[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]




                       GENETIC NON-DISCRIMINATION

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

                                HEARING

                               before the

                         SUBCOMMITTEE ON HEALTH

                                 of the

                      COMMITTEE ON WAYS AND MEANS
                     U.S. HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 14, 2007

                               __________

                           Serial No. 110-22

                               __________

         Printed for the use of the Committee on Ways and Means
















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                      COMMITTEE ON WAYS AND MEANS

                 CHARLES B. RANGEL, New York, Chairman

FORTNEY PETE STARK, California       JIM MCCRERY, Louisiana
SANDER M. LEVIN, Michigan            WALLY HERGER, California
JIM MCDERMOTT, Washington            DAVE CAMP, Michigan
JOHN LEWIS, Georgia                  JIM RAMSTAD, Minnesota
RICHARD E. NEAL, Massachusetts       SAM JOHNSON, Texas
MICHAEL R. MCNULTY, New York         PHIL ENGLISH, Pennsylvania
JOHN S. TANNER, Tennessee            JERRY WELLER, Illinois
XAVIER BECERRA, California           KENNY HULSHOF, Missouri
LLOYD DOGGETT, Texas                 RON LEWIS, Kentucky
EARL POMEROY, North Dakota           KEVIN BRADY, Texas
STEPHANIE TUBBS JONES, Ohio          THOMAS M. REYNOLDS, New York
MIKE THOMPSON, California            PAUL RYAN, Wisconsin
JOHN B. LARSON, Connecticut          ERIC CANTOR, Virginia
RAHM EMANUEL, Illinois               JOHN LINDER, Georgia
EARL BLUMENAUER, Oregon              DEVIN NUNES, California
RON KIND, Wisconsin                  PAT TIBERI, Ohio
BILL PASCRELL, JR., New Jersey       JON PORTER, Nevada
SHELLEY BERKLEY, Nevada
JOSEPH CROWLEY, New York
CHRIS VAN HOLLEN, Maryland
KENDRICK MEEK, Florida
ALLYSON Y. SCHWARTZ, Pennsylvania
ARTUR DAVIS, Alabama

             Janice Mays, Chief Counsel and Staff Director
                  Brett Loper, Minority Staff Director

                                 ______

                         SUBCOMMITTEE ON HEALTH

                FORTNEY PETE STARK, California, Chairman

LLOYD DOGGETT, Texas                 DAVE CAMP, Michigan
MIKE THOMPSON, California            SAM JOHNSON, Texas
RAHM EMANUEL, Illinois               JIM RAMSTAD, Minnesota
XAVIER BECERRA, California           PHIL ENGLISH, Pennsylvania
EARL POMEROY, North Dakota           KENNY HULSHOF, Missouri
STEPHANIE TUBBS JONES, Ohio
RON KIND, Wisconsin

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
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                            C O N T E N T S

                               __________

                                                                   Page

Advisory of March 7, 2007, announcing the hearing................     2

                               WITNESSES

Francis S. Collins, M.D., Ph.D., Director, National Human Genome 
  Research Institute, National Institutes of Health, Bethesda, 
  Maryland.......................................................     5

                                 ______

Karen Pollitz, Project Director, Georgetown University Health 
  Policy Institute...............................................    28
Sharon Terry, M.A., President and Chief Executive Officer, 
  Genetic Alliance...............................................    47
David Escher, Former Employee of Burlington Northern Santa Fe 
  Railroad, Reno, Nevada.........................................    60
William Corwin, M.D., Medical Director, Clinical Policy, Harvard 
  Pilgrim Health Care, Worcester, Massachusetts, on behalf of 
  America's Health Insurance Plans...............................    68

 
                       GENETIC NON-DISCRIMINATION

                              ----------                              


                       WEDNESDAY, MARCH 14, 2007

             U.S. House of Representatives,
                       Committee on Ways and Means,
                                    Subcommittee on Health,
                                                    Washington, DC.

    The Subcommittee met, pursuant to notice, at 2:13 p.m., in 
Room B318, Rayburn House Office Building, the Honorable Fortney 
Pete Stark (Chairman of the Subcommittee) presiding.
    [The advisory announcing the hearing follows:]

ADVISORY

FROM THE 
COMMITTEE
 ON WAYS 
AND 
MEANS

                         SUBCOMMITTEE ON HEALTH

                                                CONTACT: (202) 225-3943
FOR IMMEDIATE RELEASE
March 07, 2007
HL-5

                         Subcommittee on Health

                 Chairman Stark Announces a Hearing on

                       Genetic Non-Discrimination

    House Ways and Means Health Subcommittee Chairman Pete Stark (D-CA) 
announced today that the Subcommittee on Health will hold a hearing on 
genetic non-discrimination. The hearing will take place at 2:00 p.m. on 
Wednesday, March 14, 2007, in Room B-318, Rayburn House Office 
Building.
      
    In view of the limited time available to hear witnesses, oral 
testimony at this hearing will be from invited witnesses only. However, 
any individual or organization not scheduled for an oral appearance may 
submit a written statement for consideration by the Committee and for 
inclusion in the printed record of the hearing.
      

BACKGROUND:

      
    One of the most significant scientific accomplishments in history 
has been sequencing the human genetic code--a breakthrough that is 
already transforming the battle against a broad range of medical 
conditions. As a result, scientists have identified genetic markers for 
a variety of chronic health conditions, increasing the potential for 
early treatment and prevention. Genetic tests provide information to 
diagnose conditions, guide treatment decisions and predict future risk 
of disease.
      
    Alongside these benefits reside concerns about how genetic testing 
might be used. This threat has deterred the public and the scientific 
community from taking full advantage of the important opportunities 
that genetic information affords. Of particular concern is the 
potential for discrimination. A number of institutions, including 
health and life insurance companies, health care providers, blood 
banks, adoption agencies, the military, and schools were reported to 
have engaged in genetic discrimination against asymptomatic 
individuals.
      
