[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
THE GENETIC INFORMATION NONDISCRIMINATION ACT
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
ON
H.R. 493
__________
MARCH 8, 2007
__________
Serial No. 110-15
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COMMITTEE ON ENERGY AND COMMERCE
JOHN D. DINGELL, Michigan,
Chairman
HENRY A. WAXMAN, California JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts Ranking Member
RICK BOUCHER, Virginia RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York J. DENNIS HASTERT, Illinois
FRANK PALLONE, Jr., New Jersey FRED UPTON, Michigan
BART GORDON, Tennessee CLIFF STEARNS, Florida
BOBBY L. RUSH, Illinois NATHAN DEAL, Georgia
ANNA G. ESHOO, California ED WHITFIELD, Kentucky
BART STUPAK, Michigan BARBARA CUBIN, Wyoming
ELIOT L. ENGEL, New York JOHN SHIMKUS, Illinois
ALBERT R. WYNN, Maryland HEATHER WILSON, New Mexico
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado CHARLES W. ``CHIP'' PICKERING,
Vice Chairman Mississippi
LOIS CAPPS, California VITO FOSSELLA, New York
MIKE DOYLE, Pennsylvania STEVE BUYER, Indiana
JANE HARMAN, California GEORGE RADANOVICH, California
TOM ALLEN, Maine JOSEPH R. PITTS, Pennsylvania
JAN SCHAKOWSKY, Illinois MARY BONO, California
HILDA L. SOLIS, California GREG WALDEN, Oregon
CHARLES A. GONZALEZ, Texas LEE TERRY, Nebraska
JAY INSLEE, Washington MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin MIKE ROGERS, Michigan
MIKE ROSS, Arkansas SUE WILKINS MYRICK, North Carolina
DARLENE HOOLEY, Oregon JOHN SULLIVAN, Oklahoma
ANTHONY D. WEINER, New York TIM MURPHY, Pennsylvania
JIM MATHESON, Utah MICHAEL C. BURGESS, Texas
G.K. BUTTERFIELD, North Carolina MARSHA BLACKBURN, Tennessee
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
_________________________________________________________________
Professional Staff
Dennis B. Fitzgibbons, Staff
Director
Gregg A. Rothschild, Chief Counsel
Sharon E. Davis, Chief Clerk
Bud Albright, Minority Staff
Director
(ii)
Subcommittee on Health
FRANK PALLONE, Jr., New Jersey, Chairman
HENRY A. WAXMAN, California NATHAN DEAL, Georgia,
EDOLPHUS TOWNS, New York Ranking Member
BART GORDON, Tennessee RALPH M. HALL, Texas
ANNA G. ESHOO, California BARBARA CUBIN, Wyoming
GENE GREEN, Texas HEATHER WILSON, New Mexico
Vice Chairman JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado STEVE BUYER, Indiana
LOIS CAPPS, California JOSEPH R. PITTS, Pennsylvania
TOM ALLEN, Maine MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin MIKE ROGERS, Michigan
ELIOT L. ENGEL, New York SUE WILKINS MYRICK, North Carolina
JAN SCHAKOWSKY, Illinois JOHN SULLIVAN, Oklahoma
HILDA L. SOLIS, California TIM MURPHY, Pennsylvania
MIKE ROSS, Arkansas MICHAEL C. BURGESS, Texas
DARLENE HOOLEY, Oregon MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York JOE BARTON, Texas (ex officio)
JIM MATHESON, Utah
JOHN D. DINGELL, Michigan (ex
officio)
C O N T E N T S
----------
Page
Baldwin, Hon. Tammy, a Representative in Congress from the State
of Wisconsin, opening statement................................ 6
Capps, Hon. Lois, a Representative in Congress from the State of
California, opening statement.................................. 6
Cubin, Hon. Barbara, a Representative in Congress from the State
of Wyoming, opening statement.................................. 9
Deal, Hon. Nathan, a Representative in Congress from the State of
Georgia, prepared statement.................................... 3
Engel, Hon. Eliot, a Representative in Congress from the State of
New York, opening statement.................................... 8
Eshoo, Hon. Anna G., a Representative in Congress from the State
of California, opening statement............................... 3
Green, Hon. Gene, a Representative in Congress from the State of
Texas, opening statement....................................... 4
Hooley, Hon. Darlene, a Representative in Congress from the State
of Oregon, opening statement................................... 10
Murphy, Hon. Tim, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 7
Pallone, Hon. Frank Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 1
Solis, Hon. Hilda L., a Representative in Congress from the State
of California, opening statement............................... 9
Witnesses
Collins, Francis S., M.D., Director, National Human Genome
Research Institute, National Institutes of Health, Department
of Health and Human Services................................... 11
Prepared statement........................................... 56
Corwin, William, M.D., medical director, Clinical Policy, Harvard
Pilgrim Health Care, Wellesley, MA, on behalf of the America's
Health Insurance Plans......................................... 35
Prepared statement........................................... 119
Fishman, Burton J., Fortney & Scott, LLC, Washington, DC on
Behalf of the Genetic Information Nondiscrimination in
Employment Coalition........................................... 36
Prepared statement........................................... 77
Hudson, Kathy, director, Genetics and Public Policy Center, and
associate professor, Berman Institute of Bioethics, Institute
of Genetic Medicine, Department of Pediatrics, Johns Hopkins
University, Washington, DC..................................... 44
Prepared statement........................................... 108
Kuczynski, Christopher J., Assistant Legal Counsel and Director,
Americans with Disabilities Act, Policy Division, Equal
Employment Opportunity Commission, Washington, DC.............. 14
McAndrew, Susan, Deputy Director, Health Information Privacy,
Office for Civil Rights, Department of Health and Human
Services....................................................... 16
Prepared statement........................................... 62
Pollitz, Karen, research professor, Georgetown University Health
Policy Institute, Washington, DC............................... 38
Prepared statement........................................... 132
Swain, Frank, senior vice president, B&D Consulting, Washington,
DC............................................................. 40
Prepared statement........................................... 106
Terry, Sharon F., chair, Coalition for Genetic Fairness and
president and chief executive officer, Genetic Alliance,
Washington, DC................................................. 32
Prepared statement........................................... 72
Trautwein, Janet, executive vice president and CEO, National
Association of Health Underwriters, Arlington, VA.............. 41
Prepared statement........................................... 150
H.R. 493, THE GENETIC INFORMATION NONDISCRIMINATION ACT
----------
THURSDAY, MARCH 8, 2007
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 1:00 p.m., in
room 2123 of the Rayburn House Office Building, Hon. Frank
Pallone, Jr. (chairman of the subcommittee) presiding.
Members present: Representatives Gordon, Eshoo, Green,
DeGette, Capps, Baldwin, Engel, Schakowsky, Solis, Hooley,
Deal, Cubin, Wilson, Pitts, Rogers, Myrick, Murphy, and
Burgess.
Staff present: John Ford, Jessica McNiece, Jesse Levine,
Jonathan Brater, Ryan Long, Nandan Kenkeremath, and Chad Grant.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. I am calling the meeting to order and today we
are having a hearing on H.R. 493, the Genetic Information
Nondiscrimination Act of 2007. The bill would prevent the use
of an individual's genetic information from being used to
discriminate against them in obtaining health insurance
coverage in the workplace.
As science continues to make rapid advancements in the area
of genetics, I can't stress how important this bill is to every
American citizen. Genetic testing has increasingly become an
integral part of the American healthcare system, providing the
possibility to develop better therapies that are more effective
against disease and allow individuals to take steps to reduce
the likelihood that they will contract a particular disorder.
However, along with the increasing prevalence of genetic
testing comes the growing fear of the potential misuse of this
information by way of discrimination in health insurance and
employment. For example, people known to carry a gene that may
increase the likelihood of cancer may be denied health
insurance coverage, since insurers have an incentive to
identify and avoid beneficiaries who will cost them more money
than the average beneficiary.
Furthermore, many genetic conditions and disorders are
associated with particular racial and ethnic groups and
therefore members of a particular group may be stigmatized or
discriminated against as a result of their genetic information.
There have been several documented cases of genetic
discrimination carried out by both insurers and employers. A
2001 American Management Association survey of U.S. companies
found that a number of employers were conducting tests that
employers acknowledge might include genetic testing, as well as
requesting employees' family medical histories.
And the fear of genetic discrimination alone can have
significant societal cause. For example, many Americans may be
reluctant to undergo genetic testing because of such fear,
thereby hindering essential genetic research and clinical
practices. Many people may be deterred to participate in
biomedical research that studies gene mutations associated with
certain disease because of the fear that their information
could be used against them by insurers and employers.
And even more alarming, patients who could benefit from
genetic testing have often avoided testing out of concern for
possible repercussions, therefore losing the opportunity to
received monitoring and preventive care for conditions in which
they are at a higher risk.
A 2004 Genetics and Public Policy Center survey showed that
92 percent of respondents thought employers should not have
access to their genetic test results and 80 percent opposed
letting insurance companies have access to the results. And we
think or I should say I believe that current laws need to be
strengthened to protect against the possibility of genetic
discrimination. While the Health Insurance Portability and
Accountability Act of 1996 created Federal protections against
genetic discrimination, these protections are limited; I think
very limited.
Under HIPAA, Congress established certain restrictions for
group health insurance use of health related information in
terms of coverage and setting premiums. However, these
protections did not apply to individual health insurance nor do
they prevent insurers from denying an entire group coverage or
setting higher premiums based on the results of genetic testing
results from one of its members.
Many States have also enacted genetic nondiscrimination
laws, yet these provisions vary widely in their approach,
application and degree of protection and therefore I believe
that Federal legislation is necessary to establish a national
protection against potential genetic discrimination.
As knowledge of the human genome expands, a greater
proportion of the population will likely be identified as
carriers of mutations associated with a greater risk of certain
diseases, indicating that virtually all people are potential
victims of genetic discrimination in health insurance. And we
need to work in a bipartisan fashion to tackle this issue. I
would point out that this legislation does have a lot of
Republican, as well as Democratic support. It actually passed
the Senate twice, so it does have a lot of support on both
sides of the aisle already.
The president, President Bush, has also indicated that he
supports the bill, so we have an opportunity to actually pass
something here that will also pass the Senate and be signed by
the president and that is why I think that it is particularly
important that we act swiftly. There is absolutely no reason
why we shouldn't work together to pass the bill and get it to
the president's desk.
So in closing, I would like to thank the sponsor of this
bill. I know Representative Louise Slaughter has been pushing
this for as long as I can remember. She talks to me about it
all the time and of course, Anna Eshoo, the member of this
committee, who has also been not only a cosponsor, but a leader
on this issue. They have done a lot of work to put this bill
together over the years and it is immensely important. In my
opinion, it holds a lot of promise. So thank you.
I will now recognize our ranking member, Mr. Deal of
Georgia.
Mr. Deal. Thank you, Mr. Chairman. I am going to waive my
opening statement, but I would request unanimous consent that
all Members be allowed to insert their statements in the
record.
[The prepared statement of Mr. Deal follows:]
Prepared Statement of Hon. Nathan Deal, a Representative in Congress
from the State of Georgia
Mr. Chairman, I want to thank you for holding this hearing
today on H.R. 493, the Genetic Information Nondiscrimination
Act. I realize the Committee has limited time to act on this
possibly far reaching legislation but I am glad we are taking
this opportunity to hear about the impact of this bill.
My primary concerns with this legislation are the
definitions of ``genetic test'' and ``genetic information''. I
fear these definitions are so broad that routine medical tests
and information may be covered by this bill. Many States
including my own have enacted their own genetic
nondiscrimination legislation which include specific exclusions
we do not find in H.R. 493. In Georgia's law, the definition of
genetic testing focuses on tests for the purpose of identifying
the presence or absence of inherited alterations in genetic
material which are associated with a disease that arises solely
as a result of the abnormality in the genes. It also includes
specific exceptions for routine physical measurements;
chemical, blood, and urine analysis; tests for abuse of drugs;
and tests for the presence of the human immunodeficiency virus
(HIV). Yet, the definition of a genetic test we find in this
bill goes so far as to include an analysis which simply detects
genotypes. Nor do we find clear exceptions for routine tests or
for the abuse of drugs. This broad drafting leaves open the
possibility that tests the authors of this legislation may have
never intended to cover being included in this bill.
I am also concerned with how this legislation may interact
with the action 43 States have already taken on this issue. It
seems that in this bill, we would be legislating in a sweeping
manner; in an area the vast majority of the states have already
taken action. This could lead to a great deal of confusion in
the states about which regulations actually apply. I believe
this bill uses a standard of stringency to determine which
regulation, the State or Federal, should apply. Without a clear
determination, this could make it difficult for employers and
insurers to comply with this bill.
I realize many of our witnesses today will testify about
the need for this legislation to allay the public's fears of
being genetically tested and the important role genetic
information may play in the delivery of health care in the
future. I hope the witnesses could also help guide the
Committee to act in a specific way that would limit the bill's
unintended consequences in the future.
Again, I am glad we are taking this opportunity today and
I hope our witnesses will be able to address some of my
concerns and indicate the implications of this important
legislation.
----------
Mr. Pallone. Thank you, Mr. Deal. I next would recognize
Ms. Eshoo, who is the chief proponent of this legislation.
OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Eshoo. Thank you, Mr. Chairman, for having this
legislative hearing. It has been a long time in coming. I think
this is a very important and auspicious moment for the issue at
hand and that is as the great discovery, I think the greatest
discovery of the 20th century, just before we started the 21st
century, was the mapping of the human genome project. But with
that discovery came another one and that is that the wonder and
the manifestation of what that promise held would be withheld
because of the fear of being discriminated against, and that is
why we are here today.
I want to salute our colleagues, Congresswomen Louise
Slaughter and Judy Biggert, who have done a superb job on this.
I am proud to have played a role to help to build the coalition
of very, very important national organizations; some may be
unlikely partners, but that makes the case even stronger for us
to pass the bill. And with Dr. Collins here today, I think you
will remember when I was the co-chair of one of the bipartisan
retreats and of course, the Speaker of the House was there, as
well as the minority leader, and I believe it was Speaker
Hastert and Minority Leader Gephardt.
And they were sitting at tables next to each other, not
together, which is not atypical, right? But Dr. Collins and I
were sitting together and he was a guest; he had been invited
to come to the retreat to be instructive to all of the members
about the challenge that was before us. And I said to Dr.
Collins you must go up to the Speaker and the minority leader.
I will try to get them to stand next to you together so that
you can address them together and challenge them to take a hold
of this and make sure that it happened.
Well, that was some time ago and although it didn't happen
then, we have been helping to make it happen and I am very
excited that we are on the threshold of this and that we will
work through the bill. If there are ways to improve it, we look
forward to that. If there are ways that will essentially kill
it, I think that there are enough of us that won't allow that
to happen. I think the people in the country deserve a very
good bill in this area and I think that when this committee
passes it, we will have distinguished ourselves in a very
important way.
So thank you, Mr. Chairman. Thank you, Dr. Collins, for all
that you have done, and to the witnesses that are here today to
talk about the bill and answer the important questions that
members from both sides of the aisle will pose. Thank you.
Mr. Pallone. Thank you. And thank you for all the work you
have done over the past few years in trying to move this. I
recognize the gentleman from Michigan, Mr. Rogers.
Mr. Rogers. I will waive for more questioning time, Mr.
Chairman.
Mr. Pallone. And next we have our vice chair, the gentleman
from Texas, Mr. Green.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman, for one, holding this
hearing and also, as vice chair, I would like to welcome our
witnesses to the subcommittee and my colleague from California,
thank you for your efforts for many years. Some of us have been
cosponsors of this for six terms, it seems like. One of our
subcommittee's important responsibility is protecting the
rights of patients for their confidentiality and I hope we can
address this important issue in a bipartisan and cooperative
way.
Our society supports the idea that a person should be hired
based on their qualifications and ability to perform the job,
instead of characteristics out of their control, which have no
effect on their job performance. Racial, gender and other types
of discrimination is incompatible with merit-based economic
systems that rewards people for work and effort. Discrimination
based on health conditions is also incompatible with our
society and economy, so people should not be fired because of
their family history of a certain illness.
There should also be a consensus that people should not be
charged a higher price for health insurance based on their
family's medical history. The recent advances in the field of
human genetics has brought these issues to the forefront
because as usual, new technologies bring new benefits but also,
new opportunities for harm. Genetic testing is proven to be
extremely helpful in preventative medicine. It allows for
individuals with risk of an illness to take the precautionary
steps ahead of time, which will help keep healthcare costs to
the minimum.
It is important that we continue to support genetic testing
in order to further scientific advancement while protecting
Americans from any negative impact due to their participation.
There are over 15,500 recognized genetic disorders which affect
millions of Americans. It would be unfair to penalize someone
based on their genes by using this information improperly.
Under most circumstances, a person should be allowed to refuse
a genetic test without fear of being fired.
Also, if an individual is taking a genetic test, the test
should be conducted in terms which they agree and the results
should be released only if on the consent of that individual.
These issues are properly addressed in H.R. 493, which again, I
co-sponsored along with many supporters in the House. I believe
President Bush has made it evident he will also support these
principles. This hearing is an excellent opportunity for our
committee to work together to protect Americans from this
discrimination based on health concerns. And I yield back the
balance of my time.
Mr. Pallone. Thank you. Dr. Burgess is recognized for an
opening.
Mr. Burgess. Thank you, Mr. Chairman. Thank you for calling
this hearing. In deference to the quality of witnesses we have
today, I will just submit for the record.
Mr. Pallone. You are reserving your time for questions, OK.
