Her story, however, is 
a wake up call for what might have happened.
    It's hard to believe that here in the most advanced Nation 
on earth, even a doctor is taking a genetic test under an 
assumed name for fear of losing access to health care.
    I'm also here today to represent those out there who don't 
yet know that all of us some day will have a genetic, a 
previous position, condition or disease some time over our 
lifetime because as others have said, it will soon be possible 
to identify the 40 or more mutations that scientists estimate 
that we all carry and this will lead to predictions for many 
more health problems and solutions and we will all be at 
greater risk for genetic discrimination under the current 
circumstances.
    The Genetic Alliance maintains that predictive tests are 
not relevant to health insurance decision. First, we may never 
manifest the disease at all. Second, test results do not 
translate into health care dollar liability or work 
productivity scales on an individual basis. And in some cases 
like hemachromatosi, testing can even lead to treatments for an 
otherwise chronic, costly and even fatal condition. And 
finally, predictive information will soon become as universal 
as our imperfect genes, placing us all at risk for diseases as 
well as genetic discrimination.
    The Genetic Alliance warns that the use of predictive tests 
in health insurance determination poses new and costly burdens 
to society. Individuals and families, as you have already 
heard, would be impacted in the most profound ways. Employees 
whose tests results or medical treatments will increase group 
insurance premiums for their employers, in particular, small 
business employers, are less likely to be hired, promoted or 
retained and this is already happening. I think many of us 
already know the case of Terri Sergeant who was fired by her 
employer after 7 years, after the employer learned about her 
test results and the medical treatment that she would need to 
stay healthy and productive.
    Research is already suffering because people are reluctant 
to sign up. We risk the creation of an uninsurable and 
unemployable genetic underclass at enormous public and moral 
and economic costs if individuals are excluded from health care 
and jobs on the basis of genetic makeup.
    We recommend the following principles. One, we all possess 
imperfect genetic inheritances that will become equally 
transparent with tomorrow's technologies.
    Two, health insurance and employment in this country are 
intrinsically linked and inseparable and legislation must 
protect both.
    Three, we need strong protections of all information, 
medical and genetic.
    Four, risk-based health insurance may not work in this new 
genomics age the way it's currently structured. The science is 
literally galloping ahead of our ability to understand the full 
meaning of this new information.
    Five, without Federal protections, genetic discrimination 
has the potential to pose unfathomable social harms.
    Just to close very quickly, in funding the Human Genome 
Project, Congress showed tremendous foresight. It now requires 
an equal measure of vision and courage to pass legislation that 
will allow people to benefit from the tests and technologies 
that are really the first fruits of that history endeavor.
    You have before you H.R. 602 which we endorse as a major 
step forward, but we still more comprehensive legislation and 
we ask you, please, to take action in this area as soon as 
possible.
    Thank you.
    [The prepared statement of Mary E. Davidson follows:]
  Prepared Statement of Mary E. Davidson, Executive Director, Genetic 
                                Alliance
    Good afternoon. My name is Mary Davidson, Executive Director of the 
Genetic Alliance. The Genetic Alliance requests your assistance in 
enacting legislation that prohibits genetic discrimination.
Policy Development Outstripped by Escalating Genetic Discoveries
    Thanks to Congressional vision and your support for the Human 
Genome Project, these are remarkable and historic times. Earlier this 
year, the 3 billion letters of the DNA instruction book were published. 
And now scientists all over the world are using this genetic map to 
unravel the mysteries of heart disease, cancer, diabetes, mental 
illness, asthma, multiple sclerosis--since all diseases, with perhaps 
the exception of trauma, have a hereditary component. Already there are 
individuals and families whose lives have been touched in profound ways 
by biomedical technologies never before imagined.
    From the perspective of science, medicine and policy, we are 
confronting a ``brave new world'' with entirely new challenges. Genetic 
research is moving at breakneck speed, taxing our ability to craft 
timely public policies that safeguard the promise of genetics to 
improve health. Surveys and polls tell us that the public is worried 
about the balance between benefit and harm posed by these new 
technologies. Based on these concerns, growing numbers of individuals 
and families have decided not to pursue genetic tests or services--the 
hard-earned products of genetics research.
In the Midst of the Genetics Revolution, Healthcare Consumers Have No 
        Safety Net
    I am here today to bring attention to these two central facts.

