[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


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov


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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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