[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
GENETIC NON-DISCRIMINATION: EXAMINING THE IMPLICATIONS FOR WORKERS
AND EMPLOYERS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON EMPLOYER-EMPLOYEE RELATIONS
of the
COMMITTEE ON EDUCATION
AND THE WORKFORCE
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
July 22, 2004
__________
Serial No. 108-71
__________
Printed for the use of the Committee on Education and the Workforce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
house
or
Committee address: http://edworkforce.house.gov
______
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94-940 WASHINGTON : 2004
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COMMITTEE ON EDUCATION AND THE WORKFORCE
JOHN A. BOEHNER, Ohio, Chairman
Thomas E. Petri, Wisconsin, Vice George Miller, California
Chairman Dale E. Kildee, Michigan
Cass Ballenger, North Carolina Major R. Owens, New York
Peter Hoekstra, Michigan Donald M. Payne, New Jersey
Howard P. ``Buck'' McKeon, Robert E. Andrews, New Jersey
California Lynn C. Woolsey, California
Michael N. Castle, Delaware Ruben Hinojosa, Texas
Sam Johnson, Texas Carolyn McCarthy, New York
James C. Greenwood, Pennsylvania John F. Tierney, Massachusetts
Charlie Norwood, Georgia Ron Kind, Wisconsin
Fred Upton, Michigan Dennis J. Kucinich, Ohio
Vernon J. Ehlers, Michigan David Wu, Oregon
Jim DeMint, South Carolina Rush D. Holt, New Jersey
Johnny Isakson, Georgia Susan A. Davis, California
Judy Biggert, Illinois Betty McCollum, Minnesota
Todd Russell Platts, Pennsylvania Danny K. Davis, Illinois
Patrick J. Tiberi, Ohio Ed Case, Hawaii
Ric Keller, Florida Raul M. Grijalva, Arizona
Tom Osborne, Nebraska Denise L. Majette, Georgia
Joe Wilson, South Carolina Chris Van Hollen, Maryland
Tom Cole, Oklahoma Tim Ryan, Ohio
Jon C. Porter, Nevada Timothy H. Bishop, New York
John Kline, Minnesota
John R. Carter, Texas
Marilyn N. Musgrave, Colorado
Marsha Blackburn, Tennessee
Phil Gingrey, Georgia
Max Burns, Georgia
Paula Nowakowski, Staff Director
John Lawrence, Minority Staff Director
------
SUBCOMMITTEE ON EMPLOYER-EMPLOYEE RELATIONS
SAM JOHNSON, Texas, Chairman
Jim DeMint, South Carolina, Vice Robert E. Andrews, New Jersey
Chairman Donald M. Payne, New Jersey
John A. Boehner, Ohio Carolyn McCarthy, New York
Cass Ballenger, North Carolina Dale E. Kildee, Michigan
Howard P. ``Buck'' McKeon, John F. Tierney, Massachusetts
California David Wu, Oregon
Todd Russell Platts, Pennsylvania Rush D. Holt, New Jersey
Patrick J. Tiberi, Ohio Betty McCollum, Minnesota
Joe Wilson, South Carolina Ed Case, Hawaii
Tom Cole, Oklahoma Raul M. Grijalva, Arizona
John Kline, Minnesota George Miller, California, ex
John R. Carter, Texas officio
Marilyn N. Musgrave, Colorado
Marsha Blackburn, Tennessee
------
C O N T E N T S
----------
Page
Hearing held on July 22, 2004.................................... 1
Statement of Members:
Andrews, Robert E., Ranking Member, Subcommittee on Employer-
Employee Relations, Committee on Education and the
Workforce.................................................. 3
Johnson, Hon. Sam, Chairman, Subcommittee on Employer-
Employee Relations, Committee on Education and the
Workforce.................................................. 1
Prepared statement of.................................... 2
Statement of Witnesses:
Hudson, Dr. Kathy, Director, The Genetics and Public Policy
Center, Johns Hopkins University, Washington, DC........... 5
Prepared statement of.................................... 8
Licata, Dr. Jane Massey, Partner, Licata & Tyrell P.C.,
Marlton, NJ................................................ 34
Prepared statement of.................................... 35
Lorber, Lawrence, Esq., Partner, Proskauer Rose LLP,
Washington, DC, on behalf of the U.S. Chamber of Commerce.. 37
Prepared statement of.................................... 40
Letter answering follow-up questions..................... 85
Wildsmith, Tom, Chairman, Genetic Testing Taskforce, American
Academy of Actuaries, Washington, DC....................... 11
Prepared statement of.................................... 14
Additional materials supplied:
Alpha-1 Association and Alpha-1 Foundation, statement
submitted for the record................................... 67
American Academy of Family Physicians, statement submitted
for the record............................................. 69
American Academy of Pediatrics, statement submitted for the
record..................................................... 65
American Association for the Advancement of Science, letter
submitted for the record................................... 68
American Cancer Society, statement submitted for the record.. 84
American Osteopathic Association, statement submitted for the
record..................................................... 83
American Psychiatric Association, statement submitted for the
record..................................................... 83
American Society of Human Genetics, statement submitted for
the record................................................. 82
Association of Women's Health, Obstetric and Neonatal Nurses,
statement submitted for the record......................... 81
Catholic Health Association, statement submitted for the
record..................................................... 94
CARES Foundation, Inc., letter submitted for the record...... 64
Coalition for Genetic Fairness, statement submitted for the
record..................................................... 96
Digestive Disease National Coalition, statement submitted for
the record................................................. 65
FORCE, statement submitted for the record.................... 81
Genetic Alliance, statement submitted for the record......... 69
Gingrich, Hon. Newt, Former Speaker, U.S. House of
Representatives, statement submitted for the record........ 86
Gregg, Hon. Judd, a U.S. Senator from the State of New
Hampshire, statement submitted for the record.............. 61
Huntington's Disease Society of America, statement submitted
for the record............................................. 94
National Breast Cancer Coalition, statement submitted for the
record..................................................... 72
National Council on Disability, statement submitted for the
record..................................................... 73
National Marfan Foundation, letter submitted for the record.. 68
National Workrights Institute, statement submitted for the
record..................................................... 71
Ovarian Cancer National Alliance, statement submitted for the
record..................................................... 93
Slaughter, Hon. Louise McIntosh, a Representative in Congress
from the State of New York, statement submitted for the
record..................................................... 87
Society for Women's Health Research, letter submitted for the
record..................................................... 62
The Arc of the United States, statement submitted for the
record..................................................... 66
UJA-Federation of New York, Women's Public Policy Task Force,
statement submitted for the record......................... 62
United Cerebral Palsy, statement submitted for the record.... 64
United Spinal Association, statement submitted for the record 95
GENETIC NON-DISCRIMINATION: EXAMINING THE IMPLICATIONS FOR WORKERS AND
EMPLOYERS
----------
Thursday, July 22, 2004
U.S. House of Representatives
Subcommittee on Employer-Employee Relations
Committee on Education and the Workforce
Washington, DC
----------
The Subcommittee met, pursuant to notice, at 10:30 a.m., in
room 2181, Rayburn House Office Building, Hon. Sam Johnson
[Chairman of the Subcommittee] presiding.
Present: Representatives Johnson, Wilson, Kline, Carter,
Andrews, Payne, McCarthy, Kildee, Holt, and Grijalva.
Staff present: Kevin Frank, Professional Staff Member; Aron
Griffin, Professional Staff Member; Richard Hoar, Staff
Assistant; Donald McIntosh, Staff Assistant; Jim Paretti,
Workforce Policy Counsel; Deborah L. Samantar, Committee Clerk/
Intern Coordinator; Jo-Marie St. Martin, General Counsel; Jody
Calemine, Minority Counsel, Employer-Employee Relations; Margo
Hennigan, Minority Legislative Assistant/Labor; and Peter
Rutledge, Minority Senior Legislative Associate/Labor.
Chairman Johnson. Good morning. A quorum being present, the
Subcommittee on Employer and Employee Relations of the
Committee on Education and the Workforce will come to order. We
are holding this hearing today to hear testimony on Genetic
Non-Discrimination: Examining the Implications for Workers and
Employers. Under Committee Rule 12(b), opening statements are
limited to the Chairman and the Ranking Minority Member of the
Subcommittee. Therefore, if other members have statements, they
will be included in the hearing record.
With that, I ask unanimous consent for the hearing record
to remain open for 14 days to allow members' statements and
other extraneous material referenced during the hearing to be
submitted in the official hearing record. Without objection, so
ordered.
STATEMENT OF HON. SAM JOHNSON, CHAIRMAN, SUBCOMMITTEE ON
EMPLOYER-EMPLOYEE RELATIONS, COMMITTEE ON EDUCATION AND THE
WORKFORCE
Good morning. I want to welcome you all, and especially Mr.
Andrews, our Ranking Member, and my other colleagues. When the
NIH and Department of Energy announced they had completed a
rough map of the human genome in 2000, it opened the door to a
new era of research. The dream of detecting diseases early on,
accurately treating them with minimal side effects, if not
preventing them entirely, seemed within reach. And indeed, we
move closer to that reality every day.
With this unprecedented potential for discovery, however,
comes an equally weighty challenge for public policymakers. The
possibility of unjust use of genetic information about
individuals and their families must be addressed.
Discrimination against a potential employee because they
may get cancer someday is not acceptable. Employment decisions
should be based on an individual's qualifications and ability
to perform a job, not on the basis of factors, genetic or
otherwise, that have no bearing on job performance.
On the flip side, if in an effort to prevent that sort of
discrimination we define genetic information too broadly, it
could greatly upset some insurance markets, resulting in an
adverse selection.
The government has taken some measures to tackle this issue
by expanding the Americans with Disabilities Act to include
those that are subject to discrimination on the basis of
genetic information in relation to illness, disease or other
disorders. Additionally, the Health Insurance Portability and
Accountability Act, lovingly referred to as HIPPA, prohibited
group health plans from using genetic information to establish
rules for eligibility.
In addition, more than half of the states have enacted
their own laws that further restrict the use of genetic
information in health insurance underwriting and employment
decisions. As this Congress continues to consider further
legislation, it's vital that we move only after careful
deliberation. We need to know and understand the effects of
current law before we attempt to take further steps, so as not
to be surprised by any unintended consequences of our work to
provide the right balance of privacy for Americans.
In short, these are tough issues that have no easy answers,
and we appreciate you all being here today to give us a more
detailed backdrop for -discussion, your latest research and to
answer any questions if you can.
I now yield to the distinguished Ranking Minority Member of
the Subcommittee, Mr. Rob Andrews, for whatever opening
statement you wish to make, sir.
[The prepared statement of Chairman Johnson follows:]
Statement of Hon. Sam Johnson, Chairman, Subcommittee on Employer-
Employee Relations, Committee on Education and the Workforce
Good morning. Let me extend a warm welcome to all of you, to the
ranking member, Mr. Andrews, and to my other colleagues.
When the NIH and Department of Energy announced that they had
completed a rough ``map'' of the human genome in 2000, it opened the
door to a new era of research. The dream of detecting diseases early
on, accurately treating them with minimal side-effects if not
preventing them entirely seemed within reach, and indeed we move closer
to that reality every day.
With this unprecedented potential for discovery, however, comes an
equality weighty challenge for public policy makers. The possibility of
unjust use of genetic information about individuals and their families
must be addressed. Discrimination against a potential employee because
they MAY get cancer some day is not acceptable. Employment decisions
should be based on an individual's qualifications and ability to
perform a job, not on the basis of factors, genetic or otherwise, that
have no bearing on job performance.
On the flip side, if--in an effort to prevent that sort of
discrimination--we define ``genetic information'' too broadly, it could
greatly upset some insurance markets, resulting in adverse selection.
The government has taken some measures to tackle this issue by
expanding the Americans with Disabilities Act to include those that are
subject to discrimination on the basis of genetic information relation
to illness, disease or other disorders. Additionally, the Health
Insurance Portability and Accountability Act (lovingly referred to as
HIPAA) prohibited group health plans from using genetic information to
establish rules for eligibility.
In addition, more than half of the states have enacted their own
laws that further restrict the use of genetic information in health
insurance underwriting and employment decisions.
As this Congress continues to consider further legislation, it is
vital that we move only after careful deliberation. We need to know and
understand the affects of current law before we attempt to take further
steps, so as not to be surprised by any unintended consequences of our
work to provide the right balance of privacy and for Americans.
In short, these are tough issues that have no easy answers. We
appreciate you being here today to give us a more detailed backdrop for
discussion, your latest research and to answer any questions you can.
______
STATEMENT OF HON. ROBERT E. ANDREWS, RANKING MEMBER,
SUBCOMMITTEE ON EMPLOYER-EMPLOYEE RELATIONS, COMMITTEE ON
EDUCATION AND THE WORKFORCE
Mr. Andrews. Good morning. Good morning, Mr. Chairman.
Thank you for your courtesies, and welcome, ladies and
gentlemen. We look forward to hearing from you this morning.
We're interested in this subject, and we're here this
morning because of people like a young woman named Kim who was
a social worker at a human services agency. One day she went to
a workshop for her staff about caring for people with chronic
illnesses. She mentioned at the workshop that she had been the
primary caretaker for her mother, who had died of Huntington's
Disease. It appears that because of her family history, this
young woman, Kim, had a 50 percent chance of developing the
disease herself.
Kim had always received outstanding performance reviews as
a great employee of her agency. One week later, after
disclosing casually in the workshop that she had a family
history of Huntington's Disease, Kim was fired.
At best under present law--at best--it is ambiguous as to
whether Kim is protected by the employment discrimination laws
of our country. She should be. And if in fact the reason for
her dismissal was her genetic predisposition for a disease, she
should be protected by the laws of this country.
The purpose of this hearing today is to figure out exactly
how to do that. This is one of the rare issues in the field of
employment law where there is, at least on the surface, very
broad agreement. One voice in this debate said this: ``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.''
I could not have said it better myself. These words were
not spoken by me. They were spoken by President George W. Bush.
This is an issue on which we should reach prompt agreement.
There are many ways that we can approach this problem, and I
would hope that the hearing this morning will explore the
assets and liabilities of those various ways. But our goal
needs to be to move as the Senate has moved very expeditiously
in a nearly unanimous vote toward legislation--in fact, it was
a unanimous vote of those present--toward legislation that will
prohibit discrimination in hiring, promotion, employment
status, legislation that will protect the rights of people to
be free from invasive testing with respect to their genetic
status. This is what we need to do.
If a person walks into a hiring office this morning and the
human resources director says we're not going to hire you
because we're not hiring dark-skinned people or women or
Catholics, if an H.R. director says that this morning, they've
violated the law. And I think the law should be no less
profound if a person walks in and their medical history shows
that they have a predisposition toward leukemia or heart
disease. It's an immutable characteristic.
The point of employment discrimination law for decades in
this country, really longer than that if one looks at the
constitutional law, is that people should not be judged on
their immutable personal characteristics. They should be
viewed, as the President stated, they should be viewed on the
merit of their performance in the job. We should be judged by
who we are, not by what our genetic makeup does to the color of
our skin or our gender or our health care status.
I think it's very important that we move quickly toward a
legislative resolution of this problem. I thank the Chairman
for holding the hearing, and I look forward to working with him
and his good offices to achieve a level of consensus as the
Senate did to get this on the President's desk and outlaw this
practice.
Thank you very much.
Chairman Johnson. Thank you, Mr. Andrews. We've got a very
distinguished panel of witnesses before us today, and I want to
thank you all for coming. Dr. Kathy Hudson is the Director and
founder of The Genetics and Public Policy Center and an
associate professor in the Berman Bioethics Institute and
Institute of Genetic Medicine, Department of Pediatrics, at
Johns Hopkins University.
Before founding the Genetics and Public Policy Center, Dr.
Hudson was the assistant director of the National Human Genome
Research Institute. That's an acronym I haven't seen. How do
you pronounce it?
Dr. Hudson. It's not possible.
Chairman Johnson. NHGRI. Responsible for communications,
legislation, planning and education activities.
Mr. Tom Wildsmith is currently a consultant in the Hayes
Group's Arlington, Virginia office. Mr. Wildsmith has 21 years
of experience dealing with all aspects of health insurance
policy and financing, including 12 years operational experience
with a commercial carrier, 9 years advocacy experience with a
major health insurance trade organization.
Dr. Jane Massey Licata, a biotechnology patent lawyer
representing universities, biotechnology companies, and major
pharmaceutical companies, Dr. Licata has been involved in the
filing of numerous patent applications concerning diagnostics
and therapeutics which rely upon genetic information and human
genes, and you've been here before. We welcome you back.
Mr. Lawrence Lorber, a partner in the Washington, D.C.
office of Proskauer Rose, is an employment law practitioner who
counsels and represents employers in connection with all
aspects of labor and employment law. Mr. Lorber was formerly
the Deputy Assistant Secretary of Labor and director in the
Office of Federal Contract Compliance Programs during the Ford
Administration.
Before the witnesses begin their testimony, I want to
remind members we will be asking questions after the entire
panel has testified. In addition, the Committee Rule 2 imposes
a 5-minute limit on all questions, and you've got lights down
there which were used for he and I, and if you see the yellow
light come on, we'd like you to try to tie it up and close it
out.
And I'll now recognize Dr. Hudson as the first witness, and
you may begin your testimony.
STATEMENT OF KATHY HUDSON, DIRECTOR, THE GENETICS AND PUBLIC
POLICY CENTER, JOHNS HOPKINS UNIVERSITY, WASHINGTON, DC
Dr. Hudson. Thank you, Mr. Chairman, Members of the
Committee. Thank you for inviting me to appear before you, and
thank you for your consideration of this important issue.
My name is Kathy Hudson. I'm the director of the Genetics
and Public Policy Center at Johns Hopkins University. The
Center was created in 2002 by a grant from the Pew Charitable
Trusts, and our mission is to provide information and analysis
on genetic technologies and genetic policies for the public,
the media and policymakers.
In my current position, and in my former position at the
Human Genome Project, I've had the pleasure of working with
both Republican and Democratic staff to help craft genetic
discrimination legislation. I'd ask that my written testimony
be made a part of the record, and I'll proceed to make three
points about the promise of genetic medicine.
Chairman Johnson. We'll do that for all of you.
Dr. Hudson. Thank you.
Chairman Johnson. If you want to submit them for the
record.
Dr. Hudson. The threats to realizing that promise, and the
need for public policy protections. Last year marked the
completion of the Human Genome Project, a historic
international effort to decipher letter by DNA letter the
entire sequence of all human genes. Genes are simply
instructions, instructions for the human body to develop and
function normally, but a misspelling in those instructions can
cause disease or increase the risk of disease.
With the human genome sequence in hand, scientists can
identify quickly DNA misspellings associated with disease, and
it's relatively straightforward then to develop a genetic test.
Genetic tests provide information, information that can
provide a diagnosis and guide treatment decisions, prognostic
information about the future course of a disease, and
probabalistic information about the future risk of developing a
disease.
Today there are over a thousand different genetic tests
available, and that number is increasing steeply. They range
from tests for fatal and untreatable diseases such as
Huntington's to tests for mutations that detect a risk for
future disease such as breast cancer.
And not only is the number of tests increasing, but the
technology for testing is getting ever more powerful. It used
to be that a genetic test looked for one DNA misspelling at a
time. With new gene chip technology, we can look at hundreds,
even thousands of DNA misspellings in a single test.
As we move ahead to integrate genetics into mainstream
medicine, we need to make sure that public policy keeps pace.
Protections must be in place to assure people that the results
of their genetic tests will not be used against them. There
have been cases of genetic discrimination and breaches of
genetic privacy. Workers at Burlington Northern Santa Fe
Railroad were subjected to surreptitious genetic testing to
determine if they had a supposed genetic basis for work-related
carpal tunnel syndrome.
More recently, Heidi Williams has shared the story of how
her two young children were denied health insurance even though
they were only carriers of a recessive genetic disease and
would not themselves become ill.
Should a person's job be dependent on whether they may or
may not develop a disease at some point in the future, or
should the ability to land a keep a job be based on whether the
person can do the job today?