The gentlewoman from Colorado, Ms. DeGette.
Ms. DeGette. Thank you, Mr. Chairman. As usual, Mr. Green
said it all and better than I could have, so I will waive my
opening statement.
Mr. Pallone. Mr. Pitts.
Mr. Pitts. I will waive.
Mr. Pallone. The gentlewoman from Wisconsin, Ms. Baldwin.
OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF WISCONSIN
Ms. Baldwin. Thank you, Mr. Chairman, and thank you to our
witnesses today. I am truly delighted that this subcommittee is
taking up this very important bill. It is clear that the time
has come to extend nondiscrimination protections to include
genetic information. This particular issue, genetic information
discrimination, poses a unique challenge for us, but I think we
are up to the task. The scientific advancement that has been
made in sequencing the human genome is groundbreaking and I am
excited that the leading scientist involved with the Human
Genome Project is here today, as you have been in the past at
our bipartisan conference that I also had a chance to attend. I
am glad you are here today to share your expertise with us.
We have only just begun to understand how we can harness
the vast amount of information that is included in the genetic
code to benefit human health and longevity. We have yet to see
the limits of the ways that this information can benefit all of
us. The ability to predict disease will greatly increase our
opportunities for early treatment and prevention efforts and
this can have a real impact on people's lives.
So we must not allow discrimination to prevent us from
taking full advantage of the important opportunities that
genetic information provides. We need to provide strong
protections that will prevent employers and insurers from
denying health coverage or job opportunities on the basis of
predictive genetic information. This important protection is
necessitated by these incredible advancements in the science
and we, members of Congress, are responsible for making sure
that our laws keep up with these scientific advancements so
that we can fully realize the value of these discoveries.
I am proud to be an original cosponsor of this legislation
and I look forward to seeing these important protections
extended to all Americans. Thank you, Mr. Chairman.
Mr. Pallone. Thank you. Mrs. Capps has returned, so I will
recognize her.
OPENING STATEMENT OF LOIS CAPPS, A REPRESENTATIVE IN CONGRESS
FROM THE STATE OF CALIFORNIA
Mrs. Capps. I apologize. I did not want to miss this very
special moment. Thank you, Mr. Chairman, for holding this
hearing. I want to acknowledge my colleague, Anna Eshoo, and
her partners, Louise Slaughter and Judy Biggert for their work.
There has been a steady push to get to this day. After so many
years and it is quite an accomplishment here. And especially
with our first witness; well, with all of our witnesses, it
will be a remarkable day. To have Dr. Collins here with us
today is very auspicious. This is a very appropriate time to
have you and all of us remember when he first showed us the
charts of the completion of the Genome Project. And now we have
today's topic to deal with.
We need this hearing today because we are paving the way
for consideration of legislation that, as I said, so many of us
strongly support. The identification of genetic markers for
disease is one of the most remarkable scientific
accomplishments we have made. With Dr. Collins at the helm, we
are going to continue to see even greater accomplishments in
our understanding of genetics. As we all know, we can never
emphasize enough just how important preventive health care is
to our wellbeing. The ability to identify risks for certain
conditions promises to enhance our ability to identify and
practice greater preventive healthcare in this country.
It is about quality of life, it is about saving life, but
at the same time, as with almost all great scientific
advancements, we have also opened the door to a whole slew of
unintended consequences. I fear that preventive healthcare is
being put at risk when patients decline genetic testing for
fear of insurance or employment discrimination. I know we will
hear from at least one witness today about the juxtaposition of
a public that is overwhelmingly optimistic about the benefits
of genetic testing, but overwhelmingly pessimistic about their
privacy being protected. What a shame.
We need to work together on ways to promote ethical genetic
testing with appropriate privacy protections and with measures
in place to prevent discrimination. This is our task. I believe
we can do it. We cannot continue with a system in place that
leaves individuals who might be at risk for a disease to forego
available genetic testing for fear of losing their job or their
health insurance.
I am proud to be a strong supporter of the Genetic
Nondiscrimination Act so that we can ensure that this will not
occur in the future. I look forward to hearing from all of you
today. Thank you very much for coming. I yield back.
Mr. Pallone. Thank you. I recognize the gentleman from
Pennsylvania, Mr. Murphy.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy. Thank you, Mr. Chairman, and thank you for
holding this hearing. This is a very, very important issue that
has to be addressed. I commend my colleagues, my friends, for
putting forth this bill. It is a very important issue to be
dealing with in the area of healthcare and a couple of areas.
As it has been stated, we are learning more and more about the
genome in the role of genetics and what it can teach us about
patients; in particular, as just mentioned by my colleague, the
issues of prevention.
I would like to see a day when we recognize that treatments
have become so sophisticated for patients that understanding
their own genetic makeup, that medications and treatments can
be made person-specific and come with much more effective
treatment plans, such as cancer and other diseases. However, we
do need to protect and make sure that patient does not fear
losing their job or losing their insurance because they
complied or wanted to have these things done.
I wanted to also make sure, and one of the things I hope
that perhaps some of our witnesses will be able to address
today at the level of expertise, has to do with electronic
medical records, because I want to make sure there is no
unintended consequence of this bill that might prevent a
business that might try and help its employees by providing
electronic medical records to be seen as somehow gathering
information that might be used in some discriminatory manner.
There are so many incredible potentials we have here for
healthcare and making it better with prevention and personal
specific treatment. I hope we can get to that point and any of
the other concerns in this bill, I hope this committee will
take care of. And I yield back the balance of my time.
Mr. Pallone. Thank you. Mr. Engel of New York.
OPENING STATEMENT OF HON. ELLIOT L. ENGEL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW YOR
Mr. Engel. Thank you, Mr. Chairman, for holding this very
important hearing on the Genetic Information Nondiscrimination
Act. I echo what all of our colleagues said. The sequencing of
the human genetic code is unquestionably one of our greatest
scientific accomplishments. A researcher's ability to identify
genetic markers for diseases has given hope and promise to
millions of people regarding how to make more informed choices
about their personal healthcare.
The promise of this breakthrough is hindered, though, by
well-founded fears of how information may be abused in the
employment and insurance industry. In one notable example in
2002, the Burlington-Northern Santa Fe Railway agreed to pay
$2.2 million to 36 employees who said the company illegally
tested their blood samples to claim a genetic defect that
caused their workplace injuries. A study noted by one of our
witnesses, Dr. Collins, said that 68 percent of respondents
would not bill their insurance company if they chose to have
genetic testing done regarding their risk for cancer, colon
cancer or breast or ovarian cancer. Twenty-six percent said
they wouldn't feel safe getting tested unless they used another
name.
A 1998 joint report by the Department of Labor, Equal
Employment Opportunity Commission of the Department of Justice
stated that Federal legislation was necessary to mandate more
appropriate protections against workplace discrimination. While
many States, including mine, of New York, have laws which
prohibit discrimination in health insurance and by employers
based on genetic testing and information, it is clear that they
are not fully comprehensive and that Federal action is
necessary. Fear should not be a deterrent to knowledge.
Disregarding available tests for fear of discrimination
prevents citizens from making smarter, personalized choices and
being better informed about their own well-being.
Why wait until the standard age that everyone is
recommended to start getting mammograms and colonoscopies if
one knows he or she is at risk for these diseases? We know too
much to subscribe to one-size-fits-all medicine and once again,
it should be our physicians, not our insurance companies, who
influence our healthcare decisions. I am proud to be an
original cosponsor of this bill, it has strong bipartisan
support, and the President supports it, as it will clarify how
genetic information should be protected in both the insurance
and employment setting.
So Mr. Chairman, I thank you again for convening this
hearing and I look forward the testimony and this is one thing
that is not political. As Americans, we deserve no less. Thank
you. I yield back.
Mr. Pallone. Thank you. Recognize the gentlewoman from
Wyoming, Mrs. Cubin.
OPENING STATEMENT OF HON. BARBARA CUBIN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF WISCONSIN
Mrs. Cubin. Thank you, Mr. Chairman. The advent of genetic
technology holds tremendous promise in the healthcare field.
Along with the mapping of the human genome, researchers have
identified genes associated with diseases such as Alzheimer's
disease, cancer and diabetes. Genetic testing and the
information it garners can assess individual predisposition to
these debilitating diseases. Continued research may open the
door to earlier disease prevention, new diagnostic tools,
treatments and potentially, even cures.
Genetic technology could also play a role in making
treatment delivery more individualized and effective. As is the
case with many rapidly developing technologies, advances in the
genetic field are not without their pitfalls. Like a
fingerprint, an individual's genetic information serves as a
unique personal identifier. The potential misuse of a person's
unique genetic information is an important issue to the general
public and something that this committee is right to address.
H.R. 493, the Genetic Information Nondiscrimination Act, is
intended to prevent discrimination based on genetic
information, both in the workplace and in the context of health
insurance coverage. As a long time advocate for healthcare
privacy, I, too wish to ensure that genetic technology does not
become a tool for discrimination or limitation on access to
healthcare. H.R. 493's broad definition of genetic information,
however, in combination with its sweeping ban on requesting or
disclosing genetic information should be looked at critically.
This bill stands to directly impact our Nation's employers,
law enforcement and healthcare providers, making it imperative
that we root out unintended consequences before we move
forward. In the healthcare field in particular, H.R. 493's new
regulatory web will have to interlock with the already
extensive and complex privacy rules administered by the U.S.
Department for Health and Human Services. I am hopeful that our
panelists will be able to shed some light on the underlying
issues of genetic discrimination, as well as address concerns
that this legislation may interfere with the delivery of
important and life saving healthcare services.
Thank you, Mr. Chairman. I yield back the balance of my
time.
Mr. Pallone. Thank you. Next is Ms. Solis.
OPENING STATEMENT OF HON. HILDA L. SOLIS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Ms. Solis. Thank you, Mr. Chairman, and good afternoon. I
want to thank you for holding this very important hearing and I
want to just express that I strongly believe that
discrimination of any kind, whether it is based on gender,
race, disability or genetics, is morally wrong and should not
be tolerated. H.R. 493 is critical in protecting communities
that have historically faced discrimination, many of which are
at great risk or perceive themselves to be at risk of genetic
discrimination.
A study done by Mt. Sinai School of Medicine found that
Latino participants believed that there were more disadvantages
to genetic testing compared with other ethnic groups and they
expressed strong concern regarding testing abuses. Even though
African Americans were four times more likely to think that all
pregnant women should be genetically tested, a 2006 study
published in the Journal of the National Medical Association
stated that African Americans were also three times more likely
to believe that genetic testing would lead to racial
discrimination.
The research participants were concerned that genetic
testing results could lead to racially based population control
or would block access to health insurance and employment.
Unfortunately, these are the same communities which could
benefit significantly from genetic testing if only they were
protected. Genetic tests can help people determine if someone
is at risk of breast, ovarian and other cancers. Breast cancer,
as you know, is the leading cause of cancer among Latinos and
African American women continue to have higher rates of
mortality from breast and cervical cancer.
Native Americans and Alaskan natives continue to have the
poorest survival form of all cancers combined than any other
racial group. Cancer has been the No. 1 killer of Asian
American women since 1980. We need to make sure our residents
can access their genetic information without fear that it will
be used against them by their insurers or employers. If we do
not protect our residents from genetic discrimination,
preventable health disparities will continue to increase
unnecessarily.
I believe this bill is long overdue and I look forward to
hearing from our witnesses today and working with my colleagues
to see that this bill moves forward. Yield back the balance of
my time.
Mr. Pallone. Thank you. I recognize the gentlewoman from
New Mexico, Mrs. Wilson.
Mrs. Wilson. Thank you, Mr. Chairman. I will waive my
opening statement.
Mr. Pallone. And next is Ms. Hooley, from Oregon.
OPENING STATEMENT OF HON. DARLENE HOOLEY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Ms. Hooley. Thank you, Mr. Chairman. I am proud to say I am
a long time supporter of the Genetic Information
Nondiscrimination Act. I am hopeful that in the 110th Congress
we will finally be able to pass this important piece of
legislation. The Health Insurance Portability and
Accountability Act of 1996 was a first step in protecting
workers from genetic discrimination. However, in the light of
the rapid growth in scientific knowledge that has occurred
since 1996, it is well past the time that we take strong steps
to strengthen genetic nondiscrimination provisions.
Scientific advancements and sequencing the human genome
provide exciting opportunities that may allow us to live longer
and healthier lives. However, the potential for inappropriate
and the discriminatory use of genetic information fosters fear
in many people. We will not be able to benefit from the
extraordinary scientific achievements in genetics if people are
afraid they will be discriminated against if they undergo
genetic testing.
That is why GINA is not only an important privacy and
consumer protection bill, but also a bill critical to improve
the health of Americans and foster increased scientific
research. If people do not trust the way genetic information is
used, then the research, itself, will almost certainly be
stifled. It would be a tragedy to slow research that holds a
potential to provide such tremendous benefit. GINA strikes the
appropriate balance between the imperative of protecting the
privacy of workers and patients with the need to encourage
future scientific advancements.
This legislation will accomplish both sets of goals so that
we can feel safe in taking advantage of the improvements in how
healthcare is delivered that genetic research allows. I am also
encouraged that the president has expressed strong support for
genetic nondiscrimination. Hopefully, this time, and I am an
optimist, we can get it through the House and the Senate and
get it signed by the president. It is the best for the American
people. Thank you, Mr. Chairman.
Mr. Pallone. Thank you. And that concludes the opening
statements by members of the subcommittee. Let me just say
again that every member has the right to submit their statement
for the record.
Let me welcome the panel and mention who we have here.
First is Dr. Francis S. Collins, who is director of the
National Human Genome Research Institute and the National
Institute of Health.
Next is Mr. Kuczynski. He is assistant legal counsel and
director of Americans with Disabilities Act Policy Division for
the Equal Employment Opportunity Commission. And then we have
Ms. Susan McAndrew, who is Deputy Director for Health
Information Privacy, Office for Civil Rights, Department of
Health and Human Services.
Now, we will have 5-minute opening statements from each of
the witnesses. Those statements will be made part of the
hearing record. Each witness may, at the discretion of the
committee, submit additional briefs and pertinent statements in
writing for inclusion in the record. And I will now recognize
Mr. Collins to begin with his opening statement. You can
proceed.
STATEMENT OF FRANCIS COLLINS, M.D., DIRECTOR, NATIONAL HUMAN
GENOME RESEARCH INSTITUTE, NATIONAL INSTITUTES OF HEALTH,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Collins. Thank you, Chairman Pallone, and good
afternoon, members of the subcommittee. I am Francis Collins. I
am the director of the National Human Genome Research Institute
at the National Institutes of Health. I am a physician and a
scientist. I want to express my thanks for the opportunity to
be here today and my congratulations to this committee for
taking on this issue and moving it so quickly in the 110th
Congress. Some of us had been waiting a dozen years to get to
this point and it is gratifying, indeed, to see this hearing
being held this afternoon and to hear these statements of
strong support for the principles of the Genetic Information
Nondiscrimination Act or GINA, H.R. 493.
We stand on the brink of a revolution in healthcare. The
Human Genome Project, which was completed ahead of schedule and
under budget in 2003, read out all of the three billion letters
of our own human DNA instruction book, providing a foundation
for all of the research that we need to do in the future to
understand how environment and genetics work together to cause
health or disease. In an immediate follow-up at another project
that I had the privilege of leading, the International HapMap
Consortium, laid out a map of how the variable part of the
genome, the 0.1 percent where we differ, is organized across
chromosomes and provided with the tools to understand how it is
that some of that variation plays a role in risk of disease, be
it diabetes, heart disease, Alzheimer's or many other
conditions.
We are moving quickly towards the time where your genome
might be possible to determine, at high accuracy, for a
thousand dollars or less, because the technology is moving so
quickly and so there will be a major motivation to make that
information a standard part of the medical record. Already, we
see around us many gene discoveries happening. More than a
thousand genetic tests are now available and discoveries are
happening practically every day. Just this week there were
discoveries about genetic factors in cleft lip and palate,
other genetic factors in Alzheimer's disease, even something
about panic disorder. And in the last year we have seen
discoveries about macular degeneration, a common cause of
blindness, diabetes, prostate cancer, Crone's disease.
NIH has a major investment now in trying to take this
opportunity and move it forward at maximum speed so that we can
identify other factors that play a role in virtually all
hereditary diseases and frankly, all diseases have at least
some hereditary contribution. I should say, therefore,
personalized medicine, this hope that we can use this
information to individualize the way we approach medical
problems and focus on keeping people healthy is not for a few
people, it is for all us. We all have glitches somewhere in our
instruction books that place us at risk for something. The
opportunity to discover those and to individualize our
individual plans of prevention is one of the major hopes that
we have for reducing our healthcare costs and focusing on
keeping people healthy.
Yet, there is a cloud on the horizon and it is a cloud that
has been getting darker and more frightening over the course of
the last more than 12 years, since I have had the privilege of
leading the genome effort and worrying about this issue, and
that is that this kind of genetic information, as valuable as
it is, might be used against people. If I could see the one
slide that I brought along, I wanted to put a human face on
this particular issue.
[Slide shown.]
So this is a particular family. You can see in the
pedigree, that some are drawn as males and some as females. You
see a bright red arrow pointing to the woman who first came to
attention in one of our research protocols at NIH, and she came
to attention because, at the age of 36, she had already had
cancer of both the uterus and the colon. And it turned out her
mother and her aunt had also had both of those conditions. We
recognize that this is a condition that can be strongly
inherited. It is called hereditary nonpolyposis colon cancer
and this is one of those conditions for which the genetic basis
has been identified.