    The lack of a federal policy protecting genetic information has 
resulted in both actual and perceived acts of discrimination. It has 
also encouraged inconsistent legal responses to grievances associated 
with such discrimination. As the tax writing authority for the U.S. 
Congress, the Ways and Means Committee can enforce federal insurance 
laws that apply to ERISA plans, which provide health benefits to the 
vast majority of Americans. In addition, the Committee has jurisdiction 
over federal laws relating to Medigap policies.
      
    In announcing the hearing, Chairman Stark said, ``No one should 
face discrimination in employment or be denied health insurance based 
on their genetic information. In order to ensure that genetic science 
reaches its full potential, patients need to trust that their 
information will be protected. Otherwise, people will rightly be 
reluctant to undergo genetic tests that could save lives.''
      

FOCUS OF THE HEARING:

      
    The hearing will focus on the need for a federal policy to protect 
genetic information and legislation to achieve this purpose, 
specifically, the Genetic Information Non Discrimination Act.
      

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    Chairman STARK. We will begin the hearing, and Congressman 
Camp has been otherwise detained and probably went over for the 
vote.
    I will start, and thank you for being here to discuss the 
potential for genetic science and the need to protect genetic 
information.
    We find that patients are reluctant to undergo genetic 
tests, unless they can be sure the results won't be used 
against them, and I don't blame them. Health insurers are in 
the business of not paying out money when they can avoid it, 
and so they have got an incentive to use whatever genetic 
information they can get to deny coverage or raise rates.
    Employers can also use this information in hiring decisions 
and one of our witnesses will describe his victimization in 
that area.
    We have got to ensure that patients and workers are 
protected against the discrimination so they can realize, as 
all of us should be able to realize, the benefits of genetic 
testing.
    We have been deliberating this policy for 12 years. We made 
some improvements in HIPAA and many states have enacted some 
protection since then. The laws vary greatly and we should 
have, I think, comprehensive protections.
    It appears we are close to realizing our goal to ban 
discrimination on the basis of genetic information and the 
Senate has passed similar bills. It is my understanding the 
administration supports the bill that is now moving through 
Congress. I look forward to working with my colleagues on this 
policy.
    Congressman Johnson has graciously offered to put 
Congressman Camp's opening statement in the record. On the 
conclusion of that, we will hear from Dr. Collins, who is the 
director of the National Human Genome Research Institute at NIH 
in Bethesda.
    But if you will withhold, and Mr. Johnson, would you like 
to submit Mr. Camp's remarks or put them in the record? It is 
up to you.
    Mr. JOHNSON. If you don't mind, Mr. Chairman, I would just 
like to say that in his closing paragraph, he says, as this 
Committee considers the Genetic Information Nondiscrimination 
Act, I hope we will recognize that, with sufficient protection 
in place surrounding use of genetic information, the 
information can be used in positive ways that actually improve 
the lives of patients and we should not hinder these promising 
medical advances as we attempt to protect patients and 
employees. He thinks we can work together to do that.
    I would like to insert the whole thing in the record.
    Chairman STARK. Without objection, the opening statements 
will be in the record in their entirety.
    [The information follows:]

    I would like to thank all of the witnesses for testifying 
today about this important issue.
    I think we are all in agreement that individuals should not 
be discriminated against on the basis of their genetic 
information. Insurers should not be allowed to use genetic 
``markers'' to deny insurance coverage or increase out-of-
pocket costs, nor should employers be allowed to fire employees 
simply because they possess a gene that could lead to a 
particular disease later in life.
    However, the use of genetic information is not always 
harmful to patients. As we'll hear later from Dr. Corwin, 
advances in medicine have allowed doctors to tailor treatments 
in accordance with an individual's genetic information. Results 
from genetic tests allow physicians and other providers to 
better target preventive care and disease management techniques 
to those who need it most.
    For example, a patient that possesses a gene for a type of 
colorectal cancer would be recommended to receive more frequent 
cancer screenings. Knowing this, the health insurer would know 
to approve coverage for these additional screenings because the 
patient would be at a higher risk of developing colorectal 
cancer. Early detection and treatment has been proven to 
produce significant savings and improve quality of life.
    As this Committee considers the Genetic Information Non-
Discrimination Act, I am hopeful we will recognize that, with 
sufficient protections in place such data can to improve the 
lives of patients. These promising medical advances should not 
be hindered as we attempt to protect patients and employees. I 
am confident that we can both protect patient privacy and 
improve health care services.
    With that, Mr. Chairman, I yield back the balance of my 
time.

    Chairman STARK. Dr. Collins, why don't you proceed in any 
manner you are comfortable? I want to just tell our guests that 
Dr. Collins may have to zip out of here to make a plane, and we 
will excuse him at any time he feels it's necessary.
    Proceed.