A number of steps, as the Chairman mentioned, have been
taken to put limited protections in place. HIPPA includes some
restrictions on the use of health-related information and
explicitly includes genetic information. The privacy
regulations afford the same privacy protection for genetic
information as other health-related information, and the EEOC
has issued guidance that genetic information should be
protected under the Americans with Disabilities Act, though the
extent of those protections remains largely untested and
unclear.
As the Chairman noted, a key challenge in drafting genetic
discrimination legislation is getting the definitions right.
The key definitions are genetic tests and genetic information.
Definitions that are inexact will undermine an otherwise well-
intentioned effort. In crafting a definition that is neither
too broad nor too narrow, it's also important to ensure that
the definition is not rooted in genetic testing technologies of
the present time that will rapidly become obsolete. So the
definitions need to be able to accommodate new innovations in
genetics and genetic testing.
Finally, I want to share with you results from new research
conducted by the Genetics and Public Policy Center to look at
what the public knows, thinks, and feels about genetic testing.
We completed a very large survey in April and found that
Americans are generally very optimistic about the future of
genetic testing and its potential for improving human health,
but they are also very concerned about who is going to have
access to these test results. An overwhelming majority, 92
percent, oppose employers having access to genetic information.
Similarly, 80 percent oppose health insurance companies having
access to that information. Opposition is growing since we
asked an identical question in 2002.
In conclusion, the need for protections against genetic
discrimination grows with every new test developed and with
every new patient who decides to forego or delay genetic
testing because of their concerns about genetic discrimination.
I am confident that as you chart a path forward, you will
be able to meet the needs of scientists, health care providers,
insurers, employers, and most importantly, of patients.
Thank you.
[The prepared statement of Dr. Hudson follows:]
Statement of Dr. Kathy Hudson, Director, The Genetics and Public Policy
Center, Johns Hopkins University, Washington, DC
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------
Chairman Johnson. Thank you, Dr. Hudson.
Mr. Wildsmith, you may begin.
STATEMENT OF THOMAS F. WILDSMITH, CHAIRMAN, GENETIC TESTING
TASK FORCE, AMERICAN ACADEMY OF ACTUARIES, WASHINGTON, DC
Mr. Wildsmith. Chairman Johnson, Ranking Member Andrews,
and distinguished Members of the Committee, I thank you for
this opportunity to testify on behalf of the American Academy
of Actuaries. My name is Tom Wildsmith, and I currently serve
as the vice chairperson of the Academy's Federal Health Issues
Committee.
I've also served as the chairperson of the Academy's Task
Force on Genetic Testing in Health Insurance. The Academy is a
nonpartisan public health policy organization for actuaries of
all specialties.
Scientific understanding of human genetics is advancing
rapidly, and the technology continues to evolve. It's difficult
to predict the impact this technology will ultimately have on
the health insurance system. There are several key factors to
consider in the public policy debate over the proper regulation
of genetic information, especially with respect to health
insurance.
First, basing premiums and eligibility for coverage on a
specific person's own health is a characteristic of the
voluntary individual health insurance market, not the employer-
sponsored group insurance market. Thus, while possible future
use of genetic information for medical underwriting is a
potentially significant issue in the individual medical expense
insurance market, it's not a significant concern in the group
insurance market.
Second, medical expense coverage is unique, because beyond
the questions related to the use of genetic information, it
involves the question of whether the direct cost of genetic
testing and treatment will be covered.
Third, innovative disease management and prevention
programs depend on the ability to identify patients and high
risk individuals for appropriate interventions. It's important
that rules governing the use of genetic information not hamper
the ability of such programs to improve care.
Finally, all personal health information is, as it should
be, protected. Applying special rules to genetic information
would increase the complexity of an already quite complicated
health care system. I'd like to discuss each of these in turn.
Information on the health status of individual program
participants is not used to determine eligibility for
participation in employer-sponsored health insurance coverage,
which covers nine out of ten privately insured Americans.
Private group and individual health insurers do not currently
require applicants for insurance to undergo genetic testing or
use genetic testing to limit coverage for preexisting
conditions.
Of course, the debate is really over the future. The impact
of genetic information on the health insurance system will
change over time as the technology develops and may often be
overshadowed by broader societal concerns about the meaning and
significance of the information.
Employers will have to decide whether or not to pay for new
genetic tests and treatments. It's unclear whether genetic
technology will increase or decrease overall lifetime spending
on medical care, and what the timing of those changes may be.
We expect genetic tests that aid in the diagnosis of disease
and genetic treatments for disease to be gradually recognized
and covered by medical expense plans. Unless these new tests
and treatments produce an offsetting reduction in other medical
expenses, they may produce an overall increase medical care
cost. As the use of genetic technology becomes routine, the
question of how to pay for it will become more important.
Employers are increasingly turning to a variety of targeted
programs to prevent the development of disease in high risk
individuals and to manage its progression in those who are
already ill. To be successful, all of these programs depend on
information. As we attempt to ensure that personal health
information is not used against employees, it is important that
we not inadvertently preclude its beneficial use on their
behalf.
There is broad agreement that patients' privacy must be
protected and the confidentiality of sensitive health
information must be secured. Underwriting and pricing for group
insurance has historically focused on the overall makeup of the
eligible group, rather than on the health of any particular
individual. And HIPPA prohibits employers from using health
status to deny coverage to an employee or to make an employee
pay more than a coworker.
Genetic information is subject to the same confidentiality
rules as other forms of health information. Separate rules
governing genetic information could increase complexity in a
system that's already quite complicated.
I would also note that the definitions in the first genetic
information legislation to be enacted would likely set an
important precedent for the future. As genetic science
advances, additional legislation will be needed to address
future issues that we can't predict in advance. Legislation in
this area should be drafted carefully and try and capture what
is unique about the newly emerging genetic technologies.
Again, I thank you for the opportunity to testify on behalf
of the Academy.
[The prepared statement of Mr. Wildsmith follows:]
Statement of Thomas F. Wildsmith, Chairman, Genetic Testing Taskforce,
American Academy of Actuaries, Washington, DC
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------
Chairman Johnson. Thank you, Mr. Wildsmith. We appreciate
your comments.
Dr. Licata, you may proceed.
STATEMENT OF DR. JANE MASSEY LICATA, PARTNER, LICATA & TYRRELL
P.C., MARLTON, NJ
Dr. Licata. Good morning. When the Federal Government first
began really trying to address the issue of genetic privacy and
nondiscrimination it was around 1995, and at that time, I was
pregnant with my youngest child. In September of 2001, I came
before this Committee on his very first day of kindergarten,
and was slightly late, and thank you for your indulgence. And
at that time, we were beginning to really take a serious attack
on the issue, figuring out how to create a balance that fairly
allocated the risks and obligations between all the players in
this very complex situation.
And here we are today, a few years later. He's getting
ready to start the third grade in a few weeks, and some things
have changed, and we've progressed, and we actually have a much
more complex proposal before us, but it actually is very well
crafted and very well balanced. So I would just very quickly
like to talk about what the risks and obligations that we need
to address are, and how the--some of the suggestions that are
currently before us that have been very well stated in the
Senate proposal, could be considered by this Committee and
hopefully the House.
We've talked about HIPPA and all the wonderful things that
HIPPA does. It's a very important legislation. The Act has done
a lot for Americans, but it does not prevent insurers from
collecting genetic information or limit the disclosure of
genetic information about individuals to insurers, and it does
not prevent insurers from requiring applicants to undergo
genetic testing.
We have the ADA. And although the law is a very important
law and we have guidance, it does not explicitly address
genetic information in all cases or deal with unaffected
carriers of a disease who may never get the disease themselves,
individuals with late onset genetic disorders who may be
identified through genetic testing as being at risk of
developing a disease, or others identified through family
history as being at risk for developing the disease. It does
not protect workers from requirements or requests to provide
genetic information to their employers.
And we also have Title VII of the Civil Rights Act, which
could--and I'm a law professor, so I'm always looking for good
arguments--provide a basis that genetic discrimination based on
racially or ethnically linked genetic disorders constitutes
unlawful race or ethnicity discrimination. But there's only
really a few markers where that would be relevant. The two that
have actually been addressed in most stages of legislation are
Tay-Sachs and sickle cell anemia.
Forty-one states have actually enacted some sort of
legislation on genetic discrimination in health insurance, and
31 have enacted legislation on genetic discrimination in the
workplace. So we've come a long way. there's been good
progress. There's been a great public debate.
But we're at a critical point now where we need to create a
basis for all the players in the market. When I speak of all
the players, I'm talking about the individuals who clearly have
a privacy interest to protect themselves and their families;
the researchers, who want to continue this important research
who need to recruit subjects and be able to have as much
information as possible to really get the right answer as to
the relevance of the marker and the correlation to a particular
disease or condition.
We need to talk about business, and not just the people
that are insuring through self-insurance and providing this as
a benefit to their employees, but the companies that need to
get investors, particularly in the biotechnology and medical
industries where people are very concerned about this as an
issue because it creates unpredictability and risk.
We're talking about unpredictability in a genetic marker
and how you interpret it; it's even worse if you're a
biotechnology company and you're trying to raise money, and the
thought of whether if you even could come up with a good
genetic diagnostic or a good genetic therapy, how that would
play out in the marketplace, given people's fears that they're
afraid of what is going to happen to the information once it's
created, because you're opening literally a Pandora's box.
And we're also looking at the broader economy. OK, we're
looking at the issue of the cost to the employer and the cost
in the workplace of protecting this information. But there's a
greater cost in the overall economy for not taking the
opportunities for the best medical care, for not allowing
people to get the information and use the information to
preserve their health and to be able to actually maybe even
reduce health care costs overall, and also basically to be able
to compete in a worldwide economy where we are the leaders
right now in genetic research.
So asking to create a basis where we really have a fair
apportionment of risk and also responsibility is what the bill
that we're currently considering is all about. We're looking at
what is the job of the employer and what is the rights of the
individual. And the perspective on the individual is terrific,
because we are giving the autonomy to the individual to give
the consent as to how their information is used, and we're
putting the responsibility on the company to protect that
information and preserve the public trust. Thank you.
[The prepared statement of Dr. Licata follows:]
Statement of Dr. Jane Massey Licata, Partner, Licata & Tyrell P.C.,
Marlton, NJ
With the completion of the first map of the human genome, we now
have a basis for determining our unique genetic makeup and probable
medical future and to permit personal diagnostics and therapeutics to
be created for us. This is no longer the stuff of science fiction.
Everyday new genetic markers are identified and correlated with human
biology and disease. The future of medicine lies in genomics.
Worldwide, university and pharmaceutical company researchers alike are
mining databases of genetic information and rapidly identifying new
drug targets, diagnostic markers and creating a basis for novel
therapies. Tests designed to determine the presence or version of genes
that cause diseases or conditions carry with them the most intimate
details of our biological past and future as well as a devastating
potential for discrimination. Analysis of our genetic material also
provides information about our parents, siblings and children which
impacts not only on ourselves but on family privacy. The potential for
misunderstanding or misuse of this information is so great, however,
that it is essential that we establish a national policy for the
protection of an individual's privacy interest in their genetic
information.
The Genetic Information Non-discrimination Act is an important and
timely legislative initiative to prohibit health insurance and
employment discrimination against individuals and their family members
on the basis of predictive genetic information or genetic services.
Predictive genetic information is information about an individual's
genetic tests (i.e., the analysis of human DNA, RNA, chromosomes,
proteins, and certain metabolites in order to detect genotypes,
mutations, or chromosomal changes); information about genetic tests of
family members; or information about the occurrence of a disease or
disorder in family members. Information about the sex or age of the
individual, information about chemical, blood, or urine analysis of the
individual, unless these analysis are genetic tests, and information
about physical exams and other information relevant to determining the
current health status of the individual are specifically excluded from
the definition of predictive genetic information. Genetic services are
health services, including genetic tests, provided to obtain, assess,
or interpret genetic information for diagnostic and therapeutic
purposes, and for genetic education and counseling.
An insurer may not deny eligibility or adjust premium or
contribution rates for a group on the basis of predictive genetic
information or information about a request for or receipt of genetic
services. An insurer may also not request or require genetic testing.
Further, the insurer may not request, require, collect or purchase such
predictive genetic information. The insurer may also not disclose
predictive genetic information or a request for genetic services;
disclosures to the Medical Information Bureau and the individuals's
employer or plan sponsor are specifically prohibited. However, with
respect to payments for genetic services, the insurer may request
evidence that such services were performed (but not the results) and if
the evidence is not provided, may deny payment. An insurer may also
request that an individual provide predictive genetic information so
long as such information is used solely for the payment of a claim and
limited to information that is directly related to and necessary for
the payment of the claim (i.e. the claim would otherwise be denied).
Disclosure is limited to individuals within the plan who need access to
the information for payment of the claim.
Prior, knowing, voluntary, written authorization for the collection
or disclosure of predictive genetic information is provided for.
Disclosures between health care providers for the purpose of providing
treatment are exempted.
Civil actions for legal and equitable relief including civil
attorney fees and the costs of expert witnesses are provided for. Civil
penalties, payable to the United States Treasury, are also provided
for. Further, it is provided that these provisions shall not be
construed to supersede any State law provision that more completely
protects confidentiality or privacy or protects against discrimination
with respect to such information.
Further, employers, employment agencies and labor organizations are
prohibited to fail or refuse to hire, discharge or otherwise
discriminate on the basis of predictive genetic information. Employees
may also not be classified on the basis of predictive genetic
information or a request for genetic services. Employers may not
request, require, collect or purchase predictive genetic information
about employees for genetic monitoring without prior, knowing,
voluntary and written authorization by the employee and without
informing the employee of the monitoring results. Genetic monitoring is
the periodic examination of employees to evaluate changes in their
genetic material (e.g. chromosomal damage or evidence of increased
occurrence of mutations) that may have developed during the course of
employment due to exposure to toxic substances in the workplace in
order to deal with adverse environmental exposures in the workplace.
Any monitoring must conform to OSHA or FMSHA requirements. Further, the
results of the monitoring may not disclose the identity of an employee.
Any predictive information about an employee must be treated or
maintained as part of the employee's confidential medical records. A
Federal or State court may award any appropriate legal or equitable
remedy which may include payment of attorney's fees and costs,
including the costs of experts. The EEOC may also enforce.
This bill is a well considered proposal. It addresses some of the
most significant privacy and nondiscrimination issues in a thoughtful
and balanced manner.
Many genetic marker are not conclusively diagnostic but rather may
indicate a predisposition to a disease or condition or may presently be
believed to have a correlation with a disease or condition. In such
cases it would be especially troublesome if the information were relied
upon to make employment or insurance decisions. However, there are well
established genetic markers which can be diagnostic. It is therefore
important that the definitions of genetic information and information
relevant to determining the current health status of an individual not
allow for inadvertent access to some genetic information or test
results. There is also an exception concerning sharing of information
between health care providers for treatment. Again, I would suggest
that health care providers are accustomed to dealing with sensitive,
confidential information, for example HIV status, and accordingly a
blanket exception is not required. The individual's prior written
consent to make the information available between health care providers
should not be an undue burden and helps identify the information as
sensitive and confidential. Further, there is an exception for
information for payment of a claim. This provision places individuals
in the position of paying for the genetic test themselves or risking
the disclosure. While there are provisions that restrict the scope of
the disclosure and to whom the information would be disclosed, I would
suggest that the results never be disclosed an insurer or employer. I
would also suggest that there be clarification as to what would be
sufficient evidence that the services were performed, i.e. a receipt
from a licensed laboratory or health care professional that a genetic
test was performed should be sufficient.
Unfortunately it is those seeking individual health insurance
protection who may be at the greatest risk for discrimination. While
there are provisions that cover individual policies in some instances,
individuals require the same protections as group participants. Also,
while there are provisions for civil suits and administrative actions,
I would suggest that there should be significant penalties for any
knowing violation by an insurer or employer. Under the current scheme,
the employee or insured, who may not have reasonable access to legal
representation, may not be able to effectively protect their privacy
interests. I would therefore suggest the Government take a proactive
role and that there be substantial civil penalties provided for in the
event there is any violation. Clearly, this is provided for to some
extent under the proposed legislation, however, strengthening the role
for government enforcement could be helpful.
While some states, like my state, New Jersey, have enacted genetic
privacy acts, I believe it is essential to establish a consistent,
national policy to protect against genetic discrimination in employment
and insurance and to protect the privacy of this most sensitive and
personal information. These issues cross state boundaries and affect
all of our citizens. New Jersey's Genetic Privacy Act which was enacted
in 1996 declared that genetic information is personal information that
should not be collected, retained or disclosed without the individual's
authorization. The Act prohibits discrimination by employers against
employees carrying genetic markers of diseases or behavioral traits. It
is unlawful for an employer to refuse to hire or employ, or to
discharge or require to retire, an employee because of the employee's
genetic information, or atypical hereditary cellular or blood trait, or
because the employee refused to submit to a genetic test or make
available the results of a genetic test to the employer. It also
prohibits the use of genetic information in the fixing of rates or
withholding of life insurance and bans the use of genetic information
to establish the amount of insurance premiums, policy fees, or rates
charged for a health insurance contract. The penalties for violation of
the provisions of the Act include fines and prison terms. Actual
damages, including economic, bodily or emotional harm proximately
caused, may also be recovered for wanton disclosure of genetic
information. The New Jersey Act is an important first step in
controlling the flow of genetic information, however, Federal
legislation is still needed.
The time is now for the Genetic Information Nondiscrimination Act.
This legislation addresses some of the most urgent needs in protecting
an individual's privacy and in assuring access to genetic testing and
services. Until recently, access to this type of testing was limited to
those who could afford to pay for it privately. By paying it for it
themselves, they could also have greater assurance of confidentiality
concerning the testing and the results. While wider acceptance of the
need and validity of genetic testing has made insurers more comfortable
with reimbursement for this type of service, there is a huge risk to
the insured or employee that very sensitive information, which could
easily be subject to misinterpretation may be widely distributed as a
part of the insurance information system. I would suggest erring on the
side of making such information as inaccessible as possible to third
parties since the risk of misunderstanding or misuse is so great.
______
Chairman Johnson. Thank you, ma'am. Appreciate your
testimony, too, and thank you for coming back.
Mr. Lorber, you may begin your testimony now.
STATEMENT OF LAWRENCE Z. LORBER, ESQ., PARTNER, PROSKAUER ROSE
LLP, WASHINGTON, DC, ON BEHALF OF THE U.S. CHAMBER OF COMMERCE
Mr. Lorber. Thank you, Mr. Chairman and Members of the
Committee. My name is Lawrence Lorber. I am a partner in the
Washington office of the Proskauer Rose law firm and have
practiced labor law in government and private practice for over
30 years. I am here testifying on behalf of the United States
Chamber of Commerce. We are honored to be invited to this
extremely important hearing.
At the Chamber, I am chairman of the Equal Employment
Opportunity Subcommittee of the Chamber's Labor Relations
Committee. The Chamber also serves as co-chair of the Genetics
Information Nondiscrimination in Employment Coalition, the GINE
coalition, which is a group of trade associations and
professional organizations formed to address concerns about
workplace discrimination based on employees' genetic
information.
I have served as a technical adviser to the coalition with
respect to the various genetics bills introduced in the House
and Senate. And briefly, as the Chairman noted, in my prior
government experience, I was the Director of the Office of
Federal Contract Compliance Programs at the Department of Labor
and issued the first regulations under Section 503 of the
Rehabilitation Act, which prohibited discrimination and
required affirmative action with respect to then called
handicapped or disability discrimination. Those regulations
established the principle of job relatedness in the area of
disability discrimination, and they also set the standards for
pre- and post-offer employment medical inquiries of employees.
And I was honored to be appointed to the first board of
directors of the Office of Compliance, the congressional office
which interprets and enforces the Congressional Accountability
Act, which, as you know, applies 11 labor and employment laws,
including the ADA, to the Congress and congressional
instrumentalities.
The issue before the Congress is whether a new Federal law
regulating employer collection and use of information about an
individual's genetic predisposition to disease or disorders is
necessary at this time, and if so, what form should the law
take. However, the Congress and certainly this Committee must
be aware of a very salient fact. It must be acknowledged today
that the workplace is already subject to extensive and complex
statutory and regulatory oversight by Federal, state and local
government. This has created a confusing matrix of overlapping
laws and regulations and imposes a significant cost on our
economy. And while in many cases providing important
protections, also opens the door to abusive, frivolous and
costly litigation.