All of the people that you see in yellow, therefore, are at
high risk of having the same condition, but the good news is
that knowing you are risk for this condition allows you to
undergo medical screening, such as colonoscopy, beginning at an
early age; 35 is often recommended. And then one can find the
evidences of an early tumor while it is still easily treated,
by a surgical procedure. However, in this family, the fear of
genetic discrimination made it very difficult for these family
members to decide what to do. Ultimately, the woman with the
arrow was tested; she was found to have a mutation.
Other family members were offered the chance to find out
their status. Her four sisters, as you can see there, given
that information, still decided not to be tested because of
their fear that this might be used against them. And they are
out there somewhere without having life saving information
because of this very specific issue, an issue which you all can
help us with by getting this legislation passed this year.
This in not a partisan issue, of course. Let me give you
one other example. You can take that slide down. Health
professionals are not immune to this risk, as well. I am aware
of a physician who lives in Chicago who is in a family with a
lot of breast cancer. She decided to undergo BRCA1 testing. She
decided to do this under a false name because of her concern
about this being used against her. What are we doing here?
Asking people to use a false name to have a genetic test that
might be useful? The test was----
Mr. Pallone. Dr. Collins, I am going to ask you to
summarize, because we do have votes.
Dr. Collins. Sure.
Mr. Pallone. And then I will indicate what we are going to
do. If you could wrap up.
Dr. Collins. Certainly. Her test was positive. She didn't
get that into her medical record. An ultrasound that was done
later for another purpose was not looked at carefully because
of that consideration. A year later, she was diagnosed with
ovarian cancer. It could have been diagnosed if that
information had been known.
So let me finish. We remain deeply concerned about the
impact of potential genetic discrimination on both research and
clinical practice. Unless Americans are convinced this
information will not be used against them, this era of
personalized medicine may never come to pass. The result will
be a continuation of our current one-size-fits-all medicine,
ignoring the evidence that genetic differences among people
help explain why some of us benefit from a therapy while others
do not. This is an issue of equity. It is an issue of justice.
Twenty-four out of the 33 members of this subcommittee are
cosponsors of this bill, which I am delighted to note. And the
president, in his visit to NIH last month, again called on
Congress to pass such a bill, so we are delighted to see this
issue being taken up so early in this Congress and are hopeful
this will be the year when the American people are given a gift
that is long overdue, protection at the Federal legislative
level against genetic discrimination.
Thank you, Mr. Chairman. I would pleased to answer any
questions.
[The prepared statement of Dr. Collins appears at the
conclusion of the hearing.]
Mr. Pallone. Thank you. Let me explain what we are doing.
We have one vote, then we have 10 minutes on the motion to
recommit for debate and the we will have three more five-minute
votes, so I think, since there is only about 7 or 8 minutes
left, we should break now, rather than hear from the next
speaker, so figure about, I don't know, half an hour, maybe
even 45 minutes. And those are the last votes of the day, so we
will break and then we will come back after that. Thank you.
[Recess.]
Mr. Pallone. The committee will reconvene and we will start
where we left off, with Mr. Christopher Kuczynski. I am sorry
for the delay, but that is what happens around here. We will
have no further delays because we are done voting.
CHRISTOPHER KUCZYNSKI, ASSISTANT LEGAL COUNSEL AND DIRECTOR,
AMERICANS WITH DISABILITIES ACT POLICY DIVISION, EQUAL
EMPLOYMENT OPPORTUNITY COMMISSION
Mr. Kuczynski. Thank you, Mr. Chairman, and members of the
subcommittee. I am pleased to be here today on behalf of Chair
Naomi Earp to answer your questions concerning H.R. 493, the
Genetic Information Nondiscrimination Act. Since February 1997,
I have been Assistant Legal Counsel and Director of the
Americans with Disabilities Act Policy Division at the United
States Equal Employment Opportunity Commission. In this
position, I oversee the development of agency policy on the
ADA, counsel EEOC field and headquarters offices that are
investigating and litigating ADA charges of discrimination, and
provide technical assistance on the law to a wide range of
stakeholders.
In the late 1990's, I was part of an inner-agency working
group that developed what ultimately became Executive order
13145, which prohibits Federal agencies from discriminating in
employment on the basis of protected genetic information, and I
provided substantial input on the policy guidance that EEOC
issued in July of 2000 to implement that Executive order. Peter
Gray, of EEOC's Office of Legal Counsel, who is with me today,
also worked on the inter-agency working group that developed
the Executive order and was the primary drafter of the EEOC
policy guidance on that order.
As this subcommittee is aware, the administration has
issued a Statement of Administration Policy supporting Senate
passage of a similar bill in the 109th Congress, and former
EEOC Chair, Cari Dominguez, on February 13, 2002 expressed this
agency's support for legislation prohibiting employment
discrimination on the basis of genetic information.
Now basically, my understanding is title II H.R. 493 would
do essentially three things. First, with carefully defined
exceptions, it would prohibit employers from obtaining genetic
information about job applicants and employees that would
indicate a predisposition to or increase risk of acquiring a
condition in the future. Consistent with limitations that the
ADA imposes, employers would still be permitted to conduct
medical examinations of applicants and employees to detect
conditions that actually exist and that may affect their
ability to perform their jobs.
Second, the bill would prohibit employers from using
genetic information indicating that a job applicant or employee
has a predisposition to or increased risk of acquiring a
condition in the future to deny someone a job or other equal
employment opportunities. And in this way, the law is
consistent with other laws that the EEOC enforces, such as
title VII of the 1964 Civil Rights Act, the Age Discrimination
in Employment Act and the ADA, which prohibit discrimination on
the basis of some protected status.
Finally, title II of H.R. 493 requires that employers keep
genetic information about applicants and employees confidential
with limited exceptions. In this respect, the law is similar to
the Americans with Disabilities Act, which itself contains
confidentiality provisions about medical information that
employers acquire.
I know that issues have arisen concerning the relationship
of some of H.R. 493's requirements regarding the collection and
confidentiality of genetic information to requirements in the
Health Insurance Portability and Accountability Act, HIPAA. The
EEOC will need to work with the Department of Health and Human
Services, the agency responsible for interpreting and
implementing HIPAA, assuming that GINA is enacted with current
provisions, requiring EEOC to promulgate regulations. We would
work closely with other agencies, including the Departments of
Labor and the Treasury, who have responsibility for issuing
regulations under HIPAA's current nondiscrimination provisions
and title I of GINA, as necessary to ensure consistency in the
interpretation of terms such as ``genetic information'' and
``genetic tests'' that appear in titles I and II. We have well-
established procedures for doing this type of coordination.
Additionally, we would have the benefit during the notice
and comment period prior to issuance of final regulations, to
hear from the public, other Federal agencies, employers and a
wide range of stakeholders on the proposed regulations.
Additionally, if EEOC's experience with enforcing and
implementing the ADA is any indication, compliance with the
requirements of the confidentiality provisions of the GINA
should not present insurmountable problems. For example, the
ADA allows employers to collect medical information about
employees as part of voluntary wellness programs and requires
that the information gathered be kept confidential. We have no
data to suggest that employers have been deterred from
establishing wellness programs because of concerns about the
ADA. Indeed, wellness programs seem to be more popular than
ever before.
The ADA also allows employers to obtain medical information
about applicants and employees in other situations, such as
during a medical examination conducted after a job offer has
been made, but before employment begins, when an individual
with a non-obvious disability requests a reasonable
accommodation or when an employer reasonably believes that a
current employee's medical condition prevents him or her from
performing a job or from performing it safely.
Again, we have not observed that employers are either
reluctant to obtain medical information they need or that the
applicability of the ADA to some of this information is causing
serious compliance problems.
Thank you for the opportunity to appear before you today. I
look forward to your questions.
Mr. Pallone. Thank you, Mr. Kuczynski. Ms. McAndrew.
SUSAN MCANDREW, DEPUTY DIRECTOR FOR HEALTH INFORMATION PRIVACY,
OFFICE FOR CIVIL RIGHTS, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Ms. McAndrew. Thank you, Mr. Chairman and members of the
subcommittee. My name is Susan McAndrew. I am the Deputy
Director for Health Information Privacy in the Office for Civil
Rights in the Department of Health and Human Services and as
such, I am responsible for the administration and enforcement
of the Privacy Rule that was issued pursuant to the Health
Insurance Portability and Accountability Act of 1996. I thank
you for this opportunity to testify on the role that the
Privacy Rule plays in the protection of genetic information
today. I will just start with some brief background material on
the Privacy Rule and then turn to the provisions that will be
of most interest to this committee.
The Privacy Rule establishes, for the first time, a set of
national standards to protect health information, but it is not
universally applicable to health information wherever it
resides. The standards apply to health information that is
individually identifiable and we call that information
protected health information. But it only protects that
information when it is being held and maintained by what we
call covered entities. These entities are health plans,
healthcare clearinghouse and those healthcare providers that
engage in electronic transactions for which the HIPAA
legislation required the Secretary to adopt standards for the
electronic exchange of information, most commonly, how they go
about billing for their services.
The Privacy Rule protects the information, largely by
establishing limitations on how that information is to be used
and disclosed, and puts the individual in control to the extent
feasible, by requiring that the information only move outside
of the entity with the individual's written authorization. The
rule does make clear that there are exceptions to when that
written authorization is required and these permitted uses and
disclosures are largely or primarily focused on the core
functions of the health industry that is--the need for this
information to treat the patient and to get that treatment paid
for in a prompt and accurate manner, as well as to allow
healthcare providers and health plans to conduct normal health-
related business practices.
There are a limited number of other exceptions that the
rule recognizes where public interest may require that this
information be disclosed without first obtaining the
individual's written authorization. The Privacy Rule also
establishes a Federal floor of privacy protections thus allows
State and other Federal law to provide more protection as well
as business entities to adopt practices that are more
protective of privacy
With regard to this legislation, I want to focus on three
things. First, individually identifiable genetic information is
protected health information under the Privacy Rule today, but
we protect this information as we would any other individually
identifiable health information. There are no special rules in
the Privacy Rule that would add heightened protections because
this is genetic information. What the legislation would do, if
it is adopted in its current form, would be, for the first
time, to introduce a definition of genetic information into the
Privacy Rule and apply different protections to this
information.
Second, with regard to health plans, currently, the Privacy
Rule permits a health plan to use protected health information,
and this includes genetic information, for their core business
practices; that includes determining enrollment and eligibility
for benefits under the plan, as well as underwriting premium
rating and the activities related to the creation, renewal or
replacement of a contract for insurance. Under this
legislation, the health plan would be prohibited from using
genetic information for these activities. And the rule also
currently allows health plans to condition enrollment or
eligibility for benefits under a plan on obtaining an
individual's authorization for the release of protected health
information if that request is made prior to the enrollment.
This is so the plan can get the necessary health information in
order to make a determination about enrollment. However, under
this legislation, to the extent the information sought pursuant
to this type of authorization was genetic information as
defined by the bill, that would no longer be permitted.
In addition, for the first time, not only would the bill,
title I, make these activities a discriminatory practice for
the health plan, similar to what title I of HIPAA does today in
some circumstances, but----
Mr. Pallone. I am just going to ask you to summarize a
little, because we are a minute over.
Ms. McAndrew. OK. I am sorry. The other point that should
be made is that the Privacy Rule does not govern a business
simply because it is an employer. However, the rule protects
the information if the business is involved in healthcare, from
flowing from the healthcare side of the business to the
employer's side for employment activities that that business
would need. And that largely would be the topic of title 2. And
I appreciate your having us here today and we look forward to
answering your questions.
[The prepared statement of Ms. McAndrew appears at the
conclusion of the hearing.]
Mr. Pallone. Thank you. Thanks a lot. I am going to start
by recognizing myself for 5 minutes for questions and I will
start with Dr. Collins. I have a couple questions for Dr.
Collins.
More than a thousand genetic tests are now available, but
most of them are for rare diseases. How rapidly is the science
of genetic testing progressing from more common conditions?
Dr. Collins. Very rapidly, indeed. With the success of the
Human Genome Project, with this follow-after effort called the
HapMap Project that has allowed us to really get a sense of a
landscape of genetic variation, that 0.1 percent of our DNA
where we differ, we now have the tools to be able to scan the
entire genome and identify subtle variations that increase the
risk of diseases like diabetes, Alzheimer's disease, prostate
cancer, Crohn's disease.
All of the diseases I just mentioned, in fact, have had
those discoveries made within the last year and a half and you
can anticipate now with these tools in place and with the
advances in technology that now make this kind of laboratory
work much cheaper than it used to be, you will see a profusion
of these discoveries coming out in the course of the next 2 or
3 years. We will discover the major hereditary factors in the
common diseases that fill up our hospitals and clinics in the
relatively near future.
Mr. Pallone. So basically, we will see it in the mainstream
practice of medicine, would you say?
Dr. Collins. We have already seen, in some instances, such
as the example of hereditary colon cancer that I presented in
my opening statement, an opportunity to integrate this kind of
testing for a common disease in a way that saves lives.
Mr. Pallone. Now, are there any other barriers, though,
that would exist for bringing it into the mainstream? Is there
anything Congress should be doing to remove barriers or would
just move it along fine?
Dr. Collins. The main barrier is the one we are here to
talk about this afternoon, is this fear of discrimination and
which is not an unreasonable fear.
Mr. Pallone. OK.
Dr. Collins. Obviously, we also need to be sure we have
supported the medical research to know the answers as crisply
as possible so that people who get this information can be
given accurate information and that is what NIH and our fellow
agencies supporting medical research are committed to doing.
Mr. Pallone. Let me ask this. I mean, basically, I think
you have answered even my second question because you say that
doctors are already testing whether some of us carry gene
mutation. Well, you stated before that doctors can already test
whether some of us carry gene mutations that increase our risk
for disease and that more research will expand that capability.
But how far can you go with this? Can you offer a guess
regarding what proportion of the population would someday be
able to learn about their own inherited risk of disease?
Dr. Collins. I think ultimately, all of us, because we all
carry these risks. Some of us can guess what some of those are
from our family history, but not all that accurately. As we
learn more and more precisely about the DNA variance that
convey those risks, we will be able to offer much more
specificity. I would see a time, if this legislation
successfully passes and if the research moves at the rate that
it seems clearly to do, where each of us, in perhaps as little
as 5 years would have the opportunity to find out what our
future risks are based on extensive DNA analysis and to be able
to alter our lifestyle, our medical surveillance, our diet, our
exercise plan to reduce the risks of the things that are
highest on our list, instead of doing this in a one-size-fits-
all approach, which is our current strategy and which sometimes
works and sometimes doesn't.
Mr. Pallone. And everybody has at least one gene mutation,
so everybody is going to be impacted?
Dr. Collins. Everybody has dozens of these.
Mr. Pallone. OK.
Dr. Collins. There are no perfect specimens, not even in
the halls of the United States Congress.
Mr. Pallone. So that is why this discrimination issue
affects us all and why we have to deal with it.
Dr. Collins. It absolutely does. We are all at risk unless
we solve this problem.
Mr. Pallone. All right, then let me ask Ms. McAndrew; well,
this is what I wanted to ask. I know you deal with the privacy
issue. The Bush administration has issued two Statements of
Administration Policy in response to the Senate passing this
bill. In both of those cases, the administration said that they
favor an Act of legislation to prohibit the improper use of
genetic information in health insurance and employment, and as
recently as January 17, President Bush said, and I quote, ``I
really want to make it clear to the Congress that I hope they
pass legislation that makes genetic discrimination illegal.''
In other words, if a person is willing to share his or her
genetic information, it is important that that information not
be exploited in improper ways and Congress can pass good
legislation to prevent that from happening. What I want to ask,
with regard to GINA, am I correct in assuming that you or your
office agree with President Bush and support the legislation
before us today? I know you mentioned a little bit about it,
but if you could just answer that.
Ms. McAndrew. Yes, we are in support of the
nondiscrimination provisions of this bill and they really are
beyond the scope of the Privacy Rule, to effect, and we are in
support of this legislation to address those problems.
Mr. Pallone. Thank you. Thank you. I yield to the gentleman
from Georgia, Mr. Deal.
Mr. Deal. Thank you, Mr. Chairman. I am going to ask a
series of questions, Mr. Kuczynski. I am going to start with
you. And I think they lend themselves to rather short answers
and I would like to get through as many of these as I possibly
can.
Under title II of H.R. 493, can the practices, actions or
communications of in-house healthcare be a basis for violations
under 202(a), 202(b) and 206(b) of the Act? To clarify, I mean
providers employed by an employer covered by the bill to
provide healthcare services as a benefit for employees.
Examples, of course, being in-house clinics, hospitals or
universities that provide health services to employees as a
benefit of employment.
Mr. Kuczynski. Yes, I think that if the employers providing
health services as a benefit of employment, that benefit of
employment would be subject to nondiscrimination requirements
of title II, as it would be with respect to all of the other--
it is the same principle as would apply under any of the civil
rights laws that we enforce.
Mr. Deal. Would the same rule apply if the employer
contracted with a doctor to provide healthcare services to an
employee? In other words, could the practices, actions or
communications of such a provider be the basis of a violation
under sections of the Act?
Mr. Kuczynski. Again, if the employer is contracting with a
third party to provide health services on its behalf, the
employer has to ensure that that provider is conducting itself
and providing those services in a manner that does not
discriminate under GINA. Again, the same is true under the
Americans with Disabilities Act, where we have said that an
employer can't do, through a third party, what it could not do
directly, so the employer would be liable.
Mr. Deal. That would be yes, they would be considered
violations of 202(a), 202(b) and 206(b) of the Act?
Mr. Kuczynski. Yes, the employer could be responsible for
those.