   STATEMENT OF FRANCIS S. COLLINS, DIRECTOR, NATIONAL HUMAN 
    GENOME RESEARCH INSTITUTE, NATIONAL INSTITUTES OF HEALTH

    Dr. COLLINS. Thank you, Mr. Chairman. Good afternoon.
    Yes, I am Francis Collins. I am a physician and a 
scientist. For the last 14 years, I have been at the National 
Institutes of Health and I have had the great privilege of 
leading the Human Genome Project, which many have considered to 
be the most important scientific undertaking that humankind has 
ever mounted, reading out the letters of our own DNA 
instruction book.
    The purpose of this was to advance medicine, to improve the 
likelihood of people staying healthy and to treat disease more 
effectively when it occurs. We are making great progress.
    The Human Genome Project accomplished all of its goals 
ahead of schedule and under budget in 2003 and, on top of that, 
we have now built several more new discovery engines that have 
put us in a position now to be able to discover what, in fact, 
are the hereditary factors in a long list of diseases that are 
particularly common in our population. In just the last 2 
years, we have discovered major genetic factors for macular 
degeneration, one of the most common causes of blindness in the 
elderly; for prostate cancer, for Crohn's disease; and in a 
particular explosion of information happening right now about 
adult onset diabetes.
    We have known that these are conditions that run in 
families, but now we are on the brink of very precisely 
identifying why that is and providing the opportunity to tell 
individuals who are at high risk about their risk, and 
therefore giving them a chance to reduce that risk by changing 
diet, lifestyle or medical surveillance.
    This then puts us in a circumstance of being able to 
contemplate a future of truly personalized medicine. You 
wouldn't go to the shoe store and buy any old pair of shoes off 
the rack; you would want to be sure it was your size. Yet in 
medicine, we have often been forced to practice one size fits 
all because we didn't have the information about individual 
parameters to be able to do a better job. We are now able to do 
that in some instances, and that is growing by the day, not 
only in terms of predicting risk of disease but also being able 
to choose the right drug for the right person at the right 
time, based on their individual DNA sequence.
    Yet there is a cloud on this horizon. The cloud gets darker 
and more threatening every day, and that is the risk of genetic 
discrimination.
    Individuals who might wish to have this information about 
their own future risk of illness or about what drug they might 
best be treated with are terrified that if that information 
gets into the wrong hands, it may result in loss of their 
health insurance or potentially loss of their job. While there 
is, as the Chairman has indicated, effort under way in many 
states to deal with this, it is a patchwork of different kinds 
of laws with many exceptions. If we really want to protect the 
American public, we would have to do it with Federal 
legislation.
    Twelve years ago, colleagues of mine and myself wrote a 
paper in the journal Science advocating for the importance of 
this kind of Federal legislation. It has been a long, hard slog 
getting to this hearing today where it does appear that finally 
there is momentum to see this happen.
    Let me quickly put a human face on the issue. On the screen 
over here, you see a diagram of a family. You can tell who are 
boys and who are girls by the figures here. I draw your 
attention to the individual with the red arrow.
    This woman came to seek advice because she had suffered 
from both uterine and colon cancer at a relatively early age, 
in her thirties. It turned out, so did her mother and so did 
her aunt.
    After some investigation, it turns out that this is one of 
those situations where the precise DNA glitch could be 
identified. She was actually not sure she wanted that done 
because of her concern it might be used to take away her health 
insurance. But ultimately she decided to go through with it.
    She was found to carry a specific misspelling in a 
particular gene, which confers this high risk of colon and 
uterine cancer to anybody in the family who carries that same 
glitch. The other people you see there in yellow are all at 
high risk of also having that same misspelling and a test is 
immediately available for them.
    Yet, in this family, after much discussion amongst the 
family members, not a single one of them decided to take 
advantage of that test, even though we know that in this 
situation, knowing you're at high risk can be life saving, 
allowing you then to get into a program of annual colonoscopy 
starting at a very early age, picking up that early tumor while 
it is still easily treated.
    So, this is a real example where the risk of genetic 
discrimination is probably going to cost somebody their life 
because of their fear of being able to get the information that 
they otherwise need. That is not just this family. A recent 
survey done by my colleague, Kathy Hudson, revealed a couple of 
weeks ago 93 percent of the American public, when asked the 
question whether this kind of genetic information ought to be 
available to employers or health insurance companies said, 
absolutely no. So, this is a widespread concern.
    At NIH, where we do a lot of genetic research, fear of 
genetic discrimination is causing many people to decide not to 
participate in that research, which both deprives them of the 
opportunity to get useful information and deprives all of us of 
the results of the research.
    So, we need to take action, and the sooner the better. 
Every day that goes by, we are missing out on opportunities. As 
this kind of information more and more moves into the 
mainstream, and it will soon, it will have a dampening effect 
to say the least if people are afraid of obtaining this 
information about themselves.
    This is about all of us. There are no perfect genetic 
specimens. We all have these glitches. We have the chance to 
find out what they are in a way that will benefit us. But we 
need to be assured that that is safe.
    Thomas Jefferson wrote the words that you see over there on 
the Jefferson Memorial: ``Our laws and institutions must go 
hand in hand with progress of the human mind.''
    Progress of the human mind has led us now to this 
remarkable point where we can read our own DNA instruction 
book. Our laws and institutions need to keep up with that, 
providing people with the kind of reassurance that this 
information is safe to obtain and won't be used against them. 
This is an issue of equity, of justice and of civil rights. You 
don't get to pick your DNA; it shouldn't be used against you.
    The President of the United States in his visit to NIH 
earlier this year strongly endorsed the need for this 
legislation. Secretary Leavitt has been very much out in front 
of the promise of personalized medicine and the need for better 
policies to provide a safe harbor for people who wish to have 
the information as part of their medical care. So, all of us 
hope that this will be the year where the American people are 
given a gift by the Congress that is long overdue: Federal 
legislative protection against genetic discrimination.
    Thank you very much. I will be glad to answer your 
questions.
    [The prepared statement of Dr. Collins follows:]
    