 In the midst of the Genetics Revolution, people who could 
        benefit from the new technologies are afraid to use them. They 
        are afraid to have genetic tests or participate in research 
        because they fear losing their insurance and their jobs if 
        their insurance companies and their employers learn the results 
        of those tests.
 Congress could put these fears to rest once and for all by 
        enacting Federal legislation that makes it illegal for 
        insurance companies to deny coverage and for employers to 
        refuse to hire, promote or fire people based on genetic test 
        results. This would encourage people to take advantage of the 
        rapid advances in genetic testing and other new technologies 
        that can improve public health, alleviate human suffering and 
        extend productivity.
    These protections will ensure true nondiscrimination and facilitate 
the future sustainability of the biotechnology and healthcare 
industries.\1\
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    \1\ Insurance Industry Sustainability: Research focusing not only 
on survival rates and the probability of future disease, but also on 
future health care needs and the availability, effectiveness, and 
potential cost savings of early intervention, is of great potential 
benefit. Not only would patients better understand their prognoses, but 
physicians could improve treatment modalities, and plan sponsors and 
insurers could better evaluate the appropriateness of covering specific 
tests, their likely impact on insurance costs, and their potential 
implications for risk classification in the individual market.
    Some of the key questions that remain are:
    --How accurately will genetic tests predict future health care 
needs?
    --Will meaningful interventions be available for genetic disease?
    --Will genetically based treatments become available?
    --What impact will genetic technology have on overall medical care 
expenditures?
    Policy-makers need a clear understanding of these issues so that 
proposals regulating the use of genetic testing information can find 
the best balance between the concerns of the public, the predictive 
ability of genetic test results, and the affordability of health 
insurance.
---------------------------------------------------------------------------
Speaking on Behalf of the Genetic Alliance, Families and the Public
    I speak today on behalf of the Genetic Alliance--the largest 
genetics coalition worldwide, representing more than 300 lay advocacy, 
research, health professional, public and private sector organizations 
and their millions of members. The mission of the Genetic Alliance is 
to promote healthier lives for everyone impacted by genetics. Since 
1986, we have worked to speed the translation of scientific and 
technological advances into quality healthcare and consumer-informed 
public policies. The Genetic Alliance Helpline and Discrimination 
Survey put us into daily contact with people with stories to tell about 
the benefits as well as liabilities of genetic testing. Annually, we're 
in touch with over 100,000 people about genetics and related issues.
    I also speak today on behalf of known and unknown victims of 
genetic discrimination--individuals like Terri Seargent and Dave 
Escher, who have already felt the sting of genetic discrimination, and 
others out there who are struggling for their rights and still others 
who have chosen not to forsake their privacy and anonymity. Their 
struggles reaffirm the principle that ``Genetic information is 
inherently personal and must be treated as confidential and 
proprietary.'' (Alliance Guiding Principle)
We're All At Risk. ``Genetics Is About ALL of US''
    Finally, I am here today representing those who don't yet 
understand that ``Genetics is about ALL of us.'' Because every man, 
woman and child has some genetic predisposition, condition or disease 
resulting from inherited or acquired genetic changes.
    Tests are currently available for approximately 700 genes, most of 
which are associated with relatively rare disorders. However, that 
number will soon grow to the thousands with an understanding of the 
genetics of more common health problems. For the most part, these will 
be predictive tests, opening windows to early detection and prevention 
of diseases currently thought to be untreatable. It will be possible to 
identify the 40 disease-causing mutations that scientists estimate that 
we all carry. And we will be able to search for diagnoses and 
predictors for multiple diseases, disorders and conditions, on the 
surface of one tiny microchip, perhaps available at our local 
drugstore. For every person identified with a genetic disease, there 
are usually 4 to 7 non-symptomatic family members who would benefit 
from the knowledge gained from a genetic test. This will also create an 
explosion in the ability to identify risk factors and make predictions 
for a broad range of health problems--from rare conditions to common 
complex diseases. This is wonderful and will help so many of us live 
healthier and more productive lives.
    With this explosion comes a sense of greater risk for disease. Our 
real risk has not changed, but our awareness of risk has. And we don't 
even understand the exact implications of these newly identified risks. 
It may take us 100 years to determine whether certain risk factors are 
meaningful or not and to what degree, taking mitigating and co-mingling 
factors of other genes and the environment into account. It is now even 
more apparent that genetic conditions are universal and we are all 
increasingly at risk for genetic discrimination.
What Is Genetic Discrimination?
    Genetic discrimination is the inappropriate use, or misuse, of 
genetic information in making health insurance and employment 
decisions. Discrimination based on predictive information is just one 
of several categories of misuse of genetic information that people are 
reporting.
What Is A Predictive Genetic Test?
    These are tests for conditions like breast and ovarian cancer, 
Alzheimer's and Parkinson's Disease, Alpha-One, colon cancer and 
others. Test results indicate the risk or probability or likelihood of 
a disease occurring over our lifetime. Positive test results simply 
mean that one's risk is higher than the average person. The condition 
may or may not happen at all.
Does Genetic Discrimination Based on Predictive Genetic Tests Really 
        Happen?
    Through our Genetics Helpline and Discrimination Survey, people 
have come to the Genetic Alliance with their stories about the 
unauthorized use of genetic information in employment and insurance 
coverage decisions. This should not come as a surprise. We live in a 
society with a long history of discrimination based on ethnicity, 
class, gender, physical and mental impairment and now genetics. And we 
already witnessed the tragic consequences of discrimination based on 
sickle cell disease test results in the 1970's.
If Genetic Discrimination Is A Serious Problem, Why Aren't People 
        Coming Forward? Why Aren't There Any Test Cases?
    First, people don't know what to make of genetics--much less 
genetic discrimination. Without a sound scientific and social compass, 
they are unable to assess the fairness of the situation in which they 
find themselves. Second, our legal rights are equally obscure. State 
and federal laws and regulations make up a complex patchwork of 
protections that vary by state, health plan and employment situation 
and create major obstacles to legal action. Third, there are cases out 
there that have not yet seen the light of day. When people lose their 
health insurance or employment, they hold tight to the last vestiges of 
privacy and anonymity at all costs and are reluctant to get burned 
twice. Fourth, we know that the door is wide open for discrimination 
and that this potential will certainly increase with all the new 
predictive tests on the horizon.
Is the Public Concerned about Testing and Research?
    We know that people are deciding not to have predictive tests and 
not to participate in research based on fears that insurance companies 
and employers will use this information to cancel healthcare insurance 
and deny them jobs.\2\
---------------------------------------------------------------------------
    \2\ Genomics and Managed Care: Preparing for the Revolution By: 
Carl Peterson [Healthplan 41(5):14-20, 2000.  2000 AAHP 
``Concern among consumers is high. In a mid-June Time/CNN poll of 1,200 
U.S. adults, three-quarters of respondents feared having health 
insurers gain access to disease predisposition data. An even greater 
number (84 percent) were concerned about government access to personal 
genetic information.''
    Genomics Research: However, Knowledge and Understanding Remain 
Modest Release Harris Interactive Polling Date:6/19/01 1,000 Adults 
polled June 2001 When asked what their greatest fears are, the answers 
given most often are that genetic information may be misused (45%)''
    In genetic testing studies at the National Institutes of Health, 32 
percent of eligible people who were offered a test for breast cancer 
declined to take it because of concerns about loss of privacy and 
potential for discrimination in health insurance. May 2001
---------------------------------------------------------------------------
Let's Put a Personal Face on this Growing Problem.
    Gail, a physician, knew about BRCA1 and 2 testing--predictive tests 
that indicate a predisposition to breast and ovarian cancers in some 
women. Because of a strong family history of breast and ovarian cancer, 
she opted to take the genetic test under an assumed name. In course of 
a gynecological exam and while she awaited test results, a possible 
abnormality on an abdominal ultrasound was noticed and confirmed by a 
radiologist. Because Gail's risk factors were not recorded in her 
medical record, he let it go. Had he known her history, a very 
different course of action would have been taken.
    Fortunately, this story has a happy, though sobering, ending. 
Because Gail is a physician, she understood the problem and took charge 
of her own medical care. She requested a follow-up study, her genetic 
test came back negative and everything turned out to be OK. However 
this story is wake-up call for what MIGHT have happened.
    Without a safety net, there was no way for Gail to use critical 
information about her own health without fear of discrimination and 
losing her health insurance. It is hard to believe that in one of the 
most advanced nations on earth, we are driven to undergo anonymous 
genetic testing for fear we will lose our insurance and access to 
healthcare. Gail felt that she had no safety net.
Why the Potential for Genetic Discrimination Based on Predictive Tests?
    The door to discrimination is wide open because most state laws do 
not prohibit the use of predictive test information in health insurance 
determinations. About half of the states do provide some form of 
nondiscrimination protection. However, in most cases, state protections 
are inadequate and do not address predictive information specifically. 
State laws are generally described as a colorful, complex and 
inconsistent patchwork of definitions, provisions and right to action 
and often do not address predictive information specifically.
    Looking to existing Federal protections, HIPAA's protective 
jurisdiction is also variable and inadequate, depending on whether 
someone belongs to an individual or group health plan or his employer 
is self-insured. In the individual market, there are no protections 
whatsoever. The genetic condition can be excluded or the premium set as 
high as the market and consumer can bear. Because there are no 
restrictions or ceilings to the premium, access can be effectively 
blocked by pricing someone out of the market. In the small group 
market, the group member is protected to the degree that rate hikes--
resulting from member medical treatments or increased risk--are spread 
across the group pool. The employer is responsible for how the 
increased tab for premium increases is covered or shared with 
employees. In the small business situation, these HIPAA protections 
result in serious potential vulnerabilities, both for the employee and 
the business owner. Increased premiums may threaten the solvency of a 
small business and put owners on the alert for employees whose medical 
condition and treatments are causing group rate hikes. In a small work 
environment, health and personal issues are sometimes common knowledge 
and the identified employee known to all. As has been well documented 
in the recent EEOC case involving Terri Sergeant and her former small 
business employer, HIPAA regulations leave both the employee and small 
businesses vulnerable to the misuse of genetic information in making 
employment decisions.\3\
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    \3\ Congressional Research Service Report for Congress RL30006: 
Genetic Information: Legal Issues Relating to Discrimination and 
Privacy The Health Insurance Portability and Accountability Act of 1996 
P.L. 104-191, the Health Insurance Portability and Accountability Act 
of 1996, has been hailed as taking ``important steps toward banning 
genetic discrimination in health insurance'' but has also been 
criticized as not going far enough. The Act prohibits a group health 
plan or issuer of a group health plan from using genetic information to 
establish rules for eligibility or continued eligibility and provides 
that genetic information shall not be treated as a preexisting 
condition in the absence of the diagnosis of the condition related to 
such information. It also prohibits a group health plan or issuer of a 
group health plan from using genetic information in setting a premium 
contribution. However, the Act would not prohibit group health plans or 
issuers of plans (i.e., insurers) from requiring or requesting genetic 
testing, does not require them to obtain authorization before 
disclosing genetic information, and does not prevent them from 
excluding all coverage for a particular condition or imposing lifetime 
caps on all benefits or on specific benefits. In addition, this Act 
does not address the issues of the use of genetic information in 
contexts other than health insurance such as employment.
---------------------------------------------------------------------------
    With regard to protection under the Americans with Disabilities Act 
(ADA), people with predictive genetic information will probably not 
fare too well, given the trend in the courts over recent years. When 
Congress passed the ADA in 1990, Congress intended that the law would 
cover individuals with a broad range of diseases, such as epilepsy, 
diabetes, breast cancer, heart conditions and mental illness. Indeed, 
some Members of Congress even explained that the ADA would protect 
people who experience discrimination on the basis of predictive genetic 
information, on the grounds that such individuals would be ``regarded'' 
as disabled and hence covered under the law.\4\
---------------------------------------------------------------------------
    \4\ See, e.g., 136 Cong. Rec. H4627 (statement of Rep. Waxman).
---------------------------------------------------------------------------
    Unfortunately, soon after the ADA went into effect in 1992, and 
culminating in a trio of cases by the Supreme Court in 1999, the ADA's 
scope of coverage has been significantly restricted. Thus, in many 
cases, individuals with conditions such as cancer, epilepsy, diabetes, 
heart and respiratory conditions, mental illness, and a range of other 
health conditions, who have alleged discrimination based on such 
conditions, have been turned away at the courtroom door on the grounds 
that they are not sufficiently ``disabled'' to receive legal protection 
under the ADA.\5\ In essence, the courts have required that to be 
covered under the ADA, an individual must be so debilitated by his or 
her impairment that it is difficult for the person to function at all. 
Moreover, if such an individual can take medication or receive a device 
(such as a pacemaker) that will enable the person to function, he or 
she will not be considered ``disabled'' under the ADA. In addition, 
even if an employer refuses to hire an individual expressly because of 
a health condition, this will not be sufficient to claim that the 
employer ``regarded'' the individual as disabled unless the individual 
can also prove that the employer believes many other employers would 
act the same way. The same reasoning that has eliminated legal 
protection under the ADA for individuals with a range of health 
conditions will likely be used to deny coverage under the ADA for 
individuals with predictive genetic information or family histories 
regarding such conditions.
---------------------------------------------------------------------------
    \5\ For a comprehensive discussion of how the ADA's coverage has 
been significantly restricted, see Feldblum, Definition of Disability 
Under Federal Anti-Discrimination Law: What Happened? Why? And What Can 
We Do About It?, 21 Berkeley Journal of Labor and Employment Law 91 
(2000)
---------------------------------------------------------------------------
Predictive Tests Are Not Relevant to Decisions about Health Insurance 
        Coverage
    First of all, the person may not ever manifest the condition. One's 
actual risk depends on interactions with other genes and with the 
environment. There is just so much that we don't know at this time and 
may never know, since we're talking about tremendous levels of 
complexity.
    Second, we don't yet really know the exact level of risk indicated 
by the test results. The meaning of test results will evolve over time 
with longitudinal research that follows participants over their 
lifetime, assessing the interplay with other genes and the environment 
and the actual expression or incidence of the condition. And while the 
current risk percentages reflect scientists' best guesses, this is not 
good enough if the results can be used to deny health coverage and 
employment and disrupt productive lives.
    Third, test results do not translate directly into healthcare 
dollar costs for any one particular person. Everything in medicine 
today is measured in terms of evidence-based and outcomes research and 
cost benefit analysis. However, the use of predictive test results to 
make health insurance decisions doesn't fit this paradigm. Predictive 
tests are not linear, black and white measures of healthcare dollar 
liability for you or me; currently they may have some meaning for pools 
of people, but not individuals. The science is too new and the 
variability of expression for two identical genotypes too great. We 
cannot measure healthcare dollars or future productivity based on 
computations using genetic test results as the yardstick.
    Fourth, it is impossible to lump all predictive tests in one 
category. Health dollars could even be saved through the development of 
preventative treatments that forestall the occurrence of an expensive 
chronic conditions. In the case of hemochromatosis, for example, early 
identification could lead to phlebotomy treatments that stop the 
development of an otherwise insidious, chronic, expensive and possibly 
fatal condition.
    And finally, we all have flawed genes. With so many predictive 
tests already on the radar screen, we will all be at risk for genetic 
discrimination.
The Use of Predictive Tests in Health Insurance Determinations Puts 
        People at Increased Risk for New Social and Medical Harms and 
        Poses New Societal Burdens.
    First of all, the use of predictive tests in health insurance 
determinations impacts individuals and their families in the most 
personal ways--loss of privacy, healthcare, and employment. That is why 
people are choosing not to have genetic tests that could, in some 
cases, save their lives. This was the case with Gail and with countless 
others who choose to safeguard access to healthcare for their families 
by deciding not to risk their employment which provides their health 
insurance. We know that this strategy, while logical, can put the 
individual at medical risk, the family at financial risk, and sometimes 
results in serious, even fatal, health consequences.
    Second, employers may fear hiring or promoting or retaining someone 
whose test results or recommended treatment threatens to raise the 
group insurance rate. We have already seen this happen in the case of 
Terri Seargent who was essentially symptom-free--jogging several miles 
every day--but was fired from her job after her employer learned about 
her positive genetic test results and preventative medical treatment.
    Third, falling public confidence impacts everyone. We're all 
waiting for the benefits of biomedical research. However, without 
nondiscrimination assurances, people will not participate in the very 
studies that could lead to more precise interpretations of ``risk'' 
measures, better understanding about interplay between gene and 
environment and other genes, and the development of preventative 
treatments--sometimes for their own condition.
    Finally, the real measure of genetic discrimination is the 
potential for broad societal impact and burden. If we systematically 
exclude individuals and families from healthcare and jobs on the basis 
of genetic make-up, we are risking the creation of an uninsurable and 
unemployable genetic underclass at enormous public, moral and economic 
cost.
Genetic Alliance Recommends These Core Principles To Guide Policy 
        Decision-Making
 We all possess imperfect genes that will become equally and 
        increasingly transparent with tomorrow's technologies.
 Health insurance and employment in this country are 
        intrinsically linked. Legislation must address genetic 
        nondiscrimination protections in both health and employment. 
        They are inseparable.
 It is important to take a broad view of the implications and 
        impact of predictive genetic test results for individuals and 
        families and for the small business employer.
 Without Federal legislation protections, genetic 
        discrimination will affect increasing numbers of individuals 
        and families and pose unfathomable social harms. The focus of 
        civil rights advocacy in the 21st century will be genetic 
        discrimination.
 Risk-based health insurance may not work in this new genomics 
        age. How can we have a risk-based health insurance system when 
        the meaning of the risks that are being identified through new 
        genetic tests is unknown? The science is literally galloping 
        ahead of our ability to understand this new information. And 
        this distorts the usefulness of information resulting from 
        genetic tests.
Genetic Alliance Advocates for Comprehensive Federal Nondiscrimination 
        Legislation Looking to HR 602 as a Model for Legislation
 Legislation must cover all genetic information--including 
        family history, medical tests and healthcare service records--
        which can be used to predict future health risks in healthy 
        individuals.
 Legislation must ensure that those entities holding genetic 
        information about individuals will not disclose it to third 
        parties without the written permission of the individual.
 Legislation must provide individuals who experience genetic 
        discrimination the right to seek redress through courts of law, 
        with access to meaningful remedies.
 Legislation must prohibit both health insurers and employers 
        from collecting predictive genetic information and from using 
        it to discriminate in the health care system and the workplace.
Opposition to Unwarranted Discrimination in Health Insurance and the 
        Workplace
    Finally, I want to point out that this testimony has focused on the 
hardships faced by those who experience discrimination based on 
predictive genetic information or family histories. However, we urge 
you to consider the fact that if these individuals are eventually 
diagnosed with a medical condition at some future point (whether such 
health conditions are genetically caused or not), they should also not 
be subject to unwarranted discrimination in health insurance and the 
workplace. As noted above, the reason people with predictive genetic 
information cannot rely on the ADA is because their brothers and 
sisters with actual medical conditions cannot rely on the ADA either.
    This is why we can not stop at legislation like HR 602 alone 
without clarifiying the ADA and considering the need for additional 
protective legislation. When a healthy individual tests positive for a 
gene that could cause a condition like Alzheimer's or bipolar disease, 
it is not always clear if signs of that condition have occurred. To 
ensure that people will not be afraid to seek treatment and receive a 
diagnosis, we need to assure them that, if a condition does manifest, 
their access to healthcare and employment will be protected.
Safeguarding the Potential of Genetics to Improve Health.
    Completion of the sequencing of the genome is a wonderful and 
inspiring scientific accomplishment, however it has also accelerated 
the need for universal protections of genetic information that help to 
describe future risks for health and disease. Assurances against the 
abuse of personal genetic information will safeguard our hopes for 
improving public health through new genetics knowledge and 
technologies.
    Congress demonstrated extraordinary vision in funding the mapping 
of the human genome. It requires an equal measure of vision and courage 
to pass the legislation that makes it possible for people to benefit 
from the new tests and technologies and creates a safety net for 
healthcare consumers. Otherwise, the remarkable achievements of the 
Human Genome Project will be rendered meaningless.
    In a country founded on precepts which offer protections against 
discrimination, on the basis of sex, race or religion, we certainly 
have room for perhaps the most basic factor of all--our genes, 
representative of both our shared inheritance and the essence of our 
diversity.
    The Genetic Alliance calls for the unequivocal prohibition of 
genetic discrimination in health insurance and employment, and all 
other aspects of life. Every American--regardless of genetic 
inheritance--is entitled to the protection that Congress alone can 
provide.
    Thank you very much for this opportunity to present testimony on 
this important topic.

    Mr. Stearns. Thank you.
    Dr. Young for your opening statement.