Therefore, as a matter of sound pubic policy, there ought
to be a reluctance to add to this mass of regulation and a
requirement that any law address a real issue which is not
dealt with by the existing body of employment law. Therefore, I
believe it is critical to make one salient point. There is
simply little or no evidence of employer collection or misuse
of genetic information in today's workplace. This is despite
continued predictions that in the absence of new law, the fear
of increased insurance costs, absenteeism and low productivity
will inevitably drive vast numbers of employers to genetic
testing of the workforce and employment discrimination or
exclusion based upon genetic makeup.
Well, whether it's due to the threat of liability under the
extensive existing protections, fear of public backlash, moral
concerns or simply a lack of interest, employer collection and
misuse of genetic information remains largely confined to the
pages of science fiction. As my testimony makes abundantly
clear, the current body of Federal law, including the ADA,
Title VII of the Civil Rights Act, HIPPA and other Federal laws
are more than ample to deal with any misuse of genetic
information.
And even if there were some lapse in Federal law, 32 states
have laws specifically prohibiting employment discrimination
based upon management makeup. Twenty-six have laws specifically
regulating employer acquisition and disclosure of genetic
information, and 25 states have laws regulating the privacy of
genetic information. Forty-nine states have laws similar to the
ADA.
I would like to discuss the development of the reported
cases in these states except for one problem--there isn't any.
In states such as California, which has, as we all well know,
an extensive employment litigation docket, there are no
reported cases. In New Jersey, which also has a vigorous state
employment litigation practice, there are no cases under the
genetic privacy law.
Employment plaintiff lawyers are not the proverbial potted
plants, nor are they shy about attempting to extend the
parameters of the law. Yet there are no reported cases. If the
states are deemed to be the laboratories for the Federal
Government in this area, the Petri dishes have grown no
cultures.
Perhaps it is because there is no problem, or perhaps it is
because there are sufficient causes of action under existing
law to temper the enthusiasm of any employer which for whatever
reason may wish to exclude someone because of their genetic
makeup.
We would also note that the EEOC, the Federal Government's
primary agency dealing with issues of employment
discrimination, has already taken the position that
discrimination on the basis of genetic information violates the
ADA, and in the one reported case, the EEO swiftly and
effectively dealt with the issue, enjoined the practice and
secured a multi-million-dollar settlement for the alleged
victims.
In conclusion, as the representative of employers and as a
leader in the effort to increase health insurance coverage, the
Chamber of Commerce is excited about the potential of genetic
science leading to more effective treatments and early
interventions. However, we just as strongly believe that an
additional broad workplace regulatory scheme is unnecessary at
this time. Science is not assisted by overregulation and
frivolous litigation.
We appreciate the opportunity to highlight the extensive
existing protections against genetic discrimination as well as
the complete lack of evidence that employers are engaged in the
collection and misuse of genetic information.
Thank you.
[The prepared statement of Mr. Lorber follows:]
Statement of Lawrence Z. Lorber, Esq., Partner, Proskauer Rose LLP,
Washington, DC, on behalf of the U.S. Chamber of Commerce
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------
Chairman Johnson. Thank you, sir. You know, in your written
testimony, I think you mention two concerns that have not been
mentioned in the past. Would you detail those a little bit
further?
Mr. Lorber. Well, there have been some concerns, and as
pointed out by another member of this panel, that there may be
a lapse in the ADA. There may be a gap in the ADA's coverage
with respect to testing. And we don't believe that's the case
the EEOC has taken that position, and I think that
nevertheless, if there is such a gap, if it's identified, we
believe the EEOC in the first instance could deal with it, and
second, to the extent to which even after that experience is
examined, perhaps there might be some need for limited targeted
legislation.
But beyond that, as I indicate in a broad discussion in the
testimony, there are a plethora of laws to deal with it, and
indeed, Congressman Andrews, in your instance, I believe that
individual would have a cause of action under Section 504 of
the Rehabilitation Act as well as the ADA if she were a public
employee. So that I don't believe there simply is a gap that
necessitates this very expansive legislation.
Chairman Johnson. Could you maybe give me a hypothetical
example about how an employer without trying to discriminate
might inadvertently run afoul of the proposed law this coming
out?
Mr. Lorber. Oh sure. Well, the proposed laws, we must
understand, don't only deal with genetic testing, and that's an
issue that's front and center. The genome studies are indeed
studying and mapping genetic information. The proposed laws
deal with genetic history, and indeed the proposed laws have no
limit on the length, the extent to which genetic history or
family history could be found.
Indeed, it's been stated that if there were a descendant of
the Plantagenets working in the United States today and
somebody read one of their histories, an employer could be
found guilty because it knew that someplace in the far distant
past there might be a condition which might be indicative of a
genetic marker.
So there is no limit in the proposed legislation with
respect to what the scope of it is. We're not talking about
genetic testing. We're talking about family history. If an
employer sends flowers to somebody because a parent died of a
condition which might be indicative of a genetic marker, that
employer could be deemed to have genetic information.
So I think that we're looking at laws that are so broadly
framed that there is no exclusion. And indeed, the legislation
before the House, I might add, is the unique situation of
having no limits on damages, no requirement to go to an
administrative agency. This problem, which is a problem perhaps
in the future, is dealt with more severely than the problems of
racial discrimination, disability discrimination and gender
discrimination in which the laws have been carefully tailored
to strike a balance between the remedy and the harm.
Chairman Johnson. I might add that anytime you all have a
comment to make, we would let you do that. That's one of the
benefits of running a Committee. Dr. Hudson, we hear the terms
``predictive'' and ``protected'' genetic information used. Can
you tell us about the significance of those two terms?
Dr. Hudson. Predictive and protected. Predictive genetic
information generally refers to when a genetic test result
gives information that provides a probability that the
individual will develop a disease at some point in the future.
That information is usually based on a person will have a 50
percent increased likelihood of developing a certain disease by
age 60, for example. So it's imprecise information, but it's
valuable in the health context because an individual and their
doctor can put in place preventive measures to decrease that
risk.
Protected genetic information is not used in the medical
context, but is used in the legal context and has been variably
defined. And in fact, how that term is defined is really the
crux of good genetic discrimination legislation. If that
definition is too narrow, then the bill will be meaningless,
and in fact that's the case in many states that do have genetic
discrimination legislation. The definition is so narrow as to
make it virtually meaningless. And in other cases, the
definition is so broad that it includes virtually anything.
For example, the definition of genetic information in the
HIPAA regulations starts out with a fine definition of genetic
information--results of genetic tests, analysis of DNA. And
then it goes on to say it's information from medical
examinations. Well, of course, that brings in almost the entire
universe. So somewhere in between is a nice, precise definition
that will work legislatively.
Chairman Johnson. Thank you very much. Mr. Andrews, do you
care to question?
Mr. Andrews. I want to thank each of the witnesses for
their efforts, outstanding testimony. I especially want to
welcome Dr. Licata back. And I think that your remarks about
balance are correct. I appreciate the contribution that you and
your colleagues and the many groups that support this
legislation made in trying to strike that balance.
Mr. Lorber, I want to ask you some questions. I understand
that part of your position is that existing law would deal with
any problem that might manifest itself. Is that a fair
statement?
Mr. Lorber. That's correct.
Mr. Andrews. I want to walk through the existing law as I
understand it. The EEOC has given an interpretation or issued a
guideline I suppose it is, that says that a genetic
predisposition if used in a discriminatory way, violates the
ADA, correct?
Mr. Lorber. That's correct.
Mr. Andrews. But the EEOC's position is not binding on the
courts, is it?
Mr. Lorber. Well, it's an agency interpretation. As you
well know, in the Burlington Northern case, it acted upon and
enforced that interpretation.
Mr. Andrews. But the court was not compelled to accept that
interpretation, correct?
Mr. Lorber. It's an interpretation that was issued--I would
think it would fall within the Chevron protections of agency
interpretations, but then again, Mr. Congressman, the courts
sometimes don't accept--
Mr. Andrews. But under ADA, it doesn't flow from a
rulemaking or from an adjudicatory proceeding, so it's not due
any specific legal deference, other than what the courts in
their discretion want to give it, right?
Mr. Lorber. The EEOC guidelines have, and I would add that
the impact of the guidelines obviously affects a charge filed
with the EEOC. And if the charge raises those issues, the EEOC
district office will act upon that guidelines and issue
probable cause determination. The individual then could be
represented by the EEOC.
Mr. Andrews. But you don't take the position that those
guidelines bind a court, do you?
Mr. Lorber. Courts could--obviously, courts interpret
regulations and guidelines as they see fit, as we well know.
Mr. Andrews. Is that a no?
Mr. Lorber. And they interpret statutes, as well.
Mr. Andrews. We'll take that as a no. With respect to Title
VII, you point to a couple of cases where there is a
disproportionate racial or gender impact which gives rise to a
Title VII claim. What about cases where the condition or
disease does not give rise to such an impact? For example, my
understanding of dementia, of Alzheimers, is that it cuts
across racial and gender lines rather equally. So if someone
was denied employment because they had a genetic predisposition
toward dementia, are they protected under Title VII?
Mr. Lorber. Well, I think they'd be protected under the
ADA, because remember, the ADA--
Mr. Andrews. I understand your position on ADA.
Mr. Lorber. Well, but let me--
Mr. Andrews. What about Title VII?
Mr. Lorber. Let me talk about Title VII cases, and indeed
Mr. Wildsmith must be aware of the Manhart and the Norris cases
involving sex-based actuarial tables. And the Supreme Court
said, regardless of what the actuarial tables may show, the
reliance upon them to the detriment of somebody who we
certainly don't know when they will die, violated Title VII.
That same analogy, because the ADA brings into its ambit job-
relatedness, would apply to the ADA. So you cannot parse these
laws.
Mr. Andrews. I asked you about Title VII, and I asked you
about a case where someone has a predisposition toward
dementia, where there is to my knowledge no evidence of any
disparate racial impact. Does that lay out a claim of violation
in Title VII?
Mr. Lorber. Well, it may not. But again, we're talking
about the Congress knows a plethora of employment laws, and you
can't parse one and not the other.
Mr. Andrews. I didn't ask about the plethora. I asked about
Title VII.
Mr. Lorber. Well, lawyers deal with the plethora, and
that's their problem.
Mr. Andrews. I know that. But does this lay out a claim--is
it your position that it doesn't lay out a claim under Title
VII?
Mr. Lorber. It depends how the employer and what the
underlying data would show. To the extent to which, for
example--
Mr. Andrews. If the underlying data say that there is no
disparate racial impact for dementia does it lay out a claim
under Title VII?
Mr. Lorber. If hypothetically it doesn't and there's no
gender impact, then perhaps not. But as I said--
Mr. Andrews. The list of state privacy protections that you
cited, that you went through, aren't these privacy protections
preempted by ERISA? So if someone is in an ERISA plan--
Mr. Lorber. That's not been litigated. I don't know that
they are, and--
Mr. Andrews. Is it your position that it is or it isn't?
Mr. Lorber. Well, I would suggest that it may be helpful to
have one body of employment law and not have employers subject
to 32 state laws and a Federal law. So if you're talking about
preemption, if you're talking about this law preempting all of
these state laws, and if this law is carefully tailored, and if
we don't find employers whipsawed, then maybe there are areas
of discussion.
Mr. Andrews. I would never want to prejudge the position of
any group, least of all the Chamber, but the Chamber pretty
consistently has argued for a broad ERISA preemption, and I'd
be surprised if the Chamber didn't argue for a rather broad
ERISA preemption here. If it touches the concerns--
Mr. Lorber. But would this Committee recognize preemption
of the legislation before it with respect to all of these state
laws?
Mr. Andrews. I think the state laws are valid. But for
those who favor a broad ERISA preemption, it seems to me that
you have to draw the conclusion that state laws don't protect
the millions of people who are in ERISA plans, do they?
Mr. Lorber. Well, I don't believe that's--and again, that's
an area of legislation we know about the Delta Airlines case,
which goes one way--
Mr. Andrews. So can we count on the Chamber to argue in
favor of upholding these state privacy laws against an ERISA
preemption claim?
Mr. Lorber. If and when those are litigated, we'll have to
see what the matter is before the court.
Mr. Andrews. We eagerly await your position. Thank you very
much.
Dr. Licata. Could I interject a data point?
Chairman Johnson. You may.
Dr. Licata. Just in case you're interested in knowing, is
that I've actually looked at most of these state laws, and if
you're trying to sort of get a feel for where perhaps the House
version and the Senate compromise version sort of would place
you, is that there's only basically--less than the number of
state laws I could count on one hand. I'm not sure whether it's
four or five. I could double check for you--that would actually
have more stringent requirements. The position that the Federal
legislation is considering is very well balanced and has taken
a lot of these issues into consideration, so that--most states
in fact are much narrower and have a lot of gaps in them, so
that if your concern is what would be the impact of preemption,
is that right now, the Federal Government is extremely on
target in addressing a broad base of concerns.
Chairman Johnson. Thank you. Mr. Carter, you are recognized
for 5 minutes.
Mr. Carter. Thank you, Mr. Chairman. Mr. Wildsmith, on page
2 of your testimony, you claim that basing premiums and
eligibility coverage on specific person's own health is not a
characteristic of the employer-sponsored group insurance
market. Why is that?
Mr. Wildsmith. If you think about an IBM, for instance,
they have tens of thousands of employees. They have millions of
dollars in medical expense each year. It's very easy to predict
what their costs will do from year to year. Whether any
particular employee gets sick or not is not going to move the
number appreciably at all.
With group insurance with any employer of any size, you're
dealing with the aggregate cost for all of the employees and
all of the dependents. So you look at the age, the gender
makeup. You look at the claims from last year, and that gives
you the information you need to predict what next year's costs
are going to be. It's simply not cost effective to ask every
member of the group to undergo medical testing or to pull
medical records on them, because it's the aggregate costs that
count.
Mr. Carter. But you will--I used to be in county
government, and we were self-insured.
Mr. Wildsmith. Yes.
Mr. Carter. And we would hear the argument as our costs
went up, they could individually say it was the money that was
spent by that sick person and by that sick person and by that
sick person, and, you know, we've got these many people that
seem to be headed for being chronically ill and this, that and
the other. And, therefore, the price of poker is going up. But
it's still not--they still don't look at it that it--they're
making the argument to us as county employees, they certainly
made that argument on an individual health basis.
Mr. Wildsmith. If you look at the projections, what's
generally going on is you have X million dollars in claims in
fiscal year 2003. You're projecting them forward to 2004. If
you have a truly catastrophic claim, a really nasty trauma case
or a really nasty neonatal case, that will cause a blip in your
experience, and many employers buy stop loss insurance to
protect against that.
But it's not generally good practice to base your pricing
on an act of God in 1 year, because you purely don't know
whether that's going to reoccur in the next year.
Mr. Carter. You mentioned in your testimony that HIPPA
already prohibits discrimination against the individual members
of a health insurance plan on the basis of current health
status or on the basis of some future predisposition to a
particular disease.
Mr. Wildsmith. Yes.
Mr. Carter. How do these protections work?
Mr. Wildsmith. The easiest way to think of them is to think
about yourself as a new employee with the company and what the
employer can or cannot do. If you meet the requirements, you're
a full time employee, whatever it is to qualify for the medical
benefits, when the open enrollment comes around, the employer
cannot say, eh, you can't come in because you've got cancer or
because your wife had cancer or because you have a genetic
predisposition.
The employer also can't say, well, the contribution is 40
bucks a month for everybody else, but for you, it's 60 because
you're getting a little older, you're a little sicker. We think
you're going to have bad things happen. At core, those are what
the HIPPA protections do.
Mr. Carter. How do the HIPPA privacy regulations address
the de-identification of medical information?
Mr. Wildsmith. I can talk to you about how the information
is used in pricing. I'm not an attorney, so the details of the
privacy rules, I need to step away from.
Mr. Carter. That's fair enough. Thank you, Mr. Chairman. I
yield back my time.
Chairman Johnson. Thank you, Mr. Carter. Mrs. McCarthy, do
you care to question? You are recognized for 5 minutes.
Mrs. McCarthy. Thank you, Mr. Chairman, and I thank the
Committee for bringing this subject to this debate. I think
it's extremely important.
First, I'd like to say that I believe decisions about
generic testing and what to do with the results should be made
by patients and their health care providers without fear of
negative consequences, such as an employer choosing not to hire
them because they carry a gene for a disease. Whether or not
this discrimination is actually happening already, I do believe
that it is happening. But whether you believe it's happening or
not, the fact is that people fear that it's happening or it can
happen to them, and I think that's the part we have to really
start to address there, and therefore will opt out not to get
the testing done unless we in Congress take a definite stance
against this type of discrimination.
There's a family that I've be working with on Long Island
who came to me because they lost their son to a disease called
Long QT, which is a genetic disorder. After this boy's death,
each one of the immediate family members was genetically tested
for the disease, and it was found that some were carriers of
the gene that caused the disease, and one child is actually
having the disease. The child with the disease is now being
monitored and treated, so the genetic testing in this case has
prevented the family from possibly losing another child.
In New York, we already have some legislative protections
against genetic discrimination, health insurance and in the
workplace. And yet this family still experienced concerns about
whether they or their kids would be discriminated against once
people knew they had these genes, and they aren't the only
ones.
Since I introduced my bill to help screen people with
genetic cardiac disease, I have gotten calls from people from
all over the country with this disorder, but also expressing to
me their concerns about genetic discrimination. In January when
I reintroduce this bill, because my bill is not going to go
anywhere this year--we've just run out of time--I plan to add a
clause with regards to the discrimination.
About 40 other states besides New York have taken action to
protect, but as you have mentioned, it's a web, and it is a
web. We've looked at that.
I guess my question to all of you would be, in the Senate
version, which has already passed overwhelmingly, the genetic
discrimination bill, when a health care plan or an employer
misuses an individual's genetic information, what can a person
do? Can you compare for me what rights the individual has in
the same circumstances under the House version which Louise
Slaughter has been trying to get passed for I believe over 5
years? I'm not sure if you're even familiar with it. It's H.R.
1910, which is a lot more in detail. And I think, Dr. Hudson,
more to the point of where it's not too wide and it's not too
narrow from everything that I know, and I believe she's been
working with a lot of the groups that do the genome research
and everything, and I have a place on Long Island, Cold Spring
Harbor, that's doing genome research, and I'm very involved
with them on that issue, too.
Our world is changing tremendously because of the medical
technology that's out there. But I have to say with that, we
are going to have to start looking at things because, you know,
when you do the genetic testing or if you--I'm working with Dr.
Watson, who is doing--looking into cancer, so we can have the
markers. And so it's going to be a new world probably within 5
years even more advanced than what we have out there today.
So I appreciate any insight any of you have on that.
Dr. Hudson. Well, you're exactly right that the fear of the
misuse of this information is very widespread. We've been doing
town halls around the country this summer and talking to
citizens in cities across the United States. And recurrently,
the biggest concern that they share with us is their fear if
they have this test results, it may be misused.
Mr. Lorber raised the issue of, well, there's not really a
whole lot of genetic discrimination cases being brought. But in
those that have been brought, it has not been a normal
American. It has been extraordinary individuals who have
learned about this discrimination and pursued it.
Because in these cases, the employers aren't saying, oh,
and by the way, we're doing these genetic tests. This was
secretive genetic testing, and the fact that it was uncovered
at all is a fairly remarkable testament to the individuals who
were involved in that case.
So it is not widespread cases, but the cases that have been
brought should reflect to us that it's not unheard of that
these cases are happening. So I agree with you there.
The other point I'd like to make is that even without
widespread discrimination, the fear that citizens have is going
with them into their doctor's office and influencing their
decisions of whether or not to have a genetic test and whether
or not to participate in genetic research. We know this is
happening. It's damage now, it's damage today, it's damage that
we can do something to prevent.
Mrs. McCarthy. And just to follow up, I'd like to go
backwards, because I always like to go back in history,
especially medical history. It wasn't that long ago, 30 years
ago, when we started discovering more and more women were
getting breast cancer, and no one in the family would even talk
about cancer, mainly because they felt they would be
discriminated against.
We got over that. We did pass laws to make sure that
someone couldn't be discriminated against, and this is what
we're dealing with now, because we're into a different world of
medicine.