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Chairman STARK. As I understand it, most of us are not 
offered these tests at our regular annual physicals and so we 
don't have many cases of actual discrimination. People have 
suggested we wait until the testing is more universally 
performed. Would you have any comment on that strategy?
    Dr. COLLINS. If you were standing in the middle of a train 
track and the train was headed toward you but it wasn't going 
to hit you for another 10 minutes, I suppose you could decide 
to wait a little longer and see if you could just, in the nick 
of time, jump out of the way.
    If, on the other hand, you are a thoughtful person or 
trying to preserve life, it would probably be better to make 
another plan.
    Yes, you are quite right. Most of us have not yet been 
offered this kind of test. Even though there are a thousand 
tests available, they are mostly for rare diseases. As the 
family I showed you indicates, oftentimes the trigger is a very 
strong history and not all of us have family histories like the 
one I have shown you.
    But increasingly, this is coming into the mainstream. 
Certainly with the proliferation of discoveries about diseases 
like diabetes and Alzheimer's, asthma, hypertension and so on 
that are happening right now, it is only a matter of time, a 
short period of time, before this does find its way into the 
kind of talk you are going to have with your physician in the 
next few years. Do you want to know about these risks? Many 
people will want to answer that, yes, and to be reassured that 
it is safe to do so.
    Chairman STARK. Well, where do I go, Doc? Say, all right, I 
am a believer and I want to go have my DNA recorded and then I 
want somebody to tell me which of these ugly things are going 
to happen to me, is that available to people with an internist 
as a primary care physician or people in health plans, 
generally? What do you do if you want to do it?
    Dr. COLLINS. At the present time, the first thing would be 
to collect a really detailed family history. Because family 
history is actually a genetic test that is quite revealing and 
actually free. You don't have to send off your DNA anywhere. 
Then a physician who is knowledgeable about genetics, which 
increasingly is more and more physicians--that is something we 
are working on--or a genetic counselor could look at your 
pedigree and say, okay, here are some particular things that we 
might want to think about testing for.
    At the present time, that would be the trigger. We are not 
at the point where we yet have any tests that are being 
recommended for everybody as a screening test for future risk. 
Before taking that step, you want to be----
    Chairman STARK. But even though you don't recommend it, is 
there one?
    Dr. COLLINS. So, if you want to go to the worldwide web, 
you can find organizations that will market a lot of genetic 
tests to you at a certain price. I would be a little wary of 
those. If you look carefully, many of those are tests that have 
not been scientifically validated. They will also oftentimes, 
after offering you the test, try to sell you a nutritional 
supplement that will take--do something about your genetic 
deficiency. So, there is a little bit of a racket going on.
    Chairman STARK. I can't get by the Viagra ads on the 
Internet, much less worrying about those guys selling me the 
other supplements.
    Dr. COLLINS. These are in some of the same category, I am 
afraid. So, we are not quite there.
    But, Mr. Chairman, I think again for some people we are 
there. For that family, we are there. You will hear from Mr. 
Escher on the second panel, about how this kind of genetic 
testing was applied to him without his knowledge.
    Again, why would we want to wait to fix this issue from a 
policy perspective until we have hundreds of millions of 
victims? If we can kill the risk here earlier on, we should do 
so.
    Chairman STARK. Is there something we should do in 
Medicare, aside from this protection? I don't suppose Medicare 
pays for this yet. Is there something we should do that would 
encourage or accelerate the more generalized use of these tests 
for the benefit of those of us who are Medicare beneficiaries?
    Dr. COLLINS. Sir, that is a great question. In fact, we 
have been in discussions with CMS about what would be the 
criteria to begin to reimburse for these genetic tests.
    The Secretary's Advisory Committee on Genetics, Health and 
Society, SACGHS, has been meeting on a variety of topics like 
this and, in fact, issued a report about a year ago on coverage 
and reimbursement for genetic tests, which specifically 
addressed the question that you asked and, I think, made a 
number of points about what criteria Medicare might want to 
consider in making a decision about when to cover for these 
kinds of predictive genetic tests.
    I think those are thoughtful recommendations. I think they 
are under serious consideration. It is, in fact, a very good 
thing that there is at a high level this advisory Committee 
that advises Secretary Leavitt about genetics, because this is 
coming along so quickly.
    Chairman STARK. What does a genetic, you know, nice, broad, 
all-inclusive genetic test cost? To the closest thousand 
dollars.
    Dr. COLLINS. That is a hard question, because both of the 
number of genetic tests is expanding quickly and the cost is 
coming down so fast. At the present time, you could test a 
specific place in your DNA sequence and ask whether it is a 
letter T or a letter C for something in the neighborhood of 
less than 50 cents. But, of course, on top of that you have to 
have quality control and you have to have somebody who is going 
to sit down with you and spend health professional time going 
over the meaning of the result.
    So, I actually think it is not the cost of the test that is 
going to be limiting. It is going to be the other important 
aspects of that, as far as the delivery of that information, so 
that you can use it in a way that benefits your own health, 
instead of just giving you a laundry list that doesn't make 
sense.
    Chairman STARK. Thank you.
    Mr. Johnson, would you like to inquire?
    Mr. JOHNSON. Thank you, Mr. Chairman.
    You know, I appreciate the fact that people, including me, 
want their genetic information protected from the wrong eyes. 
This legislation that we are considering has a fairly broad 