                  STATEMENT OF DONALD A. YOUNG

    Mr. Young. I am Dr. Don Young, Interim President of the 
Health Insurance Association of America. I'm pleased to be here 
today to discuss concerns about the potential genetic 
discrimination in health insurance. HIA is well aware of the 
public apprehension about the use of genetic information in the 
insurance marketplace. At the same time, there's a great deal 
of misinformation about this matter. Nine out of 10 Americans 
with private insurance coverage receive it through the 
employer-based group market in which no information on genetic 
testing or individual health status is used to determine 
eligibility for coverage or to set individual premium rates. 
Further, Federal law already provides significant protections 
to consumers. Under HIPAA, health insurers offering coverage in 
connection with group health plans cannot use genetic 
information or the results of a genetic test to refuse to cover 
employees or their family members, refuse to renew coverage, 
charge covered employees or their family members higher 
premiums, impose pre-existing condition waiting periods or 
cancel coverage. The remaining 10 percent of Americans purchase 
their private insurance through the individual market. Under 
HIPAA, insurance carriers offering coverage in the individual 
insurance market are also subject to substantial restrictions 
on the use of genetic information or the results of genetic 
testing.
    In addition, the majority of States have passed laws to 
protect individuals who undergo genetic testing. Additional 
legislation is unnecessary given current insurer practices. 
Independent research confirms that health insurers are not 
either asking for or using genetic test results in their 
underwriting decisions, even in those States where no genetic 
testing legislation has been enacted.
    Many of the so-called genetic nondiscrimination proposals 
contain definitions of genetic testing that are often 
unnecessarily broad. While they purport to apply to newer 
genetic technologies they frequently sweep in tests and 
information collection practices that have routinely been used 
by insurers for many years to ensure that premiums are fair to 
all purchasers. The result would be to prohibit generally 
accepted principles of the individual insurance market that 
have served consumers well for many decades. Although well 
intentioned, if enacted, these proposals would hurt the very 
people they are intended to help. For many people premiums 
would unfairly rise and as experience resulting from similar 
State laws as clearly demonstrated, many people would not 
purchase individual insurance leading to more uninsured 
Americans.
    We're also concerned about proposals that would apply 
restrictions on the use of genetic information on insurance 
products not covered by HIPAA, such as disability, long term 
care and supplemental insurance. These products are very 
different than medical expense insurance. Individual applicants 
would have the opportunity to favor themselves at the expense 
of other policy holders by making purchase decisions based on 
risk characteristics that are known or suspected by them, but 
unknown to the insurer. Current Federal law including HIPAA 
privacy rules and the Gramm-Leach-Bliley Act also require 
health insurers to protect the confidentiality of personal 
health information including genetic information.
    HIPAA's members are increasingly concerned about the 
multiplicity of Federal and State laws governing the privacy of 
personal health information. It is becoming increasingly costly 
to our customers to comply with all these differing and at 
times conflicting Federal and State requirements. Additional 
requirements specific to genetic information would further 
increase the cost of health insurance without adding to the 
substantial privacy protections now in place. In addition, by 
requiring an artificial segregation of an individual's medical 
record, such requirements could lead to harmful medical errors 
and lost opportunities to provide preventive care and will 
establish a harmful precedent of allowing selective reporting 
by providers.
    Given the emerging nature of the new technologies, the 
importance of the individual market to Americans who cannot get 
insurance through the work place, the already high costs of 
coverage and the demonstrated lack of any abuse by health 
insurers, it is vital that we avoid premature action that would 
undermine access to affordable health care coverage in the 
future.
    It is also important that the public policy debate be 
carried on in a way that does not feed unjustified public fears 
about insurers' use of genetic information and thus discourage 
people who could benefit from these new tests from undergoing 
them.
    I would be pleased to any questions you may have on this 
very important topic.
    [The prepared statement of Donald A. Young follows:]
   Prepared Statement of Donald A. Young, Interim President, Health 
                    Insurance Association of America
Introduction
    Chairman Stearns, distinguished members of the committee, I am Dr. 
Donald A. Young, Interim President of the Health Insurance Association 
of America (HIAA). I am very pleased to be here today to discuss 
concerns about the potential for genetic discrimination in health 
insurance. HIAA is the nation's most prominent trade association 
representing the private health care system. Its more than 300 members 
provide health, long-term care, dental, disability, and supplemental 
coverage to more than 123 million Americans. It is the nation's premier 
provider of self-study courses on health insurance and managed care.
    HIAA is well aware of the fact that there is considerable public 
concern about the potential for genetic discrimination in the insurance 
marketplace. At the same time, we are convinced that there is a great 
deal of misinformation about this matter. In particular, we believe 
that calls for federal legislation to address this issue fail to 
appreciate the extensive array of federal and state laws already in 
place, and the potential negative consequences of additional federal 
requirements. In this regard, it appears that advocates for increased 
government regulation of the private health insurance market often 
overlook the need for the appropriate balance of risk and cost in a 
voluntary health insurance market. I would like to begin by summarizing 
current legal protections against genetic discrimination in the health 
insurance sector and the inappropriate disclosure of genetic 
information.
Current Legal Protections Against Insurance Discrimination
    Current federal law already provides significant protections to 
consumers. Let us first look at group health insurance coverage. Under 
the Health Insurance Portability and Accountability Act of 1996 
(HIPAA), employer-sponsored group health plans and health insurance 
issuers offering coverage in connection with group health plans cannot:

 Refuse to cover employees or their family members based upon 
        genetic information or the results of a genetic test; 
        1
---------------------------------------------------------------------------
    \1\ HIPAA Title I, Subtitle A, Part 1, Section 101 (ERISA Section 
702(a)(1)).
---------------------------------------------------------------------------
 Refuse to renew coverage based upon genetic information or the 
        results of a genetic test; 2
---------------------------------------------------------------------------
    \2\ HIPAA Title I, Subtitle A, Part 1, Section 102 (ERISA 
702(a)(1)) (for individual enrollees); HIPAA Title I, Subtitle A, Part 
1, Section 102 (PHSA Section 2712) (for groups).
---------------------------------------------------------------------------
 Charge covered employees or their family members higher 
        premiums based upon genetic information or the results of a 
        genetic test; 3
---------------------------------------------------------------------------
    \3\ HIPAA Title I, Subtitle A, Part 1, Section 101 (ERISA Section 
702(b)(1)).
---------------------------------------------------------------------------
 Impose pre-existing condition waiting periods upon employees 
        or their family members based upon genetic information or the 
        results of a genetic test; 4 or
---------------------------------------------------------------------------
    \4\ HIPAA Title I, Subtitle A, Part 1, Section 101 (ERISA Section 
701(b)(1)(B)).
---------------------------------------------------------------------------
 Cancel coverage based on genetic information or the results of 
        genetic testing. 5
---------------------------------------------------------------------------
    \5\ HIPAA Title I, Subtitle A, Part 1, Section 101 (ERISA Section 
702(a)(1)).
---------------------------------------------------------------------------
    In highlighting these existing protections, it should be noted that 
about nine out of 10 Americans with private health insurance coverage 
receive it through some type of employer-sponsored 
arrangement.6
---------------------------------------------------------------------------
    \6\ William S. Custer and Pat Ketsche, The Changing Sources of 
Health Insurance, HIAA, December 2000.
---------------------------------------------------------------------------
    HIPAA also speaks to the issue of genetic discrimination in the 
case of individual health insurance coverage. Under HIPAA, insurance 
carriers offering coverage in the individual insurance market cannot:

 Deny coverage to individuals previously covered by employer-
        sponsored group health plans; 7
---------------------------------------------------------------------------
    \7\ HIPAA Title I, Subtitle B, Section 111 (PHSA Section 2741).
---------------------------------------------------------------------------
 Impose preexisting condition waiting periods on such 
        individuals based on genetic information or the results of 
        genetic testing; 8 or
---------------------------------------------------------------------------
    \8\ HIPAA Title I, Subtitle B, Section 111 (PHSA Section 
2741(a)(1)(B)).
---------------------------------------------------------------------------
 Cancel coverage to people covered under individual health 
        insurance policies based on genetic information or the results 
        of genetic testing.9
---------------------------------------------------------------------------
    \9\ HIPAA Title I, Subtitle B, Section 111 (PHSA Section 2742).
---------------------------------------------------------------------------
    These protections are substantial. Nevertheless, Congress was 
extremely careful with the restrictions it placed on the individual 
market for two reasons:

1. The individual insurance market is about one-tenth the size of the 
        group market,10 and families generally purchase 
        individual coverage voluntarily with their own after-tax 
        dollars. Congress was concerned that imposing significant new 
        restrictions on insurers offering policies in the individual 
        market would reduce, rather than expand, coverage in this 
        relatively small and fragile market. The unique and fragile 
        nature of this market has been well documented,11 as 
        have been the unanticipated consequences of prior efforts to 
        ``reform'' this market.12
---------------------------------------------------------------------------
    \10\ The Changing Sources of Health Insurance.
    \11\ American Academy of Actuaries, Risk Classification in 
Individually Purchased Voluntary Health Insurance, February 1999; U.S. 
General Accounting Office, Health Insurance for Children: Private 
Individual Coverage Available, but Choices Can Be Limited and Costs 
Vary, GAO/HEHS-98-201, August 1998; U.S. General Accounting Office, 
Private Health Insurance: Millions Relying on Individual Market Face 
Costs and Coverage Trade-Offs, GAO/HEHS-97-8, November 1996; American 
Academy of Actuaries, Providing Universal Access in a Voluntary 
Private-Sector Market, February 1996.
    \12\ Stephen Zuckerman and Shruti Rajan, ``An Alternative Approach 
to Measuring the Effects of Insurance Market Reforms,'' Inquiry, Spring 
1999, page 44; William S. Custer, Health Insurance Coverage and the 
Uninsured, HIAA, January 1999; Frank A. Sloan and Christopher J. 
Conover, ``Effects of State Reform on Health Insurance Coverage of 
Adults,'' Inquiry, Fall 1998, page 280; Melinda L. Schriver and Grace-
Marie Arnett, Uninsured Rates Risk Dramatically in States with 
Strictest Health Insurance Regulations, The Heritage Foundation, August 
20, 1998; Jill A. Marsteller et al., Variations in the Uninsured: State 
and County Level Analyses, The Urban Institute, June 11, 1998.
---------------------------------------------------------------------------
1. While federal laws predating HIPAA set certain requirements for 
        health benefit coverage in the employer-based market, it 
        traditionally has been the role of the states to regulate 
        insurance in the non-group market.
    In addition to the federal protections outlined above, the majority 
of states have passed laws to protect individuals who undergo genetic 
testing. As a result, insurers that offer policies in the individual 
market are generally limited in their ability to use genetic 
information in risk classification and risk selection.
Current Health Insurer Practices
    A recent Public Policy Monograph issued by the American Academy of 
Actuaries notes that private health insurers do not require applicants 
for insurance to undergo genetic testing or use genetic testing to 
limit coverage for preexisting conditions.13 Similarly, a 
survey conducted in 1998 found that no HIAA member company requires 
applicants to undergo genetic testing in determining whether to offer 
or renew major medical coverage, and that our members had no plans to 
do so. In addition, the survey found that member companies do not 
exclude coverage for certain benefits or establish differentials in 
premium rates or cost-sharing for coverage on the basis of genetic 
information. Independent research confirms this--health insurers are 
not ``either asking for or using presymptomatic genetic test results in 
their underwriting decisions,'' even in states where no genetic testing 
legislation has been enacted.14
---------------------------------------------------------------------------
    \13\ American Academy of Actuaries, Genetic Information and Medical 
Expense Insurance, June 2000.
    \14\ Mark A. Hall and Stephen S. Rich, ``Laws Restricting Health 
Insurers' Use of Genetic Information: Impact on Genetic 
Discrimination,'' American Journal of Human Genetics, January 2000, p. 
293.
---------------------------------------------------------------------------
Current Privacy Protections
    Some pending genetic nondiscrimination proposals include provisions 
that would impose special confidentiality requirements regarding 
genetic discrimination. Once again, however, current federal law 
already speaks to the confidentiality of personal health information, 
including genetic information. For example, the preamble to the HIPAA 
privacy rule, published December 28, 2000, specifically notes that 
genetic information is included in the term ``protected health 
information'' and subject to sweeping new requirements governing the 
use and disclosure of health information by health plans; health care 
clearinghouses; and doctors, hospitals, and other health care 
providers. In addition, the Gramm-Leach-Bliley Act (GLBA), enacted 
November 12, 1999, requires health insurers and other covered financial 
institutions to protect the privacy of nonpublic personal information. 
In the case of insurers, the statute delegates the enforcement of these 
requirements to state insurance authorities, and states are now 
considering legislative and/or regulatory responses to GLBA. 
Furthermore, the National Association of Insurance Commissioners has 
adopted a model regulation to guide state policy makers in complying 
with GLBA's privacy requirements.
    I should note that HIAA's members are increasingly concerned about 
the multiplicity of federal and state laws governing the privacy of 
personal health information. It is becoming increasingly costly for our 
members to sort through and comply with all of these vary requirements, 
especially when an insurer does business in a large number of states. 
This cost ultimately is borne by consumers in the form of higher 
premiums. It is for this reason that HIAA has called for federal 
preemption in the case of privacy requirements. For purposes of this 
hearing, suffice it to say that HIAA strongly opposes additional 
federal requirements that would uniquely govern the privacy of genetic 
information. This would only further complicate an already difficult 
situation. HIAA member companies believe it is important to treat all 
medical information--including genetic information--equally to assure 
strong and uniform confidentiality protections. In this regard, I think 
it is important to note that health insurers have an excellent track 
record of processing literally hundreds of thousands of information 
transactions daily, with virtually no violations of patient 
confidentiality.
    One final point is in order. It is increasingly critical that 
providers in an integrated system share health information and 
communicate about such information in order to treat patients 
effectively and avoid harmful medical errors. Genetic information, 
including the results of predictive genetic tests, is an integral and 
inextricable part of the medical record of each patient. This 
information can and should be used by providers and health plans to 
ensure that prevention--often the most effective type of care--is 
provided. Early detection, identification, and treatment are often 
critical to success. In addition, as the technology of genetic testing 
becomes more sophisticated, health professionals will need to know the 
results of genetic tests to avoid harmful medical errors. To require 
genetic information to be segregated and kept ``private'' in an effort 
to avoid the perceived risk of discrimination would thus be contrary to 
the best interests of the patient.
                             hiaa concerns
    Given current federal and state restrictions on the use of genetic 
information in the health insurance sector, HIAA opposes additional 
legislation in this area. We have a number of concerns regarding such 
proposals.
Individual Health Insurance
    HIAA is concerned about genetic nondiscrimination proposals that 
are at odds with the fundamental principles of the individual health 
insurance market and go beyond the restrictions imposed by HIPAA. In 
the individual health insurance market, each person must decide whether 
or not to participate based on the perceived value of coverage, i.e., 
the relationship of the premium they must pay to their perception of 
their risk of loss. In this market, risk selection (whether or not to 
accept an application for insurance and issue a policy) and risk 
classification (ensuring that the policy provisions and premiums 
charged are consistent with the level of risk involved)--together known 
as underwriting--are important for consumers and health insurers alike. 
For consumers, underwriting ensures fairness among purchasers of 
insurance since their premium reflects the likelihood of needing health 
care services. In addition, underwriting protects the solvency of the 
insurance program, making it possible for the insurer to fulfill the 
promise to pay claims as they become due. No less important, 
underwriting helps stabilize and hold down premiums by avoiding the 
effects of adverse selection. For insurers, underwriting protects the 
insurer's financial health by allowing premiums to be set at a level 
commensurate with the expected level of claim cost. This financial 
health is necessary to ensure ongoing operations and the continuing 
ability to develop and market new products. In short, both consumers 
and insurers benefit when the insurance system can offer financially 
sound, competitively priced products to a broad range of 
consumers.15
---------------------------------------------------------------------------
    \15\ Risk Classification in Individually Purchased Voluntary Health 
Insurance.
---------------------------------------------------------------------------
    In enacting HIPAA, Congress expressly, and wisely, refused to 
impose federal price controls, or to extend additional guarantee issue 
requirements, to individual insurance products. Such controls and 
requirements would impede the ability of insurers to engage in 
legitimate risk assessment activities that are necessary to set 
premiums commensurate with actual risk. Laws prohibiting insurers from 
accurately weighing the risks of offering coverage at a certain price 
in the individual insurance market--for example, by proscribing the use 
of information on health status--would compromise the ability of 
insurers to remain financially viable and to meet their obligations to 
existing policyholders. States that have enacted guaranteed issue and 
some form of community rating in their individual health insurance 
markets have experienced significant increases in the price of 
indemnity insurance options, and are seeing a drop in the number of 
people covered in the individual market. For example, following the 
adoption of community rating and guaranteed issue in New Jersey in 
1993, average rates for the most popular individual indemnity health 
plans rose to more than double the national average of rates for 
similar coverage. During 1996 alone, the number of people with 
individual coverage in the state declined 17.2 percent, and the number 
of families covered declined 37 percent.
    To sum up, in a voluntary, individual insurance market, 
restrictions on the ability of insurers to evaluate applicants and 
charge appropriate premiums will simply result in higher average 
premiums and fewer consumers purchasing coverage. At a time when more 
than 42 million Americans lack health insurance, this would certainly 
not be a very prudent course of action.
HIPAA ``Excepted Benefits''
    HIAA also is concerned about proposals that would apply 
restrictions on the use of genetic information on insurance products 
not covered by HIPAA, such as disability, long-term care, and 
supplemental insurance. Disability income, long-term care, supplemental 
insurance and other HIPAA excepted benefits are commonly purchased by 
individuals--much more frequently than is the case for comprehensive 
medical expense insurance. In general, these insurance products are 
also held for longer periods of time, and are more sensitive to biased 
or adverse selection based on long-term health prospects. Consequently, 
restrictions on risk selection and risk classification would be much 
more detrimental for these types of coverage.16
---------------------------------------------------------------------------
    \16\ American Academy of Actuaries, Risk Classification in 
Voluntary Individual Disability Income and Long-Term Care Insurance, 
Winter 2001.
---------------------------------------------------------------------------
    While there appears to be considerable concern about the potential 
for insurers to discriminate against consumers based on genetic 
information, there appears to be a conspiracy of silence regarding the 
potential for individual consumers to use genetic information in a way 
that disadvantages insurers and their other policyholders. The 
potential for such ``biased selection'' or ``adverse selection'' is 
especially a risk in the case of insurance products that are 
voluntarily purchased by individuals, who can choose the timing of 
their insurance purchase, as well as the extent and duration of 
coverage. In these cases, individual applicants have the opportunity to 
make decisions that favor themselves at the expense of the insurance 
program by making purchase decisions based on risk characteristics that 
are known or suspected by them but unknown to the insurer. If the 
insurer is unaware of a risk characteristic, it cannot be reflected in 
the premium charged, and applicants with that characteristic will on 
average contribute less to the insurance pool than they receive from 
it. Without the ability to properly assess the risk, insurers would see 
more and more high cost individuals purchase coverage at an average 
premium level. As this occurred, premiums would rise for all 
policyholders, some of which might find that the value received for 
their premiums no longer justified continued coverage.
    Of course, biased or adverse selection is not necessarily an 
intentional deception on the part of the consumer. It can also occur if 
the insurer fails to inquire about a health condition, or is prohibited 
from doing so. In any case, this situation would be akin to one in 
which you had a test that would indicate how likely it is that a fire 
would occur in your home and used that information to time the purchase 
of fire insurance.
Definitional Problems
    Another problem arises with proposed definitions of such terms as 
``genetic test'' and ``genetic information,'' which are often 
unnecessarily broad. While these definitions purport to apply to newer 
genetic technologies, they frequently sweep in tests and information 
collection practices that have been routinely used by insurers for many 
years, especially in the individual health insurance market. For 
example, some proposals define the term ``genetic information'' in a 
way that includes information gathered when asking about an 
individual's family history. Similarly, some proposals include a 
definition of ``genetic test'' that could be construed to include 
routine tests such a blood pressure reading, even including ``the 
analysis of . . . phenotypes,'' which would include almost any 
observable characteristic of an individual. In fact, Dorland's 
Illustrated Medical Dictionary defines phenotype to include ``the 
entire physical, biochemical, and physiological makeup of an individual 
as determined both genetically and environmentally.''
    Furthermore, while some proposals provide a ``safe harbor'' for 
routine laboratory tests, the language used may not be adequate. This 
safe harbor language is often circular, only protecting those tests to 
the extent they do not constitute ``genetic tests'' as defined by the 
bill. It is unclear how a safe harbor excludes anything from the scope 
of ``genetic tests'' if it does not apply to genetic tests. In any 
event, the current definitions are unnecessarily vague and seem likely 
to encourage litigation.
    The American Academy of Actuaries monograph cited earlier 
summarizes the problematic nature of overly broad definitions as 
follows:
          If a ban on information obtained from ``genetic tests'' 
        defines such tests to include medical history, routine physical 
        examinations, and other routine laboratory testing, it would 
        severely hamper individual medical expense insurance 
        underwriting. Since some individuals' health risks would be 
        unknown, the pool of insurance purchasers might soon include a 
        disproportionate number of people with higher-than-average 
        anticipated medical expenses. This biased selection would cause 
        premium rates to rise, making individual medical expense 
        insurance even less affordable than it is now.17
---------------------------------------------------------------------------
    \17\ Genetic Information and Medical Expense Insurance.
---------------------------------------------------------------------------
Evolving Technology
    It is important to remember that genetic technology is still 
evolving and we do not know what its ultimate capacity or impact on 
society will be. Given the demonstrated lack of use of genetic 
information and existing legal protections, HIAA believes it would be 
premature at this time to enact additional legislation, locking-in 
certain legislative parameters in the face of the rapid evolution of 
these genetic technologies.
Conclusion
    In conclusion, HIAA opposes federal legislation intended to 
prohibit discrimination based on the use of genetic testing or genetic 
information because:

 It is overly broad, covering information on current health 
        status that insurers have used for many years. Even where a 
        particular proposal includes a ``safe harbor'' for routine 
        laboratory tests, the language used is circular in nature or 
        unduly vague.
 It is unnecessary given current federal and state laws, 
        including those governing the confidentiality of personal 
        health information.
 It is unnecessary given current insurer practices.
 It could restrict the ability of insurers to set appropriate 
        premiums and would be unfair to many consumers, who would be 
        forced to give up their individually purchased insurance.
 It could inappropriately restrict an insurer's ability to 
        assess and select risk for individual insurance products or 
        HIPAA ``excepted benefits.''
 It would be risky to lock-in certain legislative parameters 
        given the rapidly evolving field of genetic testing.
    The public sensitivity about the use of genetic information is 
understandable, given that genetic technology is new and unfamiliar. 
However, insurer use of genetic information is subject to the same 
restrictions as is any other type of personal health information. 
Independent research confirms that individuals are not being denied 
access to coverage based on genetic test results. Given the emerging 
nature of the new technologies, the fragility of the individual market, 
the high cost of coverage, and the demonstrated lack of any abuse by 
health insurers, it is vital that we avoid premature action that would 
undermine access to affordable health care coverage in the future. It 
is also important that the public policy debate be carried on in a way 
that does not feed unjustified public fears about insurers' use of 
genetic information and thus discourage people who could benefit from 
these new tests from undergoing them.

    Mr. Stearns. Thank you.
    Dr. Venter, for your opening statement.

                  STATEMENT OF J. CRAIG VENTER

    Mr. Venter. Good afternoon. My name is Craig Venter. I'm 
the President and Chief Scientific Officer of Celera Genomics, 
headquartered just up the road in Rockville, Maryland. Chairman 
Stearns, members of the subcommittee, thank you for this 
opportunity to testify on behalf of myself and the 
biotechnology organization of which Celera is a member. If you 
have no objections, I would like to insert my written comments 
into the record and make a brief opening comment.
    Mr. Stearns. By unanimous consent, so ordered.
    Mr. Venter. Thank you. I'd also like to start by thanking 
Congresswomen Slaughter and Morella for their tremendous 
leadership on this issue and speaking out so well on it.
    I'm a scientist who has been at the forefront of the 
genomic revolution and like many of my colleagues in the 
private industry and public genome project, I'm concerned about 
the misuse of genetic information. With the dawn of a new era 
of medicine and science, now that we have sequenced and 
assembled the nearly 3 billion letters of the genetic code that 
make up the human genome, I believe this basic knowledge that 
we're providing to the world will have a profound impact on the 
human condition and treatments for disease and our view of 
ourselves in the biological continuum. However, one of my 
continuing concerns is about having this information, is that 
someone would want to use this knew knowledge as a basis of 
discrimination.
    Much has happened in the 3 years of Celera's history when 
the PE Corporation, now Applera and I launched Celera in June 
1998 our goal was to sequence the humane genome and build an 
information company to provide researchers in industry and 
academia with new information for genomic discoveries. Today, 
we're using that information in a massive effort to understand 
the products of our genes, proteins that go into build a new 
kind of pharmaceutical company that will incorporate all this 
new information and technologies for faster, cheaper 
therapeutic discoveries. We've seen major changes in the last 3 
years.
    Just 1 year ago, Francis Collins and I--Francis is the head 
of the public funded genome effort at NIH--stood before the 
world at the White House with President Clinton to announce our 
respective progress on the human genome. We both individually 
selected to talk about genetic discrimination as the biggest 
concern for the future of research in this field. In fact, a 
CNN-Time poll conducted that morning reported that 46 percent 
of Americans believe that the impact of the human genome 
project would be negative.
    Most are pleased that President Bush has recently voiced 
his concerns about genetic discrimination and to do something 
about it.
    Clearly one of the ways we can combat this fear is through 
higher science literacy, but education, while important, can 
only do so much. I believe that new laws are critical in order 
to maximize the medical benefits from new genomic discoveries, 
in part, from misunderstandings about what these discoveries 
can lead to.
    Sequencing the human genome showed us that there were fewer 
genes than earlier estimates. The fewer genes means more 
complexity, not less. This shows that we're clearly much more 
than the sum totals of our genes, just as society is greater 
than the sum total of each of us. Biology is not based on the 
idea that there is one gene, one protein, one disease. Our 
physiology is based on the complex, seemingly infinite 
interactions amongst all our genes and the environment, just as 
our civilization is based on the interactions amongst all of 
us.
    This information should help dispel the notion of genetic 
determinism. There's a tendency to think of DNA as the perfect 
predictor of an individual's future health. Many years of work 
in genomics has taught me one must discuss the genomic context 
of the environment. I do not believe the human condition can be 
seen as merely a manifestation of individuals DNA sequenced 
information and that computation that goes with such sequenced 
information. Individuals need to be assured that arbitrary 
subjective conclusions will not be based on the analysis of 
their DNA.
    It's ironic that approximately 1 week prior to Celera's 
publication of the human genome, an event that should have 
given all of us great joy and optimism for the future, an 
agency of the U.S. Government, EEOC had to go to court for the 
first time to block a private employer from compelling its 
employees to submit to genetic testing for work-related 
injuries, in this case, carpal tunnel syndrome, on the threat 
of dismissal for noncompliance.
    It was clear that this was just bad science as well as bad 
policy showing that discrimination is not based on fact. It's 
usually based on ignorance.
    We sometimes hear the following question, why should in the 
insurance company not be allowed to use tests or information 
from an individual's genome, DNA, in making its decisions? 
Don't they already do things with high blood pressure or 
smoking? In response, it's important to note that DNA is not 
like other tests. An individual's DNA is, in a sense, the 
ultimate personal identifier and from a technical point of view 
there's virtually no limit to what one's examining DNA can lead 
to once a sample goes to a testing lab.
    Some individuals clearly fear that use of such tests will 
affect their livelihoods and standing in the community. 
Moreover, other family members, because they share a certain 
amount of DNA, may be affected by the decision without their 
consent or even knowledge.
    I'm excited by the promise that the genomic era in science 
and medicine brings. We are working at Celera to turn this 
information into new diagnostics and new therapeutics so people 
can benefit directly from this information. We all need to work 
together to ensure that fear does not inhibit people from 
taking advantage of these new discoveries. I, along with BIO, 
urge Congress to draft carefully worded legislation that would 
prohibit discrimination in health insurance based genetic 
discrimination and testing.
    Thank you.
    [The prepared statement of J. Craig Venter follows:]
 Prepared Statement of J. Craig Venter, President, Celera Genomics, on 
        Behalf of The Biotechnology Industry Organization (BIO)
    Mr. Chairman and members of the Subcommittee, thank you for the 
opportunity to testify today about this critically important topic.
    Good afternoon. My name is Craig Venter. I am President and Chief 
Scientific Officer of Celera Genomics, headquartered in Rockville, MD. 
In August of 1998, the PE Corporation, now known as the Applera 
Corporation, and I launched Celera Genomics. Our initial goal was to 
sequence the human genome and to build an information business to 
provide researchers in industry and academia with an integrated 
information and discovery system for genomic information. Today we are 
using that information and an industrial scale effort to understand the 
products of our genes--proteins--to build a new kind of therapeutic 
company that will integrate genomic, proteomic and genetic variation 
information together with new technologies for faster and cheaper 
disease-related discoveries. I am testifying on behalf of myself and 
the Biotechnology Industry Organization (BIO). BIO represents almost 
1000 biotechnology companies, academic institutions, state 
biotechnology centers and related organizations in all 50 U.S. states 
and 33 other nations.
    We have all been dazzled over the past few years at the pace of 
scientific discovery. At Celera we are very proud of our role in 
sequencing the human genome and the mouse genome. That was just the 
beginning. Using this information, even more will become known about 
how our bodies develop, function, and change.
    This information will be enormously powerful. Armed with these 
data, scientists will be able to identify the biological basis of 
disease.
    Understanding the function of genes in key cellular processes has 
become an important basis for creating new drugs and therapies. This 
information could, for example, tell us how and why certain diseases 
afflict certain people. It could also tell us why certain medications 
are safe and effective for some people, but cause adverse reactions or 
are ineffective for other people with the same diagnosis. This 
information could lead to the development of cures and treatments for 
diseases that affect tens of millions of Americans and their families.
    The results of this research are likely to be a more 
``personalized'' medical paradigm than exists today. Drugs and 
therapies are likely to be more targeted as we learn more about the 
impact and role of genes. While medicine will become more 
individualized based in part on the genetic code it will be based on 
statistical information in contrast to deterministic information. I 
believe, as does BIO, that this new paradigm is likely to be extremely 
effective in improving the lives of millions of Americans and their 
families.
    We are on the verge of a true revolution in medicine. But there is 
a chance it will not happen as we hope. It will not be a failure of the 
science. There is increasing evidence people fear their genetic 
information will be used to deny them health insurance or a job. This 
fear is keeping them from seeking medical help. If people believe that 
a new system of individualized medicine will lead to denial of health 
insurance or other benefits, they will not take advantage of what the 
new system could offer. The revolution at hand may not be realized 
because people are afraid to take part in it.
    BIO has long supported federal legislation aimed at alleviating 
these fears. At Celera we started the push for legislation on genetic 
discrimination long before we announced the first assembly of the human 
genome. People must have confidence they can take advantage of 
technological developments without fear that the information gained 
from this technology will be used against them.
    Mr. Chairman, we want to encourage people to get information about 
their health and take necessary steps to improve their lives.
    BIO, as I have in the past, supports national legislation to ensure 
that individuals' personal medical information, including genetic 
information, is safeguarded against misuse. For example, BIO strongly 
supported barring discrimination on the part of group health plans 
based on ``genetic information'' during congressional consideration of 
the Health Insurance Portability and Accountability Act (HIPAA). We 
must assure the public that the great promise of biotechnology research 
will not be tarnished by abuses of this technology. I am proud of the 
fact that BIO worked effectively in 1996 to secure enactment of an 
amendment to HIPAA that provided these important protections against 
discrimination by health insurance companies based on ``genetic 
information'' about the individual. But HIPAA does not cover the 
individual insurance market. On behalf of BIO and myself I believe 
these protections should be expanded to this market.
    BIO has also consistently supported federal legislation--and now 
regulations--that create federal standards to protect the 
confidentiality of, and safeguard against misuse of, all personal 
medical information including genetic information.
    With the implementation of the HIPAA medical privacy regulations, 
individuals have much greater assurance that genetic information 
created and used in the health care context will not be disclosed to 
employers, insurance companies or other third parties without the 
specific authorization of the individual. Protecting individuals from 
the misuse of this information--genetic discrimination--is 
complimentary to HIPAA regulations that make the information harder to 
get.
    As with most complex issues, however, as Congress debates 
legislation to protect individuals from genetic discrimination, there 
are other critical issues to consider. Please keep the following issues 
in mind:

 In legislating to prevent genetic discrimination be careful 
        not to restrict biomedical research
 Leave the debate about price controls for another day
 Use updated definitions
Promote Critical Biomedical Research
    As noted, BIO believes that individuals' personal medical 
information must be safeguarded against misuse. While we must protect 
patients' rights, however, it is critical to allow important medical 
research to go forward. We are already beginning to see the results of 
biomedical research. As of today, 117 biotech products have helped a 
quarter billion people worldwide. Another 350 biotech medicines 
targeting more than 250 diseases are in late stage development. These 
products target unmet medical needs.
    Mr. Chairman, BIO and I believe protecting patients and promoting 
critical research are mutually attainable goals. Federal policy must 
ensure the achievement of both.
    Health researchers often use and share health care information, 
including genetic information. Therefore, federal policy must not 
impose barriers to use of these data. Consequently, any federal 
proposal to prohibit genetic discrimination must be carefully written 
to ensure that research uses of information are not inhibited.
Price Controls
    Just as BIO cannot support price controls on products of its 
members, it has concerns about federal legislation that would regulate 
the price of insurance products.
Update Definitions of Key Terms
    Genetics is a new and dynamic field. By legislating on genetic 
discrimination, Congress is charting new territory. Whatever action 
Congress takes will have large ramifications. Future regulations and 
legislation--at the federal and state levels--are likely to be based on 
this proposal.
    As Congress addresses this complex issue, therefore, it is 
essential that it draft legislation carefully define terms such as 
``genetic information''.
Conclusion
    In sum, genetic information is extremely valuable. Armed with the 
information these technologies will provide, patients could make 
lifestyle and medical care choices that would have otherwise been 
unavailable. In addition, the knowledge gained by research used to 
develop new tests and the information gleaned from those tests will 
lead to new drugs and therapeutics to treat disease and maintain 
health.
    However, public anxiety could limit its potential. BIO and I have 
long supported federal legislation that will ensure that a person's 
individual medical information, including genetic information, cannot 
be misused. Consequently, we support carefully drafted legislation 
prohibiting discrimination in health insurance based on genetic 
information.
    Thank you for the opportunity to testify today. I'll be happy to 
answer any questions you may have.

    Mr. Stearns. I thank you.
    Dean Rothenberg, welcome, for your opening statement.

                STATEMENT OF KAREN H. ROTHENBERG

    Ms. Rothenberg. Thank you. Good afternoon, Chairman Stearns 
and members of the subcommittee. It's a pleasure to be here 
today and it's always a challenge to go last because if you 
have to listen very carefully to what everybody said before you 
and second to the questions and then decide that everything you 
wrote may not be exactly on point or has already been said. So 
if I can also ask permission I will put my statement into the 
record.
    Mr. Stearns. By unanimous consent, so ordered.
    Ms. Rothenberg. Thank you. And I thought maybe talk a 
little bit more informally trying to address, if I might, some 
of the points that are already made and some of the questions 
that have already been asked.
    I've been asked, I think, specifically, to focus on the 
legal and public policy implications. Prior to being Dean and 
I'm hoping to continue in this area for many years I was 
running the law and health care program and the University of 
Maryland and for the last 7 years we have been doing research 
and scholarship on the ethical, legal and social implications 
in genetics, in particular, studying various State and Federal 
approaches to issues of genetic privacy and discrimination, 
both in the insurance and employment context. And there's two 
good studies over here or maybe they left, the Congresswomen 
and a number of Members of Congress who have expressed a lot of 
interest in this area, including the chairman who has really 
been a leader as well.
    Mr. Stearns. Thank you.
    Ms. Rothenberg. Based on these experiences then I thought 
what I could do is to put into context first where we are at 
the State level, so we know what we need to do, if anything, at 
the Federal level, then give you a little bit of perspective of 
where we are with HIPAA from my perspective, and where we are 
with the HHS privacy rules so then we can figure out what, if 
anything, we still need to do and then make some suggestions of 
where I think we may at a Federal level need to go as a matter 
of public policy.
    But before going to the details, the very first question is 
do we need to worry specifically about genetics? And I think 
there's been a lot of debate about is it any different than 
medical information, what is it that's special. I think that we 
could argue with the scientists about whether it's any 
different or not than other sorts of medical information, but 
as a social issue in our society it is different. And that's 
because we've had a history of discrimination based on genetics 
that goes back many, many years. And many of us are still alive 
to remember it. Some of us didn't remember it, but it's still 
in our memory. And two, the other thing about genetic 
information as stated earlier, it isn't just information about 
us. It's information about our blood relatives, some of them 
that we might not even have relationships with, but it goes 
into the future and continues into the future.
    So with those two points I think it is special enough for a 
number of States now up to 40 to have actually passed anti-
discrimination and privacy integrated approaches to dealing 
with problems in both the health insurance and the employment 
arena. And of the 18 members on your subcommittee, I'm proud to 
say that in 15 of those States including the chairman's, there 
is legislation on the books and they vary to some degree, but 
every one of those State laws has an integrated approach that 
includes provisions of both anti-discrimination and privacy 
protections.
    Now before we're patting ourselves on the back that, in 
fact, we've solved it in up to 40 States and we only need to 
worry about the 10 that haven't yet passed a law, it's 
important to know that up to one-third of the population in 
those States would not be protected by those laws because they 
are covered through ERISA self-funded plans and the ERISA pre-
emption does not allow State laws to kick in. So we have a 
patchwork of approaches State by State and we have an ERISA 
pre-emption which prevents a number of people in each of those 
States from being protected. Again, it's very deliberate that 
they, in fact, have both anti-discrimination and privacy 
protections integrated.
    Now let's look at HIPAA just for a minute. HIPAA was a 
great and significant step forward as a matter of public 
policy. Now why was that? One, it was significant because it's 
the first piece of legislation that used the term genetic 
information. I mean it recognized that there is something about 
genetic information that might need some special protection. 
And as stated by the chairman, it specifically dealt with 
discrimination and eligibility and in premiums and continuing 
eligibility. I think Dr. Young mentioned that as well. But 
something else was really significant as a matter of social 
policy that you did with HIPAA and that is that you said that 
genetic information will not be deemed a pre-existing condition 
in the absence of the diagnosis of the condition. Now what does 
that mean and why is that so important? What that says is if 
you have a positive test, a predictive test for let's say 
BRCA1, for example, you're not sick. You don't have a pre-
existing condition. So if 10 months later, you develop breast 
cancer they can't hold coverage from you because you had a pre-
existing condition. So as a matter of social policy, the 
chairman and his colleagues said you should not be 
discriminated against or not be deemed sick and I think that is 
very significant as a matter of public policy. The problem is 
that HIPAA in itself still has a lot of gaps. I think my time 
is running out, but I can conclude at this point and we can 
come back to that.
    Mr. Stearns. We can come back to that.
    Ms. Rothenberg. Thank you.
    [The prepared statement of Karen H. Rothenberg follows:]
   Prepared Statement of Karen H. Rothenberg, Dean and Marjorie Cook 
         Professor of Law, University of Maryland School of Law
    Good afternoon, Chairman Stearns and members of the Subcommittee. 
It is a pleasure to be here today. I am Karen H. Rothenberg, the Dean, 
Marjorie Cook Professor of Law, and the founding Director of the Law & 
Health Care Program at the University of Maryland School of Law. I have 
been working for the last seven years on issues directly related to 
genetic testing and its legal, ethical and social implications, and I 
have written numerous publications on genetics and related legal issues 
in health care. Over the last few years I also contributed to a series 
of studies on legislative approaches to genetic information in both 
health insurance and workplace contexts which were published in 
Science.
    My remarks will focus on the legal, ethical, and public policy 
implications related to the potential for discrimination in health 
insurance based on predictive genetic testing. Toward this goal, I will 
first examine whether genetic information is different than other types 
of medical information and whether it requires a special public policy 
approach. I will then examine what role legislative approaches may play 
in addressing the use, misuse, and privacy of genetic information, 
particularly in the health insurance context. I will conclude that 
effective genetic nondiscrimination legislation requires a 
comprehensive approach, including strong privacy protections and 
enforcement mechanisms, at the federal level.
    Genetic information is personal, powerful, predictive, pedigree-
sensitive, permanent, and prejudicial. As a result, it is information 
people commonly wish to keep private, although DNA databanks and 
computer technologies make protecting people's privacy increasingly 
difficult. Most individuals expect that all medical information should 
be protected. The potentially harmful risks associated with genetic 
information may demand that we pay special attention to its use, misuse 
and privacy.
    While most Americans are optimistic about the use of genetic 
information to improve health, many are concerned that genetic 
information may be used by insurers and employers to deny, limit or 
cancel their health insurance. This concern is affecting the choices 
individuals make about their own health care and their decisions 
whether to participate in research. In a Time/CNN poll conducted in 
June, 2000, 75% of those polled indicated they would not want their 
health insurance company to have information about their genetic code.
    Genetic information has implications not only for the individual, 
but also for his or her blood relatives, including parents, siblings, 
cousins and future offspring. Thus, the intergenerational impact of 
genetic information (and inheritability) makes the risk for misuse, 
including stigma and discrimination, significant and unique. Genetic 
information may be linked to certain ethnic and racial groups, many of 
whom have suffered from discrimination and eugenic policies that 
historically were ``justified'' by genetic findings. For example, 
restrictive immigration laws against Eastern Europeans in the 1920s, 
sterilization policies, Nazi atrocities, and insurance and employment 
discrimination against carriers of the sickle cell trait were justified 
by the power of genetic information. Even the discovery in the mid-90s 
of specific gene mutations that may be associated with higher rates of 
breast and ovarian cancer in the Ashkenazi Jewish community has raised 
concerns about how this information may be used to discriminate against 
them. The African American and Indian communities are also very 
concerned about behavioral genetic studies on violence and alcoholism.
    An individual's genetic makeup is unique and cannot be altered. 
Even though a predictive test result is not a diagnosis, it is still 
powerful information and there is risk for misinterpretation by both 
providers and patients. People may believe that their fate is 
predetermined genetically and there is nothing they can do to change 
it.
    The fear of genetic discrimination in the health insurance context 
is a reality. It is argued that individuals who might otherwise choose 
genetic testing will decline it based on their fear that they or their 
family members will not be able to obtain or maintain health insurance 
coverage. As a result, the future of research on the benefits and risks 
of testing for genetic conditions, including susceptibility to such 
common diseases as cancer and heart disease, may also be inhibited. 
Thus, now that the mapping of the human genome has been accomplished 
and as new genetic tests emerge, policy makers need to evaluate the 
development of legislative and regulatory strategies to address these 
concerns.
    In the 1970s, a few states began to pass legislation that addressed 
genetics issues recognizing even then the potential for discrimination. 
North Carolina, for example, passed legislation prohibiting health 
insurers from refusing to issue insurance or charging higher premiums 
based on the sickle cell trait or hemoglobin C trait. By 1991, a new 
generation of state legislation began to evolve with the passage of a 
Wisconsin law prohibiting health insurers from:

 requiring or requesting an individual or a member of the 
        individual's family to obtain a genetic test;
 requiring or requesting directly or indirectly into the 
        results of a genetic test;
 conditioning the provision of insurance coverage or benefits 
        on genetic testing; or
 considering genetic testing in the determination of rates.
    This approach attempts to integrate protection against 
discrimination in insurance practices, coverage, benefits, and rates 
with some privacy protection for the individual and his/her family. 
Similar approaches have been incorporated to varying degrees in 
legislation passed in 39 other states. Conversely, a dozen states have 
no legislative protections in place regarding health insurance. In 
fact, of the 18 states represented by the members of this subcommittee, 
three states have no legislation that addresses genetic 
nondiscrimination in health insurance. As for the 38 states with 
legislation in this area, the states vary regarding the substance of 
the protections they afford. This creates a patchwork of protections 
within our nation.
    The development of public policy to address genetic information and 
health insurance must be analyzed in the context of a complex and 
inadequate health insurance system, the uncertainty about the future 
scope and impact of genetic testing, and the political realities of a 
pluralistic society. The current patchwork of state legislative 
approaches does not provide a comprehensive solution to genetic 
discrimination and health insurance.
    Just a few years ago, with the exception of a few states, these 
laws focused narrowly on genetic tests, rather than more broadly on 
genetic information generated by family history, physical examination, 
or the medical record. Now the trend is to include family history into 
the definition of genetic information. Meaningful protection against 
genetic discrimination requires that insurers be prohibited from using 
all information about genes, gene products, or inherited 
characteristics to deny or limit health insurance coverage.
    Second, a large proportion of the population receives health 
benefits from self-funded plans not subject to state insurance laws. 
The federal ERISA preemption prevents a statewide approach to 
regulating the use of genetic information by all plans providing health 
benefits.
    With these policy considerations in mind, as early as 1995 the 
following recommendations were developed by the National Action Plan on 
Breast Cancer (NAPBC) and the Working Group on Ethical, Legal and 
Social Implication of the Human Genome Project (ELSI) for both state 
and federal policy makers to protect against genetic discrimination:

1. Insurance providers should be prohibited from using genetic 
        information, or an individual's request for genetic services, 
        to deny or limit any coverage or establish eligibility, 
        continuation, enrollment or contribution requirements.
2. Insurance providers should be prohibited from establishing 
        differential rates or premium payments based on genetic 
        information, or an individual's request for genetic services.
3. Insurance providers should be prohibited from requesting or 
        requiring collection or disclosure of genetic information.
4. Insurance providers and other holders of genetic information should 
        be prohibited from releasing genetic information without prior 
        written authorization of the individual. Written authorization 
        should be required for each disclosure and include to whom the 
        disclosure would be made.
    The recommendations further provide that genetic information be 
defined as ``information about genes, gene products, or inherited 
characteristics that may derive from the individual or a family 
member.'' Insurance provider is defined as ``an insurance company, 
employer, or any other entity providing a plan of health insurance or 
health benefits including group and individual health plans whether 
fully insured or self-funded.'' These recommendations remain valid 
today.
    As you know, in the last few years, a number of members of the 
Senate and the House have taken a leadership role in introducing 
federal legislation that integrates these recommendations. Although 
none of these proposals have passed, they have influenced other health 
insurance legislation. The Health Insurance Portability and 
Accountability Act of 1996, or HIPAA, specifically prohibits a group 
health insurance plan from using ``genetic information'' to establish 
rules for eligibility or continued eligibility. It also provides that 
genetic information shall not be treated as a preexisting condition 
``in the absence of the diagnosis of the condition related to such 
information.'' Thus, a healthy woman who tests positive for a BRCA1 
mutation would not be deemed to have a pre-existing condition related 
to breast cancer and this genetic information could not be used in the 
determination of eligibility for a group insurance plan, including 
self-funded plans. This is a significant first step in the evolution of 
federal legislation, but it is only a first step, and gaps remain.
    Of course, this incremental approach to health care reform does not 
provide the comprehensive protection outlined in the NAPBC/ELSI 
recommendations. It does not prohibit insurers from requiring or 
requesting genetic testing or requiring or requesting the results of 
genetic testing. Thus, the burden is on the individual to prove that 
the insurer did not use genetic information to deny coverage or affect 
the terms and conditions of insurance. Nor does it prevent a plan from 
excluding all coverage for a particular condition, or imposing lifetime 
caps on all benefits or on specific benefits. It appears that this form 
of discrimination against women with breast cancer and/or a genetic 
predisposition to breast cancer, for example, would be permitted as 
long as plan characteristics are not ``directed at individual sick 
employees or dependents.'' Absent other contractual and legal 
protections, plans could exclude, for example, prophylactic surgery 
specifically. HIPAA provides even less protection for employees not in 
group plans and provides no coverage for the uninsured. Thus, even if 
the uninsured had access to genetic testing, the risk of future 
insurance discrimination would be a reality. In addition, the uninsured 
would not benefit from genetic information if they could not afford to 
pay for the related prevention and intervention strategies, including 
more frequent mammograms and surgical interventions.
    State anti-discrimination statutes also integrate various levels of 
privacy protection. At the federal level, the recently published HHS 
Privacy Rule fails to provide the kind of protection that can be 
uniquely afforded by strong anti-discrimination legislation. For 
example, whereas the Privacy Rule protects individuals from the 
unauthorized release of their health information, it does not prevent 
inquiries into their genetic makeup. This is a gap that must be filled. 
Meaningful privacy protections must prohibit insurance companies from 
requesting or requiring genetic information, and performing genetic 
tests.
    Finally, federal legislation must include a strong enforcement 
provision, so that individuals who experience genetic discrimination or 
privacy violations not only will have the right to seek legal redress, 
but will have access to meaningful remedies.
    Perhaps our greatest public policy challenge will be to determine 
when, if at all, it will be appropriate to make the transition from 
predictive testing for high-risk individuals and families within a 
research context to testing for the general population. Will the 
commercial market promote testing for the general population before we 
have been able to carry out the benefit/risk analysis even in the high-
risk population? As the flow of genetic information increases, so too 
will the risk of its misuse. Should testing be restricted until we 
enact anti-discrimination and genetic privacy legislation nationwide? 
What implications will testing have on cancer surveillance and 
prevention strategies within our healthcare system? How will 
individuals be able to integrate predictive testing results with health 
behavior, lifestyle, and environmental factors that may significantly 
contribute to cancer morbidity and mortality? These questions have no 
simple answers.
    Thus, given the varied state approaches that have developed in 
recent years, and the noteworthy but incomplete federal approaches, it 
is imperative that we develop comprehensive federal strategies to 
protect the public. For today, we face the onset of a revolution. 
Federal legislation stands to offer a pre-emptive strike in favor of 
genetic privacy and against genetic discrimination, potentially helping 
individuals to avoid doing battle alone in the health insurance arena.
    Thank you.