Dr. Licata. If you'd like the answer to the question about
the individual's remedies, there's actually in terms of this
concept I'm trying to promote about if people understand,
everybody understands the rules that we're playing under and
what's important to each stakeholder, that you can come up with
good solutions, is that the currently pending House version
took a more traditional litigation mindset. So if you were
wronged, what could you do as the employee? Well, you could go
to court, and the court could award appropriate legal or
equitable relief and attorney's fees, including the cost of
expert witnesses, which you would definitely need in a case
like this. In cases where your plan sponsor or your insurer
violated any of the provisions. It was a very broad, general
type term you see in Federal legislation.
And there was provision also for civil penalties that were
fairly modest, $50,000 for a first violation, $100,000 for
subsequent violations, and it was paid to the government, and
there was provisions for private right of action. So basically,
if something happened that the law was violated, you had--you
basically would have to be one of these extraordinary
individuals to basically be able to go through all of this
litigation.
What I particularly think is a great provision is what are
people afraid of? I'm going to lose my health insurance.
Mrs. McCarthy. Right.
Dr. Licata. Right? Isn't that the issue?
Mrs. McCarthy. Yes.
Dr. Licata. All right. What does the compromise bill do? It
establishes additional enforcement for violations by allowing
the participant or the beneficiary the right to benefits that
they do under the plan without exhausting administrative
remedies if doing so would cause irreparable harm to their
health.
OK. Right when you have the risk, when they need their
doctor's counsel, when they need the health services to
possibly even mitigate downstream health issues, they would be
able to keep their insurance or get it back fairly quickly.
Great remedy.
In addition, the court can reinstate the coverage
retroactive to the date of violation. OK. There might be a
period where the family can suffer, but they might not be
forced into bankruptcy over these issues. It allows the
Department of Labor--and this is great from my standpoint too--
is I think the best way to get people to comply with the law is
to let them know what the rules are and then say it's a
compliance issue. Build it into your cost of doing business.
But frankly, it's cheaper to do this than to contemplate
litigation. What happens? You're in violation. A hundred dollar
a day fine. What's your cap? Half a million dollars. OK, a
business can deal with that. They can factor that in, and it
would be stupid for them not to make a relevant plan of doing
business that takes into consideration protection of this
information. They do it for HIV. They do it for other very
sensitive information. It's something businesses know how to
do.
So here you have a rational proposal that allows the
business to make good decisions, allows investors to make good
investments in the health care industry going forward for the
next decade, gives autonomy and protection to the individual. I
mean, what a perfect balance.
Mrs. McCarthy. Thank you.
Chairman Johnson. The gentlelady's time has expired. Mr.
Payne, you're recognized for 5 minutes.
Mr. Payne. Thank you very much. This is a very interesting
topic. I'm sorry I missed the testimony, and I might ask a
question that may have been covered in the testimony. But I'd
like to ask Ms. Hudson, Dr. Hudson, the principles of any
generic nondiscrimination bill.
Could you just briefly articulate the principles that any
generic nondiscrimination legislation should encompass? And
this business about core definitions. I didn't get a chance to
go through it, but I know that you highlighted the important of
core definitions for any generic discrimination bill, and I
wonder if you could comment on the existing definition, how
many fall short in your opinion.
Dr. Hudson. So the definition in my view of a genetic test
should incorporate analysis of DNA, of RNA, of proteins, of
chromosomes, and also include beyond that the genetic test of
information from family members. And the broad definition of
genetic information really needs to include the family medical
history information.
So in talking about how that information can be used, I
think we would all agree that it would be unjust if an
individual's employment was conditioned on the health of some
blood relative. I think we would agree that it would be unjust
if their employment were conditioned on whether or not they
carried a genetic mutation that predisposed them to some
genetic disease in the future.
This does not restrict an employer's ability to use
information about a person's current health that interferes
with their ability to currently perform the essential functions
of that job. So we're not altering the ability of employers to
make sure that their workforce is able to do the job.
Mr. Payne. Thank you. Yes?
Mr. Lorber. Well, I would just point out that Dr. Hudson
talked about blood relative. H.R. 1910 is not restricted to
blood relatives. It is absolutely not restricted to blood
relatives. And indeed, I think 1053 has the same infirmity. So
that the extent to which we're looking at genetic information
which is genetically passed down through blood relatives, the
bills don't go beyond that, and that's one of the problems. The
bills are expanded beyond what science seems to think is
appropriate.
Mr. Payne. Dr. Licata, and then we could hear from Dr.
Hudson again.
Dr. Licata. I think it's a really important issue, because
my initial position when I first started thinking about this
issue, was as a scientist. And when I looked at it as a
scientist, I said, why would you ever consider outside of
someone that has a genetic link? Because that's the relevant
information.
And it was pointed out to me something very important which
completely altered my understanding of why the bill is crafted
as it is, which is that we're in the employment context, OK,
we're in the health care context for a family. If this
information is available that someone in the family has a
particular genetic marker, the record does not necessarily and
probably would not reflect if that family member was adopted.
So that what's happening is the whole family, without a
complex explanation or actually even--revealing even more
private information, that a child was adopted or something, you
know, there was some relationship in a family that was not as
it might have appeared to be.
They're still going to have this issue of discrimination in
the workplace, the health care issue, without explanation. What
happens to them during that gap period? So I think that it
makes a lot of sense to put the burden not on the individual
but the burden on the employer, and then you can balance it
out. But the information, it can still be explained, but the
immediate reaction is it covers everybody without asking all of
those underlying questions.
Chairman Johnson. Mr. Lorber, do you care to follow up?
Mr. Lorber. Yeah. The burden we're talking about is the
burden of litigation. And I simply want to point that out. And
second, to the extent to which we're talking about symptomatic
conditions, they are covered by the ADA. To the extent we're
talking about asymptomatic conditions, the Supreme Court in the
Bragden case talked about an 8 percent correlation between
carrying an HIV gene and being HIV positive. Yet they found
that sufficient to find coverage under the ADA.
The point we're trying to make is not that this is an issue
which should be ignored. The point we're simply trying to make
is that this is an issue which we believe is susceptible to the
vast body of law today, and the extent to which we're dealing
with a real problem, I don't know that it's sound public policy
to pass yet another law to have another 18-month period before
the law takes effect, which once the new law is passed, it will
presumption that the old laws don't cover this situation, have
yet a new body of regulations.
This doesn't make any sense when we believe and we've
stated in our testimony, and I think we've taken an expansive
view, as Congressman Andrews noted, an expansive view, of what
the ADA covers. We believe that this is the situation which
should be protected against, but we believe that this is a
situation which is protected against. And that's the problem
we're dealing with.
Do you really want yet another law on top of all the other
laws and have some court, with all due respect, whether they'll
adopt one regulation or another regulation. Then we're going to
have the courts parsing or triaging among all these laws to
determine what little niche this problem fits in. It doesn't
make any sense. And for the employers, the problems that Dr.
Licata are talking about are problems of litigation, and they
are very expensive. They are a disincentive to hiring, and they
are a disincentive to providing the basic level of benefits
that we want employers to provide.
Mr. Payne. Let me just--I guess reclaiming my time, I guess
I might have about 2 minutes left since you preempted my time--
I assume you'll give me my time back. Thank you. I'm not a
lawyer. I didn't know the rules now.
[Laughter.]
Mr. Payne. Let me ask Dr. Licata if you would like to just
comment briefly on that, and then I'd like to hear from Dr.
Hudson and then one last short question.
Dr. Licata. And I guess the point is, is that I'm really
concerned and what I think is the importance of this
legislation is it is a way of managing information. It's
information that is very precious, and it's information where
we have to set forth a national public policy about how we're
going to do business with this type of information, and how
we're going to respect this information that belongs and can
have such a huge impact on a personal interest.
So what I suggest, and if you look at the problem, it's how
to properly manage the information in a business context. We
know how to do that. And it's by creating a scheme that has a
basis of good regulations built on a good, rational law that
allow people to know what the ground rules are. Once they know
that, they will comply with the law so the rare case that's
going to be litigated is not what you should be afraid of. We
should be worried about the huge cost of doing business and the
huge cost to our medical economy, our health care economy, if
we don't step in and make some rational decisions now.
Mr. Payne. Thank you very much. And Dr. Hudson? Thanks, Dr.
Licata.
Dr. Hudson. Thank you. I'd like to respond to Mr. Lorber's
argument that it should be crystal clear to all of us that the
ADA covers genetic discrimination based on predictive genetic
information. He uses in support of that argument a Supreme
Court case, Bragden v. Abbott. That was an HIV case. There is
no HIV gene. There are a number of interesting correlations
between the rationale that was used in that case. It was not a
genetics case, and we have not tested whether or not the ADA
does or does not cover genetic information.
There are cases that are being brought under the ADA where
people who have cancer are not being considered disabled under
the ADA. The notion that somebody who is at risk of developing
cancer would be covered under the ADA I think leaves a lot of
uncertainty and thus the concern among the American public.
Mr. Payne. Thank you. My time is probably--Mr. Lorber, I
just want to ask a simple question. You could probably give
another little response, so it's giving you an opportunity. Let
me just ask you, does the Chamber support the predisposition,
that genetic disposition should be a disability under the ADA?
Mr. Lorber. We believe it is. We believe the agency has
stated that it is.
Mr. Payne. And therefore the Chamber would support that?
Mr. Lorber. The agency has taken that position. And we've
endorsed that position in the testimony.
Mr. Payne. And they agree with the ADA?
Mr. Lorber. That the ADA covers this issue, yes.
Mr. Payne. OK. Thank you.
Chairman Johnson. Thank you, Mr. Payne. If you all have
additional comments, we would accept them in writing. Mr.
Lorber, let me just ask you one quick question. Do you know of
any employer that is considering--that asks people that
question about genetic history before they hire them?
Mr. Lorber. Mr. Chairman, absolutely not. As I said, I'm
Chairman of the Chamber's EEO committee. We asked the Chamber
members, we surveyed the Chamber members, does any employer--
and there are a lot of employers who are members of the
Chamber--conduct genetic testing, as for genetic information,
want to have genetic information--let me go beyond the
Chairman's question. And the response was no, they don't want
it. They don't need it. They don't know what to do with it, and
they're afraid if they have it, they're going to be sued under
all the laws we've talked about.
Chairman Johnson. Thank you.
Mr. Andrews. Mr. Chairman, if I may, I have three unanimous
consent requests--two unanimous consent requests.
Chairman Johnson. Go ahead.
Mr. Andrews. One is I'd like to enter into the record a
list of 23 national health care and advocacy organizations that
are in support of genetic non-discrimination legislation. The
second is, I have statements from our colleague, Congresswoman
Slaughter, who has introduced an excellent bill, and from
Senator Gregg, who championed the bill in the Senate. I'd ask
that those be entered into the record.
The final, if I could make one more--
Chairman Johnson. Without objection, so ordered.
Mr. Andrews. Thank you. Let's be careful when we talk about
employers asking for information to also understand that health
insurers may ask for information, which is where the rubber
really meets the road.
Mrs. McCarthy. Mr. Chairman, may I ask one question that
I'm confused on? I know you want to leave.
Chairman Johnson. Go ahead, Mrs. McCarthy.
Mrs. McCarthy. I'll go down there and talk to--
Chairman Johnson. I might add, you've had 4 minutes
already. We'll give you one more.
Mrs. McCarthy. Well, there's only a few of us here.
Chairman Johnson. One for the road.
Mrs. McCarthy. Let me understand something. Let's just say
I go to the dentist and obviously they basically ask me for my
medical history, has anything changed, and I say no, whatever.
But supposing I did tell them, all right, I've just discovered
I have this. Now when I go outside, each and every one of us
nowadays has to sign a form that says that we are--the Privacy
Act--that we are doing this. I'm not so concerned about my
doctor having all the information in the world. But I also know
if I'm going to a new insurance company, they are going to
research my past history of health care, wherever I have been
in the last two, three, 5 years. Now if I come up, just say,
with something genetic and I'm going to tell my doctor that
because I wanted him to know, you know, what I'm dealing with,
then eventually, if I change insurance companies and another
insurance company gets the information from my doctor, how do
we protect our patients?
Mr. Wildsmith. Actually, in the group market, if you get
your coverage through an employer, they are not going to go
back and pull your medical history.
Mrs. McCarthy. That's actually the part I wanted to know. I
never was clear on that issue.
Chairman Johnson. We'll call you ``ten minute McCarthy.''
Thank you, ma'am.
Listen, I want to thank the witnesses for their valuable
time and your testimony and both the witnesses and members for
their participation and let you know that if you have something
to hand us in writing, we'll take it.
If there's no further business, the Committee stands
adjourned.
[Whereupon, at 11:41 a.m., the Subcommittee was adjourned.]
[Additional material submitted for the record follows:]
Statement of Hon. Judd Gregg, a U.S. Senator from the State of New
Hampshire, Submitted for the Record
The rapid advances in the science of genetics are creating
opportunities for all of society that must not be hindered. At the same
time, these same advances, and the prospects for legislating in this
area, rightly raise serious challenges and concerns that must be fully
understood and addressed. I commend Chairmen Boehner and Johnson for
holding this hearing to review the important implications of genetic
non-discrimination for workers and employers.
Last year we celebrated the 50-year anniversary of the now fabled
discovery by Watson and Crick of the double helix. Also last year, the
Scientists at the NIH Human Genome Project completed the sequencing of
human DNA. These are major historical developments that will
permanently change the course of biological science.
As the science has progressed, so too have reservations with what
we will do with this new information we are uncovering. This new
understanding of the genetic basis of disease holds dangers as well as
opportunities. Although we have yet to see proof of widespread
discrimination, it is difficult to ignore the few, albeit egregious,
cases that have been publicly documented.
Further, we know that individuals are afraid to get genetic tests
or seek genetic counseling out of fear that they will lose their health
insurance or face discrimination in their employment. The medical
progress made possible by genetic research is dependent on the
willingness of study volunteers and patients to undergo genetic
testing. However, such consent can be difficult to obtain today. Fears
about the possible misuse or unauthorized disclosure of genetic
information appear to adversely impact the desire of individuals to
participate in genetic research. Such fears also extend to clinical
practice, discouraging both patients and providers from taking full
advantage of genetic tests and technologies. For instance, a national
telephone survey of more than 1,000 people found that 63 percent of
respondents said they would not take genetic tests if health insurers
or employers could get access to the results.
Because our public policies lag behind the science, the promise of
the Human Genome Project is going unfulfilled. Fear of discrimination,
or even potential discrimination, threatens society's ability to use
new genetic technologies to improve human health and the scientific
community's ability to conduct research needed to understand, treat,
and prevent disease.
After six years of dialogue, numerous hearings, and hours of
deliberation, I am pleased that the Senate adopted important
legislation in this field which was unanimously reported out the
Health, Education, Labor, and Pensions Committee. I am also pleased
that the first civil rights legislation adopted under my Chairmanship
deals with an issue of true 21st Century concerns. This is the first
civil rights act of the 21st Century.
Summary of S.1053, the Genetic Information Nondiscrimination Act
The Genetic Information Nondiscrimination Act, which passed the
Senate on October 14, 2003 by a vote of 95 to 0, establishes in federal
law basic legal protections that prohibit discrimination in health
insurance or employment based on genetic information. It is our belief
that establishing these protections will allay concerns about the
potential for discrimination and encourage individuals to participate
in genetic research and to take advantage of genetic testing, new
technologies, and new therapies.
I want to acknowledge that in drafting this legislation we
encountered many challenges. There are numerous, and sometimes
conflicting, statutes in both the health and employment fields that had
to be reconciled. Likewise, we devoted considerable attention to
crafting definitions that matched the developing science of genetics,
as well as fit with the realities of the workplace and benefits
practices.
The legislation provides substantive protections to those
individuals who may suffer from actual genetic discrimination now and
in the future. Further, it establishes clear, common sense rules that
will prevent confusion, litigation, and, most importantly,
discrimination.
A key component of the legislation is its privacy
provisions. Although current law already contains medical privacy rules
covering genetic information, this legislation addresses some
additional concerns and closes loopholes that are unique to genetics.
For instance, it protects the privacy of genetic information at work
and prohibits the use of genetic information in health insurance
underwriting.
This bill prohibits an employer from making employment
decisions (hiring, firing, etc.) based on genetic information, or even
the fact that an individual or family member requested or received
genetic services.
This bill prohibits health insurance plans from denying
eligibility or enrollment in the health plan based on genetic
information. And it prohibits health insurance plans from charging
higher premiums based on an individual's--or his or her family
member's--genetic information.
Most importantly, the legislation recognizes that all
individuals, whether they are healthy or sick, and ALL medical
information, whether genetic or otherwise, should be afforded the same
protections under law.
While genetic discrimination may not be widespread at this point in
time, this legislation ensures that discriminatory practices will never
become common practice. From the past we have learned that employees,
employers, insurers and others all work best together when the rules
are clear and opportunities for personal achievement and health are
available. This legislation tells everyone what is expected of them and
avoids the trip wires and uncertainty of some of our existing laws.
Unlocking our genetic code unleashes new power. And power produces
new responsibilities in protecting the privacy of our genetic
information and protecting it from misuse. It is my sincere belief that
any concerns about new regulations on employers or health plans are far
outweighed by the benefits of scientific advances that will further
revolutionize the medical field. With no silver bullet solution in
sight to cure what ails our expensive and troubled health care system,
I believe all stakeholders--employees, insurers, health providers, as
well as the employers that provide the health care benefits--will
welcome reasonable legislation that fosters medical advances that can
lead to the prevention and cure of disease.
______
Statement of the Society for Women's Health Research, Submitted for the
Record
The Society for Women's Health Research supports a ban on
discrimination by health insurers and employers on the basis of
predictive genetic information. For several years the Society has
endorsed genetic nondiscrimination legislation. Today we urge the House
Education and the Workforce committee to consider and pass S. 1053, the
Genetic Information Nondiscrimination Act. S. 1053 passed the Senate
unanimously and is supported by the Administration.
Over the past several years, remarkable advances have been made in
the field of human genetics that hold extraordinary promise for
improving the health and quality of life for millions of Americans.
Scientists can use predictive genetic testing to determine an
individual's susceptibility to illnesses such as breast and ovarian
cancer, colon cancer, amyotrophic lateral sclerosis (ALS), and
Alzheimer's disease. The availability of this information can help
people make informed decisions about prevention and treatment options,
and allow them to live longer and healthier lives,
However, the ability to determine genetic predisposition to disease
can also have negative repercussions. Many people who might be helped
by genetic testing are afraid to take advantage of this medical
technology because of tears that their genetic information will be used
against them. Health insurers may deny coverage to individuals who
carry genetic mutations that may cause theta to develop serious or
debilitating diseases later in their lives. As a result, many
individuals choose not to undergo genetic testing or to take part in
medical research.
The Society is particularly concerned about the impact of genetic
discrimination on the participation of women in clinical trials. For
over a decade, the Society has worked to secure the inclusion of women
in medical studies, and to encourage them to take part in this
research. However, women will be reluctant to enroll in clinical trials
if they fear that their medical information will be used against them
by health insurers and employers. Without a guarantee of protection
from genetic discrimination, all of the progress which has been made in
ensuring that women have access to clinical trials will be of little
value, and both women and research will suffer.
The Society encourages the passage of S. 1053, the Genetic
Information Nondiscrimination Act, which will allow Americans to
utilize the enormous potential of genetic testing and further medical
research.
______
Statement of the UJA-Federation of New York, Women's Public Policy Task
Force, Submitted for the Record
The UJA-Federation of New York Women's Public Policy Task Force
submits this testimony to with regards to The Genetic Information
Nondiscrimination Act of 2003 (S. 1053). This historic act will
prohibit discrimination as a result of genetic information with regard
to health insurance and employment.
UJA-Federation of New York is an umbrella organization that raises
funds through an annual campaign of more 77,000 donors and distributes
the funds to a network of more than 100 member agencies serving the
greater metropolitan area of New York. The Women's Public Policy Task
Force of UJA-Federation of New York is an advocacy group comprised of
volunteers and professionals seeking to work with state and federal
legislative bodies in an effort to improve the lives of women and thus
strengthen all communities.