Mr. Deal. OK. I understand that the uniformed military
service is exempt from the bill. Would the actions or
communications of a healthcare provider employed or contracted
to by NASA, the FBI, the Border Patrol or State governments be
covered under the Act?
Mr. Kuczynski. They would be as they are under the other
civil rights laws.
Mr. Deal. If an employer offered to provide a service to
provide for and maintain electronic personal health records,
would that activity be subject to sections 202(b) and 206(b) of
GINA?
Mr. Kuczynski. If that involves the provision of health
services under GINA, then the individual would have to give a
prior knowing, written, voluntary consent to the provision of
their services, but yes, the employer would have to make sure
that those services were provided in a way, including
maintaining the confidentiality of that information that was in
compliance with GINA.
Mr. Deal. I take your answer, then, to be yes?
Mr. Kuczynski. Yes.
Mr. Deal. Would the same rule apply if the employer
contracted with a private company to maintain personal health
records in a storage service for their employees? If the
employer provided family medical history, for example, to be
placed in such personal health records stored at the private
company, is that fact alone a disclosure and violation of
section 206(b) even if the company agrees to keep such material
confidential?
Mr. Kuczynski. I don't think I understood the last part of
the question. If the employer is contracting with a third party
to maintain the electronic records and there is a disclosure
that would violate GINA?
Mr. Deal. Yes. Is the fact that they are storing it, even
though they agree to make it confidential?
Mr. Kuczynski. I think that the fact that they are storing
it, I don't think would be. I think the violation would be if
the information was disclosed. Again, this is assuming that the
individual has given prior knowing, written and voluntary
consent to the provision of the health services. They have done
that. They can be stored, if they are disclosed in violation of
section 206, that would be a violation.
Mr. Deal. Would the fact that they are being stored by an
outside contractor make any difference?
Mr. Kuczynski. No, but the responsibility for and the
violation, the liability would be the employer's liability. The
Act, as I understand it, doesn't regulate so much the practices
of the provider, be it a healthcare provider or an entity that
is storing the records, it is regulating the conduct of the
employer and it is saying to the employer you are responsible
for making sure that entities with whom you contract are
carrying out their functions in a way that is consistent with
the requirements of this Federal law.
Mr. Deal. So if they contract with a private company, then
any practices, actions or communications of that private
company could be the basis for a violation under section
202(a), 202(b) and 206(b) of the Act, is that right?
Mr. Kuczynski. Well, communications that violate 206, I
mean, to the extent that there are communications that are
conducted in the normal course of business, sharing
information, be it the provider of storage, if an entity is
storing records or if an entity is providing health services, I
think that they would be permitted to exchange information to
the extent necessary to provide those health services or to the
extent necessary to store the information.
Mr. Deal. But that would only be to the extent allowed
under 206(b), is that right?
Mr. Kuczynski. Well, I mean, I think there is a question as
to whether this law really is intended to disrupt the manner in
which providers of health services carry on their business. I
don't think, for example, that it would be a violation if, in
order to provide services to an individual who has agreed to
have them provided, that information was shared, let us say,
from a doctor to a lab that needed to have that information in
order to carry out the health services to which the employee
had already consented. I don't think that GINA is inconsistent
with that type of sharing of information.
Mr. Deal. Under title II, assuming there was not a section
209(2)(b), could the practices, actions or communications of a
health plan, administered or sponsored by an employer as an
employee benefit, be the basis of violations under title II?
Mr. Kuczynski. When employers contract with providers to
offer health insurance, for example, on behalf of the employer,
the employer is again liable if that benefit is being provided
in a discriminatory way. The same would be true under title
VII. For example, if higher rates were charged to women than to
men, it would be sex discrimination or fewer benefits were
offered to African Americans than to whites.
Mr. Deal. So I take that to be a yes, then?
Mr. Kuczynski. Yes.
Mr. Deal. I would like your interpretation of section
202(b)(5)(b). Assume that genetic monitoring is not required by
Federal or State law and the business nonetheless feels that
safety requires such monitoring. If the employee says that he
does not want to be subject to such monitoring, does the
employer still have the right to reassign him away from the
position that the employer feels needs monitoring or must the
employer allow the employee to continue without the monitoring?
Mr. Kuczynski. I think the monitoring under the section
that you cited has to be consented to voluntarily and if a
condition of submitting to that monitoring, if you don't submit
to the monitoring the result is going to be that your
employment is going to be adversely affected, then I think it
would render the monitoring not voluntary and would render it a
violation of the section concerning voluntary monitoring.
Again, the same would be true in an analogous situation with
the wellness program under the ADA.
The ADA says employers can offer voluntary wellness
programs, but we have said that in order to be truly voluntary,
the program can neither require participation nor penalize
individuals for nonparticipation. I think in this case, if the
person's employment status was adversely affected as a result
of non-consent to the monitoring, then it would be a violation
of GINA.
Mr. Deal. Dr. Collins, a reading of this statute, reference
is made to detecting a genotype. Does that reference to
detecting a genotype cover pharmacogenetic tests?
Dr. Collins. Pharmacogenetic tests or sometimes called
pharmacogenomic tests is one that analyzes whether an
individual has a variation that might predict whether a
particular drug is going to be beneficial, whether it would
fail to help them or whether it might even cause a toxic side
effect, we are learning how to do that increasingly for an
increasingly long list of drugs. This is a test of a genotype.
Mr. Deal. So it would qualify?
Dr. Collins. It would be covered under the language that is
present in GINA.
Mr. Deal. Does the definition also cover forensic DNA
identification tests, tissue typing for organ donation and
paternity tests?
Dr. Collins. To the extent that those tests are conducted
in a way that detects genotypes, mutations or chromosomal
changes, they would qualify as genetic tests and to the extent
that they were contemplated as being used to make decisions
about health insurance coverage or employment, then they would
be protected under the provisions of this bill.
Mr. Deal. One very quick last one. My understanding is that
if someone is determined to have O or AB blood types, it also
detects that that person is an O or AB genotype. Do you agree?
Dr. Collins. I do. That is a circumstance where the
analysis of the AB or O protein is actually a direct correlate
with the genotype of that individual, so it is making a very
precise prediction about genotypes, so in that instance, yes,
you have a circumstance where a protein directly detects the
genotype and therefore it would qualify and be protected under
the provisions of this bill. I might add that ABO blood type
can be a risk factor for disease. That is not widely known. The
very first association ever reported between a genetic
variation and a disease was ABO blood type and Hodgkin's
disease.
Mr. Deal. Thank you, Mr. Chairman.
Mr. Pallone. Thank you. I recognize the gentlewoman from
California, Ms. Eshoo.
Ms. Eshoo. Thank you, Mr. Chairman. I am sorry I have had
to try and divvy up my time between here, obviously the Floor
and some other things. Again, thank you to everyone that is
testifying today. We need you, we are grateful to you, and what
you tell in this part of the record is a very important part of
this effort.
Dr. Collins, your testimony has cited several studies
demonstrating that people are afraid of discrimination on the
basis of their genetic information. In many ways, you are one
of the parents of this effort, because you pointed this out a
long time ago. Can you fill that out and instruct the committee
about the frequency of it, the number of people refusing the
opportunity to take a genetic test?
Has this grown since the mapping took place? And also, how
the fear manifests itself relative to doctors that provide the
appropriate preventive care? Because this is another area, I
think, where it is affected and at any rate, can you fill that
debate out and give us more about it? It will broaden and
deepen our understanding of it.
Dr. Collins. I would be happy to.
Ms. Eshoo. Thank you.
Dr. Collins. And I should say that in the second panel,
because I have looked at the statements, Dr. Hudson will
present you with new statistics just collected in the last week
or so about this public concern based on a statistically valid
survey indicating that, in fact, something like 80 percent of
the members of the public are deeply concerned about this issue
of genetic information being used against them, particularly in
health insurance, but also in employment. And that is a
consistent response that we have been seeing now over the
course of some 10 years since those surveys have been taken. I
see no evidence that there is any diminution in that concern
and that is despite the fact that many States have passed
genetic nondiscrimination legislation.
Ms. Eshoo. How many States, Dr. Collins?
Dr. Collins. More than 40 States have either a health
insurance or an employment provision or both, but again, I
think people who have looked at that realize that there are
loopholes and you never quite know what State it might end up
in a few more years. And if you really want complete protection
in this country, it ought to be at the Federal level. So the
concerns, as I mentioned, are largely about the anxiety about
health insurance in the workplace.
When you look at what this means on the ground, in terms of
how people are facing the possibility, not hypothetically, but
in their own lives about having such a genetic test, the best
data we have comes from studies we do at NIH. We invite people
who have had a strong family history of a particular condition
to participate in a research study that will involve some
genetic testing. We have done this particularly for breast
cancer and we have done this for colon cancer in families like
the one I mentioned in my opening statement.
And it is actually quite consistent and quite disturbing
that roughly one-third in each of the studies that we have done
of people who otherwise wish to go through the testing, wish to
have the data, were convinced it would be useful to them to
know if they were at high risk ultimately decide not to take
the test because of this concern that the information might
leak out. And this is despite our assuring them that we try to
keep careful records, that we have certificates of
confidentiality and so on. This goes deep enough that that is
not reassuring.
The family I told you about is still walking around out
there, with many individuals, at high risk for colon cancer,
untested because of this concern and at serious risk of having
a very bad outcome and here is a condition that we know how to
prevent, knowing you are at risk, getting into a screening
program with colonoscopy is life saving. In terms of what it
means with health professionals----
Ms. Eshoo. Can I just inject something?
Dr. Collins. Yes.
Ms. Eshoo. I think my colleagues, that what Dr. Collins has
just referred to, that is an extraordinary amount of fear, to
not act on the diseases that he just mentioned. I mean,
imagine; people knowing that they have it, have something very
serious and not exercising to do something about it because of
this fear. So I just kind of wanted to highlight that.
Dr. Collins. Another example of how this plays out in a
very disturbing way in medical care is individuals who decide
they do want to go through with the test but are fearful about
this may do so by using a false name. To get the results back,
they may have to tell their health provider, ask their health
provider not to put it into the record because then it might
find its way into an insurer's database and so you have a
patient asking their health provider to not tell the truth
about information that may be critical for their future medical
care.
What is wrong with our system if it encourages that kind of
very distressing behavior which, need I say, is bad for medical
care, as in the example I briefly mentioned in the opening
statement of a physician who ended up with metastatic ovarian
cancer which might have been detected earlier, except her
provider and the radiologist who was doing the study of a
particular pelvic ultrasound didn't know she was at high risk
because she had been tested under a false name. What a strange
and sad situation.
Ms. Eshoo. Thank you very, very much.
Mr. Pallone. Thank you. Dr. Burgess.
Mr. Burgess. Thank you, Mr. Chairman. Dr. Collins, I am
going to assume you have genetic counselors talking to these
patients?
Dr. Collins. Yes. And genetic counselors are absolutely
critical to convey this very complex information.
Mr. Burgess. I don't know. I am just internalizing this
conflict for myself. I think my fear of colon cancer would far
outweigh my fear of discrimination at any level, but that is--
--
Dr. Collins. And I agree with you and I am startled by
those statistics, as well.
Mr. Burgess. Would your understanding of the bill that we
have before us, the bill that we are discussing, would it cover
the different mutations, the chromosomal changes that would be
present in tumors, if you got, say, receptors on the breast
cancer, this type of study would be covered under this Act, is
that correct?
Dr. Collins. So again, the way the language is written, as
far as the definition of a genetic test, this, if it is related
to a manifested disease, which in this case would be a breast
cancer, this would not cover a measure on that particular thing
that was of proteins or metabolites, but it would if it was a
DNA test. So if you did a per 2 analysis that was based on DNA
or RNA, that would be protected information according to the
language of the bill.
Mr. Burgess. And just to take one step back to Chairman
Deal's question about the blood types, would the Rh factor also
be protected information?
Dr. Collins. It would be protected information in the sense
that it detects, even though it is done as an antibody test, it
detects, specifically, the presence of a particular genotype.
Mr. Burgess. I realize it is a little bit of circular
logic, but would someone be in violation of the law by putting
a charge of RhoGAM on a patient's super bill, thereby the
inference is they must have had an RH negative blood test, but
thus we have disclosed genetic information?
Dr. Collins. I think one should pay close attention to this
rule of construction which says nothing in this bill should be
construed to limit the authority of a healthcare professional
who is providing healthcare services with respect to an
individual to request if such an individual or a family member
of such individual undergo a genetic test, which would mean it
would be entirely appropriate to know whether a woman is, in
fact, RH negative as part of their routine OB and GYN care,
which I know you are very much in charge of, as a physician.
Mr. Burgess. Correct, but is the act of charging for the
RhoGAM, is that an unauthorized disclosure of that patient's RH
negative status?
Dr. Collins. Disclosure to whom? I am not sure I am
following.
Mr. Burgess. To the insurance company, to Sigma, Aetna,
Medicaid, whoever is the third party payer.
Dr. Collins. Well, surely if you have any kind of genetic
testing that you are expecting the third party payer to cover,
which we certainly expect third parties should cover, otherwise
the advantages of all these discoveries aren't going to happen,
that cannot very well be a violation of this bill. The
insurance company cannot request or require, but they can
certainly see the information in order to arrange for
reimbursement.
Mr. Burgess. So the insurance company would not be able to
say we need verification that patient was RH negative.
Dr. Collins. Yes, they can ask for proof of that, but they
could not demand or require or request it if it had not already
been medically indicated. Again, I hope, in this regard that I
am not treading into territory that I, as a non-legal expert
and not precisely----
Mr. Burgess. Don't worry about it. I do it every day.
Dr. Collins. All right, I will do my best.
Mr. Burgess. It never stops anyone here. Let me just be
sure that I do, before we leave this side, let me just be sure
I understand. You have the bill in front of you?
Dr. Collins. I do.
Mr. Burgess. Page 15, down about at the bottom quarter of
the page where it starts out, ``In general,'' we get into the
definition of a genetic test and the language, ``There is the
occurrence of a disease or disorder in a family member of the
individual,'' not to be limited to heritable genetic disease.
So would that include infectious or contagious diseases within
family members that would be the subject of this legislation,
as well?
Dr. Collins. I am not sure I have the same version, but I
think I see where you are referring to.
Mr. Burgess. Bottom of 15, top of 16.
Dr. Collins. In my version it is more like 9, but anyway, I
think, yes, I am looking at the version which is offered by Mr.
George Miller of California, which is the substitute to H.R.
493 that came out of the previous committee. So the intention,
certainly, of this bill is to include family history as part of
genetic information. Let me explain why that needs to be,
because there has certainly been a good deal of discussion
about that and some of the State provisions do not include
family history.
At the present time, most genetic tests that are offered to
people in terms of giving them a risk of future illness
prediction are triggered by the discovery of a family history.
The family I told you about with colon cancer wouldn't have
been offered a test, except that there were a number of
affected individuals.
If family history is not included in the definition of
genetic information, then you can imagine a circumstance where
a test is positive, but the family history is used as the
reason to discriminate and that would rather destroy the
purpose of the whole provision in the first place, so I think
most of us who have looked at this over now 12 years of talking
about these definitions would agree that family history
absolutely has to be part of the definition. But then, you are
asking family history----
Mr. Burgess. But what about a contagious or an infectious
disease?
Dr. Collins. So again, infectious diseases do have
hereditary contributions in terms of potential risk.
Interesting anecdote. In those individuals in Asia, for
instance, died of avian flu, there are some examples where in
one household more than one individual has dies. You have yet
to see an example where both spouses have died, but there are
many instances of a child or siblings. That tells you there is
some genetic contribution to susceptibility to flu. We know
that is true of many other infectious diseases.
So I don't think it is possible to absolutely draw a bright
line between what is an infectious disease with no genetic
component and what is a genetic component for another type of
disease, so I think the language that is in here basically
covers the circumstances. I can't imagine, although, if you
were interested looking at a circumstance where an infectious
disease was placing an individual at risk because it was
occurring around them, but you would limit that examination to
family members.
Mr. Burgess. Just one last question on this subject. Would
that meant that data would have to be segregated from the
balance of the patient's clinical data?
Dr. Collins. No, the only segregation, as I understand it
in this bill, of separate information relates to employer
records.
Mr. Burgess. OK. Ms. McAndrew, let me ask you a couple of
questions, if I could. Currently, health plans in the country
are subject to the Privacy Rules under HIPAA, is that correct?
Ms. McAndrew. That is correct.
Mr. Burgess. And the HIPAA Privacy Rule recognizes that
there are a number of important uses and disclosures of
information by health plans that are necessary for payment
purposes and to conduct normal business operations. Fair
statement?
Ms. McAndrew. Yes.
Mr. Burgess. Does title I of H.R. 493 alter in any way the
ability of the health plans to use and disclose information,
including genetic information for normal payment and normal
business operations purposes?
Ms. McAndrew. We would need to take a close look. It would
not appear that, with regard to claims processing, that there
is any affect on title I, from title I on that activity. It
does, however, prohibit the use of genetic information for
other types of activities for which the Privacy Rule currently
allows a health plan to engage in with regard to other types of
protected health information, such as premium rating,
enrollment and determination of eligibility for benefits. Those
would become discriminatory uses under title I and prohibit the
use of genetic information with regard to those particular
purposes.
Mr. Burgess. So it would prohibit the disclosure of that
information?
Ms. McAndrew. It would prohibit the use of, by the health
plan, of genetic information for those purposes.
Mr. Burgess. OK, just going back to my RhoGAM example, is
that a concern here?