    Mr. Stearns. I thank you.
    When I come to my questions I'm going to start off with 
trying to understand what the genetic tests mean and then I 
would like to go to this HIPAA and talk about it. And then I'd 
like to go a little bit to the reality of how do insurance 
companies actually go to price this and talk some of that. Dr. 
Young, you can help me.
    But Dr. Venter, I want to go to some things that I have off 
the internet that you have said publicly, so I'll just read a 
little bit of these.
    ``Our understanding of the human genome has changed in the 
most fundamental ways. A small number of genes, some 30,000, 
support the notion that we are not hard wired. We now know the 
notion that one gene leads to one protein and perhaps one 
disease is false.'' Is that true, that one gene leads to one 
protein and one disease. Is that false?
    Mr. Venter. There are examples where that does occur, but 
they're extremely rare.
    The scientific community and the public has been misled by 
the early successes in genetics thinking those were general 
rules.
    Mr. Stearns. That is fundamental to our discussion and the 
American people have to realize that. If I do a DNA test and I 
find a gene, that gene and one protein that it develops is not 
going to do a disease. In fact, you go on to say a little later 
that ``one gene leads to many different protein products that 
can change dramatically once they are produced. And we also 
know that the environment acting on our biological steps may be 
just as important in making us what we are as our genetic 
code.''
    Do you say that's still true?
    Mr. Venter. Absolutely.
    Mr. Stearns. Okay. So you take my DNA. You look at it. The 
protein is not just one protein. You sort of indicate there 
could be perhaps be 300,000 proteins that are developed from 
these 3,000 genes. Again, I'm quoting from you.
    Mr. Venter. Yes.
    Mr. Stearns. So the probabilities that exist between the 
environment and the 300,000 proteins or whatever the number of 
proteins that are developed from one gene make it extremely 
difficult, I suspect, to determine a predisposition with any 
guarantee. Is that true?
    Mr. Venter. I think that's very much along the right lines 
and I think a lot of people here have used the right language. 
They've talked about probabilities, not yes or no answers.
    Mr. Stearns. Probabilities. Okay.
    Mr. Venter. And probabilities can be--there are very high 
probabilities or very low probabilities, but they don't mean 
that you get a disease and they won't mean that you won't get a 
disease.
    Mr. Stearns. Okay, that's very fundamental to our 
discussion. Could I safely say contrary to Dr. Francis Collins 
that the genome has not yet been fully decoded?
    Mr. Venter. I think his agency is still working on closing 
a number of gaps.
    Mr. Stearns. Dr. Francis Collins has been out there saying 
it's been decoded and mapped and I'm saying from what you have 
just told me between the environment an don those proteins that 
we cannot accept on a probability statistical basis determine a 
predisposition if we do a DNA.
    Mr. Venter. Is your question do we thoroughly understand 
the human genetic code? The answer is absolutely not. It will 
take most of this century to even approach that.
    Mr. Stearns. The discussion that there's going to be 
rampant discrimination based upon predisposition after taking a 
DNA test is not accurate because we don't know what that means. 
Is that true?
    Mr. Venter. The difference that I would make is, in fact, 
the cases are discrimination has not been based on knowledge, 
just in the railroad case.
    Mr. Stearns. Okay.
    Mr. Venter. The employees at the railroad----
    Mr. Stearns. It's very important for the American people to 
understand that----
    Mr. Venter. Their discrimination was based on absolute 
ignorance in that case, not based on genetic knowledge.
    Mr. Stearns. Yes.
    Mr. Venter. But the company thought that by using genetic 
knowledge they would have a basis of discriminating. It turns 
out they were just fundamentally wrong in their reasoning.
    Mr. Stearns. The railroad was ignorant.
    Mr. Venter. But it doesn't mean there was no 
discrimination.
    Mr. Stearns. Based upon all scientific evidence, we do not 
have a strong understanding of what a DNA test means in terms 
of a predisposition toward a disease. That's my point.
    Mr. Venter. We do with some diseases. There are some 
extremely rare genetic disorders where it's very clear cut 
scientifically, for example, with the Huntington's Disease 
gene, if you have a certain number or a triplet repeat, the 
likelihood of getting Huntington's Disease is so high, it's the 
closest we'll ever get to a yes/no answer. Most diseases and 
most human conditions will not fall in that degree of 
probability.
    Mr. Stearns. Okay. Let me change the subject a little here.
    Ms. Davidson, both you and Mr. Young note the provisions of 
HIPAA which already prohibit discrimination of eligibility and 
premium contribution based upon genetic information. 
Specifically, HIPAA prevents any group health plan or insurance 
provider in connection with a group health plan from refusing 
to cover employees or their family members based upon genetic 
information or results of genetic testing.
    Now is HIPAA sufficient? I mean do we need another and I 
would say to Mr. Young first, Dr. Young, do we need another 
full genetics bill like our colleague, Slaughter, and our 
colleague Connie Morella talked about? In the health area, I'm 
not talking about employment because basically this committee 
is dealing with health.
    Mr. Young. No, we do not. We have HIPAA, but we also have 
Gramm-Leach-Bliley which we haven't talked about today and we 
have the various rules and regulations in the States and it's 
important when we come back and talk about insurance, not only 
are there privacy and nondiscrimination provisions, but there 
are very strong rate setting provisions as well and we can 
return to that later. We do not need additional legislation.
    As I said in my testimony, it will harm the people we're 
trying to help.
    Mr. Stearns. Ms. Davidson?
    Ms. Davidson. Thank you for your question. Let me just take 
a quick second just to tell you that my answers to this are 
really informed by the fact that we run a genetics help line so 
we receive calls from the public numbering somewhere between 
3,000 to 4,000 calls per year from people who are having 
genetic tests who have concerns about genetics as well as who 
have been diagnosed with genetic conditions. From time to time 
we certainly get an increasingly number, actually, of questions 
asking about insurance coverage and HIPAA coverage. The two 
vulnerabilities that we're seeing in particular is certainly in 
the individual market and part of this may reflect the fact 
that I have two children in their 20's. They're just entering 
the employment market and had not, if I didn't know as a parent 
how important it was that they stay on COBRA and have this 
continuous coverage, they might actually have difficulty. My 
son was in the position of setting up his own business and in 
an individual market because HIPAA doesn't provide protections 
there, it does provide premiums, but there's no ceiling on the 
premium and the other point of vulnerability, if I can just 
take 1 second is also in small businesses, because again, this 
goes back to why, how insurance and employment are linked 
because in a small business people's medical information is 
often known to everyone and again the case of Terri Sergeant 
was one where her employer found out about her premium, about 
her medical care and was concerned about possible increases to 
the group premium and dismissed her.
    Mr. Stearns. We're going to go a second round here, but I 
want to get the ranking member, Mr. Towns, because my time has 
expired.
    Mr. Towns. Thank you very much, Mr. Chairman. Let me just 
start with you, Dr. Young. You mentioned Gramm-Leach-Bliley, 
but it's my understanding that most of the States have not 
actually adopted it. I think it's like maybe 5 or 6 States have 
moved forward, others have not.
    Mr. Young. No, it's moving very quickly.
    Gramm-Leach-Bliley led to the National Association of 
Insurance Commissioners developing a model law which we 
supported. And that model law now is being enacted across the 
States.
    Mr. Towns. How many States, Dr. Young? Because just as a 
matter of a few weeks ago, it was only a few States that 
actually had adopted it.
    Mr. Young. Virtually all the States currently have privacy 
rules on the book. Many of them go back to the 1980 model and 
they are changing those to update them to Bliley, but those 
laws are in place. All that's happening now is the updating of 
them to the GLB.
    Mr. Towns. I don't want to get into this kind of--the State 
of Iowa has said we're not going to do it, period. There are 
some problems, but that's for another day, another hearing. But 
I just don't want you to mislead anybody by saying that that's 
a catch-all and a for-all. It's just not. And I just want to 
make that point.
    Mr. Young. We'd be happy, if you want me to submit for the 
record, a listing of the States and their current status.
    Mr. Towns. I would like to have it. I'd appreciate that.
    Do all genetic tests have to be approved by the FDA, Dr. 
Venter?
    Mr. Venter. I'll defer to others here, but my understanding 
is no.
    Mr. Towns. Dean Rothenberg?
    Ms. Rothenberg. There is a dispute about how much authority 
the FDA has, but right now there are a lot of genetic tests 
that have no regulation under the FDA.
    Mr. Towns. Do you think that the legislation being put 
forward by Congresswoman Morella and Congresswoman Slaughter is 
actually needed?
    Ms. Rothenberg. I was hoping to be able to finish in the 
analysis of both HIPAA and its gaps as well as the HHS Privacy 
Rule that we do need the law and the reason is is because where 
HIPAA started in the right direction, it doesn't have in it any 
type of protection with respect to requiring or requesting 
genetic testing. It also has very little protection. I would 
disagree with Dr. Young, about the individual market, and of 
course, those that are uninsured that want availability for 
genetic testing, if they then want to get insurance at a later 
date, it becomes problematic. It is the beginning of protection 
in the anti-discrimination area for group health plans and 
Chairman Stearns is right that we don't really have a lot of 
data on how it is being utilized in part because how would 
anybody know individually if there was a problem if you don't 
have any restriction on the information that they can collect? 
How would an individual know, in fact, or even a group know? 
You can't have an individual distinction with respect to the 
premium differential, but you can raise the whole premium on 
the group after you've gotten information. I don't think Dr. 
Young would disagree with that, but how would anybody even know 
and the reason why you need a different type of protection is 
because discrimination with genetics is different than race and 
sex. You don't know when you see it. So if you want to argue 
that you've been discriminated against based on race, you're 
not giving up that part of any privacy. If you want to argue 
that you've been discriminated against based on predictive 
genetic information, you've got to give up your privacy to make 
the anti-discrimination claim and one of the reasons why this 
new legislation attempts to integrate both limiting who gets 
the information with discrimination protections is it fills 
that gap and the HHS Privacy Rule doesn't do it either because 
it just relates to health care providers. It doesn't relate to 
insurance companies and it doesn't relate to information about 
getting genetic information. It just deals with protecting 
information in the record. So that's, I think, why you need 
either to amend what you've already got or to have a 
comprehensive Federal approach that matches what they're 
attempting to do at the State level.
    Mr. Towns. Yes, Dr. Young? Thank you very much, Dean.
    Mr. Young. Health insurers don't ask about predictive 
genetic testing and about genetic make up. As I said, 90 
percent of people get their coverage from the large employer 
market and there is no information about any kind of health 
status is asked or requested for because the group is large 
enough that the risk can be spread across a large group.
    When talking about the individual market which is 10 
percent or so, our interest there are simply knowing are you 
sick today? The overwhelming number of people who buy insurance 
in the individual market, I'm sure like Ms. Davidson's family, 
are very healthy and we need to be able to set the lowest rates 
possible, this is a very, very price sensitive market. It tends 
to be younger people. It tends to be people at low income and 
if they look at rates that are high they are going to forego 
the insurance. We've seen the experiment in the States where 
States have tried to guarantee, issue and community rating much 
of what this legislation would do and there, the number of 
uninsured has climbed dramatically because people forego their 
insurance. It's not the insured leaving the State. It's 
individuals will not buy since this is voluntary and they pay 
for it after tax dollars.
    Second, people who are insurance products in the health 
arena are generally in those products for 2, 3 or 4 years. It's 
unusual that people have the same product over a long period of 
time. We simply have no interest from a health insurance point 
of view in knowing if somebody is going to develop Huntington's 
Disease or Alzheimer's 10, 15 or 20 years from now, so we want 
to know where they are today.
    As to Dean Rothenberg's question who's looking at the 
rates, I can assure you State regulators are looking at the 
rate.s When you come in for rate increases either a block of 
business in the individual market and the rate increases for 
the whole block, you cannot have rate increases for a single 
person or single out two, three or four once the policy has 
been issued.
    Likewise, in a small group market the States know the 
insurance in their States and they look very carefully at those 
rates and there can be long periods of time where you don't get 
a rate increase because the State is looking at it and asking 
for more information. There is a great deal of oversight of 
this industry at the level of the States, both in terms of 
discrimination and pricing of the product, but I'll come back 
to it again. The point I made earlier, you're going to harm the 
people you're trying to help. If you raise overall rates, then 
people who are low income are going to forego buying in the 
individual insurance market. We know that because experience 
has shown it.
    Mr. Towns. You'll leave that statement in the record, harm 
the people they're trying to hurt?
    Mr. Young. No, no. Trying to help. You'll harm the people 
you're trying to help. Let there be a correction.
    Mr. Towns. Okay, fine.
    Mr. Stearns. The gentleman's time has expired. The 
gentleman from Illinois, Mr. Shimkus?
    Mr. Shimkus. Thank you, Mr. Chairman. It just shows you 
that Mr. Towns is listening to the answers.
    Mr. Young. And I appreciate that.
    Mr. Shimkus. I know, that's very good. I'm sorry for being 
in and out, but I've just been in the back room and I 
appreciate the panel here and this great debate and also 
learning about group versus the individual market. I've picked 
up some things.
    Insurance companies do, based upon good record, at least 
automobile insurance, good record, health insurance may do 
nonsmokers. There may be some alcohol-related provisions that 
affect the rate structure, am I correct?
    Mr. Young. Generally, it is simply--we're talking in the 
individual market, this question has already been asked in the 
large group market. In the individual market it's generally are 
you sick now? Do you expect to have major surgery in the near 
future? Have you been in the hospital in the last year? It is 
health status kinds of information. They may ask about alcohol. 
They may ask about smoking. They may ask about other personal 
behavioral kinds of things.
    Mr. Shimkus. Ms. Rothenberg, you mentioned and I'm just 
trying to get some information, behavioral genetic studies on 
violence and alcoholism. Can you explain what you mean by that?
    Ms. Rothenberg. What the term means?
    Mr. Shimkus. Right. And how it ties in, I guess, to my 
previous question of a concern. If you're saying through 
genetics we can make some implication on future behavioral 
aspects which may affect cost pricing in the insurance market.
    Ms. Rothenberg. Yes. Actually, most of the studies with 
respect to behavioral genetics haven't made it through as far 
as I know in the insurance market. I think Dr. Young would 
agree with me on that.
    Most of those concerns have been expressed in research, 
genetics research that is now being done based on certain 
population groups. And this brings me back to a point you 
raised earlier about the breast cancer community and their 
concerns, particularly the Ashkenazi Jewish community which has 
a lot of concern about genetic discrimination because many of 
the earlier studies with respect to the breast cancer gene were 
associated with a particular ethnic group, the Jewish 
community, and there was concern in that community about what 
impact it might have on buying in certain markets. There's been 
assurances from the insurance company that there isn't of that 
going on.
    I would like to correct, however, that in the individual 
market if anybody has looked at an application the very first 
question it usually asks you is have you had any medical tests 
within the last 5 years and it doesn't say in parens exclude 
predictive genetic tests, end parens. And the reality of it is 
is that the individual consumer doesn't really know how to 
answer that question and that's a very generic question. So I 
think that's one that would need further clarification.
    In the future, if we continue to do tests with respect to 
behavioral traits, there's nothing that would prevent an 
insurance company from asking those questions or even asking 
for the tests right now. I don't think they would do that. I 
don't think it would be wise, but there's no law that would 
prevent it.
    Mr. Shimkus. The other great balance and we're going to be 
going into that debate in the next couple of days here in 
Washington is the whole debate over employer response over 
health care group coverage and the cost and 42 million 
uninsured Americans right now.
    Dr. Young, what do you see as far as the ability of the 
insurers working with employers if we then move to behavioral 
genetic studies or other aspects, is this--or even the tort 
aspects that could evolve. What's that do to the cost of 
affordable health care?
    Mr. Young. The insurance industry and particularly its 
customers, the Americans, are facing substantial challenges in 
terms of various regulations and legislation. We've been 
regulated primarily at the State level and regulated quite 
heavily over the years. What is new beginning with HIPAA and 
now the other legislations being considered is a second layer 
of the Federal regulation. That is certainly a substantial 
contribution in driving up costs. The CBO estimate for the 
Patient Bill of Rights of 4.2 percent, in fact, translates into 
$230 billion over 10 years. That's a lot of money that the 
American public is going to have to pay for.
    We are also seeing increasing mandates. There's mandates in 
HIPAA. There's mandates in Federal legislation and increasing 
mandates at the State level for services, many of whom services 
are good, very good services, but the question is do people 
want to purchase them and will people forego insurance because 
of that. The major growth area in the uninsured are people who 
work, who are offered insurance through the work place and who 
decline it because even the 20 percent or 25 percent that they 
have to pay is too much for them in terms of their low incomes, 
so costs and factors driving costs are very important 
components. As I said earlier, at the State level in the 
individual insurance market, the consumer buys the product out 
of their own pocket. It's entirely voluntary and they are very, 
very price conscious and will turn down insurance or not 
purchase it if the price doesn't look right to them.
    Mr. Shimkus. And I will just end with my time, Mr. 
Chairman, to say if the additional costs of additional 
regulation would be filtered back into the health care delivery 
system or the funding of our hospitals to adequately pay for 
our professionals, that's one thing, but I am concerned about 
the excessive regulation and the spiraling costs and the 
inability for people to have some coverage which is critical in 
the high cost medical field that we have today. That's the 
balance and I appreciate the panel and Mr. Chairman, I yield 
back.
    Ms. Capps. The gentleman's time has expired. The gentleman 