The issue of genetic testing has become increasingly relevant as
the mapping of the Human Genome has been completed and as new advances
in science and technology are continuously being discovered. Many
potentially life-saving genetic tests have been developed, allowing
people to identify their personal risk profile for developing certain
diseases in the future. While the findings of most tests do not
guarantee the development of a disease, the knowledge that a genetic
predisposition exists gives a person the opportunity to take steps that
may prolong or enhance the quality of life.
The genetic testing issue has specific relevance to the Jewish
community. Specific mutations of two genes, commonly known as BRCA1 and
BRCA2, have been proven to indicate a greater risk of developing breast
cancer (it is strongly suspected by the medical community that both of
these mutated genes could also cause prostate/colon cancer). These
genes are prevalent among Ashkenazi Jewish women. As early detection
leads to the highest breast cancer survival rates, it is beneficial for
a woman to find out whether she is at increased risk; having that
knowledge would allow her to be vigilant and ensure early detection.
Women should be free to use this genetic technology without fear of
discriminatory ramifications.
Despite the potential benefits of this genetic test, studies have
shown that women are not likely to undergo a genetic test, regardless
of whether the test would be for their own health reasons or as part of
a scientific research project. The reason why people are shying away
from genetic testing is a pervasive fear of discrimination. Many people
genuinely believe that their eligibility for health insurance or
employment opportunities may be compromised based on their genetic
information.
Underlying the fear of discrimination is the issue of privacy and
the fact that people feel that their private genetic information is not
protected and can be disclosed to any employer or insurer. While
protections relating to health insurance, employment and privacy do
exist to some extent, they are clearly not sufficient to allow people
to be tested with confidence that there will be no negative
repercussions. Discovering an increased risk of disease is traumatic
enough without having to worry about losing employment or insurance
coverage. Existing protections must be improved and better communicated
to the public. It is unacceptable to allow important research to falter
and to let life saving genetic advances go to waste.
The bipartisan Genetic Information Nondiscrimination Act of 2003
(S. 1053) addresses these legitimate fears. This legislation will
establish strong protections against discrimination based on genetic
information both in health insurance and employment. Support for the
bill has come from a wide range of organizations representing patients,
medical professionals, families and employees. We should give all
Americans the comprehensive protections against genetic discrimination
in health insurance and employment they deserve by enacting this
important legislation.
With regard to health insurance discrimination, the Act will:
Prohibit enrollment restriction and premium adjustment on
the basis of genetic information or genetic services.
Prevent health plans and insurers from requesting or
requiring that an individual take a genetic test.
Prevent health plans and insurers from pursuing or being
provided information on predictive genetic information or genetic
services prior to enrollment--the time when this information is most
likely to be used in making enrollment decisions.
Cover all health insurance programs, including those
regulated by the federal government under ERISA, state-regulated plans,
Medigap, and the individual market.
With regard to employment discrimination, the Act will:
Prohibit discrimination in hiring, compensation, and
other personnel processes.
Prohibit the collection of genetic information.
Require genetic information possessed by employers to be
confidentially maintained and disclosed only to the employee or under
other tightly controlled circumstances.
Cover employers, employment agencies, labor
organizations, and training programs.
We are happy to support The Genetic Information Nondiscrimination
Act of 2003 (S.1053), legislation that will protect people from the
threat that their genetic information can be used against them in any
way. We hope that Members of the House will join Members of the Senate
in passing this historic legislation.
______
Letter from CARES Foundation, Inc., Submitted for the Record
July 20, 2004
The Honorable Sam Johnson
Committee on Education and the Workforce
Subcommittee on Employer-Employee Relations
House of Representatives
Washington, DC 20515
RE: Statement for the Record-Hearing on Genetic Nondiscrimination
Policies
On behalf of the CARES (Congenital Adrenal Hyperplasia Education
and Support ) Foundation, Inc., I thank you for holding this hearing on
genetic nondiscrimination policies. This is an issue of great
importance to people with Congenital Adrenal Hyperplasia (CAH) and
their parents.
CAH is a genetic condition which results in the body's failure to
produce either or both of two critical hormones, cortisol and
aldosterone. With diagnosis and proper treatment, people with CAH can
lead normal and healthy lives. In its classical form, it affects 1 in
12-15,000. In its non-classical form, it affects 1 in 100. It is one of
the most common genetic diseases identified to date.
As you know, genetic testing holds enormous promise to prevent
health problems and help people cope more effectively with conditions
that are unavoidable. In the case of CAH, genetic testing can determine
whether parents are carriers of the gene variants that cause CAH. In
addition, genetic testing of a fetus can help begin treatment for this
condition even before birth.
Unfortunately, the same technologies that predict disease through
genetic testing and family history can be used to open the door to
discrimination. Currently there is no federal standard in place to
prevent to use of genetic information to deny people with CAH jobs or
insurance coverage.
This is of personal concern, as my six-year-old son has classical
CAH. Not that anyone could tell; he is a healthy, active, and
intelligent child. But because of his genetic condition, he is at risk
of facing discrimination from employers and insurers; as parents, we
already worry about our family insurance coverage.
As Senate Majority Leader Frist stated on the Senate floor about
genetics nondiscrimination legislation: ``As we greet the future, as we
look at new technology, this is just one example of this body acting
proactively, acting preemptively, so that such potential use in a
discriminatory fashion of medical advances is kept from hurting the
American people. We must take care to protect our body politic, and
this legislation does just that.''
Thank you again for holding this hearing, and the CARES Foundation,
Inc. urges you to support the enactment of genetics nondiscrimination
legislation in order to protect our children.
Sincerely,
Mark Engman
Member of the Board of Trustees
CARES Foundation, Inc.
(Congenital Adrenal Hyperplasia Research, Education and Support)
______
Statement of United Cerebral Palsy, Submitted for the Record
United Cerebral Palsy (UCP) thanks you, Mr. Chair, for conducting
this hearing on the crucial issue of discrimination based on genetic
information, and urges you to give the issue further serious
consideration for meaningful action by the House before this Session of
Congress ends.
For 50 years, UCP has been committed to change and progress for
persons with disabilities. The national organization and its nationwide
network of 105 affiliates in 37 states strive to ensure the inclusion
of persons with disabilities in every facet of society--from the Web to
the workplace, from the classroom to the community. As one of the
largest health charities in America, UCP's mission is to advance the
independence, productivity and full citizenship of people with cerebral
palsy and other disabilities, through our commitment to the principles
of independence, inclusion and self-determination. An integral, and
often overriding, part of our mission is to ensure that people who
experience disability are free from discrimination in all facets of
American society, most especially in the workplace and in the health
care and health insurance arenas.
Clearly, at the dawn of the 21st Century, medical and scientific
advancements, including genetic testing, can improve our lives. Genetic
testing can provide information on how we can prevent future health
problems and cope more effectively with unavoidable conditions. As
advocates for people who daily face discrimination on many fronts
simply because they have a disability, however, we are concerned that
the ability to predict disease and disability through genetic testing
and family history, as valuable as it is, opens the door for yet
another form of discrimination in those extremely sensitive areas of
employment and health care. Employers, for instance, finding that there
is a genetic marker for disease or disability (e.g. breast cancer,
diabetes, some forms of dwarfism, certain learning disabilities, might
refuse to hire a person, assuming there may be an impact on the
business, and the ``bottom line,'' if the person actually contracts the
disease or disability in the future. Insurance companies might refuse
to cover people with genetic markers for ``high-cost'' conditions, or
impose restrictions on coverage.
We were extremely gratified and encouraged when the Senate worked
hard, achieved a compromise and passed the Genetic Information Non-
Discrimination Act, S. 1053, in October of 2003. We have also been
happy to see that President Bush has expressed strong support for the
legislation and promised to sign a bill that mirrors the Senate's
provisions. We are further encouraged that this Subcommittee is holding
a hearing on the issue.
Now it is up to the House of Representatives to pass S. 1053, or
similar legislation, in order to protect American citizens from the
vulnerability experienced by those who are discriminated against for
characteristics, in this case literally imperceptible genetic
characteristics, over which they have no control.
We ask you, as a follow-up to this hearing, to support a vote on S.
1053, or to move similar legislation through the House as soon as
possible.
______
Statement of the Digestive Disease National Coalition, Submitted for
the Record
The Digestive Disease National Coalition (DDNC) applauds Chairman
John Boehner (R-OH) and the members of the House Committee on Education
and the Workforce for initiating this important hearing on Genetic
Discrimination.
Established in 1978, the Digestive Disease National Coalition
(DDNC) is a national non-profit advocacy organization comprised of the
major gastrointestinal voluntary patient organizations and professional
societies. Currently there are 26 member organizations that belong to
the DDNC. The mission of the Digestive Disease National Coalition
(DDNC) is to work cooperatively to improve access to and the quality of
digestive disease health care in order to promote the best possible
medical outcome and quality of life for current and future patients
with digestive diseases. The DDNC has supported and advocated for
genetic non-discrimination legislation for many years
The Digestive Disease National Coalition enthusiastically endorses
the passage of H.R. 1910, The Genetic Nondiscrimination in Health
Insurance and Employment Act as well as S. 1053, the Genetic
Information Nondiscrimination Act of 2003. The DDNC urges the committee
to pass these bills quickly so that Congress can finally address an
issue that has dangerous repercussions for millions of Americans
families. H.R. 1910, is bipartisan legislation introduced by
Congresswoman Louise Slaughter (D-NY) with currently 241 cosponsors
including 27 members of the Education and the Workforce committee. S.
1053 was introduced by Senator Olympia Snowe (R-ME) and passed the
Senate unanimously in October 2003.
This legislation has the potential to assist families, with
inherited chronic and catastrophic disorders, to be able to live
without fear of losing their health insurance coverage or their jobs.
Without safeguards in place employers and health insurance providers
could subvert science to meet their financial bottom line.
The DDNC calls on Chairman Boehner and members of the committee to
pass H.R. 1910, The Genetic Nondiscrimination in Health Insurance and
Employment Act and S. 1053, The Genetic Information Nondiscrimination
Act of 2003 as quickly as possible.
______
Letter from the American Academy of Pediatrics, Submitted for the
Record
July 20, 2004
The Honorable Sam Johnson, Chairman
Employer-Employee Relations Subcommittee
Committee on Education and the Workforce
U.S. House of Representatives
Washington, DC 20515
Dear Chairman Johnson:
The American Academy of Pediatrics urges prompt passage of federal
legislation that would prevent genetic discrimination, thereby allowing
continued progress in prevention efforts through genetic screening and
ensuring that all children have access to health insurance coverage.
The American Academy of Pediatrics is an organization of 60,000 primary
care pediatricians, pediatric medical subspecialists and pediatric
surgical specialists dedicated to the health and well being of all
infants, children, adolescents, and young adults.
The American Academy of Pediatrics strongly supports efforts to
enhance, improve and expand the ability to provide newborn screening,
counseling and health care services. Advances in genetic research
promise great strides in the diagnosis and treatment of many childhood
diseases, detected as early as the newborn period or later in
childhood. With early identification and timely intervention, we have
the ability to significantly reduce morbidity, mortality and associated
disabilities in infants and children affected with certain genetic,
metabolic and infectious conditions.
With these opportunities, however, we also have a responsibility to
ensure that careful consideration is given to the testing and screening
of children so that emerging technologies are used in ways that promote
the best interest of patients and their families. Potential benefits of
genetic screening and testing are limited by the risks of harm that may
be done by gaining certain genetic information, including potential for
discrimination by insurers and employers. For this reason the American
Academy of Pediatrics supports passage of legislation that protects
children and families from genetic discrimination.
Furthermore, the American Academy of Pediatrics is concerned that
genetic discrimination is a barrier for families to access health
insurance for their children. More than 9 million children are
currently uninsured in this country, and millions more are
underinsured. We will never achieve our goal of ensuring that every
child has health insurance coverage if genetic discrimination is
permitted. The American Academy of Pediatrics therefore urges Congress
to pass legislation that protects American families from genetic
discrimination.
Sincerely,
Carden Johnston, M.D., FAAP
President
American Academy of Pediatrics
______
Statement of The Arc of the United States, Submitted for the Record
The Arc of the United States thanks the House Committee on
Education and the Workforce Subcommittee on Employer-Employee Relations
for holding this important hearing on the crucial issue of
discrimination based on genetic information. We urge you to give the
issue serious consideration for action by the House before the close of
the 108th Congress.
The Arc of the United States (The Arc) is the national organization
of and for people with mental retardation and related developmental
disabilities and their families. Through its approximately 900 state
and local chapters, The Arc is devoted to promoting and improving
supports and services for people with mental retardation and their
families. The association also fosters research and education regarding
the prevention of mental retardation in infants and young children. An
integral part of our mission is to ensure that people who experience
mental retardation or related disabilities are free from discrimination
in all facets of society, including in the workplace and in the health
care and health insurance arenas.
As you know, genetic testing can improve our lives by providing
information on how we can prevent future health problems and cope more
effectively with unavoidable conditions. As advocates for people with
mental retardation who daily face discrimination, however, we are
concerned that the ability to predict disease and disability through
genetic testing and family history, as valuable as it is, opens the
door for yet another form of discrimination in the extremely sensitive
areas of employment and health care coverage.
We are very concerned about the possible misuse of genetic
information for families where mental retardation or related
disabilities are present or predicted. With evidence of genetic markers
for impairments (such as Down Syndrome, Fragile X Syndrome, and others)
in individuals or their children, insurance companies might refuse to
cover people with potential for ``high-cost'' conditions, or impose
restrictions on coverage for ``pre-existing conditions''. In addition,
employers, finding that there is a genetic marker for a disability,
might refuse to hire a person, assuming there may be an impact on the
company's health insurance premiums, absenteeism, or other costs of
doing business, if the employee should give birth to a child with the
disability in the future.
Last fall, the Senate, achieved a compromise and passed the Genetic
Information Non-Discrimination Act, S. 1053. President Bush has
expressed strong support for the legislation and promised to sign a
bill that mirrors the Senate's provisions. We are encouraged that the
Subcommittee on Employer-Employee Relations is holding this hearing on
the issue.
We urge the Subcommittee and the full House of Representatives to
pass S. 1053, or similar legislation, in order to protect American
citizens from the vulnerability experienced by those who are
discriminated against for genetic characteristics. We would be happy to
assist the Subcommittee regarding the issues that could affect people
with disabilities and their families.
______
Statement of the Alpha-1 Association and the Alpha-1 Foundation,
Submitted for the Record
Last fall the Senate passed the Genetic Information
Nondiscrimination Act of 2003 by a vote of 95 to 0 giving us great hope
that federal protections against the misuse of genetic information
would finally be put into place. The Alpha-1 Association and Alpha-1
Foundation support S. 1053 and H.R. 1910 believing there is a great
need to protect all Americans from genetic discrimination.
We need to live without fear of retribution in the form of genetic
discrimination. In the absence of federal legislation, states have
implemented a patchwork of laws that shield individuals from employment
and insurance discrimination. We need national policy to ensure that
all Americans have the same protections. Genetic testing allows
individuals to exercise preventative health measures, seek appropriate
therapies, and engage in essential life planning. Unfortunately, this
same information may be used to discriminate against individuals who
have no control over their inherited condition. S. 1053 and H.R. 1910
protect individuals who fear that genetic information could be misused
to ruin job opportunities, forcing them to choose between the benefit
of testing and the risk of losing employment or insurance.
Why are S. 1053 and H.R. 1910 important to individuals with Alpha-1?
As a genetic condition, those with Alpha-1 or seeking
Alpha-1 testing may face health and employment insurance
discrimination. Fear of genetic discrimination may also significantly
impact individual and family decision making.
The Alpha-1 Foundation's Ethical Legal and Social
Implications (ELSI) Working Group, has continued to discourage general
population screening in absence of protective legislation.
Those concerned about the ethics of genetic testing have
recommended Targeted detection for Alpha-1 for those currently
suffering from defined lung disease such as COPD or a family history of
Alpha-1.
The Alpha-1 Coded Testing Trial1 has offered
individuals an opportunity to receive confidential test results since
September of 2001; to date over 2,400 test kits have been requested. Of
those returning the test kits and responding to the survey
questionnaire:
---------------------------------------------------------------------------
\1\ The ACT Trial is funded by the Alpha-1 Foundation and conducted
at the Medical University of South Carolina under the direction of Dr.
Charlie Strange, Program Director. The ACT Trial offers a free and
confidential finger-stick test that can be completed at home with
results mailed directly to the participants. The test is administered
through a research study which evaluates perceived risks and benefits
of genetic testing. For more information or a test kit please email the
Registry Coordinator at [email protected], or call toll free at 1-
(877)-886-2383.
---------------------------------------------------------------------------
- Over 30% report fear of losing insurance as the reason for
seeking confidential testing;
- 34% report concern about facing higher health care costs if
results were public;
- 85% seek testing for the Genetic Knowledge. In fact, this
was the most popular response to the perceived benefits of
seeking testing.
Alpha-1 Antitrypsin Deficiency is an inherited genetic disorder
that can result in devastating and fatal lung disease that is often
misdiagnosed as asthma or Chronic Obstructive Pulmonary Disease. Alpha-
1 afflicts an estimated 100,000 individuals in the US with fewer than
6,000 accurately diagnosed. Alpha-1 is a major cause for lung
transplantation in adults and the second leading cause of pediatric
liver transplants.
______
Letter from the National Marfan Foundation, Submitted for the Record
July 21, 2004
The Honorable Sam Johnson, Chair
House Education and Workforce Committee, Subcommittee on Employer-
Employee Relations
2181 Rayburn House Office Building
United States House of Representatives
Washington, DC 20515
The Honorable Robert E. Andrews, Ranking Member
House Education and Workforce Committee, Subcommittee on Employer-
Employee Relations
2181 Rayburn House Office Building
United States House of Representatives
Washington, DC 20515
Dear Chairman Johnson and Ranking Member Andrews:
On behalf of the National Marfan Foundation, I would like to submit
this statement on Genetic Non-Discrimination. The National Marfan
Foundation represents approximately 20,000 members throughout the
United States. Marfan syndrome is a life threatening genetic disorder
that results in weakening of the aorta, the main artery that carries
blood away from the heart. With time, progressive enlargement of the
aorta causes leakage of the aortic valve or tears in the aorta wall,
which in some instances can cause death within a few minutes.
In 1991, researchers discovered the gene responsible for Marfan
syndrome, fibrillin-1. This was a dramatic step to help understand the
underlying causes of the syndrome and the hope to finding treatments
that may cure this disorder. Individuals with Marfan syndrome now face
the fear of being labeled as having a genetic disorder, a label which
employers and health insurers may use to deny their access to
employment and healthcare. This discrimination causes under utilization
of genetic tests that may be used to help diagnose other members of the
family and ultimately save their lives.
The National Marfan Foundation urges you to consider federal
legislation that contains strong genetic discrimination protections as
described by the Coalition of Genetic Fairness. Passage of legislation
this year would greatly benefit the millions of people affected with a
genetic disorder.
Sincerely,
Josephine Grima, Ph.D.
Director of Research and Legislative Affairs
National Marfan Foundation
______
Letter from the American Association for the Advancement of Science,
Submitted for the Record
July 20, 2004
The Honorable Sam Johnson
U.S. House of Representatives
1211 Longworth House Office Building
Washington, DC 20515
Dear Representative Johnson:
On behalf of the American Association for the Advancement of
Science (AAAS), I am writing to bring to your attention the conclusions
of a AAAS working group concerning the need to protect against genetic
discrimination.
The completion of the human genome sequence has raised hopes of a
medical revolution, but to take full advantage of this momentous
achievement, we must ensure the highest levels of public confidence
that genetic information will be used appropriately to improve health
and not to discriminate unfairly against people. The Senate has taken a
great stride toward this goal by passing S. 1053, the Genetic
Information Nondiscrimination Act, which is consistent with the
conclusions of our working group. AAAS encourages the House to consider
similar action as it deliberates on H.R. 1910.
The working group released a statement in 1999 which included the
following conclusions:
Individuals should be able to gain information about
their genetic makeup, but should be able to protect themselves against
discrimination by controlling access to such information.
Genetic information should be used only to enhance, not
undermine, an individual's quality of life. Society, therefore, in
pursuit of the common good, has a responsibility to protect citizens
against the misuse of genetic information.