Ms. McAndrew. To the extent that information was submitted
to the health plan for a payment purpose, it would not appear
to be an impermissible use under this bill, but if it were----
Mr. Pallone. Doctor, we have got to move on. We are over
almost----
Mr. Burgess. Mr. Chairman, let me, if possible, since this
is so important that we get this legislation, because I told
Dr. Collins he is moving really fast with his science, and I am
glad he is, and we move really slow up here and anything we----
Mr. Pallone. Twelve years, to be specific.
Mr. Burgess. Anything we do is going to be that way for the
rest of our natural lifetimes, so would it be permissible to
submit questions in writing?
Mr. Pallone. Oh, absolutely.
Mr. Burgess. OK.
Mr. Pallone. Any Member can submit questions.
Mr. Burgess. Thank you, Mr. Chairman.
Mr. Pallone. Thank you. Mr. Green.
Mr. Green. Thank you, Mr. Chairman. I want to follow up my
colleague from Texas' question, Ms. McAndrew, although, Dr.
Collins, I have questions for you, too, but following that line
of questioning, it would be impermissible use. My concern is if
the information is available, it is very difficult to find out
why they denied someone coverage and maybe some States, because
my experience in dealing with health insurance in the State of
Texas, for example, if you are denied coverage for an
individual policy, now, group policies have protections, but
for individual, but if it is even provided, there might be some
other reason they would deny coverage. Is there a concern on
that?
Ms. McAndrew. As I understand the way this is structured, I
don't think it would be any different than the current HIPAA
title I prohibitions with regard to the use of genetic
information for some health plans and to prohibit
discrimination and discriminatory policies with regard to that.
That does not bar the health plan from obtaining this
information and much of this information, as was indicated
earlier, may need to come to the health plan in order for them
to adequately, to pay for the services that these individuals
need in getting these genetic tests. I think the proper
limitation is on the misuse of that information for this
nondiscriminatory practice.
Mr. Green. But again, the misuse of it, how do you prove
that in a court of law or if you even get to the court? Because
in so many cases if a claim is denied and they happen to know
that information that your genetic background is diabetes, for
example, and the claim is denied, maybe, because that was a
preexisting condition, but that is my concern and I share Dr.
Burgess' concern about that.
I am concerned about disclosing it, period, because I think
families who have the fear of the disclosure would say well, it
is hard for me to get insurance, anyway, and if that
information is available, no matter what they use; they may use
something else. We are not underwriting in your zip code or you
are blocked or something like that, that is not discriminatory.
Mr. Chairman, I want to make sure that our final draft,
whatever comes out, that we look at that issue--that disclosure
is a concern not just that they are prohibited from using that
information. I think it ought to be prohibited use, but I also
think the disclosure is something that families will still be
afraid of disclosing that to health plans.
Dr. Collins, some people express concern that the
legislation singles out genetic information as being
fundamentally different than other types of health information.
This is called genetic exceptionalism. What is the
justification for treating genetic information differently than
some other health condition?
Dr. Collins. That is a very appropriate question because
obviously, we don't, by doing something that is really needed
here. We try to provide protection for something the public is
quite concerned about, mainly genetic discrimination. We don't
want to somehow set genetic information into this area that
sounds even scarier than any other type of medical information
and yet, it is different in certain ways.
I have this mantra of the six P's that make genetic
information separate from other types of medical information.
No single one of these would qualify, but you put all six
together and you can see there is something different here, so
let me try my six P's out on you. What is it about genetic
information? It is predictive. It says something about what
might happen in the future while you are still well. It is
prejudicial. It is the kind of information that can be used
against you. That is why we are all here this afternoon. It is
permanent. Your DNA is going to be your DNA while you are here.
It is not like your blood cholesterol or your serum sodium that
might change next week. It is what it is.
It is, this is a littlie bit of a stretch, pedigree
relevant. That is to say it affects not only you, but your
relatives and what you find out about yourself may shed light
on your kids or our parents or your siblings. It is, in the
view of most people, personal. There is something about DNA,
our own instruction book, that is a little different than
saying well, my white blood count today is 5600.
And finally, and attached to that personal is most people
think it should be private. It is not the sort of thing you
want on the Internet or the front page of the Post. So you take
those six things together and you can see that genetics fits
into all of those and other types of medical information
doesn't quite create that same sense of specialness and hence,
the appropriateness, I think, of trying to provide special
protection.
Mr. Green. Thank you. Mr. Chairman, I know I have run out
of time, but I have just one question I would like to throw out
to take a yes or no to Mr. Kuczynski of the EEOC. I know the
previous chairman of the EEOC expressed support for this
legislation. Is the current chairman, Naomi Earp, is she also
in support of this legislation from the EEOC?
Mr. Kuczynski. I believe that the chair is in support of
legislation that would prohibit the type of genetic
discrimination that I have described in my opening statement,
yes.
Mr. Green. OK. Thank you, Mr. Chairman.
Mr. Pallone. Thank you. Mrs. Myrick.
Mrs. Myrick. Thank you, Mr. Chairman. And my question is
for Dr. Collins and first of all, thank you for the fine work
you have done. It really is very exciting and we have all come
a long way because of it. But I wanted to ask about clinical
trials because I understand one of the goals of the bill is to
try and remove unnecessary barriers to participation in
clinical trials and I know a lot of times that scientists have
told me they have trouble getting people to participate in
clinical trials; it is difficult.
As you mentioned, people are scared that some of their
genetic information about disease will be made known to their
insurer or their employer and so I am curious why the bill
doesn't explicitly mention that genetic disease related
clinical trials are covered under the nondiscrimination
umbrella and I wanted to ask you if you see this as a potential
problem?
Dr. Collins. So certainly, we would not want anyone who is
contemplating participating in a clinical trial to have this
fear of discrimination to be a deterrent. We depend on people's
generosity with their time, with their very lives, to take part
in these trials so that we can advance the course of medicine.
I think when it comes to this specific area of genetics,
however, the provisions of this bill largely make that a non-
issue in specific ways, because the bill does, after all,
comment upon whether, in fact, one may allow the use of genetic
services, the request or receipt of genetic services, to be
used to discriminate and the bill specifically says no.
H.R. 493 says that is not permitted. Genetic services are
defined in the bill as (A) a genetic test; (B) genetic
counseling; and (C), genetic education. Those three things are
all part of the kinds of clinical trials that we currently
conduct that involve genetics, so anyone who is part of such a
trial has essentially, then, received genetic services and
those may not be used, according to the language in this bill,
as a means of discrimination. So I grant you, the larger
question of clinical trial participation may need attention,
but in the specific instance of genetics, the language that is
in this bill appears adequate to cover that situation.
Mrs. Myrick. So you feel it is covered, without question,
in the bill, that people are protected?
Dr. Collins. The genetic component of clinical trials, yes.
Mrs. Myrick. OK. Thank you very much. Ms. McAndrew.
Ms. McAndrew. Yes.
Mrs. Myrick. A couple questions here. For entities that are
covered by HIPAA Privacy Rule, how long is the list of
permitted disclosures?
Ms. McAndrew. We have, first, identified those disclosures
that are core to the business of providing treatment and
getting that treatment paid for and as I mentioned, the first
carve-out from the need for an individual written authorization
in order to use information or disclose it to others is for
treatment, payment and healthcare operation purposes. And that
permits the ready use of this information for its intended
purpose, to treat the individual, get that treatment paid for.
Outside of that, we do have a number of other public purpose
disclosures.
Mrs. Myrick. Like what? I mean, what would you----
Ms. McAndrew. We have, for instance, we would permit a
disclosure as required by other law. We would permit a
disclosure of information for public health purposes. There is
an exclusion for health oversight activities. There is an
exclusion for judicial and administrative proceedings. There is
an exclusion for research. Now, all of these come with their
own separate list of conditions and other protections before an
entity is permitted to release identifiable information for any
of these purposes. But the basic balance is that the need for
the information for these important public purposes overrides
to one degree or another the necessity to get the individual's
prior written permission before that disclosure is made.
Mrs. Myrick. Well, if we enacted a broad prohibition on the
use and disclosure of information by employers, in your
experience with implementing HIPAA rules, do you foresee any
issues that would arise from the obstruction or the routine
flow of information? Is there anything that would be a
potential problem?
Ms. McAndrew. Well, I think the balances would need to be
worked out. I don't have any particular expertise with regard
to what the normal practices would be in an employment setting.
The HIPAA balances were all structured in the healthcare
delivery and healthcare payments study and were really
restricted, in particular, to that need for the information and
the collection of health information in the first place. And so
looking at any other sector, whether it is the business sector,
and I think employment may be particularly complicated only
because of such a wide range of businesses that would, that are
employers whose need and legitimate need for the information
would need to be weighed and balanced.
Mrs. Myrick. I appreciate it. Thank you, Mr. Chairman.
Mr. Pallone. Thank you. Mrs. Capps.
Mrs. Capps. Thank you, Mr. Chairman, and thank you to each
of our witnesses for their testimony. Many of us are here in
this hearing because of our concern that the public's fear of
getting tested for genetic conditions may interfere with taking
full advantage of what genetic testing has to offer in terms of
prevention, early detection, early treatment. Perhaps, however,
we assume that the public understands exactly what this is and
what it might involve.
To start us off, Dr. Collins, you are a physician as well
as a geneticist. You gave some compelling illustrations of
colon cancer and understanding the gene in the role that it
could play. Perhaps, for the record, you would start us off
with just briefly mentioning a couple of other situations that
might indicate the purpose for this hearing.
Dr. Collins. I appreciate the opportunity to do so. So
certainly, the colon cancer example is one where we already
know that interventions can be life saving. That list, though,
is growing. Certainly, with breast and ovarian cancer, the
BRCA1 and BRCA2 genes, which, if misspelled, can confer a
rather high risk of both of those cancers, are now at the point
where there is clear evidence that knowing your status can, in
fact, improve your likelihood of long-term survival and that
has now been implemented in the hands of many healthcare
providers.
And yet, I just read a report that came from this past
weekend's Society of Gynecological Oncology, that only a tiny
fraction of women who are at risk, based on their family
history, are actually taking advantage of that test, a really
frighteningly small number are doing so. That particular study
did not investigate why, but I know from everything we have
been able to document at NIH, that discrimination and the fear
of it has certainly been a major factor in that.
Other types of tests, certainly we are learning more and
more about this business of how to identify risks of a bad drug
reaction, which could be, in fact, very important in preventing
some of those outcomes. There is a particular drug that is used
to treat children with leukemia, six-mercaptopurine. If you are
one of those one in 300 kids that has a particular misspelling
of the gene that coats for the enzyme that metabolizes that,
then this drug, instead of helping cure your leukemia, could
actually be fatal.
We now know how to test for that and so it is possible to
do so before administering the drug. In fact, produces even
better than that. Those kids that have that particular
situation can still receive the drug, but at one-tenth the dose
and they still have a very high likelihood of being cured of
their disease. You can imagine that that kind of test might be
seen by some as a risk factor, might therefore end up being
utilized in ways that we all would find inequitable and unjust.
And there are other examples in terms of drug testing. The
drug that is given for blood clots, something that we have been
reading about in terms of a high number of the administration
this week, warfarin, which is used in millions of people, is
also one of those that has a lot of side effects. We are on the
brink of figuring how to predict those and being able to offer
a test prior to administering the drug to reduce that risk.
Other tests for diabetes are coming along fairly quickly. A lot
of things happening there in terms of understanding hereditary
risks.
Mrs. Capps. Thank you. And we could go on and on, I know.
Dr. Collins. I probably would if you didn't stop me.
Mrs. Capps. In the next 1 minute and 45 seconds, I want to
get to people not getting tested. This also has a effect on
their own healthcare. But mention, if you would, some ways that
it would also inhibit biomedical research and clinical trials,
because it means fewer people will volunteer for clinical
research and individuals there will not be tested for
preventable disease. And if you have a second at the end, if
you would, talk about the need to include family members, as
well as the individual patient.
Dr. Collins. Great questions. Already at NIH, this is a
serious issue. We are at this point in medical history where we
have the opportunity to discover what really are the genetic
and environmental causes of illness. In order to do that, we
need to have individuals willing to volunteer to have their
environment studied and their genetics studied. And if fully a
third of the people who otherwise want to participate walk
away, then we have lost out. We have lost out in a way that is
bad for them and bad for us.
And especially, as you say, in circumstances where you are
trying to look especially at heredity, you are very interested
in enrolling families so that you can see how a particular
genetic variation has passed through the family and conveyed a
risk or sometimes a protection against disease and if even some
members of the family are afraid of discrimination, then the
whole family may end up not participating and we lose out. We
lost out, as a country, on the opportunity to learn more. We
could take care of that. Thomas Jefferson's words on the
Jefferson Memorial over there, ``Our laws and institutions
should keep pace with the progress of the human mind.'' Here is
the opportunity to make that happen.
Mrs. Capps. What a wonderful statement. Thank you very
much.
Dr. Collins. His words.
Mr. Pallone. What a great way to conclude this panel. Thank
you, Doctor. Thanks to all of you. I think we have finished
with the questions, but this really was a fascinating exercise
to listen to all of you and obviously made the case very well
for why we need to move legislation, so thank you again. I
appreciate it.
I would ask the next panel to come forward.
There are seven of you, so we are going to ask you to try
to keep your comments to the 5 minutes,if you see the red
light, please try to summarize and end because otherwise, we
will be here all night. Let me welcome you all and introduce
all of you to the committee.
We have Ms. Sharon Terry, who is the chair of the Coalition
for Genetic Fairness and president and CEO of the Genetic
Alliance. We have Dr. William Corwin, who is medical director,
Clinical Policy for Harvard Pilgrim Health Care. And then we
have Mr. Burton Fishman, who is with Fortney and Scott. And
then we have Ms. Pollitz, who is a research professor at
Georgetown University Health Policy Institute; Mr. Frank Swain,
senior vice president, B&D Consulting and former chief counsel,
Advocacy at the United States Small Business Administration.
Ms. Janet Trautwein, executive vice president and CEO of
National Association of Health Underwriters. And last, Dr.
Kathy Hudson, who is director of the Genetics and Public Policy
Center and associate professor of the Berman Institute of
Bioethics of the Institute of Genetic Medicine, Department of
Pediatrics at Johns Hopkins University.
Thank you all for being here and we will start with Ms.
Terry.
STATEMENT OF SHARON TERRY, CHAIR, COALITION FOR GENETIC
FAIRNESS, AND PRESIDENT, CHIEF EXECUTIVE OFFICER, GENETIC
ALLIANCE, WASHINGTON, DC
Ms. Terry. Chairman Pallone, Representative Deal, and
members of the subcommittee, thank you for bringing us to this
moment and for the opportunity to testify here. Representatives
Eshoo, Slaughter, Biggert and Walden demonstrate robust vision
and courage to introduce again the legislation that will make
it possible for Americans to benefit from new technologies and
tests. My name is Sharon Terry. In some way, I am the least
qualified person to appear before you. I don't have the
professional qualifications of those who testified today. And
in other ways, I am the most qualified. I represent millions of
Americans affected by genetic conditions.
I am president and CEO of Genetic Alliance, a coalition of
more than 600 disease support groups and I am the chair of the
Coalition for Genetic Fairness. Mine is not a chosen
profession. It is a vocation thrust upon me when my children
were diagnosed with a genetic condition that will rob them of
their vision in the prime of their life. Quite poignantly, the
Genetic Information Nondiscrimination Act of 2007 will not
protect my children nor the millions I officially represent.
They all have manifest disease and this bill appropriately does
not protect them. This is a critical point often obscured in
many of the arguments against the legislation.
The bill is not about those who already have signs or
symptoms of disease, but rather about those who carry a genetic
mutation which increases their chances to develop a disease.
Though my family will not benefit, I have worked on this
legislation for 12 years, since Congresswoman Slaughter first
introduced it. With others present here, I founded the
Coalition for Genetic Fairness to support this legislation and
we have had a long and uphill battle. We are several hundred
organizations strong and include many sectors of our society,
including disease support groups, health professional
organizations, women's leadership groups, labor groups and most
significantly, companies like Affymetrix, IBM and 20th Century
Fox. We thank them and those of you, who year after year, have
supported this legislation. We have compromised and conceded a
great deal during these years and we believe the bill before
you is fair and well-balanced.
My passion for more than a decade has been fueled by the
faces and the voices of the hundreds of individuals who have
contacted us, fearing for their children, their lives, their
jobs, their insurance; men, women and children, families from
communities all across this country, who have told us their
stories and in some cases, pleaded for us to help them.
In 2003, Heidi Williams of Kentucky called me when her
children were denied insurance by Humana, Incorporated. Heidi
has alpha-1 antitrypsin deficiency, an autosomal recessive
genetic disease. Humana rejected the children's application
stating that the children were carriers and so they could not
cover them. With our help, Heidi explained in an appeal that
carriers are not affected, but Humana again denied the
insurance. I called a reporter from a prominent national
newspaper, they called Humana and that night Heidi's children
were covered retroactively.
Some families are not lucky enough to have a connection
with our coalition or a reporter to help them. This year,
Heidi's daughter wrote a letter to her Congressman.
Dear Congressman Ron Lewis, My name is Jayme Williams and I
am in the fifth grade and live in Cecilia, Kentucky. My brother
and I are carriers of alpha-1 antitrypsin deficiency, a
defective gene in our DNA that can be passed on to our future
children. While my brother and I have only one defective gene,
my mother was given two and her lungs are very sick. My brother
and I were denied health insurance because we carry these
mutations. My mom tells our story because other people are too
afraid to tell theirs. Discrimination makes people very afraid.