definition of genetic information, including family history, 
which you say is important.
    Dr. COLLINS. Yes.
    Mr. JOHNSON. Do you think that is too much or not enough?
    Dr. COLLINS. I think it is actually quite critical to 
include family history. As you can see from this example, a 
family that I talked about, family history is often the trigger 
that initiates an examination that results in a genetic test 
being conducted.
    You can imagine if legislation covered only the results of 
a test but not the family history, then the amount of 
protection being offered would be quite limited and almost 
nonexistent in a situation such as this sort. After all, the 
insurance company or the employer might say, well, it wasn't 
the genetic test that caused me to decide to jack up the 
premiums or to pass over this person for a promotion; it was 
their family history. Unless family history is included in the 
definition of genetic information, then essentially this bill 
would be toothless.
    Some of the states have, I think, made that mistake and 
have bills that have genetic information that don't include 
family history.
    Mr. JOHNSON. Yes, but what percentage of the family 
history, what percentage of the time does it actually come true 
that they pick up this problem?
    Dr. COLLINS. Sure. Most of the time, family history is a 
clue but it is not certainly determinative of what is likely to 
happen.
    Mr. JOHNSON. Right. Right.
    Dr. COLLINS. Again, the point of the bill is to try to say 
if there is predictive information about somebody's likelihood 
of falling ill downstream, and they may well not fall ill 
downstream, that predictive information ought not to be used to 
take away their health insurance access or their access to a 
job. They ought to be judged on other----
    Mr. JOHNSON. I know. But our job is to try to keep the 
insurance companies from doing just what you said. How do you 
do that?
    Dr. COLLINS. The way this bill has been written, and it has 
been under construction now for many years in the many 
iterations that we have gone through over 12 years getting to 
this point----
    Mr. JOHNSON. I understand that, and that has been one of 
the problems we have had.
    Dr. COLLINS. I think it has carefully considered all the 
ways in which there might be loopholes to the protections that 
the public needs and expects and tried to cover those loopholes 
with things such as including the family history in the genetic 
information definition.
    Mr. JOHNSON. Well, but you made the statement also, I 
believe, that it requires several if not a whole bunch of 
people to figure out the family history. How do you keep all 
that information confidential?
    Dr. COLLINS. Again, it should not be confidential to the 
health care provider. Let us be clear, this bill, and it has 
some specific language in it that says this, should in no way 
be construed to interfere with the practice of medicine between 
the health care provider and the patient.
    What this is saying, in terms of the health insurance 
provisions is that the health insurance company may not request 
or require that kind of information. If they happen to obtain 
it, which they might very well in the process of reimbursement 
for services, they are not to use that information in a 
discriminatory way that would cause that person to lose access 
to health care.
    So, it is, I think, worded appropriately, so it doesn't get 
in the way of the delivery of medical care, because we all 
believe that ought to be better, not worse. But it puts in 
place protections against the misuse of the information in a 
discriminatory way.
    Mr. JOHNSON. I think our lawyers will like it.
    Thank you, Mr. Chairman.
    Chairman STARK. Mr. Thompson, would you like to inquire?
    Mr. THOMPSON. Thank you, Mr. Chairman.
    Could we talk a little bit about how the folks' concern 
that they may be subject to discrimination is affecting efforts 
in regard to research?
    Dr. COLLINS. Certainly. That is a very serious issue right 
now. This is not a hypothetical future risk. In fact, we have 
documented this over the course of more than 5 years.
    At NIH, we run many research protocols where it is part of 
the protocol to undergo a genetic test, whether it is for colon 
cancer, as in this situation, or breast cancer or diabetes or a 
variety of other conditions. Individuals are intensely 
interested in those research protocols, especially if they have 
a family history and they are wondering about their own future 
risk.
    We have documented that the most common reason why someone 
who is otherwise very interested and willing to join up to a 
research study decides to back away and that reason is genetic 
discrimination. Roughly a third of the people who would 
otherwise participate are now deciding not to, specifically 
because of this concern.
    As a physician, I can't sit across from somebody expressing 
that concern and tell them that their concerns are unwarranted. 
At the present time, without this legislation, they are 
actually, I think, looking at a serious risk. Even though we 
are very careful about how we keep the information 
confidential.
    This is permanent information. Once you have had a genetic 
test that shows something about your genome, that is going to 
be with you from now on. Without the assurance that it won't 
come back to bite you, some people just aren't willing to take 
the chance.
    Mr. THOMPSON. Are those data quantifiable, or is this 
anecdotal?
    Dr. COLLINS. They are quite quantifiable. So, I can submit 
for the record, three manuscripts that have been published that 
describe what those statistics look like. They all come up with 
this conclusion. It is about a third of individuals in these 
research studies who decide not to participate because of this 
specific fear.
    Mr. THOMPSON. Mr. Chairman, I would like to ask that those 
documents be submitted for the record. I think that that is 
very important. Because it sounds like if this bill were to 
pass, that would fix a lot of this problem.
    Dr. COLLINS. A huge sigh of relief would settle over the 
research community that we would no longer be in the 
embarrassing position of having to tell people that this is not 
a safe procedure to undergo. A huge sigh of relief would fall 
over some of the physicians who are currently in a position of 
having to advise patients with a high risk of breast cancer 
that if they are going to undergo