Policies should be adopted to ensure opportunities for
people to participate in research studies and clinical trials without
fear that their genetic information could adversely affect their health
insurance status.
Founded in 1848, AAAS is the world's largest general scientific
society and publisher of the journal, Science. The Association serves
some 262 affiliated organizations in more than 130 countries, serving
some 10 million individuals. The non-profit AAAS is open to all and
fulfills its mission to ``advance science and serve society'' though
initiatives in science policy and more.
The complete genetic discrimination working group statement is
available on the AAAS website at http://www.aaas.org/spp/dser/
bioethics/resources/gdiscrim.shtml. For further information, please do
not hesitate to contact Joanne Padron Carney of the AAAS Center for
Science, Technology, and Congress at 202/326-6798, or you may call my
office.
Sincerely,
Alan I. Leshner
______
Statement of the Genetic Alliance, Submitted for the Record
The Genetic Alliance is an alliance of genetic disease advocacy
groups, which represent millions of individuals. We understand the
promise of advanced medical research and are appalled that many
families and individuals have experienced genetic discrimination.
We urge the House of Representatives to consider and pass the
Genetic Information Nondiscrimination Act [S. 1053], to prohibit
discrimination on the basis of genetic information with respect to
health insurance and employment. We believe that all genetic
information, including family history, deserves strong and enforceable
protections against misuse in health insurance and employment. Such
safeguards will protect the rights, privacy and confidentiality of the
individual and their family.
This is an exciting and hopeful time for medicine. It is
imperative, however, that we, the public, be able to take full
advantage of new medical advances that could help prevent disease
before it develops. Genetic nondiscrimination legislation will reduce
the likelihood of genetic information being misused in health insurance
or employment decision-making. Genetic information is merely predictive
information. Simply having a positive genetic test does not mean one
will develop a disease--thus this information should not be used to
make decisions about insurance coverage or employment.
As biomedical research advances, genetic testing will become a
critical tool in the provision of healthcare. As a result, many more
people will know about their own genetic makeup, putting them at risk
of genetic discrimination. People who would like to avail themselves of
genetic testing already have enough to worry about. They should not
have the additional burden of genetic discrimination.
And so, on behalf of thousands of consumers and patient groups, we
urge Speaker Hastert to move S. 1053 off the desk and bring it to a
vote. President Bush has said he'll sign it. Public policy must keep
pace with scientific advances, and provide those advances with a
climate conducive to their translation into health benefits for all
Americans.
______
Statement of the American Academy of Family Physicians, Submitted for
the Record
The 93,700 member American Academy of Family Physicians submits
this statement for the record in support of HR 1910/S 1053, the Genetic
Information Nondiscrimination Act of 2003, which would prohibit genetic
discrimination in health insurance and employment. The AAFP strongly
supports effectively translating genetic advances to the practices of
primary care physicians, who provide most of the health care the
majority of Americans receive. Primary care physicians will need to
receive appropriate education and training, and research translation
needs to include the development of primary care tools for delivering
the fruits of genetic advances to all Americans. Nevertheless,
Americans must be legally protected from discrimination based on their
genetic make up, which is the goal of this legislation.
Background
Completion of the sequencing of the human genome of April 2003,
inaugurated an era in which genetic information will become an
increasingly indispensable part of quality health care. Researchers
predict the advent of individualized treatment, ranging from preventive
strategies to ``designer drugs,'' specifically formulated for a
patient's genetic makeup.
With these potential benefits, however, comes potential for the
abuse of personal information in non-healthcare settings such as
insurance and in the workplace, abuses that the above measures have
been designed to address. For example, HR 1910/S 1053 would forbid
insurance companies from restricting enrollment or changing premiums
based on an individual's genetic makeup. The bill also would ban
discrimination based on genetic information in the workplace.
Underpinning these issues are patients' concerns about the privacy of
their genetic information and informed consent. In short, with the
proliferation of new genetic information, lawmakers must determine how
to protect this sensitive health data.
Relationship to Primary Care
In addition to concerns about discrimination, family physicians are
keenly interested in the impact that genetic information will have on
their individual practices. Specifically, family physicians want
genetic research translated into information that can be used to help
their patients. Family physicians do address patients' illnesses, but
more importantly, they help patients integrate information about all of
their health conditions with their particular life goals. This
important family practice function will need new tools to deal with
genetic information, including the ability to perform diagnostic
genetic tests in the physician's office.
Currently, family physicians conduct almost 200 million office
visits each year, which is 73 million more visits than any other
medical specialty. In addition, according to ``The Ecology of Medical
Care Revisited,'' (New England Journal of Medicine, 2001, 344:2021-25)
more than 12 times as many people are seen in the offices of primary
care physicians as in hospitals. The sheer number of visits to family
physicians, as well as to other primary care doctors, means that most
Americans will approach them first about questions on genetic
information. We wish to be able to counsel our patients about these
issues without fear that this information could somehow be used against
them in insurance or employment.
Education and Training
Education and training of primary care physicians in genetic
information, testing diagnosis and counseling is also critical. Long
the province of subspecialists, the Genetics in Primary Care Initiative
(GPC), supported by three federal agencies (Health Resources and
Services Administration; National Human Genome Research Institute and
the Agency for Healthcare Research and Quality) was established to
``plan, implement, and evaluate outcomes of training programs in
genetics.''
As W. Burke, et al., point out, (``Genetics in Primary Care,''
Community Genetics, 2002; 5:138-146) ``Genetic tests have become
increasingly accurate in diagnosing both chromosomal and single gene
disorders and predictive tests have begun to emerge--'' Primary care
physicians need to be trained to administer and interpret these tests
so that they can provide appropriate counseling and referrals.
In addition, the Advisory Committee on Training in Primary Care
Medicine and Dentistry, which Congress established to review primary
care training programs that support family medicine, general internal
medicine and pediatrics, general dentistry and physician assistants,
also recognized the emerging field of genetic training. Its November
2001 report states, ``Primary care training programs are ideally
positioned to react quickly to meet ever-changing health care needs and
issues, whether they are related to HIV/AIDS, growing numbers of
elderly with chronic illnesses, implications of the modern genetics
revolution, the threat of bioterrorism, or other issues that will
continue to emerge and demand rapid educational intervention.''
Conclusion
While genetics is still a relatively young field, now is the time
for developing the plan to deliver genetic testing and treatment
discoveries to all Americans. There is no better mechanism for applying
these discoveries than the primary care workforce, but this workforce
will need new and special preparation and tools. The lag between
discovery and delivery in healthcare is typically 17 years, and the
primary care workforce-training pipeline is 7 or more years. The
federal government will need to be proactive in its planning and
support if Americans are to realize the fruits of genetic discoveries
in the next decade.
______
Statement of the National Workrights Institute, Submitted for the
Record
THE NEED FOR GENETIC NONDISCRIMINATION LEGISLATION
During the past several decades, our understanding of genetics has
multiplied as procedures for identifying, analyzing and manipulating
DNA have advanced. Among the many benefits of these efforts are the
ways they may influence preventive health, reproductive planning and
eventually therapies to cure illnesses with a genetic component. No one
can deny that this knowledge may be a blessing in finding cures to
diseases with genetic origins, including Alzheimer's, Huntington's and
many forms of cancer. Nevertheless, the ability to identify individuals
based on genetic characteristics necessarily predates the ability to
use this information in the treatment of the corresponding diseases and
therefore the immediate consequences of such advances have and will
continue to lead to a number of forms of individual discrimination.
Genetic Discrimination in the Workplace:
Employers are beginning to acquire and use genetic information. In
a 2001 survey of U.S. firms almost 2% were currently conducting genetic
tests for Sickle Cell and Huntington's Disease, 14% were acquiring
genetic information during workplace susceptibility testing and 20%
reported requesting family medical histories containing information on
the likelihood of disease.\1\
---------------------------------------------------------------------------
\1\ American Management Association. ``Summary of key findings.''
2001 AMA Survey on Workplace Testing: Medical Testing
---------------------------------------------------------------------------
As the acquisition of genetic information by employers increases
there have been numerous examples of discrimination. Consider:
* In a 1996 Georgetown University study of 332 families belonging
to genetic disease support groups, 22% of the respondents stated that
they that they had knowingly been refused health insurance and 13%
stated that they had knowingly been terminated from their jobs because
of the perceived risks attributed to their genetic status.
* Lawrence Berkeley Laboratories conducted testing of their
employees for sickle cell trait throughout the 1990's without their
knowledge and consent for decision-making purposes.
* In 1999 Terri Sargent, despite excellent past performance
reviews was fired from her job for having the genetic predisposition to
Alpha-1 disease though she remained asymptomatic.
* In 2001 Burlington Northern Railroad conducted genetic testing
of their employees for carpal tunnel syndrome for purposes of refuting
workers compensation claims.
Public Concern:
There has been continuing widespread concern in this country about
the potential for misuse of genetic information. Consider:
* A Harris Poll taken in 1995 of the general public finds 86% of
those surveyed indicated they were very concerned or somewhat concerned
that employers and insurers might have access to and use genetic
information.\2\
---------------------------------------------------------------------------
\2\ Harris poll, 1995, 34
---------------------------------------------------------------------------
* A 1996 study finds 87% of respondents would not want their
employers to know that they were tested and found to be at a high risk
of a genetic disorder.\3\
---------------------------------------------------------------------------
\3\ E. Virginia Lapham. Et al. ``Genetic Discrimination:
Perspectives of Consumers.'' Science, October 25, 1996, p.622
---------------------------------------------------------------------------
* In 1997 a survey finds that 63% of participants reported they
would not take genetic tests for disease if employers and health
insurers could access the results.\4\
---------------------------------------------------------------------------
\4\ National Center for Genome Resources unpublished survey, 1997.
Cited in Department of Labor ``Genetic Information and the Workplace'',
January 20, 1998.
---------------------------------------------------------------------------
* In a 2000 CNN/Time Magazine Poll 80% of those surveyed did not
believe employers or insurers should have access to genetic
information.
* A 2003 poll found 69% of respondent surveyed were very worried
or somewhat worried that employers and insurers would discriminate
using genetic information.\5\
---------------------------------------------------------------------------
\5\ Genetic Engineering News (GEN) Website poll
(www.genengnews.com).
---------------------------------------------------------------------------
Restrictions must be placed on the accumulation and use of genetic
information by employers before discrimination becomes rampant. There
is a pressing need for Congress to pass genetic nondiscrimination
legislation to address this issue. The overwhelming demand by the
American public for such legislation is clear. Without meaningful
privacy safeguards and protections against discrimination, the benefits
of genetic testing will ultimately be lost as individuals avoid tests
in the fear of adverse consequences. Indeed, if one really doubts this
growing trend of genetic discrimination consider asking an employer the
following question: ``If an inexpensive and accurate test existed that
would indicate that an individual had a predisposition to a particular
illness that would cost thousands of dollars to treat and limit their
ability to perform would you be interested conducting and using such
testing?''
______
Statement of the National Breast Cancer Coalition, Submitted for the
Record
I am Fran Visco, a breast cancer survivor, a wife and mother, a
lawyer, and President of the National Breast Cancer Coalition (NBCC).
On behalf of NBCC, and the more than 3 million women living with breast
cancer, I would like to thank you for the opportunity to provide this
testimony.
The National Breast Cancer Coalition is a grassroots advocacy
organization made up of more than 600 organizations and tens of
thousands of individuals and has been working since l99l toward the
eradication of breast cancer through advocacy and action. NBCC supports
increased funding for breast cancer research, increased access to
quality health care for all women, and increased influence of breast
cancer activists at every table where decisions regarding breast cancer
are made.
With the knowledge of the human genome expanding exponentially, the
National Breast Cancer Coalition (NBCC) believes strongly that
legislative and regulatory strategies must be established to address
the protection of individuals from the misuse of their genetic
information at the national, state and local levels of government.
Genetic information is uniquely private information that should not be
disclosed without authorization by the individual. Improper disclosure
can lead to significant harm, including discrimination in the areas of
employment, education, health care and insurance.
In 1996, the Health Insurance Portability and Accountability Act
(HIPAA, P.L.104-191), also known as HIPAA, was the first federal law
that took some significant steps toward extending protection with
regard to genetic discrimination in the health insurance arena. HIPAA
mandated the Department of Health and Human Services (HHS) to create
privacy standards to prevent unwarranted disclosures of medical
information if Congress did not enact privacy legislation by August
1999. After this deadline passed, HHS established the standards for
privacy of individually identifiable health information (known as the
``privacy regulation''). While the privacy regulation establishes some
guidelines for the methods of disclosure and access to medical
information by health plans and providers, it does not specifically
address the issue of genetic discrimination. Moreover, even within the
health care arena, the privacy regulation does not extend to all group
plans.
The time is now to extend protections against genetic
discrimination to everyone. The release of the working draft of the
human genome sequence in June 2000 and the development of new genetic
tests necessitate legislative and regulatory strategies to address the
issue of how to protect individuals from the misuse of their genetic
information.
Furthermore, the fear of potential discrimination threatens both a
woman's decision to use new genetic technologies and to seek the best
medical care from her physician, and the ability to conduct the
research necessary to understand the cause and find a cure for breast
cancer. Fear of discrimination can also prevent individuals from
enrolling in clinical trials and forgoing possible life-saving
treatment.
NBCC strongly supports the enactment of legislation that would
protect millions of individuals against discrimination not only in
health insurance but also in the workplace, and that would provide
strong enforcement mechanisms that include a private right of action.
For these reasons, NBCC supports H.R. 1910 (Slaughter) the Genetic
Nondiscrimination in Health Insurance and Employment Act. This
legislation prohibits health plans from:
Requesting, requiring, collecting or disclosing genetic
information without prior specific written authorization of the
individual;
Using genetic information, or an individual's request for
genetic services, to deny or limit any coverage for established
eligibility, continuation, enrollment or contribution requirements;
Establishing differential rates or premium payments based
on genetic information, or an individual's request for genetic
services.
This legislation also prohibits employers from:
Using genetic information to affect the hiring of an
individual or to affect the terms, conditions, privileges, benefits or
termination of employment, unless the employment organization can prove
this information is job related and consistent with business necessity;
Requesting, requiring, collecting or disclosing genetic
information prior to a conditional offer of employment; or under all
other circumstances, requesting or requiring collection or disclosure
of genetic information unless the employment organization can prove
this information is job related and consistent with business necessity;
Accessing genetic information contained in medical
records released by individuals as a condition of employment, in claims
filed for reimbursement for health care costs, and other services;
Releasing genetic information without specific prior
written authorization of the individual.
Most importantly, H.R. 1910 contains strong enforcement language
and provides individuals with a private right of action to go to court
for legal and equitable relief if they are a victim of genetic
discrimination, whether they are subject to discrimination by their
health plan or their employer.
NBCC does not support the Genetic Nondiscrimination in Health
Insurance and Employment Act (S.1053) passed by the Senate on October
14, 2003 because it does not contain sufficient enforcement provisions.
Unlike H.R. 1910, S. 1053 does not provide individuals with a private
right of action should they become a victim of genetic discrimination
in the individual insurance market.
NBCC's number one legislative priority if guaranteed access to
quality health care. However, the only way to guarantee patients have
access to the care they deserve is to provide strong enforcement. If
health care providers, employers, and insurance companies comply with
the law, then those enforcement mechanisms will never have to be used.
But as patients, we need to know that they are in place for our
protection.
NBCC believes that a right with no enforcement is really no right
at all. It is for that reason that no matter how carefully a bill is
worded, no matter how much effort is put into including ``protections''
that breast cancer patients need--if that bill does not have a strong
enforcement mechanism, then NBCC simply will not support it.
I urge you to consider and pass legislation that will protect
individual's privacy and guarantee them access to quality health care
by passing legislation to prevent genetic discrimination that includes
meaningful enforcement provisions, such as H.R. 1910. Thank you for the
opportunity to share the views of the National Breast Cancer Coalition.
______
Statement of the National Council on Disability, Submitted for the
Record
Principles for Genetic Discrimination Legislation
Protections for Individuals with Actual Health Conditions: The same
interpretations that make the ADA difficult to enforce by individuals
with genetic markers make it difficult to enforce by individuals with a
range of health conditions. When Congress considers protections for
individuals who experience discrimination based on genetic information,
it should also ensure that if these individuals are eventually
diagnosed with medical conditions, they will be protected against
discrimination.
Workplace Discrimination: Employers must not be permitted to use
predictive genetic information as a basis for taking any employment
actions or as a term or condition of employment. Nor should employers
be permitted to use this information to limit, segregate or classify
employees or job applicants.
Employers' Collection of Information: Employers should be permitted
to request predictive genetic information only: (1) to monitor effects
of toxic substances in the workplace upon an employees' written consent
to such monitoring, with the employer receiving only aggregate results
and not results for particular employees, or (2) to provide genetic
services to employees upon the employees' written consent. In either
case, results should be provided only to the employee.
Employers' Disclosure of Information: Genetic information must be
kept strictly confidential and maintained separately from personnel
files and other employee information. It should be disclosed only to
the employee, officials enforcing this legislation, or as required by
other federal laws.
Insurance Discrimination: Insurers must not be permitted to make
decisions about enrollment in health, life, disability, or other types
of insurance based on genetic information. They must also be prohibited
from using genetic information in determining premium or contribution
rates, or other terms or conditions of coverage. They must be barred
from requesting or requiring genetic tests.
Collection of Information by Insurers: Insurers must not be
permitted to request, require, collect or buy genetic information
except for the limited purpose of paying for claims for genetic testing
or other genetic services. Strict protections must ensure that when
such information is requested, it is not used to affect an individual's
enrollment, premiums, or terms or benefits of coverage.
Disclosure of Information by Insurers: Insurers must be prohibited
from disclosing genetic information to employers, entities that collect
or disseminate insurance information, or health plans or health
insurance issuers except in the limited circumstance of payment for
claims.
Health Care Discrimination: Legislation must bar health care
providers from refusing treatment to individuals, or treating them
differently, based on genetic information.
Collection of Information by Health Care Providers: Legislation
must prohibit health care providers from requiring, requesting, or
collecting genetic information about individuals who are seeking
treatment. Providers may only collect this information for the purpose
of providing genetic testing or other genetic services.
Disclosure of Information by Health Care Providers: Health care
providers must not be permitted to disclose genetic information except
to the patient, to insurers only for the limited purpose of seeking
payment for genetic testing or genetic services rendered, to officials
enforcing this legislation, or as required by other federal laws.
Education and Technical Assistance: Funding should be provided for
education and technical assistance in order to ensure that individuals
affected by the legislation are aware of its requirements.
Effective Enforcement: A private right of action to enforce genetic
discrimination legislation must be included. The EEOC should have
authority to investigate and resolve complaints relating to employment.
The full range of remedies, including attorney's fees, must be
available.
Relationship to Other Laws: Legislation must not preempt existing
state or federal laws to the extent that they provide greater
protections for individuals who experience genetic discrimination.
Position Paper on Genetic Discrimination Legislation
Introduction
The National Council on Disability (NCD) is an independent federal
agency that advises the President and Congress on issues affecting 54
million Americans with physical and mental disabilities. NCD's
fundamental purpose is to promote policies, programs, practices, and
procedures that guarantee equal opportunity for all individuals with
disabilities, regardless of the nature or severity of the disability;
and to empower individuals with disabilities to achieve economic self-
sufficiency, independent living, inclusion, and integration into all
aspects of society.
For a number of years, NCD has recognized the harmful effects of
discrimination based on individuals' genetic information and supported
the need for federal legislation prohibiting genetic discrimination as
well as the enforcement of existing legislation that may prohibit
certain types of genetic discrimination. It has addressed the issue of
genetic discrimination in several reports, including the following:
Achieving Independence: The Challenge for the 21st
Century. July 26, 1996 (expressing serious concern about the quandaries
and implications of obtaining and using genetic information; calling
for further examination of the interface of genetic testing practices
with antidiscrimination law and access to health insurance for people
with disabilities).
National Disability Policy: A Progress Report. July 26,
1996 Oct. 31, 1997 (noting the potential for discrimination based on
genetic information in employment, health care and other areas, and
urging the President to work with Congress to enact legislation
outlawing genetic discrimination and restricting access to genetic
information by employers, insurance carriers and others).