When people are discriminated against, they are sometimes told
they will lose something they need if they speak out against
the people causing the discrimination. My mom says that
everyone is created equal and deserves to be fairly treated.
Please help my mom.
Let resonate these heart-felt words from a young woman who
cannot imagine that carrying a mutation in the gene makes her
uninsurable. I assured her that we will continue to work hard
for her.
I am also reminded of Becky Fisher, who shares a mutation
for inherited breast cancer with many in her family. Having
watched her mother, aunts and cousins die of breast cancer and
she, herself, a survivor, she thinks only of her daughter, who
is brave enough to be tested and says of her, ``One of the not-
so-good things of having a documented genetic mutation makes
her more vulnerable to more than devastating disease. She also
faces the burden of never knowing when she will legally be
asked to take a genetic test as a condition of employment or
lawfully fired from a job because of high costs of medical care
or denied health insurance.''
We are all Heidi and Becky's children. We all carry
mutations for dozens of diseases and we are all vulnerable.
Aren't health and disease enough to worry about? We cannot
afford to also worry about discrimination based on these
mutations, silent mutations with no signs or symptoms. This is
simply about preventing misuse of genetic information, that
which makes up every one of us, our shared inheritance, and
that which makes us unique.
This is also about special interests. Let us put the
special interests of health of all Americans above all else.
Every one of you and each of your loved ones is at risk for
some disease or another. We cannot yet easily reduce that risk,
but it is in your hands to reduce the risk of discrimination
associated with that information. At the end of the day, we are
relying on you to make it possible for individuals to use their
genetic information for the health purposes for which it was
intended.
Some might say that Dr. Collins and his colleagues have
done the hardest work, but we understand that balancing the
policy needs of the Nation is difficult. You are pushed and
pulled in many directions. Please measure your decisions by
what truly matters when voting in committee and the full House
floor in the next weeks. Please remember that neither you nor
any of us have any choice over our ancestry, our different
abilities, our genetic makeup. As a nation, we do have a
choice.
Every American is affected by this legislation and beyond
the health insurance companies, the trade associations and the
employers' needs, all those who carry genetic mutations, they
did not ask are asking you to take the necessary measures to
alleviate the burden of discrimination that this places on our
nation. I have faith and hope that you will choose to relieve
their burdens, my burdens, your burdens. I look forward to your
good work in the weeks ahead. Thank you.
[The prepared statement of Ms. Terry appears at the
conclusion of the hearing.
Mr. Pallone. Thank you, Ms. Terry. Dr. Corwin.
STATEMENT OF WILLIAM CORWIN, M.D., MEDICAL DIRECTOR, CLINICAL
POLICY, HARVARD PILGRIM HEALTH CARE, WELLESLEY, MA
Dr. Corwin. Mr. Chairman, Mr. Deal, members of the
subcommittee, my name is Dr. William Corwin. I am the medical
director for Harvard Pilgrim Health Care, which is a not-for-
profit health plan that provides insurance plan options to more
than a million members in Massachusetts, New Hampshire and
Maine. Harvard Pilgrim has been named the No. 1 health plan in
America for 3 consecutive years. This is according to a joint
ranking by the U.S. News and World Report and the National
Committee for Quality Assurance. I appreciate this opportunity
to testify on behalf of America's Health Insurance Plans, which
is a national association for representing nearly 1300
different insurance plans providing coverage to more than 200
million Americans.
Health insurance plans are working on a daily basis to
promote the appropriate use of genetic tests to help clinicians
and patients make informed healthcare decisions and improve
health outcomes. We agree with the sponsors of H.R. 493 that
healthcare consumers should not face discrimination on the
basis of their genetic makeup and that genetic information
should be protected from unauthorized disclosure. Our policies
and programs reflect this belief. We have submitted written
testimony that focuses on three broad areas: examples of how
health insurance plans are promoting the appropriate use of
genetic tests to improve patient care; opportunities for
improving H.R. 493; and our support for the strong protections
with respect to non discrimination, confidentiality of this
genetic material.
In the next few minutes I would like to provide some
examples of how health insurance plans are promoting the use of
genetic information to help our enrollees receive the highest
quality, evidence-based care possible. And I also will briefly
comment on H.R. 493.
Through early detection that we have heard about earlier,
disease management programs and other quality improvement
initiatives, we are working to identify individuals who can
benefit from early intervention and evidence-based treatment
for these specific illnesses and diseases. Genetic information,
including the results of genetic tests, is just one of the more
sophisticated sources of data that clinicians and the health
insurance plans are using to ensure that our patients receive
appropriate preventive care, a coordination of services and
early treatment for these medical conditions.
I would like to highlight two specific examples of how
genetic tests are being used to improve patient care. In
February 2007, the Food and Drug Administration approved a new
genetic test called a MammaPrint, which indicates whether a
woman is likely, with breast cancer, to relapse earlier than
otherwise predicted. This test allows physicians to tailor
therapy for individual patients and administer chemotherapy to
only those patients who would benefit. At the same time, the
test allows physicians to identify patients who would not
benefit from chemotherapy and avoid unneeded chemotherapy or
risky and costly treatment.
Another test that we heard about earlier, the Cytochrome
P450 enzymatic test is genetically coded. The identification of
the presence or absence of this genomic marker enables a
physician to evaluate a patient's ability to process many
different kinds of medications, adjust doses intelligently, and
to avoid potential adverse drug reactions in patients who
either metabolize a drug too quickly or do not metabolize that
drug at all well. This test also is used to determine how
children with certain forms of leukemia will respond to various
doses of chemotherapy. Health insurance plans may request that
this test be performed before authorizing a course of therapy
to ensure that the appropriate care, evidence-based care, is
being provided to meet the patient's best individual patient
centered needs.
Health insurance plans are also using genetic test results
to promote preventive screening, disease management programs
and other programs to help improve healthcare for individuals
who have tested positive for a genetic disease or who have a
family history of a specific disease or condition. For example,
individuals who have the gene for the familial form of
colorectal cancer, can receive coverage for more frequent
preventive screenings. Physicians can receive reminders that
these screenings need to be done.
As scientists acquire a greater understanding of the role
genes play in disease and develop more targeted therapies and
treatments and possibly even cures, preventive screening and
disease management programs can be tailored to improve outcomes
for our individual members. These therapies will become even
more important in the future. We appreciate the interest many
subcommittee members have shown in passing additional
legislation addressing the use and disclosure of genetic
information. As you do so, we urge you to fully evaluate the
implications of any additional requirements or prohibitions and
to ensure that the new legislation does not unnecessarily
restrict the use of information needed to promote appropriate
healthcare decision making.
Working with AHIP, our industry association, we have
reviewed H.R. 493 and identified several areas where we believe
changes are needed to ensure that genetic information is
available to health plans so we can continue to assure
appropriate coverage decisions.
Mr. Pallone. Dr. Corwin, I know you still have a lot left,
so if you want to summarize a little bit? OK, thanks.
Dr. Corwin. Targeting the programs to improve quality of
patient care. We do not oppose the bill. We agree with its
intent. However, once enacted, there will be a variety of
interpretations about the bill and how its requirements would
apply in various settings. To avoid any confusion, health
insurance plans would like to encourage the subcommittee
members to assure that statutory language clearly reflects your
intent for enacting this legislation. Thank you.
[The prepared statement of Dr. Corwin appears at the
conclusion of the hearing.]
Mr. Pallone. Thank you, Doctor. Mr. Fishman.
STATEMENT OF BURTON FISHMAN, FORTNEY & SCOTT, LLC, WASHINGTON,
DC, ON BEHALF OF THE GENETIC INFORMATION NONDISCRIMINATION IN
EMPLOYMENT COALITION
Mr. Fishman. Chairman Pallone, Ranking Member Deal,
distinguished members of the subcommittee, present and absent,
thank you for this opportunity to testify on H.R. 493 and the
issue of genetic nondiscrimination in the workplace. I am
honored to be here. My name is Burton Fishman. I am of counsel
to the Washington, DC law firm of Fortney & Scott, and I appear
before you on behalf of the Genetic Information
Nondiscrimination in Employment Coalition, the GINE Coalition,
mainly of employers.
Let me be clear. The coalition strongly supports genetic
nondiscrimination and confidentiality and believes that
employment decisions should be based on an individual's
qualifications and ability to perform a job and on
characteristics that have no bearing on job performance. As a
result, the coalition supports the goals of this bill. We
commend the help of the subcommittee for the important changes
it has made and we hope to continue working with this
subcommittee, with all Members of Congress, to make genetic
discrimination legislation effective, administratively
efficient and practical. I have submitted a lengthy statement
and I do not intend repeating it and I will focus my comments
on the few issues the coalition regards as significant.
When testimony was given on a prior version of this bill in
2004, it was noted, at the time, over 30 States had passed
genetic discrimination laws covering scores of millions of
people. At that time, not a single case had been brought under
any of those laws, let alone a violation being formed. That is
still true today. Mr. Kuczynski should have pointed out that
the Burlington Northern case was vigorously and successfully
enforced under current existing law. We believed then and now
that this bill is a remedy in search of a problem.
In light of that and because of the breadth of its
definitions and the unintended intrusions this bill will impose
on employees, employers, healthcare providers and health
insurers, we ask you first to do no harm. We do not want a law
that imposes real burdens and actual costs based on distant,
contingent eventualities or the inadvertent and innocent
conduct of any employer. We share the concerns of
Representative Cubin, that we do not want a law that makes
knowledge illicit rather than one focused on illicit conduct.
We do not want a bill that regulates the flow of information
rather than the misuse of information. And I raise these points
because the proposed bill could be improved by greater
attention to the implications of its various provisions.
As currently drafted, H.R. 493 creates protections for
genetic information that far exceeds those for personal health
information under HIPAA. We do not understand why information
relating to distant, contingent eventualities requires
protections greater than those for existing medical problems.
We do not understand why a separate protective program needs to
be invented and mastered after employers have labored so long
to put HIPAA and privacy programs into place.
Further, the protective program of H.R. 493 does not
promote sound public policy. As we have heard, unlike the HIPAA
privacy regulations, there is no general exception for
disclosures for treatment or disclosures to private and
treating physicians, to unfolding police investigations, to
identify a victim of a crime or a criminal, to Government
officials investigating something other than compliance with
this law; you can't even talk to your own litigating counsel
under GINA. These exceptions should be incorporated here.
As we have heard again, from Dr. Burgess and others, the
definition of genetic information in H.R. 493 dispenses with
predictive genetic information or even a relation to an
inheritable disease. In its place, we have a definition that is
so broad as to, and I quote, ``The occurrence of a disease or a
disorder in family members of the individual.'' That's unquote,
without any limitation. We share Dr. Burgess' concern that
Congress did not intend to have colds, flus, upset stomachs and
chicken pox as part of this bill, but as it is written, it
does. The definition of genetic information should be limited
to predictive genetic information associated with the disease
that is not symptomatic at the time of testing.
In the bill, genetic information acquired pursuant to some
laws is permitted, whereas that same limitation does not occur
for others. For example, you can get information from FMLA
certifications or Workers' Comp, but you can't do so from ADA
accommodation or helping people get their health insurance,
which are far more likely sources of that information. There
should be an exception permitting the acquisition of all such
information, if collected pursuant to law and retained in
confidential files. As our position is the information should
not be the issue, the misuse of the information should. I know
I have run out of time, so I will end here, thanking you again
for this opportunity. I am looking forward to answering your
questions.
[The prepared statement of Mr. Fishman appears at the
conclusion of the hearing.]
Mr. Pallone. Thank you, Mr. Fishman. Ms. Pollitz.
STATEMENT OF KAREN POLLITZ, RESEARCH PROFESSOR, GEORGETOWN
UNIVERSITY HEALTH POLICY INSTITUTE, WASHINGTON, DC
Ms. Pollitz. Thank you, Mr. Chairman, Mr. Deal. It is a
pleasure to be here today. I am Karen Pollitz and I am an
adjunct professor of public policy at Georgetown and I direct
research on private health insurance at Georgetown's Health
Policy Institute. And I would like to focus my remarks today on
the insurance provisions of H.R. 493 of GINA and say a word
about what genetic discrimination in health insurance means. If
you haven't yet, I would encourage you to read the appendix to
my friend, Janet Trautwein's testimony. It is very excellent,
it is very thorough and it explains how health insurance works
and how it is provided and the whole process of applying for
it. And as you read through that, it is pretty lengthy and
complete, you won't see the word discrimination in there. You
will see words like correct pricing of policies and accurate
assessment of risk. And that is because certain practices that
GINA would prohibit are legal today and commonly employed,
especially in the individual health insurance market.
A key concept in medically underwritten health insurance is
really a deal between consumers and the health insurer. The
consumer promises to pay a premium and in return, the health
insurer promises to protect the consumer against the costs
associated with unknown future medical risks. And the medical
underwriting process is the process that insurers use to sort
out what are the risks that are already known and that won't be
covered under the policy. Medical underwriting is somewhat
controversial. Janet and I have had some good fights about it
over the years. Some people think it is justified and some
people would rather see it go away.
Gradually, the States and the Federal Government have
limited medical underwriting practices, much more so in group
coverage, much less so in the individual market. But I would
make a prediction that it is safe to say its days are numbered.
As Dr. Collins has testified, eventually all of us are going to
know what our future risks of medical and health problems are
going to be, so the concept of unknown future risk is eroding
and eventually we are all going to be uninsurable. So then I
think we are going to have to figure out something else.
For today, though, GINA would protect discrimination in
health insurance based on genetic information and for all the
good reasons that you have heard today. I want to tell you a
little bit just about how medical underwriting works and how
insurers could come to discover this information and of course,
people applying for coverage and then tell you about the
results quickly of a research project that my colleagues and I
just completed.
In the individual market, first, not that many people have
individual health insurance. On any given day, most of us get
coverage at work and then the next largest source of coverage
for people under the age of 65 is the Medicaid Program. So only
about 5 percent of the population in any given year has
individual health insurance. But we move through it a lot as we
are ineligible for those other more common sources of coverage,
so over a 3-year period, one in four adults will try to get
individual health insurance. They won't all succeed because,
for many reasons, but including the fact that it is medically
underwritten.
When you apply for medically underwritten health insurance,
you have to fill out an application and answer a lot of
questions about your health status and depending on how you
answer them, the insurer may ask for additional information
about you and investigate more carefully your medical history.
All applications for individual health insurance has a waiver
that you must sign that gives a complete and total access to
any and all medical records about you to the health insurer, so
if you answer yes to a question have you ever had this or has
someone in your family had that, the insurer may then ask for
your medical records and begin to dig a little more.
And it is in the course of this digging for additional
information that insurers may come across your genetic
information because there it is in your medical record.
Underwriters tell me that, on average, about 20 percent of
applications involve a request for additional information and
looking through your medical records. So this is information
that is discoverable today by health insurers.
We, as I said, studied medical underwriting practices in
the individual market in response to genetic information. It is
hard to examine in practice because not that many people have
undergone testing, so what we did, in our project, was we asked
individual health insurers to medically underwrite some
hypothetical applicants and we presented them with four pairs
of applicants. And the pairs were pretty much identical, except
one in each pair had undergone genetic testing and gotten a
positive result, so that we were trying to sort of separate how
would you behave with respect to this applicant based on this
one thing that is different, their positive genetic test
results.
In seven instances, five of the 23 responding companies
said that they would take an adverse action based on genetic
information. They would deny coverage or they would surcharge
premiums or they would exclude coverage permanently, using an
exclusion rider for the genetic information and basically call
that a preexisting condition. We then went back and asked
underwriters what actions they would take based on an
applicant's receipt of genetic services. The GINA legislation
also protects genetic services, which includes counseling of
patients about what steps they might be able to take to reduce
the risks that they learn that they have inherited.
Specifically, we asked the insurers again, would they
consider an applicant who had a BRCA1 mutation whose doctor had
discussed or----
Mr. Pallone. Ms. Pollitz. I am sorry.
Ms. Pollitz. I will wrap it up.
Mr. Pallone. Yes.
Ms. Pollitz. I just wanted to let you know that 13
underwriters responded to this question. Five said that they
would take an adverse action based on this woman having been
told about risk reduction options and 10 out of 13 said if her
doctor had recommended any, that they would turn her down,
charge her more or exclude preexisting conditions.
I would just conclude by saying that Congress and 43 States
have already acted to limit discrimination based on genetic
information to some extent, but the protections that are out
there vary, they are not complete and a comprehensive Federal
law that addresses all three of the ways that insurers can
discriminate based on genetic information is important to have.
Thank you.
[The prepared statement of Ms. Pollitz appears at the
conclsuion of the hearing.]
Mr. Pallone. Thank you very much. Mr. Swain.
STATEMENT OF FRANK SWAIN, SENIOR VICE PRESIDENT, B&D
CONSULTING, WASHINGTON, DC
Mr. Swain. Thank you very much, Mr. Chairman, Mr. Deal. I
appreciate the invitation. This is a piece of legislation that
I have been interested in and involved with for only about 2\1/
2\ years now, so in the history of this project, I am a
relative newcomer. I would ask that my statement be received
into the record and I would like to summarize a couple of
points. I suppose one reason I am here is because I have some
experience, professional experience, and it is a matter of
personal interest, as well, worrying about the burdens on small
business.
I have had a career that has had stops at the NFIB and I
was President Reagan's chief advocate at the Small Business
Administration, so I am not going to plunge into anything that
I really think is going to be a burden for small business. And
after listening to Mr. Fishman's comments, I thought well,
maybe I am here for the wrong reasons, but I must gently
disagree with some of his points. I don't think that this bill
is going to be significantly burdensome for business and I do
think that as the scope of available genetic information
accelerates, as it most certainly will and it is doing, that
business, in particular, needs the certainty and the
predictability of how to handle this information and how to
handle it in a way in which they know that as they go about
their normal business practices, normal personnel practices,
normal insurance practices, that they will not be subject to
criticism.