a BRCA1 test, they might want to do it under a false name. 
People are doing that right now.
    Mr. THOMPSON. Great. I think that is important.

    [The information follows: PENDING]

    Mr. THOMPSON. Then the other question I have is, if the 
bill were to pass, are there any things in this that we should 
be concerned about as far as it would impact prevention and 
wellness programs that are offered by some health plans?
    Dr. COLLINS. No, I don't believe that there is a concern 
there. Obviously, that was an issue in the drafting of this 
bill to be sure that we didn't discourage in any way wellness 
programs that employers----
    Mr. THOMPSON. You feel that that has been well protected?
    Dr. COLLINS. I believe that that has been very well 
protected by the way the bill has been written.
    Mr. THOMPSON. Thank you, Dr. Collins.
    I have no further questions, Mr. Chairman.
    Chairman STARK. Mr. English, would you like to inquire?
    Mr. ENGLISH. Thank you, Mr. Chairman, I would.
    Dr. Collins, welcome. We are delighted to have you here and 
I am particularly delighted to be an original cosponsor of 
Representative Slaughter's bill.
    Looking at the big picture, sir, can you tell us first of 
all what the current cost of a genetic test is? Second of all, 
if utilization increases, what likely impact is that going to 
have on the quality of genetic testing and its cost?
    Dr. COLLINS. So, currently the costs are all over the place 
in terms of a specific test. As I mentioned earlier, the actual 
cost of being able to go and look at DNA from an individual and 
say, do you have a T or a C in that position has dropped 
profoundly and is in the neighborhood of less than a dollar.
    But on top of that, there are many other costs that fit in, 
and I might mention that one of them is that some of these 
tests have been exclusively licensed to a single diagnostic 
company, which has tended to discourage competition, and so 
some of the tests have, in fact, remained more expensive than 
certainly on a technical basis you would expect they need to 
be. Including at least one that is up in the neighborhood of 
$3,500 for a genetic test.
    But those costs will be coming down, and will be coming 
down rather quickly, I think, as the number of tests grows and 
the ability to multiplex them increases.
    The wider availability of such tests, I think, would in 
fact drive costs down. It would certainly improve the 
possibilities of individualized prevention, something that we 
all hope and dream for. At the moment, if you are going to go 
to your physician and say, I think I want to practice better 
prevention, what should I do, you will get a sort of one-size-
fits-all prescription, maybe a little bit tweaked by your 
family history or your blood cholesterol, but not in an 
individual way that would be possible with this new kind of 
information.
    So, as we bring that more into the mainstream, I think that 
will have the potential of keeping all of us healthy for a 
longer period of time. Goodness knows, if we are going to 
sustain the costs of our health care system, we have to do a 
better job of focusing on wellness instead of treating far 
advanced disease.
    Mr. ENGLISH. Dr. Collins, that was going to be my next 
question. You know, assuming for a moment, I mean, there are a 
number of proposals out there for how to cure the health care 
system itself. But given the fact that most of them, I think, 
are grounded, whether they are based on a government model or a 
market model, most of them are grounded in achieving cost 
savings.
    How would a broader use of this sort of testing contribute 
substantially? Can you give us an example of a utilization of 
this test that is just now on the horizon that could have a 
significant impact on the cost of health care?
    Dr. COLLINS. My boss at the NIH, the NIH Director, Elias 
Zerhouni, is fond of pointing out the four P's of where we are 
going in terms of the practice of medicine, if we are going to 
drive down costs. That is personalized, preemptive, and 
predictive. All of those apply to what we are talking about 
here, as well as participatory, the fourth P; that is, getting 
everybody engaged in more attention to their own medical care.
    I can give you an example right now where costs have 
already been documented to be reduced. Interestingly it is the 
same condition that is diagramed there on the screen, a 
condition called hereditary nonpolyposis colon cancer. This 
affects something like one in 500 individuals in this country 
who will carry a misspelling in one of these genes that causes 
colon cancer and sometimes uterine cancer as well.
    We know that if we could identify those individuals, tell 
them of their risk, get each of them into a program of 
colonoscopy beginning at an early age, maybe age 35 instead of 
age 50, you can go through the calculations and they have even 
documented this now in real cases that have been followed for 
some time, that you will reduce substantially the downstream 
occurrence of metastatic colon cancer, which both costs 
productive years of someone's life and actually costs medical 
care dollars in great excess of what the colonoscopy would have 
cost. That is a published analysis that will tell you this is 
an approach that not only saves lives, it saves money.
    Mr. ENGLISH. Thank you, Doctor, and thank you, Mr. 
Chairman. I yield back the balance of my time.
    Chairman STARK. Mr. Becerra, would you like to inquire?
    Mr. BECERRA. Thank you, Mr. Chairman.
    Dr. Collins, thanks for being here with us. Let me ask a 
couple of questions regarding how far we extend the protection. 
I think most of us agree that we need to do more to protect 
individuals when it comes to the use of the information, 
genetic information. But we also want to make sure that because 
it is genetic information, it goes beyond just the individual 
but includes family members as well.
    How far do we extend that? At what point do you say that 
you can't protect the great-great grandchild of the person 
whose genetic information was taken?
    Dr. COLLINS. So, obviously, there is no bright line one can 
draw and say, well, family history is no longer relevant. When 
you get to that point, the way the bill has been written, it 
goes to the fourth degree relative, which is to say if you're 
talking about me, you could be talking about my mother, that 
would be one degree; my aunt, that would be two; my cousin, 
that would be three; my first cousin, once removed, that would 
be four. That is a bit of an arbitrary dividing line, but it 
seems nicely inclusive of where most of the major risks are 
going to reside.
    Mr. BECERRA. I think a number of folks would say that is 
going pretty far out, that first cousin once removed. At what 
point, are you stifling the ability to actually use information 
for valid purposes?
    Dr. COLLINS. I hope not at all. Again, the purpose of this 
bill is simply to say that that kind of genetic, predictive 
information ought not to be used by a health insurance company, 
particularly in the individual underwriting market, or by an 
employer to make decisions that would discriminate against that 
individual.
    But it is, I hope, absolutely clear that this in no way is 
intended to inhibit an interaction between a health care 
provider and their patient, trying to assess what is best for 
them as far as preventive care that is going to keep them 
healthy.
    With regard to this fourth degree relative, again, just 
look at this family that is up there on the screen. While I 
won't try to count through all the relationships, there are 
certainly people in that family who are at high risk for colon 
cancer who are fourth degree relatives of other people with 
colon cancer, because it has really traveled through that 
family in a very devastating way.
    Mr. BECERRA. Because this is science, this isn't two dice 
that we are rolling on a table, we feel pretty comfortable that 
we can make these predictions that we need that type of 
protection for purposes of nondiscrimination, because it is 
based on hard numbers and available data?
    Dr. COLLINS. It will be based on hard numbers in the sense 
that you can make a prediction statistically based on 
somebody's position in the family and what you have learned 
about their DNA sequence, what their likelihood is of falling 
ill. But I should be clear about this.
    Most of the genetic tests that are going to find their way 
into the mainstream of medicine in the next three or four or 5 
years will not be yes/no; they will be, well, your risk is 
threefold higher of getting diabetes than somebody else. Or 
your risk of getting prostate cancer is threefold lower than 
somebody else. But you could still get it.
    The idea here, though, is to be able to optimize where you 