National Disability Policy: A Progress Report. Nov. 1999
Nov. 2000 (applauding the Clinton Administration for issuing an
executive order prohibiting certain types of genetic discrimination by
federal employers, and urging the prompt reintroduction of legislation
prohibiting genetic discrimination by employers and health insurers).
Promises to Keep: A Decade of Federal Enforcement of the
Americans with Disabilities Act. June 27, 2000 (supporting the U.S.
Equal Employment Opportunity Commission's (EEOC) position on genetic
discrimination in its guidance on the definition of disability, which
considered an individual discriminated against based on a genetic
predisposition to disease or disability to be a person with a
disability protected by the Americans with Disabilities Act (ADA) by
virtue of being ``regarded as'' substantially limited in a major life
activity; calling for technical assistance from federal agencies in
emerging areas of ADA policy and enforcement such as genetic
discrimination).
NCD's interest in genetic discrimination legislation stems partly
from the fact that the need for this legislation arises due to narrow
judicial interpretations of ADA, and these same interpretations also
create the need for legislation to restore protections for individuals
who have actually developed health conditions. NCD believes that the
concerns of individuals with actual health conditions have not been
fully addressed in the dialogue about legislative proposals to address
genetic discrimination.
The Need for Federal Legislation Prohibiting Genetic Discrimination
Recent Advances in Genetic Research Have Brought Increasing Potential
for Genetic Discrimination
Recent years have brought dramatic scientific advances in the study
of human genetics. Scientists have mapped out DNA sequences in the
human body and have identified many genes that cause disease.
Consequently, they have been able to use genetic testing to identify
individuals who may be susceptible to many diseases that are
genetically linked.\1\ Tests now exist that are able to detect genetic
predispositions for many diseases and illnesses, such as Huntington's
Disease, breast cancer, cystic fibrosis, Alzheimer's disease, colon
cancer, and Parkinson's disease.\2\ The number of conditions that may
be detected by genetic tests is rapidly growing.\3\ While these genetic
advances hold tremendous potential for early identification, prevention
and treatment of disease, they also create opportunities for
discrimination against individuals based on their genetic information,
even where individuals have no symptoms of disease.
---------------------------------------------------------------------------
\1\ Deborah Gridley, Note, Genetic Testing Under ADA: A Case for
Protection from Employment Discrimination, 89 Georgetown Law Journal
973, 976 (2001).
\2\ Id. at 975; Testimony of Mary Davidson, Executive Director of
Genetic Alliance, before U.S. House of Representatives Subcommittee on
Commerce, Trade and Consumer Protection of the Committee on Energy and
Commerce (July 11, 2001).
\3\ Testimony of Mary Davidson, supra note 2.
---------------------------------------------------------------------------
In recent testimony before Congress, Dr. Francis Collins, Director
of the National Human Genome Research Institute at the National
Institutes of Health, observed:
while genetic information and genetic technology hold great
promise for improving human health, they can also be used in
ways that are fundamentally unjust. Genetic information can be
used as the basis for insidious discrimination. . . . The
misuse of genetic information has the potential to be a very
serious problem, both in terms of people's access to employment
and health insurance and the continued ability to undertake
important genetic research.\4\
---------------------------------------------------------------------------
\4\ Congressional Research Service, Genetic Information: Legal
Issues Relating to Discrimination and Privacy, Report No. RL30006 (July
19, 2001) (hereafter ``Congressional Research Service Report''), at 2.
---------------------------------------------------------------------------
Genetic Discrimination is a Historical and Current Reality
Discrimination based on genetic information is not a new
phenomenon. During the early 1970s, employers used genetic screening to
identify and exclude African Americans carrying a gene mutation for
sickle cell anemia.\5\ These individuals were denied jobs despite the
fact that many of them were healthy and never developed the disease.\6\
During the same time period, individuals who were carriers of sickle
cell anemia were also discriminated against by several insurance
companies despite the fact that they were asymptomatic.\7\
---------------------------------------------------------------------------
\5\ Department of Labor, Department of Health and Human Services,
Equal Employment Opportunity Commission, Department of Justice, Genetic
Information and the Workplace (Jan. 20, 1998) (hereafter ``Joint
Government Report''), at 3.
\6\ Id.
\7\ E. Virginia Lapham et al., Genetic Discrimination: Perspectives
of Consumers, 274 Science 621 (1996).
---------------------------------------------------------------------------
Genetic discrimination by employers and insurers has continued to
be a systemic problem. According to a 1989 survey conducted by
Northwestern National Life Insurance Company, 15 percent of the
companies surveyed indicated that by the year 2000, they planned to
check the genetic status of prospective employees and their dependents
before making employment offers.\8\
---------------------------------------------------------------------------
\8\ Larry Gostin, Genetic Discrimination: The Use of Genetically
Based Diagnostic and Prognostic Tests by Employers and Insurers, 17
American Journal of Law & Medicine 109, 116 (1991).
---------------------------------------------------------------------------
A 1996 survey of individuals at risk of developing a genetic
condition and parents of children with specific genetic conditions
indicated more than 200 instances of genetic discrimination reported by
the 917 respondents. The discrimination was practiced by employers,
insurers, and other organizations.\9\ Another survey of genetic
counselors, primary care physicians, and patients identified 550
individuals who were denied employment or insurance based on genetic
information.\10\ A study on genetic discrimination, published in 1996,
found that health and life insurance companies, health care providers,
blood banks, adoption agencies, the military, and schools engaged in
genetic discrimination against asymptomatic individuals.\11\
---------------------------------------------------------------------------
\9\ Joint Government Report, supra note 5, at 2.
\10\ Id.
\11\ Congressional Research Service Report, supra note 4, at 3.
---------------------------------------------------------------------------
Science magazine reported that in a study of 332 individuals with
one or more family members with a genetic disorder who are affiliated
with genetic support groups, 40 percent of the respondents recalled
being specifically asked about genetic diseases or disabilities on
their applications for health insurance.\12\ Twenty-two percent of the
respondents said they or a family member were refused health insurance
as a result of the genetic condition in the family.\13\ Fifteen percent
of the respondents reported that they or affected family members had
been asked questions about genetic diseases or disabilities on
employment applications.\14\ Thirteen percent reported that they or a
family member had been denied a job or fired from a job because of a
genetic condition in the family, and 21 percent reported being denied a
job or fired due to their own genetic disorder.\15\
---------------------------------------------------------------------------
\12\ Lapham et al., supra note 7, at 622.
\13\ Id. at 624.
\14\ Id. at 626.
\15\ Id.
---------------------------------------------------------------------------
In addition to these and other studies, numerous anecdotal examples
of genetic discrimination by employers and insurers have been detailed
in testimony before Congress in hearings about genetic discrimination.
Genetic Discrimination Undermines the Purposes of Genetic Research and
Testing
The misuse of genetic information not only excludes qualified
individuals from employment and denies insurance coverage to
individuals without justification, but also undercuts the fundamental
purposes of genetic research. Such research has been undertaken with
the goals of early identification, prevention and effective treatment
of disease. These goals will be undermined if fear of discrimination
deters people from genetic diagnosis and prognosis, makes them fearful
of confiding in physicians and genetic counselors, and makes them more
concerned with loss of a job or insurance than with care and
treatment.\16\
---------------------------------------------------------------------------
\16\ Gostin, supra note 8, at 113.
---------------------------------------------------------------------------
The fears engendered by genetic discrimination fears of disclosure
of genetic information to physicians and of participation in genetic
testing and research have been well documented in numerous studies. In
one study, 83 percent of the participants indicated that they would not
want their insurers to know if they were tested and found to be at high
risk for a genetic disorder.\17\ In a 1997 survey of more than 1,000
individuals, 63 percent of the participants reported that they would
not take genetic tests for diseases if health insurers or employers
could get access to the results.\18\ Additionally, researchers
conducting a Pennsylvania study to determine how to keep women with
breast cancer gene mutations healthy reported that nearly one third of
the women invited to participate in the study declined out of fear of
discrimination or loss of privacy.\19\ The results of a national survey
released by the California HealthCare Foundation in 1999 indicate that
15 percent of adults surveyed took steps to keep genetic information
private, such as paying for testing out of pocket rather than using
their insurance coverage, constantly switching doctors to avoid the
compilation of a comprehensive medical history, refusing to seek needed
medical care, and/or providing false or incomplete information to
physicians.\20\ Another study showed that 57 percent of surveyed
individuals at risk for breast or ovarian cancer had chosen not to take
a needed genetic test, and 84 percent of those individuals who had
decided to forego the test cited fear of genetic discrimination as a
major reason for their decision.\21\
---------------------------------------------------------------------------
\17\ Lapham et al., supra note 7, at 622.
\18\ Joint Government Report, supra note 5, at 2.
\19\ Id.
\20\ Genetic Alliance, The Insured, the Underinsured, and the
Uninsurable: the Role of Genetics in Health Care Coverage (Oct. 2001)
(unpublished), at 2-3.
\21\ Caryn Lerman et al., BRCA1 testing in families with hereditary
breast-ovarian cancer. A prospective study of patient decision making
and outcomes, 275 Journal of American Medical Ass'n 1885 (1996). In
another study, concern about health insurability was the leading reason
for individuals' decisions to decline cancer genetic counseling
services. Katherine P. Geer et al., Factors Influencing Patients'
Decisions to Decline Cancer Genetic Counseling Services, 10 Journal of
Genetic Counseling 25 (2001).
---------------------------------------------------------------------------
These fears eliminate people's opportunities to learn that they are
not at increased risk for the genetic disorder in the family or to make
lifestyle changes to reduce risks.\22\ They may also affect the number
of people willing to participate in scientific research.\23\
---------------------------------------------------------------------------
\22\ Lapham et al., supra note 7, at 622.
\23\ Id.
---------------------------------------------------------------------------
Genetic Test Information Has Little Value for Purposes of Making
Employment Decisions and Insurance Decisions
There is no consensus on the scientific validity of genetic tests
or their usefulness for predicting an individual's susceptibility to
exposure.\24\ The results of genetic-based diagnosis and prognosis are
uncertain for many reasons. First, the sensitivity of genetic testing
is limited by the known mutations in a target population. Many
individuals with a genetic predisposition for a particular disease will
not be identified because these markers are not among the known genetic
mutations.\25\ Secondly, many individuals are falsely labeled ``at
risk'' due to the genetic screening of family members.\26\ Thirdly,
genetic markers are generally not valid predictors of the nature,
severity and course of disease. For most genetic disease, the onset
date, severity of symptoms, and efficacy of treatment and management
are highly variable, with some people identified by screening remaining
symptom-free and others progressing to disabling illness.\27\ Genetic
tests alone cannot predict with certainty whether an individual with a
particular genetic error will actually develop a disease.\28\ These
tests evaluate people according to stereotypes of future ability to
function and the probability that disease will occur, rather than
evidence of actual disease and ability.\29\
---------------------------------------------------------------------------
\24\ Joint Government Report, supra note 5, at 3.
\25\ Gostin, supra note 8, at 113.
\26\ Id. at 114.
\27\ Id.
\28\ Joint Government Report, supra note 5, at 1; Elaine Draper,
The Screening of America: The Social and Legal Framework of Employers'
Use of Genetic Information, 20 Berkeley Journal of Employment & Labor
Law 286, 290-91 (1999).
\29\ Draper, supra note 28, at 290.
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Existing Laws Are Insufficient to Protect Individuals from Genetic
Discrimination
There are existing laws that may prohibit genetic discrimination in
some contexts. However, these laws do not reach much of the
discrimination that occurs and, in some cases, may be interpreted not
to apply to genetic discrimination at all.
The Americans with Disabilities Act\30\
---------------------------------------------------------------------------
\30\ The analysis of ADA's application to genetic discrimination in
employment also applies to Section 504 of the Rehabilitation Act, which
applies to federal employers and entities receiving federal funds.
Section 504 has the same definition of disability as that contained in
ADA.
---------------------------------------------------------------------------
The Americans with Disabilities Act (ADA), an anti-discrimination
law, protects individuals who have an impairment that substantially
limits them in a major life activity, who have a record of such an
impairment, or who are regarded as having such an impairment.\31\
Congress intended ADA to cover individuals with a broad range of
diseases, and some members of Congress explained at the time of ADA's
passage that it would protect people who experience discrimination on
the basis of predictive genetic information where those individuals
were regarded as having a disability.\32\ ADA has also been interpreted
by EEOC to prohibit some forms of genetic discrimination. In 1995, the
EEOC issued enforcement guidance advising that an employer who takes
adverse action against an individual on the basis of genetic
information may regard the individual as having a disability and,
therefore, may be violating ADA.\33\ EEOC recently settled its first
court action challenging an employer's use of genetic testing\34\ and
also issued a finding of cause in an administrative complaint filed by
a woman who was terminated based on a genetic test result.\35\
---------------------------------------------------------------------------
\31\ 42 U.S.C. Sec. 12102(2).
\32\ 136 Cong. Rec. H4627 (statement of Rep. Waxman).
\33\ Joint Government Report, supra note 5, at 6; EEOC Compliance
Manual Sec. 902, Order 915.002, 902-45 (1995).
\34\ EEOC v. Burlington Northern Santa Fe Railroad, Civ. No. 01-
4013 MWB (N.D. Iowa Apr. 23, 2001) (Agreed Order). The Railroad, which
had tested for carpal tunnel syndrome propensity, agreed to stop
requiring genetic tests, using genetic information relating to its
employees, and disclosing such information to the public.
\35\ Congressional Research Service Report, supra note 4, at 9
(describing complaint filed by Terri Sergeant alleging a violation of
ADA based on her termination after being diagnosed with Alpha 1
Antitrypson Deficiency).
---------------------------------------------------------------------------
Nonetheless, ADA is a highly problematic vehicle for fully
addressing genetic discrimination. At recent Senate hearings, EEOC
Commissioner Paul Steven Miller testified that while ADA could be
interpreted to prohibit employment discrimination based on genetic
information, it ``does not explicitly address the issue and its
protections are limited and uncertain.''\36\
---------------------------------------------------------------------------
\36\ Id.
---------------------------------------------------------------------------
ADA could be interpreted to protect individuals with genetic
markers for disease in two ways. First, as described above, such
individuals may be protected if they are regarded as substantially
limited in a major life activity B for example, if they are regarded as
substantially limited in working due to their genetic predisposition.
However, recent Supreme Court cases discussing what it means to be
regarded as substantially limited in working suggest that such claims
are extremely unlikely to succeed. In Sutton v. United Airlines,
Inc.\37\ and Murphy v. United Parcel Service, Inc.,\38\ the Court
stated that a job requirement excluding individuals based on their
impairments does not necessarily establish that the employer regards
individuals excluded by this requirement as substantially limited in
working. To be covered under the ``regarded as'' prong, the plaintiffs
would have to prove that they were regarded as substantially limited in
performing a broad class of jobs, not merely their own jobs. It may
prove extremely difficult for plaintiffs with genetic markers who are
denied employment due to an employer's concern about health insurance
premiums or productivity losses to show that the employer regarded them
as substantially limited in performing not only the job in question but
a broad class of other jobs as well.
---------------------------------------------------------------------------
\37\ 527 U.S. 471, 473-74 (1999).
\38\ 527 U.S. 516, 516-17 (1999).
---------------------------------------------------------------------------
Individuals who experience genetic discrimination may also be
covered under ADA if they are regarded as substantially limited in
other major life activities besides working. It is unlikely that most
plaintiffs will be able to establish the requisite proof to prevail on
such claims. Most courts have interpreted ``substantially limited'' so
restrictively that an individual must be extremely debilitated.\39\
Moreover, the courts have interpreted ADA to require consideration of
any measures that an individual takes to control the effects of her
limitations.\40\ Thus, it is unlikely that an individual with a genetic
predisposition for a disease, but who has not actually developed the
disease, will be able to show that he was regarded as substantially
limited in any major life activity.
---------------------------------------------------------------------------
\39\ For a discussion of how the courts have interpreted ADA far
more restrictively than Congress intended, see Chai Feldblum,
Definition of Disability Under Federal Anti-Discrimination Law: What
Happened? Why? And What Can We Do About It?, 21 Berkeley Journal of
Labor & Employment 91 (2000).
\40\ Sutton v. United Airlines, Inc., 527 U.S. at 481-88; Murphy v.
United Parcel Service, 527 U.S. at 521.
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An individual who experiences genetic discrimination may also be
covered by ADA under the first prong of the definition of disability--
that is, by showing that she has an actual impairment that
substantially limits her in a major life activity. In Bragdon v.
Abbott,\41\ the Supreme Court held that an individual with asymptomatic
HIV was covered under the first prong because she was substantially
limited in reproduction due to the risk of transmitting HIV to a fetus.
The Court found that the asymptomatic HIV was a physical impairment
based on the physiological effects of the infection. It is unclear,
however, whether courts would find a genetic marker to constitute an
actual impairment.
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\41\ 524 U.S. 624 (1998).
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Even assuming ADA did apply, in many situations it might not
prevent employers from accessing genetic information. While ADA does
bar medical inquiries before a conditional offer of employment is made,
it would permit employers to request genetic information if they could
establish that the information was job-related and consistent with
business necessity.\42\
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\42\ 42 U.S.C. Sec. 12112(c); Congressional Research Service
Report, supra note 4, at 13.
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The Health Insurance Portability and Accountability Act
The Health Insurance Portability and Accountability Act (HIPAA)
prohibits genetic discrimination by insurers in very limited
circumstances. It prohibits group health plans from using any health
status-related factor, including genetic information, as a basis for
denying or limiting coverage or for charging an individual more for
coverage.\43\ However, a plan may still establish limitations on the
amount, level, extent or nature of benefits or coverage provided to
similarly situated individuals.\44\ Thus, plans may still provide
substantially fewer services even though they may not charge more for
coverage. In addition, privacy regulations issued pursuant to HIPAA
require patient consent for most sharing of personal health information
by health insurers, providers, and health care clearinghouses.
Companies that sponsor health plans are prohibited from accessing
personal health information for employment purposes unless the patient
consents. These provisions do little to prevent genetic discrimination
in the workplace and, while they do prohibit some forms of genetic
discrimination by insurers, that protection is extremely limited.
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\43\ 29 U.S.C. Sec. 1182(a)(1), 1182(b)(1).
\44\ Id. Sec. 1182(a)(2)(B).
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Title VII
Race and gender discrimination laws may apply to certain forms of
genetic discrimination as well.\45\ For example, Title VII of the Civil
Rights Act of 1964, which prohibits employment discrimination based on
race or gender, may prohibit employers from denying employment based on
genetic markers linked to race, such as that for sickle cell anemia, or
linked to gender, such as those for breast or ovarian cancer. Some
courts have said in dicta that employment classifications based on
sickle cell anemia would create a disparate impact on African
Americans, but no lawsuit has successfully been brought challenging
such classifications under Title VII.\46\ At least one court has
rejected such a claim.\47\
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\45\ See Gostin, supra note 8, at 109; Congressional Research
Service Report, supra note 4, at 30 n.8.
\46\ Gostin, supra note 8, at 138.
\47\ Id. at 138-39.
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State Laws
A number of states have passed state laws that prohibit certain
forms of genetic discrimination. These laws, however, vary widely in
the scope of their protection.\48\ Many are narrowly targeted to
particular genetic conditions, some prohibit only certain types of
screening but do not prohibit adverse employment actions based on
genetic information, and some only address genetic counseling and
confidentiality.\49\ These laws have been described as ``a patchwork of
provisions which are incomplete, even inconsistent, and which fail to
follow a coherent vision for genetic screening, counseling, treatment
and prevention of discrimination.''\50\
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\48\ Joint Government Report, supra note 5, at 8.
\49\ Gridley, supra note 1, at 980-81.
\50\ Gostin, supra note 8, at 142.
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In light of the inadequacies of federal and state law to address
genetic discrimination issues, comprehensive federal legislation that
specifically addresses these issues is necessary.
Principles for Genetic Discrimination Legislation
NCD believes that it is crucial for any proposed legislation
addressing genetic discrimination to reflect the following principles:
Workplace Discrimination:
Any proposed legislation must provide effective prohibitions
against discrimination by employers based on genetic information.