So this is extraordinarily important legislation because
business does need the predictability. I would absolutely agree
with the points that have been made that there has not been
excessive litigation to this point over these issues. Of
course, I could turn that logic around and say indeed, although
there are 41 or 43 States that have this legislation on the
books, it apparently has not been overly burdensome for
business in those States, because indeed, there has been not
much litigation. But be that as it may, the issue is probably
not so much where there is litigation or not.
The issue was amply demonstrated by the prior panel;
apprehension and fear about engaging in these tests in the
first place, and as individuals have that apprehension and
fear, I admit it is irrational in many cases, but medical
advances and appropriate treatments will not be accelerated or
promoted. We need to have a formula, a set of protections that
is predictable for employers and also for individuals so that
there is not that factor of apprehension.
I do think that it is important to note that the bill has
been adjusted, to some degree, in the prior committee and I
think that the proponents of the legislation are not adverse to
making specific adjustments that might improve the bill.
However, I think it is very important to recognize that
protections for genetic information are important for all the
reasons that Dr. Collins stated and for one additional reason.
Indeed, my genetic information is what it is and if it were
published here today, I am not sure I would be too upset about
that. But it doesn't just tell anyone looking at it about me,
it tells them about my children, as well.
And that is an additional responsibility that I think that
I have in not disclosing that information and that anyone that
comes across that information has, as well. So that would be, I
submit, one additional reason that this particularized,
admittedly greater protection for this type of information and
other information, that would be one important reason that I
would encourage the committee to move this legislation and
report it to the Congress. Thank you.
[The prepared statement of Mr. Swain appears at the
conclsuion of the hearing.]
Mr. Pallone. Thank you, Mr. Swain. Ms. Trautwein.
STATEMENT OF JANET TRAUTWEIN, EXECUTIVE VICE PRESIDENT AND
CHEIF EXECUTIVE OFFICER, NATIONAL ASSOCIATION OF HEALTH
UNDERWRITERS
Ms. Trautwein. Good afternoon, Chairman Pallone and Ranking
Member Deal. My organization is the National Association of
Health Underwriters. We are a 20,000 member association of
insurance professionals who work with employers and individuals
all across America to help them find high quality and
affordable health insurance. We do appreciate this opportunity
to present information today on the effect that well-intended
genetic discrimination legislation could have on the costs of
health insurance, as well as the cost impact on employers who
are providing benefits such as health insurance to their
employees. We believe that health insurance affordability is
the most important component of access to healthcare.
In light of advances in the field of genetic research, some
people expressed concern about whether their genetic
information might be used improperly to prevent them from
obtaining health insurance or by employers for hiring or firing
purposes, and I want to emphasize today that NAHU believes that
health insurance or employment discrimination based on genetic
information of an otherwise healthy individual should be
prohibited, provided that the definition of the prohibited
information is carefully, clearly and narrowly defined.
We have talked a lot today about HIPAA and I just want to
point out a couple of things that I don't think that anyone
else has brought up today. HIPAA legislated many new
protections for health insurance consumers and among those
protections was a provision stating that group health plans
cannot consider any individual employee's genetic information
in a group setting in the underwriting process unless that
genetic information has already resulted in a diagnosis.
We have talked about HIPAA several times today, but
primarily from a HIPAA privacy standpoint. And I want to point
out that HIPAA has some other very important provisions. One of
them is this HIPAA nondiscrimination provision and another one
is a HIPAA portability provision and this is one I do want to
bring forth. We have heard a lot about the fear factor which
greatly concerns me because many of the people who we have been
talking about today probably already had insurance and what I
heard other people testifying say is that they were concerned
that their coverage would be cancelled.
HIPAA portability laws provide for guaranteed renewability
of contracts and the things that they are afraid of are already
illegal. And so I am concerned that we haven't done a good
enough job of educating about that and I am going to take that
into consideration, go back to our members about that. I wanted
to point that out.
When we talk about people already being subject to
nondiscrimination provisions in the group market, unless they
already have a diagnosis, what we mean is that if a generally
healthy person had some genetic tests run to see whether or not
they had markers for a particular illness, that information is
already prohibited from use. However, as we have heard earlier,
that provision does not apply in the individual health
insurance markets and we currently don't have any specific
genetic provisions relative to employment discrimination.
Many people at some point in their lives are going to be
purchasers in the individual health insurance market and I just
want to point out, as Karen said, I did enclose a lot of
information about the underwriting process as an addendum to
our testimony, only because I want people to understand why it
is important relative to the affordability of health insurance
coverage. Underwriting in the individual market is much more
difficult for a number of reasons that I have outlined in my
written testimony than it is for employer sponsored plans and
the ability to use health status in the way that we can use it
legally today is very important to keep policies affordable.
In States that have extremely limited the costs or the
information that can be used in the underwriting process, the
cost of coverage is significantly higher than it is in the
States where there is a realistic underwriting process and so I
wanted to point out, that is why we care about what this
definition is.
Just to move forward, as we look at the issue at hand
today, what we want to do is make sure that the information we
restrict is really not information that is critical to that
underwriting process because using too broad of a definition
will prevent normal underwriting procedures. The main issue is
what is considered genetic information?
As I stated earlier, HIPAA already prohibits discrimination
for any individual within a group in the absence of a
diagnosis. And I would like to point out one other thing.
During the 108th Congress, Representative Slaughter sponsored
H.R. 1910 and that particular bill had some language in it that
specifically excluded from the definition of protected genetic
information, information about the physical exams of the
individual and other information that indicates the current
health status of the individual, and this exclusion is not
present in the current version of the bill and I would hope
that you would consider including that in there because
information about current health status is critical to the
evaluation of applicants in the individual health insurance
market and that information is critical to keeping those
policies affordable.
We also would hope, believe that the definition of genetic
information should be limited to DNA or related gene testing
for the purpose of predicting risk of disease in asymptomatic
or undiagnosed individuals and that it should clearly exclude,
as it does, such items as age and gender, but an additional
exclusion should be information for physical exams and lab
work, including items like cholesterol tests that all of us
have on a regular basis.
Mr. Pallone. Ms. Trautwein, again, if you could summarize.
Ms. Trautwein. I would just summarize by saying that good
underwriting is important to affordability of health insurance.
The actions that Congress takes relative to this legislation
are going to have an impact for many years to come and we are
supportive of the concept of this legislation, but we would
hope for a few minor adjustments to make this workable so that
we don't price people out of health insurance coverage. Thank
you.
[The prepared statement of Ms. Trautwein appears at the
conclusion of the hearing.]
Mr. Pallone. Thank you. Again, I would mention to you again
that your written testimony is all going to be part of the
record. Dr. Hudson.
STATEMENT OF KATHY HUDSON, DIRECTOR, GENETICS AND PUBLIC POLICY
CENTER, ASSOCIATE PROFESSOR, DEPARTMENT OF PEDIATRICS, JOHNS
HOPKINS UNIVERSITY
Ms. Hudson. Mr. Chairman, Congressman Deal, Dr. Burgess, I
appreciate the opportunity to testify this afternoon and regret
that I am the only thing standing between you and happy hour. I
might just share my thoughts on H.R. 493 and the results of a
survey that we completed this week about Americans' attitudes
about genetic testing. You heard from Dr. Collins this morning
his incredible enthusiasm about the future of genetic medicine.
The American public shares his enthusiasm. In our survey, we
found that more than 90 percent of Americans support the use of
genetic testing by doctors to identify a person's risk of
future disease or to determine a patient's risk of having a bad
reaction to a particular medicine.
This enthusiasm extends to genetic research with again,
more than 90 percent supporting research use of genetic testing
and two-thirds trust researchers to have access to their
genetic information. But growing uncertainty and fear threaten
public confidence and the future of genetic medicine. More than
90 percent of Americans are concerned that the results of their
genetic tests could be used in ways that are harmful to them.
As a result, patients may pass up genetic testing that could
benefit their health or go to great lengths to keep genetic
information out of their medical records and out of insurers'
hands.
While people trust their doctors and they trust genetic
researchers, they simply do not trust health insurers and
employers to safeguard their genetic information. In our
survey, 93 percent said that health insurers should not be able
to use a person's predictive genetic information to deny or
limit insurance or charge higher prices and a similar number
said they feel employers should not be able to use this
information to make decisions about hiring and promotion.
Researchers need to be able to reassure research volunteers
their genetic information will not be used to discriminate
against them and today researchers can't provide such
assurances.
This week I was in Philadelphia conducting focus groups
about how ordinary citizens would feel about participating in
large population study to understand the genetic, environmental
and lifestyle contributors to health and disease. And we heard
substantial enthusiasm about this study in hopes that the study
would benefit others in the future, but their enthusiasm and
altruism was overshadowed by concerns about privacy of genetic
information and its misuse.
I want to say just a word about H.R. 493 would affect the
conduct of research. The bill would explicitly allow
researchers, for the first time, to tell research participants
that it is simply against the law for health insurers or
employers to use genetic information to discriminate. The
impact of this legal change would be substantial. Some are
concerned that the mere fact of participation in genetics
research could be construed by insurers or employers as
indicating a heightened genetic risk and might therefore be
used to discriminate them. H.R. 493 would prevent this, as the
bill prevents insurers and employers from using information
about individuals' receipt of genetic services. Therefore,
participation in genetics research would be protected and could
not be used to discriminate.
Turning to the clinical context, some opponents of H.R. 493
have suggested that the bill would make it hard for healthcare
providers to collect family history information, to request or
recommend genetic testing and to use this information to
provide the best possible care. This is simply not the case.
H.R. 493 very clearly states that the bill does not limit the
ability of healthcare professionals who are providing
healthcare to request that a patient undergo a genetic test.
Dr. Corwin's example earlier of MammaPrint, he is correct. The
plan cannot request or require that the patient take this test
because that is really not a plan's role. That is the
provider's role.
In conclusion, H.R. 493 prevents the misuse of genetic
information while protecting the ability of healthcare
providers to collect and use the information that they need to
take the very best possible care of their patients. H.R. 493
also protects individuals who participate in research from
having their information or even the fact of their
participation used in harmful ways. More than three-quarters of
the respondents in our survey believe that there should be a
law that prevents employers from using results of genetic tests
to make decisions and three-quarters also believe there should
be a law to prevent insurers from using results from predictive
genetic tests to deny or limit insurance or charge higher
prices.
The message is clear. The need for Congress to act grows
with every new test developed in every patient who decide to
forego or delay testing because of discrimination. Thank you
for taking up consideration of H.R. 493. And I beat the red
light.
[The prepared statement of Ms. Hudson appears at the
conclusion of the hearing.]
Mr. Pallone. You did, indeed, and I thank you for that.
Although we are not going to happy hour. I yield myself 5
minutes to ask some questions and I will start with Dr. Corwin.
In your testimony you talk about opportunities to improve
the legislation. Specifically, you cite the need to allow
health insurance plans to request genetic tests to promote
preventative screening and disease management and you also note
that Congress should include a more precise definition of
genetic information. In my hand here, though, I have a memo
which I would like to insert into the record, from the Blue
Cross Blue Shield Association to their congressional relations
coordinators regarding legislation introduced in the Senate
during the 109th Congress, which is identical to the bill
before us today.
And this memo states, and I quote, ``The definitions of
genetic information and genetic tests included in the final
bill are narrow and the final version includes insurers and
group health plans to use and allows insurers and group health
plans to use and disclose genetic information without special
consent for treatment, payment and healthcare operations, such
as for determining medical necessity, paying claims, detecting
fraud and conducting quality management programs.'' That is the
end of the quote.
Mr. Pallone. Doctor, could you explain to me why you are
calling for these changes when it would seem, at least from
this memo, that the current provisions of the bill should
already sufficiently address the concerns that you listed?
Obviously there is a discrepancy and I would just like you to
explain that. I don't know if you have the whole memo, but I
think that that section pretty much describes it.
Dr. Corwin. Thank you for the question. I am obviously not
privy to what the Blue Cross memo says.
Mr. Pallone. Well, you know what? Why don't I give it to
you while you are sitting there, but I will be honest with you,
that doesn't really add anything from what that paragraph is.
Dr. Corwin. Our concern is that the health plans be allowed
to request tests when they advocate for the better health care
of our patients and our members. Health plans design programs
on a basis to help address some of the variation that occurs in
healthcare. There is a tremendous amount of variations, I am
sure you are aware, in healthcare across the country and that
that leads to inferior and less competent care in many
circumstances.
And as we heard earlier in some of the testimony from Dr.
Collins about some of these great tests that are going to be
available to us in the very near future, being able to design
programs to make sure that our members get the care that they
need is going to be very, very critical in terms of helping
control these costs and making sure that our members actually
get those tests that will help them prevent these unfortunate
diseases from progressing.
Be that as it may, that everything is not ideal, the
medical care system is not perfect, that people don't always
follow up on tests, being able to help direct our membership to
those tests and make sure that they get those important follow-
up diagnostic examinations on the periodic intervals that are
indicated would be very important to health plans.
As the bill is currently worded, our concern is around the
fact that it prohibits us from being able to do that at this
point in time and deliver evidence-based care or ensure that
evidence-based care is given to the patients in a timely
fashion. I hope that addresses your question. If it doesn't, I
will take this back, take a better read of it and then respond
to you off-line.
Mr. Pallone. Well, you are free. No, I appreciate your
response but also feel free to look at that and get back to me,
if you like. Thank you. Ms. Pollitz, insurers have testified
before that they do not currently ask about genetic information
on applications or medical underwriting questionnaires. If that
is true, then how do insurers obtain information about an
applicant's genetic status?
Ms. Pollitz. As I mentioned, the underwriting process asks
an initial set of questions and about half of applications, the
industry tells me, are decided based on how applicants answer
those first sets of questions. But the other half of the
insurers say I don't know, so a red flag has gone up somewhere
and they need to get additional information. Sometimes that is
as simple as calling the patient and asking for clarification.
You said you are taking this drug; what was the dose, when did
you stop? Sometimes it is more in-depth and there is a call to
the physician or there is a request for medical records.
Once the records are delivered to the underwriter, even if
they didn't ask for the whole thing, even if they just asked
for part of it, they are obliged, I mean, they will be fired if
they won't, to go through and read everything that is in that
medical record so that they can say that they did a thorough
job of evaluating the risks. So when we asked the participating
underwriters who worked with us on our study how often or have
they ever seen or encountered genetic information in that way,
most of them said they had at least once. So they do come
across it.
Mr. Pallone. OK, thank you. I yield to the gentleman from
Georgia, Mr. Deal.
Mr. Deal. Thank you, Mr. Chairman. I want to pick up on the
Blue Cross Blue Shield letter that you are talking about.
Obviously, this is a comment that this one particular company
made with regard to legislation in the last Congress, but they
are pointing out parts that they think legislation should
include that are important and they referenced it to last
year's version.
For example, they point out the definitions of genetic
information and genetic tests included in the final bill are
now focused on predictive genetic tests and family history. The
definitions do not include current health status or information
from routine blood tests that are critical for underwriting and
et cetera. In that regard, Ms. Terry, my understanding is that
your objective is to cover predictive tests that are for the
purpose of identifying genetic markers for genetic disease and
that it is not your objective to cover genotypes or forensic
DNA tests or other markers that are not markers for future
disease. Is that correct?
Ms. Terry. Not exactly. Our intent is to cover genetic
information so that it is not misused in insurance or
employment.
Mr. Deal. Well, let us talk about that, then. And maybe you
are not the one I have to ask, since you are not the doctor.
Let me ask the doctor next to you, then. Doctor, don't we think
that at some point there is a correlation between genetic
information and being able to treat patients properly?
Dr. Corwin. Easily answered in a yes. We do believe that
there is a need for genetic information to treat people in a
predictive way and that would get to the ability to address the
preventative measures I talked about earlier.
Ms. Terry. And also, although I am not a doctor, I do know
that, in fact, the bill does allow the practice of medicine
that is not impacted and we are talking about insurers and
employers.
Mr. Deal. All right, let us get specific about that, then.
And Doctor, that is what I want to ask you. Do you think a
doctor can tell a patient that he won't treat that patient
unless they undergo a genetic test? And would that be
prohibited under this legislation?
Ms. Hudson. A doctor can request and a doctor can strongly
recommend that a patient undergo a genetic test and could
decide that it is not medically appropriate to go forward with
the specific line of treatment in the absence of that genetic
test result. That would be within the practice of a standard
practice of medical care.
Mr. Deal. So there are situations, then, when knowing what
the genetic test might show would be important to the treatment
of that patient, is that right?
Ms. Hudson. That is absolutely correct and I think we heard
a number of examples this morning of drugs where there are
adverse reactions and unless you know what the genotype of the
patient is, the doctor, not the health plan, the doctor needs
to know that genetic information before prescribing that
medication.
Mr. Deal. And are you saying, then, that your
interpretation is that a doctor can refuse to treat a patient
and it be not in a violation of this statute?
Ms. Hudson. There is no restriction on medical practice, at
all, in this bill.
Mr. Deal. What about if the doctor was an employee of the
employer of the patient?
Ms. Hudson. The rule of construction in the bill, as I read
it, does not have any, is not limited by who the employer is of
the healthcare provider that is providing the care. The
relationship between the provider and the patient is not
affected by who employs that particular physician, whether it
is an insurance company, whether it is----
Mr. Deal. My understanding is that that restriction is not
in title II. I guess we can clarify that later. Back to Ms.
