[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
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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\
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\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
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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.
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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\
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\4\ See, e.g., 136 Cong. Rec. H4627 (statement of Rep. Waxman).
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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)
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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.]