pay your highest level of attention as far as your own 
prevention, instead of having everybody do the same thing, 
which is what we have largely been doing before. But most of 
these tests are not going to be deterministic; they are going 
to be predisposing.
    Mr. BECERRA. I have one last question, Mr. Chairman, and 
Dr. Collins this is going to take you somewhat off base, so 
ratchet your brain a bit, because this is a different question. 
It still relates to genetic information.
    I would like you to give me your thoughts, and if you can't 
give me too much right now, I would love to chat with you later 
on about this.
    Right now, we are talking about not misusing this 
information, not taking it beyond the health care arena to make 
decisions. I have a concern that we are seeing more and more 
genetic information being withheld because of the ability to 
patent genetic information, genes, and therefore keep it out of 
the public domain unless you are able to pay the high price to 
get the information.
    I know that is not necessarily the subject of this hearing, 
but I am wondering if you have any thoughts about the whole 
issue of patenting genes and genetic information?
    Dr. COLLINS. Thank you, Mr. Congressman. Yes, I have a lot 
of thoughts about that and if we had more time, I am sure we 
could dig deeply into that. I am aware of the bill that you and 
Mr. Weldon have recently introduced on the topic of gene 
patenting.
    This has been a subject of intense interest from the Genome 
Project's perspective. One of the things that we did to try to 
defuse what was a bit of a gold rush toward claiming parts of 
the human genome was to put all of the information that we 
derived on the Internet every 24 hours, basically making it 
prior art and therefore less likely to have IP claims upon it. 
But, of course, a lot of genes did get claimed anyway.
    The NIH has worked hard, I think, to put out guidelines on 
this topic. I would particularly want to refer to the 
guidelines on research tools and also the guidelines on 
licensing of genetic discoveries because it is not just 
patenting, it is licensing that often either creates a good or 
a bad situation.
    I think we make a mistake, though, when we think of 
patenting of genes as a moral issue. I think it is really a 
legal question. The real deciding question ought to be, is this 
benefiting the public or not? Because clearly there are 
instances in which a patent benefits the public by providing 
the kind of impetus for developing a product that the public 
needs.
    One can cite the example of erithropoetin, for instance, as 
a very valuable pharmaceutical and those who developed that 
would tell you that a patent on the gene was essential from 
their perspective to invest the hundreds of millions of dollars 
that it took to get that drug to market. But is it reasonable 
to patent a gene where there is no therapeutic sort of pathway 
that is apparent? Many of us would say, no.
    In more than 10 years of working on this issue, it 
shareholder become clear to me that it is extremely nuanced and 
there is no sort of straightforward, easy answer to the kind of 
important question that you have just asked.
    I actually think, compared to where we were 10 years ago, 
there is a lot more sensibility out there. But we are living 
with the legacy of a lot of patents that were issued in the 
course of the last 10 years that, in retrospect, may not have 
necessarily been good for the public. How we sift through that 
thicket and try to continue to make progress is providing a bit 
of a challenge.
    I am getting on a plane in about 3 hours to go to Europe to 
talk about an international project to try to inactivate every 
single one of the genes in the mouse, the mouse being our most 
important laboratory model. The biggest thing that is getting 
in our way is the thicket of patents about the technologies 
that have been developed to do this. It is actually creating 
quite a major headache. In retrospect, some of us wish that 
people had not been so quick to rush out there and claim those 
discoveries.
    Mr. BECERRA. Thank you for the answer.
    I yield back, Mr. Chairman.
    Chairman STARK. Mr. Camp.
    Mr. CAMP. Thank you, Mr. Chairman.
    Dr. Collins, good to see you again. I am sorry, I apologize 
for being late to the hearing.
    I appreciate your testimony, and obviously, this 
legislation has a lot of bipartisan support. It passed 
Education and Workforce with a voice vote. The idea of 
restricting insurers' use of genetic information or employers, 
for purposes to either deny people coverage or deny them 
employment is something that nobody wants to see happen.
    But I have a question. You mentioned in response to a 
question that, obviously, having a health care provider and 
patient could be very, very helpful. The question I have is, if 
an individual has this information and needs extra cancer 
screenings or blood tests, their insurer is going to know 
because they are going to have something out of the norm.
    How do we safeguard using genetic information for positive 
reasons and also preventing it being used for the bad reasons?
    Dr. COLLINS. So, the drafting of this legislation very much 
seems to take that into very serious account in trying to get 
the balance right. Because, clearly, you don't want to 
discourage the use of what could be highly valuable information 
because something in this legislation seems to imply that it is 
improper.
    Again, there is nothing in the legislation to say that a 
health insurer who learns about genetic information of one of 
the people that they cover is in trouble, as long as they did 
not request or require this and as long as they do not use this 
in a way to discriminate. But, clearly, they are going to 
obtain this information.
    Employers may, by accident, obtain this information. There 
is clear language in here to say there is a safe harbor if this 
is genuinely something that was dug out improperly, that there 
is no culpability on the part of the employer for that.
    I guess I take particular comfort in the language here, the 
rule of construction, which says, and I am quoting here: 
Nothing shall be construed to limit the authority of a health 
care professional who is providing health care services with 
respect to an individual to request that such individual or 
family member of such individual undergo a genetic test.
    So, they are trying very hard, I think, to make it clear 
what the goal is and what the goal is not. I think the way this 
is couched would accomplish that goal of encouraging the use of 
genetic medicine without allowing the discriminatory use, which 
will cause the public to stay away from it.
    Mr. CAMP. As well, you're correct, not only will insurers 
get that information, but any employer will have copies of 
those insurance claims, they are going to have knowledge of any 
special test in the future that may be required because of a 
propensity for some kind of illness found out as a result of 
genetic testing.
    Dr. COLLINS. Again, I think the bill makes it clear that 
employers who obtain that information as part of the routine 
practice of--the fact that they are responsible for health 
coverage for many of their employees are not held responsible 
for that. That is not considered a violation.
    It is considered a violation, on the other hand, if they 
require it or in other way put pressure upon the employee to go 
through a test that the employee was not planning to undertake.
    Mr. CAMP. You also indicate in your testimony that if 
safeguards are not put into law, there could be not as many 
advances in scientific research in this area.
    Dr. COLLINS. Yes.
    Mr. CAMP. That you are finding some research participants 
are concerned the information that may be found will be used 
against them?
    Dr. COLLINS. Yes, and there are well documented examples of 
that.
    Mr. CAMP. Is there any indication that some people just 
don't want to know what their genetic information is?
    Dr. COLLINS. That is certainly true. In particular, in a 
circumstance, of course, where there is nothing you can do 
about it, genetic tests can predict your propensity for future 
illness. People are particularly interested if that is then 
tied to an action they can take to reduce that risk. In fact, 
it is that kind of study that we are primarily conducting at 
NIH where there is a potential intervention. Most people want 
that information.
    The kind where you can't do anything about it, there are 
some research studies of that sort. Certainly some people 
decline simply because that is not information they want.
    Mr. CAMP. Just finally, I see my time is about to expire, 
but can you quantify the amount of research that might go 