from Tennessee, Mr. Bryant.
    Mr. Bryant. Thank you, Mr. Chairman, I have an opening 
statement, if I might ask unanimous consent to be able to just 
add it to the record.
    Mr. Stearns. So ordered.
    Mr. Bryant. I apologize to the panel. We were in and out as 
Mr. Shimkus said quite a bit. I haven't been in yet, but I have 
to leave fairly shortly to go to another meeting, but I did 
have a chance to review some of the testimony and I want to 
thank you all for being here.
    Ms. Rothenberg, I think you're down on the end there. I 
thought you were supposed to be down at this end. I finally 
identified you. In your written testimony you state that a 
predictive test result is not a diagnosis and I think I agree 
with that. But do you believe that or do you not believe that a 
health care plan should not provide genetic counseling to help 
patients plan their health care and if so, wouldn't this 
require tests, this type of test for the patient? Do you think 
there should be some results, some positive results, some 
preventative type action involved in this?
    Ms. Rothenberg. I think the taxpayers and Congress would 
not have invested in the Human Genome Project if we didn't 
think it held out the promise for a better life for all of us. 
And not to have to be in a situation where we would all be 
afraid about getting a test. Wouldn't that be a shame, in fact.
    What I think the principle, the underlying principle that 
should be determined in responding to your question is to ask 
all other things being equal, does it make sense for an 
individual to get that information and that requires an 
informed consent process between their health care provider and 
themselves.
    I would not want a situation in which an insurance company 
could require you to have to take a predictive genetic test in 
order for them to then make a determination about whether 
they're going to pay for a particular procedure. And there have 
been cases in which prior to approving prophylactic 
mastectomies for women, providers, insurance companies said 
well, you need to have a genetic test. If you don't have the 
predisposition for, you don't have BRCA1, you don't have BRCA2, 
you don't have BRCA3, what is the rationale for a prophylactic 
mastectomy. I don't think that is a rampant problem, but I 
think the determination about whether to get a genetic test 
should be a medical determination, not a determination made by 
an employer or an insurer.
    Mr. Bryant. Thank you. Dr. Young, I also agree with the 
concept of insurance, a company ought to be able to fairly 
evaluate the risks they're about to insure before they take 
that on. I think that's common sense and I think most people 
understand that. And so we are put in a difficult position 
here.
    As I listened to your testimony I agree with you that you 
tend not to look long term, that you're interested in the 
information today and more what's current. We've heard 
testimony here before I think where, particularly insurance 
companies, HMOs, usually don't keep patients very long, or keep 
insurance very long. There's quite a turnover there. So 
sometimes we see the preventative care side of it neglected 
because you're not going to have that person long enough term 
to really be the beneficiary of that good preventative care. 
And I think we're talking about this a little bit here. You 
bring in genetic testing and that really complicates the 
matter.
    If there's a question somewhere in those comments, I'd like 
for you to answer it, but from the perspective of the insurance 
company and this type of testing and how it would relate maybe 
to preventative care and is it from a risk insurable 
standpoint, is that feasible for companies to do that, health 
care companies?
    Mr. Young. Once the individual has insurance, we can't deny 
their coverage and that's as it should be. I think the issue 
that Dean Rothenberg raised was a very good one and I think in 
that situation it was of the breast and the individual who 
wanted a bilateral mastectomy and are they or are they not at 
increased risk? I think in that situation if that is an 
important question to be addressed, the doctor should request 
the test. That's the appropriate mechanism. That kind of 
interaction should be done between the doctor and the patient. 
The insurance company will have a responsibility to see whether 
the employer's coverage covered it or not. Most benefits are 
covered commonly across all insurers, but not all and that's 
entirely the purchaser and the employer who makes that 
decision, but in the example given, I think that it's a very 
reasonable question to ask and in my mind one the doctor should 
have asked with the patient before it ever came up to the 
insurer.
    Mr. Bryant. My time is about to run out. But I think we all 
agree too that we want to keep as many people insured as we 
can. Forty-two, 43 million are uninsured and many of the people 
insured today are insured through small companies, smaller 
companies, smaller plans.
    Mr. Young. Yes.
    Mr. Bryant. And I can understand where you've got a big 
plan and you don't even look at the questionnaire, you just 
insure the person. Many cases, they're smaller plans where you 
do have to assess individual conditions because you just can't 
jack up the rates in a small plan because you've got fewer 
people and they're paying this.
    Mr. Young. That's the small group market, so employers, 5 
people, 10 people, 15 people, 20 people. There again you cannot 
eliminate the coverage. You cannot deny Ms. Jones or Mr. Smith 
or somebody else coverage because of their health condition, 
but what the insurer does do each year as part of its annual 
renewal in setting a premium it looks at all the factors that 
affect that group. But in setting the premium, you look at 
rising drug costs and make your best guess for next year, you 
look at rising physician fees and make your best guess and you 
look at the experience of that small group in terms of its 
utilization. A group of people who are 25, 30, 35 is going to 
have a lower experience rating than a group that's more heavily 
wedded to people who are 50 to 55. But having said that again I 
need to stress those rates are subject to review and approval 
by State Insurance Commissioners. Those rates are simply not 
granted without oversight and review.
    Mr. Bryant. Mr. Chairman, I think my time is exhausted.
    Mr. Stearns. I thank the gentleman. Dr. Venter, I think 
your written testimony states that genetic information is not 
different from other medical information. You further state 
that it is an integral part of the medical information. Is that 
still--is that true?
    Mr. Venter. When it's medically related. Genomic 
information in all of our genetic code is not necessarily 
medically related to a disease.
    Mr. Stearns. Right.
    Mr. Venter. But when there's a specific test done either 
for predictive measures or diagnostic measures, then it's 
definitely medical information in my view.
    Mr. Stearns. I think what I'm trying to get to is do we 
need to have a broader concept of privacy of medical 
information and not have different or conflicting rules for 
different type of medical information? For example, maybe 50 
years ago people wouldn't want their cholesterol levels known, 
they wouldn't want their blood pressure known. They wouldn't 
want their pulse known. And they would think that that would 
require a whole new privacy whereas today, it's not considered. 
It's private, but it's not considered with the enormous impact 
if somebody knows your cholesterol level or your heart beat or 
your pulse. So I guess my question is do you think we need a 
broader concept of privacy of medical information to in effect, 
which I think Mr. Bryant was talking about when we talked to 
Dr. Rothenberg, Dean Rothenberg, about the idea of genetic 
counseling to help patients plan their health care because 
somewhere if I have problems and I could determine from my 
genetics it was a problem I'd want counseling on what to do.
    Mr. Venter. Well, you've talked about preventive medicine 
and I can give you a wonderful example. A few years ago we 
found three new genes in collaboration with Burt Vogelstein at 
Johns Hopkins University that are linked to colon cancer. We 
can now measure in the population and there's tests 
commercially available to determine whether somebody has an 
increased risk of getting colon cancer from these mismatched 
DNA repair enzyme changes. But by measuring those genetic 
changes, we cannot determine who's going to get colon cancer 
and somebody might mistakenly say well, this person has a 
greatly increased risk of colon cancer, therefore their medical 
coverage is going to cost a lot more. In fact, it empowers that 
individual to then be aware of early symptoms for colon cancer 
and even get annual colonoscopies because colon cancer is 
readily treatable if it's caught early. So it changes the 
nature of the information in terms of empowerment of 
individuals.
    At the same time, this earlier discussion about whether 
there was a genetic basis of behavior, we've been there in the 
past history of the U.S. in the 1930's with eugenics. The 
biggest fear that most of us have in the scientific community 
is just bad science and bad interpretation of the information. 
So at what stage does it become medical information? If 
somebody thinks that it's related to criminal behavior, 
measuring something in your genetic code, that's got nothing to 
do with medical outcomes. It probably has nothing to do with 
actual outcomes, but the discrimination is based on what people 
assume.
    Mr. Stearns. Let's take a more specific case example of a 
managed care program. So Aetna gives you a managed health care 
program. It includes insurance company, they provide all the 
doctors and all the patients and everything and they sit down 
with you to counsel you and they find out, based upon what you 
said that you have colon cancer. Shouldn't they know that to 
tell you to have a colonoscopy on a regular basis? I'm just 
taking the devil's advocate now. It seems like a managed health 
care insurance care would want to know this so that they could 
say to you, by golly, we're going to save your life. Instead of 
a colonoscopy every 10 years, we're going to have it every 2 
years on your or every 3 years to see if there's polyps.
    Mr. Venter. I'm not sure we're disagreeing on this issue. I 
think that would be extremely valuable information for the 
medical practitioners to know and perhaps even for getting the 
tests. Right now there's problems in insurance companies 
covering annual colonoscopies for people over 50, let alone if 
you're 20 years old and you know you have a greatly increased 
risk of getting colon cancer, but it could lead to decreased 
medical cost because it would be preventive measures.
    Mr. Stearns. Dr. Young, any comment you might have?
    I guess what I'm trying to do is see if we need to have a 
broader concept of privacy of medical information or do you 
think the way we're going now is satisfactory?
    Mr. Young. Medical information needs to be protected. We do 
not disagree with that. The public is very concerned about this 
and I think as I said and as other witnesses have said, they 
may be forgoing tests and studies that are important to their 
health because of their concern, so we need to alleviate that 
concern. The legislation though that's in place, I think, goes 
a very, very long way in doing that already and the risk is in 
doing additional harm. In terms of medical records, the 
physician should have access to information. Our medical system 
today is very complicated. It's no longer one doctor that sees 
a patient. There may be several. There may be physical 
therapists. There may be laboratory people. Information is out 
there. We have to protect it, but it should be used to help the 
people. Health insurers use that information for things like 
sending out reminders to people to come in and get their asthma 
drugs if they haven't had their drug filled or to come in for 
their annual Pap smear or their mastectomy screening or their 
prostate screening. We need to protect that information, but 
that's not to say it shouldn't be used when it's necessary to 
improve care. It's used for chronic disease management 
programs, care management programs. So we have to protect it. 
We have to reassure the public, but we should not do something 
that is not in the patient's interest in terms of how that 
information is used and I think we have a lot of regulations 
out there now and I don't see the need for additional 
legislation, particularly that which would segregate the 
information.
    Mr. Stearns. Okay, my time is expired. The gentleman from 
New York.
    Mr. Towns. Thank you very much, Mr. Chairman. Dr. Venter, 
let's see, how do I want to phrase it? Do most of your trade 
association make tests that can be used to identify genetic 
disposition with respect to certain diseases?
    Mr. Venter. I'm not in a position to answer that. I don't 
know. I would assume not.
    Mr. Towns. You are representing the trade association, 
aren't you?
    Mr. Venter. I'm here on behalf of myself and the BIO 
organization. We can get information for you from the BIO 
representatives.
    Mr. Towns. Because I would think if you're representing 
them, you have some knowledge of who might be----
    Mr. Venter. Well, you know in your own case you don't have 
infinite knowledge of all the people you represent.
    Mr. Towns. That's true, but I have a general idea because 
they keep reelecting me.
    Mr. Venter. My election is only for a day.
    Mr. Towns. The question I guess I wanted to ask was what 
happens to the information? Who do they sell it to?
    Mr. Venter. I don't think I'm the--as a leading scientist 
in this field the person to be able to answer the question on 
what diagnostic companies do with the information. Usually, 
they provide it back to the physicians and the health care 
provider that ordered the information in the first place.
    Mr. Towns. Anybody might be able to help me with this 
because I have a funny feeling here.
    Ms. Rothenberg. I think you're asking a very good question 
and I think it gets to the point and the question that Chairman 
Stearns asked and that is what is left that still needs to be 
covered that isn't already covered with the privacy rules? And 
what isn't yet covered anywhere except in a patchwork at the 
State level is that nothing prohibits the insurance companies 
from requiring or requesting information or requiring testing. 
That doesn't mean they're going to do it, but there's nothing 
that prohibits it.
    Second, nothing in the privacy rules speaks to insurance 
companies. The focus is on health care providers, unless those 
are the same, or employers who happen to be the insurers.
    So in your situation, there is not a Federal way to 
approach that problem right now. You're absolutely--you're 
asking the right question.
    Mr. Towns. Thank you. Do you want to make a comment on 
that, Dr. Young?
    Mr. Young. Yes. I think part of the issue here is 
traditional State regulation versus the Federal and what we 
need to do. Part of it though is how one specifies the 
definition of genetic information and that definition now is 
extremely broad which will encompass almost everything that is 
health status. We've heard that everybody has genetic defects, 
everyone has genetic problems, so how do you craft that 
legislation that will not do harm in terms of using information 
in the individual's own personal welfare, whether it's the 
doctor or whether it's in making insurance and benefit coverage 
decisions? That would be the real challenge.
    Ms. Rothenberg. Well, under the proposal though to the best 
of my knowledge, it allows for written authorization from the 
individual, but they just have to be told what it's going to be 
disclosed for, so that the individual gets to decide where the 
information goes, rather than somebody else without their 
knowledge.
    Mr. Towns. Could the employer purchase it?
    Mr. Young. I'm sorry?
    Mr. Towns. Could the employer purchase this information?
    Mr. Young. No, that is also prohibited in terms of the 
employer doesn't have access, by and large, to the medical 
records of the employee. Now they can ask for written consent 
and get that kind of information, but we would not feedback 
that kind of personal information. We would generally not even 
have that kind of information. All we have are the claims, so 
we know what encounters have occurred and what we've paid for, 
but we don't have additional information other than that in the 
overwhelming number of circumstances.
    Mr. Towns. I've been around this place a long time. When 
you hear one situation you always feels like there are 100 
situations. I'm thinking about the Burlington Northern 
situation. I just sort of feel there's a lot of others. We know 
about this because it's highly publicized, but the point is 
that how many more are there out there? That's the question.
    Mr. Young. Well, the Burlington, of course, was not a 
health insurance issue.
    There has been research that's looked at this. There's been 
research that has failed to show----
    Mr. Towns. Why is that not a health issue?
    Mr. Young. I'm sorry?
    Mr. Towns. Why do you say--it's genetic. I don't understand 
the statement you made.
    Mr. Young. Okay. I think in the discussion that is going on 
and a point that you made earlier to the Congresswomen is that 
the problems facing health are different than the problems 
facing life insurance, the problems in terms of employers are 
different than health. The issue is the same, but how one deals 
with those problems and the solutions one comes up with will be 
tailored differently for the wide audience the legislation 
would apply to.
    Mr. Towns. I agree, yes. Ms. Davidson?
    Ms. Davidson. Yes, I just wanted to speak to the question 
about whether there have been sufficient studies in this area 
because I would suggest that there have not been and it really 
is time that we take a very sound thorough and in-depth look 
and that's one of the things that my organization is beginning 
to do on a pilot basis. There have been other, a couple of 
other pilot studies, but I don't think that they really have 
given us the kind of information that we need.
    But again, I would come back to not only is this happening 
on an anecdotal basis, but it is happening in a handful of 
cases of very brave people who have essentially given up on 
their privacy and the privacy of their family and their 
extended family to come forward and be public about their 
particular circumstances, but it really comes back to the issue 
of whether or not and I appreciate your questions, Mr. 
Chairman, whether or not the combination of HIPAA and State and 
Federal regulations and laws, whether that really gives a 
sufficient safety net for consumers.
    If I can take 1 second also, just to come back to the whole 
question of information and the question also about services 
because it is so critical, it is so critical that people are 
able to access the medical care that they need, the genetic 
tests that they need, the counseling that they need and that 
their concern really be on obtaining that and getting the best 
medical care possible. I think where I would like to see 
legislation move is not on controlling information because we 
all know, we've all been in that doctor's office trying to 
collect the information so we can maximize our 15 seconds. What 
is so important here, really, is that there be assurances that 
the information be protected, not that it be controlled, 
because that will stop research. That will really inhibit 
quality health care.
    Mr. Towns. I agree. Thank you very much, Mr. Chairman, 
you've been very generous with your time.
    Mr. Stearns. Let me first of all thank my distinguished 
ranking member for his participation and thank our second panel 
for your participation and also for waiting. I think what we've 
had today is very illuminating and a very comprehensive 
coverage of a lot of the issues that we failed to talk about 
here in Congress on genetic privacy, so I'm glad at least 
finally to have this hearing. This might be something that we 
should have additional hearings on. I think we have touched 
some very sensitive subjects, but I think we can all agree that 
if the States march out with individual genetic privacy bills 
that the Federal Government is going to have to step up to the 
plate and do something so that we don't have companies and 
individuals all having to comply with 50 different States so 
that if nothing else, the Federal Government might have to do 
something to bring all this in so that we pre-empt the States 
with Federal legislation, but at the same time I think we 
pointed out how important this is for the individuals who have 
the genetic testing, but at the same time we have to protect 
their privacy. So I want to thank all of you and the committee 
is adjourned.
    [Whereupon, at 2:02 p.m., the subcommittee was adjourned.]
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