Employers must not be permitted to use predictive genetic information
as a basis for hiring, firing, or taking any other employment action,
or as a term or condition of employment. Nor should an employer be
permitted to use this information, or be permitted to limit, segregate
or classify employees or job applicants. This information should not be
permitted to play a role in an employment agency's referral of
individuals for employment; in decisions by a labor organization about
admission to its membership; or in admission to or employment by a
training program.
Collection and Disclosure of Genetic Information by Employers:
Any proposed legislation must contain strict limits on the
collection and disclosure of genetic information by employers so as to
prevent that information from being used for discriminatory purposes.
Employers must not be permitted to collect genetic information except
under very limited circumstances that will be used only to benefit
employees and only on a voluntary basis.
Specifically, employers should be permitted to request predictive
genetic information only: (1) for the purpose of monitoring effects of
toxic substances in the workplace, and only if an employee has provided
written consent to such monitoring, the employee is informed of the
results, the monitoring conforms to national standards, and the
employer does not receive results for particular individuals but rather
receives only aggregate results for all individuals monitored; and (2)
for the purpose of providing genetic services to employees, but only if
such services are provided with the employee's written consent and only
the employee receives the results.
Additionally, employers must maintain strict confidentiality of
genetic information of applicants or employees that is in the
employers' possession. Genetic information should be kept confidential
and maintained separately from personnel files and other non-
confidential information. It should be disclosed only to the employee,
to officials enforcing this legislation, or as required by other
federal laws.
Insurance Discrimination:
Any proposed legislation should contain comprehensive protection
against genetic discrimination by providers of health, life,
disability, and other types of insurance. Legislation must bar insurers
from making decisions about enrollment based on genetic information. It
must also prohibit insurers from using genetic information in
determining premium or contribution rates, or other terms or conditions
of coverage. Finally, it must bar insurers from requesting or requiring
an individual to undergo genetic testing.
Collection and Disclosure of Genetic Information by Insurers:
Any proposed legislation must prohibit insurers from requiring,
requesting, collecting, or buying genetic information about individuals
who are covered or seeking coverage.
Insurers should be permitted, however, to obtain this information
only for the limited purpose of paying for claims for genetic testing
or other genetic services. Strict protections must be in place to
ensure that when such information is requested, it is not used to
affect an individual's enrollment, premiums, or terms or benefits of
coverage.
Insurers must also be prohibited from disclosing genetic
information to health plans or issuers of health insurance (except in
the limited circumstances described above where the information is used
for purposes of payment of claims), employers, and entities that
collect and disseminate insurance information.
Health Care Provider Discrimination:
Any proposed legislation should protect against genetic
discrimination by health care providers. Health care providers must not
be permitted to refuse treatment to individuals, or treat them
differently, based on genetic information. For example, ``futile care''
policies, under which medically indicated treatments may be denied
based on determinations that such treatments would be ``futile'' in
light of an individual's expected quality of life, should be prohibited
to the extent that they result in denials of treatment based on genetic
information.
Collection and Disclosure of Genetic Information by Health Care
Providers:
Any proposed legislation must prohibit health care providers from
requiring, requesting, or collecting genetic information about
individuals who are seeking treatment. Providers may only collect this
information for the purpose of providing genetic testing or other
genetic services.
Health care providers must not be permitted to disclose genetic
information except to the patient, to insurers only for the limited
purpose of seeking payment for genetic testing or genetic services
rendered, to officials enforcing this legislation, or as required by
other federal laws.
Education and Technical Assistance:
Any proposed legislation should include funding to permit education
and technical assistance to be provided by appropriate organizations in
order to ensure that individuals affected by the legislation are aware
of its requirements. Such assistance is important to ensure effective
enforcement of the legislation.
Effective Enforcement Mechanisms:
Any proposed legislation must contain a private right of action for
individuals to enforce its provisions. Additionally, EEOC should have
the authority to investigate and resolve complaints of violations of
the employment provisions of the law. In order to be effective, the
legislation must provide for the full panoply of legal remedies,
including attorney's fees.
Relationship to Other Laws:
Any proposed legislation must serve as a set of minimum standards
that do not preempt more stringent standards that may exist in other
laws. Thus, the legislation must not preempt stronger state laws.
Similarly, it must not preempt other federal laws that may be
applicable where those laws provide stronger protection against genetic
discrimination.
Addressing Protections for Individuals with Actual Health
Conditions:
As discussed above, courts have interpreted ADA in a number of ways
that severely restrict the number of people protected.\51\ They have
interpreted ADA to protect only individuals who are so limited in major
life activities that they are extremely debilitated, and to exclude
protection for many individuals who take mitigating measures to control
the effects of their impairments. They have made it extraordinarily
difficult for individuals to establish that an employer regards them as
substantially limited in working. These interpretations of ADA have
resulted in far more limited protection than Congress envisioned when
it passed ADA.
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\51\ See Feldblum, supra note at 39.
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The same interpretations that make ADA difficult to enforce by
individuals with genetic markers make it difficult to enforce by
individuals with a range of health conditions. When Congress considers
protections for individuals who experience discrimination based on
genetic information, it should also ensure that if these individuals
are eventually diagnosed with medical conditions, they will be
protected against discrimination.
______
Statement of FORCE, Submitted for the Record
FORCE: Facing Our Risk of Cancer Empowered is a national
organization representing the concerns of the estimated 500,000
Americans with hereditary predisposition to breast and ovarian cancer.
Our organization urges the House to vote on S.1053, the Genetic
Information Nondiscrimination Act. Our members are concerned citizens
who have been impacted by hereditary cancer. They favor passage of this
comprehensive bill to protect individuals from insurance and employment
discrimination on the basis of predictive genetic test results.
Current laws such as HIPAA do not go far enough to protect
citizen's rights. The general population still feels vulnerable to the
possibility of discrimination. By passing this bill, Congress will be
making a strong statement that discrimination based on genetic
information is unacceptable. As genetic research progresses and more
disease-predisposing genes are identified, it is important that genetic
discrimination is outlawed. Individuals who have already had gene
testing and those who might choose to be tested in the future must be
protected from possible discrimination.
Genetic testing is improving the lives of thousands of Americans,
providing information on how to prevent future health problems, and
cope more effectively with unavoidable conditions. Nevertheless, under
current law, many people are afraid to be tested or to participate in
research that will lead to better prevention and treatment of diseases.
They fear that their genetic information will be misused by employers
and health insurers.
Our organization strongly endorses the passage of a comprehensive
federal legislation to prohibit genetic discrimination in health
insurance and employment. We urge the House of Representatives to call
a house vote on S1053. Passage of a nondiscrimination bill will save
lives by removing a significant barrier to patients availing themselves
to genetic testing.
Thank you in advance for your consideration of this matter. We hope
that you will keep the best interests of your constituents in mind and
take immediate action to pass this bill.
______
Statement of the Association of Women's Health, Obstetric and Neonatal
Nurses, Submitted for the Record
The Association of Women's Health, Obstetric and Neonatal Nurses
(AWHONN) appreciates the opportunity to comment on the issue of Genetic
Discrimination. AWHONN is a membership organization of 22,000 nurses
whose mission is to promote the health of women and newborns.
AWHONN members are registered nurses, nurse practitioners,
certified nurse-midwives, and clinical nurse specialists who work in
hospitals, physicians' offices, universities and community clinics
across North America as well as in the Armed Forces around the world.
Last October the United States Senate took historic action when it
passed S.1053, the ``Genetic Information Nondiscrimination Act'' by a
margin of 95-0. The bill's passage was the result of years of hard work
and bi-partisan compromise. The legislation establishes strong
protections against discrimination based on genetic information both in
health insurance and employment.
The bill prohibits health insurance enrollment restriction and
premium adjustment on the basis of genetic information and prevents
health plans and insurers from requesting or requiring than an
individual take a genetic test. The bill also prohibits discrimination
in hiring, compensation and other personnel processes, prohibits the
collection of genetic information and covers employers, employment
agencies, labor organizations and training programs.
The benefits of genetic testing are enormous and science is
revealing genetic markers for many different ailments at an increasing
rate. Research has already identified genetic markers for conditions
including cancer, diabetes, Alzheimer's disease, Huntington's Disease
and cystic fibrosis.\1\ Unfortunately, the same science that can help
reveal an individual's predisposition to certain health problems may
also open the door to discrimination. No individual should have to
choose between the benefits of genetic testing and keeping a job or
health insurance.
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\1\ Mary Davidson testimony--cancers, Alzheimers. For CF, see i.e
http://odp.od.nih.gov/consensus/cons/106/106statement.htm.
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The House needs to take immediate steps to act on this
legislation--the fear of genetic discrimination has prompted many
Americans to avoid genetic tests that could literally save their lives.
By providing patients with this type of health information, we empower
them to seek appropriate treatment options and/or lifestyle changes
that can prevent disease onset. As a nursing organization whose mission
is advancing women and newborn health, AWHONN recognizes the need for
comprehensive federal legislation that protects individuals from
genetic discrimination and believes that the ``Genetic Information
Nondiscrimination Act'' passed by the Senate will provide strong
protection against access to and misuse of genetic information.
The House must act now and take action on the Senate version of the
``Genetic Information Nondiscrimination Act'' to help secure the health
and well-being of all Americans.
Thank you for the opportunity to submit testimony on this crucial
legislation.
______
Statement of the American Society of Human Genetics, Submitted for the
Record
The American Society of Human Genetics (ASHG) has endorsed the
passage of federal legislation to prohibit discrimination in health
insurance and employment on the basis of genetic information. ASHG
commends the bipartisan enthusiastic passage of S. 1053 last year in
the Senate, and urges similar House action.
ASHG is the primary professional organization for human genetics in
the Americas, representing nearly 8000 researchers, physicians,
laboratory practice professionals, genetic counselors, nurses, and
trainees actively engaged in genetics discovery, teaching and the
development of health care applications and services derived from
research findings.
Our members are keenly aware of the challenges faced by individuals
and families involved in genetic evaluation and diagnostic procedures
at the rapidly evolving interface between biomedical research and
health care. Many of us have personally experienced cases in which
testing or its outcome led to adverse effects on insurance or
employment. While the number of publicly documented cases of
discrimination based on genotype may be considered small at this time,
the rapid advances being made in genetics will provide more
opportunities for persons to be adversely affected by test results. The
potential misuse of genetic information by insurance companies and
employers has also been an impediment in recruiting subjects for some
research studies.
From the geneticist's point of view, the absence of a federal
standard that prohibits employment and health insurance discrimination
based on genetic information results in:
1. difficulty in recruiting subjects into genetic research studies
2. patient avoidance of genetic services
3. underutilization of genetic testing
4. difficulty in obtaining insurance coverage when attempted
5. several cases recognized that have not resulted in legal action
6. significantly increased time and effort in genetic evaluation
and counseling sessions resulting in increased service costs
Many states have enacted some form of genetic non-discrimination
legislation, but the laws are quite varied in their focus and scope.
Federal legislation would assure individuals and families in our mobile
society that neither health care coverage nor employment status would
be jeopardized by their participation in genetic testing. Such
protection will eliminate some of the concerns (real or perceived) that
have deterred participating in genetic research studies or seeking
genetic testing. This protection will speed the progress in
understanding genetic disease and how we can prevent or treat these
disorders.
We appreciate the opportunity to comment on this important issue,
and will work with you and your staff on any details necessary to
accomplish the task.
______
Statement of the American Osteopathic Association, Submitted for the
Record
The American Osteopathic Association (AOA) represents the nation's
54,000 osteopathic physicians. The AOA is pleased that the Subcommittee
on Employer-Employee Relations of the House Committee on Education and
the Workforce is holding a hearing on genetic nondiscrimination. It is
an issue that will increasingly affect patients and physicians as
further advances are made in the field of genetic testing.
In 1997, the AOA House of Delegates adopted a policy prohibiting
discrimination in employment, insurance, coverage, and access to care
based on genetic information. The policy was reaffirmed in 2002.
The completion of the Human Genome Project and genetic testing are
contributing to advances in medical knowledge that hold great promise
for the future in diagnosis, management, and treatment of the human
condition. However, such knowledge can also provide the basis for
unethical and discriminatory behavior in employment and insurance
coverage.
It is the position of the AOA that access to health care should not
be restricted on the basis of genetic testing and that discrimination
in employment on the basis of genetic testing should be prohibited.
Furthermore, health care plans should be prohibited from restricting or
denying coverage or raising premiums on the basis of genetic testing.
We believe that patients must be able to discuss genetic testing
options with their osteopathic physicians without fear of
discrimination from employers, potential employers, or health care
plans for having undergone such genetic testing or participating in
clinical trials to test new therapies. We are concerned that there is
no law on the books to prevent such discrimination.
For the past several years, the AOA sent letters in support of
genetic nondiscrimination legislation. Most recently, letters were sent
to Senator Snowe (R-ME) in support of S.1053 that passed the Senate
last year and Representative Slaughter (D-NY) in support of H.R.1910.
As physicians, we understand the value of genetic research,
testing, and therapy in the diagnosis and treatment of certain
diseases. Our patients should not forego genetic testing or promising
therapy out of fear of discrimination. We urge the House of
Representatives to pass genetic nondiscrimination legislation.
President Bush stated publicly that he supports S.1053 and is committed
to enacting legislation to prohibit genetic discrimination in health
insurance and employment.
The President and the Senate have acted. It is now time for the
House to act.
______
Statement of The American Psychiatric Association, Submitted for the
Record
The American Psychiatric Association (APA), the national medical
specialty society, founded in 1844, whose over 35,000 psychiatric
physician members specialize in the diagnosis and treatment of mental
and emotional illnesses and substance use disorders, appreciates the
opportunity to provide a statement on genetic non-discrimination. We
thank the Committee for allowing us to provide this statement.
Genetic testing offers tremendous promise in identifying current
and potential future health risks. At the same time, we have
significant concerns that Americans' genetic information could be
misused. Our concerns are shared by a strong majority of Americans: a
U.S. Department of Labor survey showed that 63 percent of respondents
would refuse to take a genetic test if insurers or employers could
access their private results.
We believe Congress can help by passing the strongest possible
enforceable genetic non-discrimination legislation. Employers and
insurers should not be permitted to discriminate on the basis of a
person's genetic profile and family history.
Our concerns extend beyond patients' reluctance to take a genetic
test. Such reluctance means that people are disinclined to participate
in clinical studies that require genetic testing, hurting our efforts
to identify causes and new treatments for diseases, including mental
illnesses. Worse, some patients' reluctance could keep them from
getting a proper diagnosis today, as well as potentially life-saving
treatment. Perhaps the most pernicious potential consequence of not
enacting a ban on genetic discrimination is that Americans could lose
their jobs or their health insurance, based simply on their family
history.
Protecting patients' genetic information is essential to providing
the highest quality medical care. We believe a patient's genetic
information should only be used or disclosed by a health care plan,
provider, or clearinghouse with the informed, voluntary, and non-
coerced consent of the patient. As our knowledge of genetics grows,
especially through the Human Genome project, the possible misuses of
genetic information will expand unless enforceable safeguards are
enacted.
The U.S. Senate voted 95-0 to pass the ``Genetic Information Non-
discrimination Act of 2003'' (S. 1053), with the support of President
Bush. Similar but stronger legislation (H.R. 1910) is now cosponsored
by 241 members of the House. Both bills would ban employers and
insurers from discriminating on the basis of a person's genetic profile
and family history. APA urges Congress to pass and the President to
sign the strongest possible enforceable genetic non-discrimination
legislation into law.
Thank you for this opportunity to deliver this statement. Please
call on the APA as a resource, as we would be happy to assist the
Committee on the vital issue of genetic non-discrimination in any way.
______
Statement of the American Cancer Society, Submitted for the Record
Genetic research is one of the most exciting areas of scientific
advancement today. As our knowledge about the genetic basis of common
disorders grows, however, so does the potential for discrimination in
health insurance and employment. This possibility can have a dramatic
and chilling impact on patient care and research. For example, a
genetic test exists for inherited breast cancer that allows healthy,
high-risk women to find out whether they carry the altered gene so they
can determine with their doctor whether to pursue available medical
options. Unfortunately, many of these women may choose not to be tested
for fear that the information could be used to deny them the health
insurance coverage they need to fight disease or to deny them future
employment.
We need legislation that allows medical research to advance, while
at the same time protects the rights and needs of patients and their
family members. The American Cancer Society endorses the ``Genetic
Nondiscrimination in Health Insurance and Employment Act'' now pending
in the House (H.R. 1910) and its companion ``Genetic Information
Nondiscrimination Act'' (S. 1053) in the Senate. These bills support
the goal of allowing people to benefit from advances in genetic testing
without fear of losing their heath insurance or job opportunities.
Specifically, the legislation prohibits health insurance companies
from denying or canceling health coverage on the basis of genetic
information, using genetic information to determine insurance rates,
and requesting or requiring genetic information or genetic tests.
Decisions about genetic testing and results from genetic testing should
be made by patients and their health care providers, without fear of
negative consequences. The bills also provide important workplace
protections, prohibiting employers and employment organizations from
using genetic information as a means to deny or limit employment for
individuals who they suspect may have an inherited predisposition to
disease.
The Senate has already taken a strong stand on the need for this
type of legislation, passing S. 1053 overwhelmingly by 95-0 vote in
October 2003. The American Cancer Society urges the House to take
prompt action on this important legislation to ensure that critical
patient protections are enacted before the end of this Congress.
______
Letter from Lawrence Lorber Answering Follow-Up Questions, Submitted
for the Record
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Statement of Hon. Newt Gingrich, Former Speaker, U.S. House of
Representatives, Submitted for the Record
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Statement of Hon. Louise McIntosh Slaughter, a Representative in
Congress from the State of New York
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Statement of the Ovarian Cancer National Alliance, Submitted for the
Record
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Statement of the Catholic Health Association, Submitted for the Record
The Catholic Health Association (CHA), the national leadership
organization of more than 2,000 Catholic health care sponsors, systems,
facilities, and related organizations, would like to commend the House
Education and Workforce Subcommittee on Employer-Employee Relations,
and its chairman, Representative Sam Johnson, for holding a hearing on
the problem of genetic nondiscrimination.
As the Subcommittee is no doubt aware, last year the United States
Senate overwhelmingly passed the Genetic Information Nondiscrimination
Act of 2003 (S 1053). CHA strongly supports this legislation, which we
believe would serve as an important compliment to other federal and
state laws that recognize the need to protect an individual's genetic
information from being used in a discriminatory manner in the health
insurance and employment markets.
Specifically, the bill would:
Prohibit health insurers from restricting enrollment or
adjusting fees on the basis of predictive genetic information
Bar health insurers and employers from requiring genetic
testing and from obtaining predictive genetic information
Prevent employers from discriminating based on genetic
information in all areas of employment, including hiring and
compensation
Genetic science has seen marvelous growth over the past several
years, and Catholic social teaching validates its use when respect for
personal dignity, the defense of human life, and support of the common
good is its goal. CHA believes that S 1053 reflects this principle. It
is our hope that today's hearing will be the first step toward passage
of the legislation by the House of Representatives before the end of
the 108thCongress.
______
Statement of the Huntington's Disease Society of America, Submitted for
the Record
As staunch supporters of legislation banning genetic discrimination
in the workplace and by health insurers, the Huntington's Disease
Society of America (HDSA) urges Congress to schedule immediate House
action on the ``Genetic Information Nondiscrimination Act'' (S.1053),
which was unanimously passed by the Senate in November 2003.
HDSA believes Genetic Nondiscrimination legislation must include
strong and enforceable protections against wrongful discrimination in
health insurance and employment so that individuals may utilize genetic
testing in order to make critical life decisions as well as to be able
to participate in clinical research without fear of consequence for
themselves or their families. Individuals at risk for Huntington's
Disease (HD) often elect to pay for testing out of pocket for fear of
genetic discrimination.
The Huntington's Disease Society of America urges Congress to pass
comprehensive federal legislation prohibiting genetic discrimination.
Genetic testing can improve our lives by providing information on how
we can prevent future health problems, and cope more effectively with
unavoidable conditions. But the ability to predict disease through
genetic testing and family history opens the door for genetic
discrimination, particularly in employment and health insurance.
Sincerely,
Huntington's Disease Society of America
______
Statement of the United Spinal Association, Submitted for the Record
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Statement of the Coalition for Genetic Fairness, Submitted for the
Record
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