Terry again. If I understand your policy, if a disease has
manifested itself, you don't believe that the restrictions in
the bill need to apply to genetic information related to that
disease, is that right?
Ms. Terry. So again, what we are looking for is making sure
that genetic information is not misused by the employer or the
insurer.
Mr. Deal. You made a distinction in your testimony between
manifest and not manifest. So your policy is that we are
talking about the not manifest diseases that these tests might
disclose, is that right?
Ms. Terry. So my policy is that when we give examples like
MammaPrint or Hepatitis C, et cetera, that those are manifest
disease and that in the course of treatment, doctors might,
indeed, highly recommend, as Kathy said, a genetic test and
that is certainly part of the usual course of medicine.
Mr. Deal. OK. Mr. Fishman, let me ask you this. As you read
this bill, does it focus on discriminatory misuse of genetic
information or does the language focus more on the flow of
information?
Mr. Fishman. Well, one of our concerns is, I hope and I
guess I failed to articulate properly, is that it seems to us,
it seems to my coalition and to me, personally, that the focus
of this bill is, in fact, not on the misuse of information or
the discriminatory use of information, it is on the
acquisition, including the innocent acquisition, and the flow
of that information. I think that, inevitably, any bill that is
directed at the flow of information rather than the abusive use
of the information, inevitably will have unintended
consequences and we have heard of a couple.
I have tried to identify a couple. I think Dr. Corwin has
identified a couple. I think that the purposes of this bill and
the goals of this bill can be achieved if you direct your
attention to the conduct that you wish to prohibit, rather than
hope that people who have hundreds of motives will or will not
take tests, may or may not take tests, will or will not have
insurance. This committee and this Congress should focus on the
abusive conduct that you wish to penalize and make that the
focus of the bill.
Mr. Pallone. Thank you, Mr. Deal. Dr. Burgess.
Mr. Burgess. Mr. Fishman, perhaps you could continue with
that line for just a moment, because I am concerned about the
unintended consequences. I do think that some protections are
necessary. I think the promise of genomic medicine is enormous
and will benefit, perhaps not those of us in our generation,
but certainly, our children and our children's children, and we
want to be certain that it is done correctly, so could you
detail for me a little bit more, flesh that out a little bit
more about what you are concerned about?
Mr. Fishman. Well, I will try to. I think that many of my
colleagues on this end of the prior panel's over-expansive in
their denials about what this bill covers. I think the bill is,
I think the definition is over-expansive and I think some of
the exclusions are under-exclusive. For example, in section 210
there is a provision that attempts to exclude manifest ailments
from the reach of this bill, but it says that only medical
information that is not genetic information can be disclosed.
So we have the bizarre situation of let us say, a company
nurse who is treating someone who has collapsed and during the
triage, would say oh, it is probably my heart because my dad
had a heart problem, too. Under GINA and because she has now
just learned family history, which is genetic information, that
nurse could possibly tell a treating physician I have a patient
who has collapsed but could not say oh, by the way, it may be a
heart problem because his dad had a problem. And that is simply
a drafting problem that I think comes from over-inclusiveness
because the direction of the bill is directed at the flow of
information rather than the abusive use of the information.
That is one of the reasons that my oral testimony and a
good deal of my written testimony is devoted to thinking about
including, as part of the text of this statute, the exceptions
and exclusions that are included in the HIPAA regs for the
privacy parts where treatment is the first exception under
HIPAA where there should be an exception for treatment. That
nurse should not have to wonder whether the mere utterance of
oh yes, I know that his dad had a heart attack is a potential
problem that could lead to a jury trial and punitive damages
under the enforcement scale of title II.
I mentioned in my oral testimony the definition of a
disease that occurs in a family member that is not an
inheritable disease, that is not an asymptomatic disease, that
is not even a disease that is genetically related. There ought
to be some focus on what the purpose, what is the goal of the
bill? You have heard my co-panelists talk about discrimination
in insurance and employment. You haven't heard of a single
employment discrimination case but one and yet, we are going to
have an entire legislative scheme devoted to what nobody has
yet been able to demonstrate even exists.
My clients, large and small, have difficulty finding
employees who can do the job and can come to work regularly,
they don't particularly care much about your genomes. Most of
them don't even know what it is and I am one of them. Let us
focus on the abusive conduct and craft a bill that is narrowly
directed to achieve the goal that we all share, which is
nondiscrimination in employment and insurance and let us not
focus on our hopes and our prayers for how medicine can develop
in 2030.
Mr. Burgess. I thank you for your candor. Dr. Corwin, I was
particularly intrigued by the comments you had for improvements
to 493, and under one of the bullet points that medically
indicated testing should be encouraged to promote consumer
access to appropriate coverage and treatment. And I think we
heard from someone else on the panel that these are decisions
that actually should be made by the doctor, not the insurance
company. Would you care to expound upon that?
Dr. Corwin. Thank you very much. It is a great question.
From my perspective, and with all due respect to my colleague,
I would disagree with her on that point. I think that health
plans do have a role for requesting and requiring certain
genetic testing to be done for the purpose of treatment. With
all due respect to all my colleagues, there are times that
evidence-based medicine is not practiced in a timely way and if
we know that individuals are going to need pharmacogenomic
testing for the purpose of delivering the best possible care to
them and to be able to decide what is the best possible
chemotherapeutic protocol for non-small cell lung cancer, which
is a devastating disease, and within a very short period of
time, we will have this type of genomic information available
to help decide what is the best possible test. It is not
inappropriate for the plans to be able to request that kind of
testing to be done to ensure that the patient gets the best
possible care. If it is not done, one is using the best guess
scenario once again. I would hope that in every case that
wouldn't be necessary, but in some cases, it may be.
Mr. Burgess. Well, I always resented it when insurance
companies would challenge my clinical acumen, but it was
probably appropriate in other doctors' cases.
Dr. Corwin. I would totally agree.
Mr. Burgess. Well, I think you referenced somewhere in here
the Cytochrome people are, as being another area where this may
have some applicability.
Dr. Corwin. In Dr. Collins' example about the leukemic
children, that is very true and it is also going to be true for
a number of other drugs, specifically some of the newer
antimicrobial agents that are being developed for fighting
infections will not work as well in some people, but will work
extra well in other people and dosage adjustments will become
much more difficult without having testing ahead of time and
having that information available, so it would be appropriate
to require that kind of testing in those situations.
Mr. Burgess. Thank you. Once again, Mr. Chairman, just
reserve the right to submit written questions.
Mr. Pallone. We are also going to do a second round now, so
if you want to stay, you can ask questions again. I will yield
to myself for 5 minutes. I don't know if I will use the whole
five, but I just wanted to ask Ms. Trautwein a question. We
heard, in Dr. Corwin's testimony that AHIP does not oppose GINA
and I am just curious to know whether or not NAHU supports or
opposes the enactment of GINA.
Ms. Trautwein. Well, that is a great question. I was very
curious about the Blue Cross letter, because we actually worked
very closely with the people on the Senate side, as well,
coming to the language that was there. Sometimes on the other
side things are a little different than they are over here.
Mr. Pallone. That is for sure.
Ms. Trautwein. And I think that many of us thought that
that possibly might have been the best thing that we could get
out of there rather than coming up with something worse, so I
would just state that for the record. Now, relative to the
consideration over here, I think you guys might be able to
improve on their work a little bit. And I think it is not
broad-scale adjustments we are talking about. Some minor
adjustments to the definitions could make this a truly good
piece of legislation. And so I would say that we support it
with a few caveats there, that we think that you could make it
a little bit better and you have an opportunity to do that and
I would hope that you will.
Mr. Pallone. Thank you. Ms. Pollitz, is providing
healthcare limited by this bill, as Mr. Fishman seemed to
suggest? If you would just comment on that.
Ms. Pollitz. Actually, I think Dr. Hudson was correct, that
the bill doesn't limit the way physicians practice medicine and
it doesn't even prohibit health insurers from asking about the
results of a genetic test. It just says that a health insurer
can't tell a patient to undergo a genetic test. Dr. Collins
talked about the six P's of genetic testing and you could add
profound to that. I think this is an incredibly personal and
profound decision to undergo genetic testing and people may not
want to. Not just because they fear it, they may not want to
for other reasons and if they don't there may be other
consequences that come from that and we have heard about them
today, that they may be foregoing treatment options and so
forth, but nobody can tell somebody to take a test. Doctors can
recommend it, but the health plans need to stay out of that.
They can ask, for purposes of medical appropriateness review
and so forth, if a test was taken, what was the result, but
they can't force a patient to take a test.
Mr. Pallone. OK, thank you. I wanted to go back to Dr.
Hudson, actually, and ask if Congress failed to take action on
genetic nondiscrimination legislation, how do you believe
scientific research would suffer as a result? In other words,
if Congress were able to pass this legislation, how do you
believe scientific research would benefit?
Ms. Hudson. We are at a stage now where we can do the
research to uncover those weak genetic contributors that are
interacting with environmental factors and with lifestyle
factors to common diseases, which you really haven't had the
power to explore before and in order to do that, we are going
to have to do massive studies that include hundreds of
thousands of people who actively participate and share not only
their genetic information, but their environmental exposures,
their lifestyles, et cetera. That is sort of the next big push
in medicine and medical research and if we don't pass this
bill, we won't get people to sign up and we won't understand
how genes and environment and lifestyle work together and how
we can intervene to reduce our risks of disease.
Mr. Pallone. OK, thank you. And then from your survey data,
it is clear that the public is concerned about who has access
to their genetic information, but in terms of protections from
genetic discrimination, what do you think the public expects
and wants and do you think that that this bill will address
those concerns?
Ms. Hudson. I think the public clearly wants legal
protections at the Federal level against misuse of genetic
information and I disagree with some of my colleagues here. I
think that the bill does include very specific and concise
prohibitions on the use of genetic information, not just how it
travels, but how it is actually used and I think those are
appropriate restrictions on the use of genetic information both
in title I and in title II. I think we are going to have a very
big job ahead of us when this bill passes and I believe it will
pass. When this bill passes, we have a very big job to then
educate the American public that they are now protected and
they can, with confidence, take a genetic test that is
appropriate for them or participate in biomedical research.
There is a lot of suspicion out there that we will have to
overcome with the right information about the protections that
will be put in place by H.R. 493.
Mr. Pallone. Thank you. Mr. Deal.
Mr. Deal. Thank you. The reason I think some of us are
asking very specific questions is that this is the kind of
legislation that has profound consequences and many times the
direct opposite consequences of what was intended by the
legislation, if it is not carefully crafted, and that is the
reason that some of the questions that I am asking and others
are asking are being posed. And let me just take a few more
shots at it. I am looking at a chart comparing permitted uses
and disclosures under HIPAA rules versus the same thing under
this legislation and some of it goes directly to the issues we
have already talked about. HIPAA, for example, has a business
associates disclosure permission.
It says it has to be related to the delivery of the health
functions. It has an exception for treatment, payment,
healthcare operations. We don't see a similar provision in this
legislation. So I guess my question would be am I correct that
the 202(c) appears to say that even if you are providing a
health service, you are still subject to the prohibitions of
section 206(b) and if so aren't we creating a huge problem if
there is no treatment or operations exception built into this
legislation like is built into HIPAA? Mr. Fishman, this is sort
of a lawyer's question, I guess.
Mr. Fishman. I am not sure it is, but I will give it a
shot. I think it is correct and that is really the core of my
testimony this afternoon. It is an odd situation that I find
myself in. My clients don't collect this information and they
don't use this information. There is no evidence that they even
care about this information. But they are going to be included
in a privacy regimen that is both, we think, over-inclusive and
needlessly burdensome and seems to ignore the highly
reticulated privacy program that the HIPAA regulations created
after months of regulatory oversight with reams of public
comment.
I cannot, for the life of me, understand why this committee
or why this lobby would want to ignore the kind of effort that
HHS underwent to learn, from public comment and from survey of
the very same people that you are trying to include here, and
not include the kinds of learning that they discovered would
make HIPAA, the HIPAA privacy regs, meaningful and useful. For
my purposes, and as I said, this is almost tangential, because
my clients, members of my coalition, don't gather genetic
information, don't do genetic testing, don't use genetic
information in employment decisions and don't want to.
But it seems we are going to get dragged into a privacy
regimen that is additional to the one they spent about $10
billion and a hundred million hours trying to learn. It is
highly, highly structured, it is highly directed to meet
particularized needs and for the life of me, I, as someone who
used to be in a regulatory agency, I can't understand why this
body wouldn't want to use the benefits of all of the efforts
and all of the learning that HHS has proffered in creating the
HIPAA regs.
Mr. Deal. Back to the specific, a doctor who is employed,
is he under the prohibitions that you read into this bill?
Mr. Fishman. As I said, in 210, I hope it is a drafting
error and all I can do, like most of you folks, I live in an
imperfect world and I can't make the language that I read into
something other than what I honestly read. In 210 there is an
exception that is supposed to be for medical information that
is not genetic information, which means, to me, that genetic
information is still regulated and if I am a doctor employed by
an employer covered by GINA, I have to be concerned with
whether the information I am relating, even for treatment
purposes, to another physician or to anyone else, is included
as regulated in 210. And if it is regulated in 210 and I
violate it, I am in the enforcement soup of title VII, which is
what you have included in this bill. I don't think that is what
you intended. I hope you can correct it, but as currently
drafted in this imperfect world, that is what I read.
Mr. Deal. Thank you, Mr. Chairman.
Mr. Pallone. Thank you. Dr. Burgess.
Mr. Burgess. Well, Mr. Fishman, let me just ask you. The
Mayo Clinic, for example, where all of the doctors are not
independent contractors, they are employees of the Mayo Clinic
system, would that system be at risk in what you are concerned
about in 210?
Mr. Fishman. Well, it is not only that. One of the members
of our coalition is CUPA HO, which is ``College and University
Professional Association.'' That means all of those medical
schools and all of those universities, they are included, too,
and have to face this problem. It may not be a problem if they
don't convey the information, but if they do convey the
information, why would you want to introduce the possibility of
raising that doubt and causing that delay? Why isn't the
exception here the same as PTO in HIPAA?
Why would you even want a physician at the Mayo Clinic or
at the University of Texas to have to worry about wait a
minute, I now know genetic information. This exclusion, which
appears to be intended to help me treat manifest ailments, it
is not that I am only covered for medical information that is
not genetic information. Why should that poor person have to
pause, to hesitate to try to figure this out when it seems that
it was not the intent of Congress to want to cover that sort of
a situation. And that is where I am. I am not a physician, two
doctorates, but neither one in medicine, so there I am.
Mr. Burgess. Well, and I thank you for your frankness and
your candor. I was on the outside looking in when Congress, in
'96 or '97 passed, as part of the Health Insurance Portability
and Accountability Act, what we now know as the HIPAA privacy
regulations. It seems like it was a fairly short section of
that Kennedy-Kassebaum bill and many years later delivered to
my doorstep, was an enormous cost compliance that didn't seem
to do a whole lot to further patient care. I never felt like I
was the problem in the first case.
Mr. Fishman. Well, I think there are something like 1,275
pages of HIPAA regs, so you are not responsible for that.
Mr. Burgess. I do understand why you are concerned about
what would seem to be a fairly narrow provision in this and in
the field of unintended consequences and I know we have gone a
long time today, Mr. Chairman. I see you holding your forehead
and I am sensitive to that fact and I appreciate the fact that
we can submit written questions, but Ms. Trautwein, before we
finish up today, you mentioned concern about affordability of
health insurance and I will just tell you that that is the one
thing that is always on my mind, the decisions we make here,
are they helpful or hurtful as far as the average middle class
family affording their health insurance. Do you have some
further thoughts on that?
I remember when this, and I wasn't here when this body went
through the discussion of patient bill of rights, but I do
remember hearing about the for every dollar cost increase there
is, we knock so many people off of the rolls of the insured. Do
you have any thoughts about what the effect of this legislation
will be?
Ms. Trautwein. Well, I think if we make some needed
changes, it is not going to impact things too much at all,
other than to provide some protections that are obviously
needed. I think we do need to look at the definitions that are
there because right now they are broad and I am very concerned
that a regulator, some point down the road, people who would be
under compliance with this would not be clear on what it was
that they were or were not supposed to do and what Congress
intended. And so my suggestion is that we just get really clear
and very specific on what is and is not protected information
and don't leave it to someone else to figure out. Let us be
specific. If we don't mean current health status, let us say
that. If we don't mean routine exams and lab work, let us say
exactly what we mean and that way we can underwrite
appropriately and particularly in the individual health
insurance market, given what we have today and given what Karen
Pollitz said, that things will change; of course they will, but
right now, we don't want to price people out of coverage now
and create a problem that is much worse than what we started
with by causing many more people to become uninsured because
they are priced out of coverage. And so I think we can do this,
we can tighten this up and make it better, but I think it needs
a little bit of work.
Mr. Burgess. Well, Mr. Chairman, I am going to surprise you
and yield back 16 seconds. I do thank the panel for their
forbearance today. I know it has been a long day, but this is
important legislation and I appreciate you all participating.
Mr. Pallone. Thank you very much. I want to thank all of
you. I thought it was very thoughtful and useful discussion
today, so I really thank you. It really wasn't that long, it
was just because we had the hour that we were voting, I think.
Let me just remind the Members that you may submit additional
questions for the record to be answered by the relevant
witnesses and they should be submitted to the committee clerk
within the next 10 days. And without objection, this meeting of
the subcommittee is adjourned. Thank you, everyone.
[Whereupon, at 5:20 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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