forward if these safeguards are put in place? Is that possible 
to do?
    Dr. COLLINS. In a certain sense, that we can already tell 
you that studies that offer people genetic information as part 
of the research protocol, a third roughly--and this has been 
true of several different studies--of the people who are 
offered the possibility of participating and who say they want 
to, basically then walk away because of their fear of genetic 
discrimination.
    So, we would increase the participation overnight if we 
could assure people that that is no longer a risk. My hope is, 
it won't be long before we can do that.
    Mr. CAMP. All right. Thank you very much again. Thanks for 
your testimony.
    Dr. COLLINS. Thank you.
    Chairman STARK. Ms. Tubbs Jones, would you like to inquire?
    Ms. TUBBS JONES. Thank you, Mr. Chairman.
    Good afternoon, Doc. How are you?
    Dr. COLLINS. Good afternoon. Just fine.
    Ms. TUBBS JONES. Good. My predecessor, the Honorable 
Congressman Louis Stokes, has a building named after him at 
NIH.
    Dr. COLLINS. My laboratory is in that building.
    Ms. TUBBS JONES. It is in that very building? I thought 
that it might be.
    I want to speak to you about health disparities and the 
impact that genetic testing could well have on the high rate of 
health disparity among African Americans and people in the 
majority in the country.
    Tell me your impression as to whether this will assist in 
relieving us of disparities or perhaps elevate some of the 
disparities.
    Dr. COLLINS. It is a very important question, and one that 
many of us have been wrestling with in terms of the most 
effective way to get the answers to the causes of health 
disparities, which we know continue and are vexing and 
troubling and do not show signs of going away any time soon.
    Obviously, when you see a circumstance where a particular 
group is experiencing a higher rate of an illness or a more 
severe form of the illness, there are many reasons why that 
might be. Certainly access to health care often turns out to be 
a very significant one, as do other environmental circumstances 
such as diet, such as cultural practices. But, of course, 
genetics is always in there as a possible contributor.
    We don't know in most instances whether it is an important 
contributor or not. Until we find out, it is hard to come up 
with a good prescription of how it is we can close these gaps 
as far as experiences of good health.
    I will tell you one example. Prostate cancer. We have known 
for a long time that prostate cancer runs in families. We also 
know that prostate cancer tends to afflict African American 
males at a substantially higher rate and oftentimes at an 
earlier age. The question has been, what is that about?
    Within the last year, there has been a discovery of a major 
gene that seems to be involved in prostate cancer risk, 
initially discovered in Europeans and subsequently, in a very 
careful study of African Americans, it looks as if it may be 
even more important in that group. So, in this one instance, we 
might have a clue that at least part of that health disparity 
ties into this particular genetic factor.
    Now, that could be extremely useful to know in the sense 
that that genetic factor may predict a bit about how to follow 
those individuals and what kind of intervention might work. 
Instead of the one size fits all, well, you know, you should go 
to the doctor, you should have your PSA, maybe, maybe not, 
depending on who you ask. Now, finally, we are going to have 
more of a bright light shining on the cause of this illness. 
What I am saying for prostate cancer is now being attempted for 
diabetes, another disease of major health disparity.
    Ms. TUBBS JONES. The true dilemma is that, historically, 
African Americans have been reluctant to participate in any 
type of research based on their experiences of discrimination 
in research in health care.
    Dr. COLLINS. Understandably.
    Ms. TUBBS JONES. To add to that, the genetic testing 
presents another level of concern.
    I also am smiling because I am sitting here thinking about 
the fact that Reverend Sharpton has now learned that he is 
related to Strom Thurmond. I guess Strom is turning over in his 
grave, but just to think about the connection between--for 
majority and minority in terms of that.
    But I really want to go back and focus--that was kind of a 
lightness in what I was talking about. But the reality is that 
discrimination, which may appear to be or a policy which maybe 
appear to be neutral on its face can have a discriminatory 
impact. That is why in litigation with regard to 
discrimination, we look to not only whether it is neutral on 
its face but whether it has a discriminatory impact.
    I am just saying to you, based on my experiences in that 
and the fact that I am African American and represent a large 
population, and I know I speak on behalf of the Congressional 
Black Caucus on this issue, that as we walk down this road, we 
need to be particularly concerned about the impact that this 
could have on not only African Americans but other minorities 
in our country about access to health care and research and the 
like.
    I thank you for your response. I think that we have an 
opportunity to really make a significant impact. But I am just 
trying to back up and say, pay close attention.
    Dr. COLLINS. I am totally with you. I agree that is an 
issue that we ought to have at the top of our agenda as we see 
how personalized medicine begins to become a reality.
    My hope would be that this bill, which takes genetic 
information off the table in important decisions about 
employment and health insurance, will be a step in the right 
direction.
    Ms. TUBBS JONES. Because it looks like possibly--and Mr. 
Chairman I know I am over time and I am almost done--that as we 
provide health care to all Americans, the worry is that there 
will be those who will cherry pick the most healthy people and 
leave the people who need the most health care out in a pocket 
by themselves, which makes their health care so much more 
expensive.
    I am hoping that, as we go down the genetic trail, we don't 
give people who want to discriminate another opportunity.
    Dr. COLLINS. I completely agree we you. At the moment, they 
have that opportunity in certain loopholes. This bill aims to 
plug those.
    Ms. TUBBS JONES. Thank you, Mr. Chairman. Thank you, Doc.
    Chairman STARK. Thank you.
    Mr. Emanuel.
    Mr. EMANUEL. Mr. Chairman, thank you.
    Dr. Collins, I will try not to make you late for your 
flight to Europe here.
    Pretty much a lot of the other questions I was going to ask 
have been asked. So, if I could just narrow it down to just one 
particular subject, and that would be the overlap between the 
research you are talking about, genetic code, genetic 
information, and the area of medical records.
    I am hoping our full Committee and this Subcommittee will 
deal with the issue of medical records, electronic medical 
records, and how do we want to do something over here and 
something over here and the two aren't either complimentary or 
cognizant of each other.
    So it is not a specific question, how do you protect 
genetic information. But it is a specific question. If you 
could look forward, what guidance would you give to us? As I do 
think we have to deal with medical records, electronic medical 
records that is. What information would you impugn to us or 
give to us so we do that right, so that we can accomplish both 
goals?
    Dr. COLLINS. That is a great question and one that many of 
us----
    Mr. EMANUEL. I will make sure my staff know, since they 
thought about it.
    Dr. COLLINS [continuing]. Many of us are thinking about 
exactly that, and certainly Secretary Leavitt is both extremely 
persuasive about the need to hurry up here with electronic 
health records and also very committed to this idea of 
personalized medicine. So, this is being discussed at a very 
high level in the Department of Health and Human Services.
    That includes, by the way, a serious discussion about how 
we should take genetic information that is going to find its 
way into these electronic records and standardize it so that 
you could actually make some sense out of it when you are 
trying to compare across different databases.
    For me, as a researcher, the chance that over the course of 
the next few years we might be able to learn an awful lot more 
about the interaction between genes and the environment will 
mean that we need to have standard ways of keeping track of 
both environmental exposures and genetic information in an 
electronic form.
    I think actually these things dovetail quite nicely. 
Because the fact that you are trying to develop an electronic 
health record with a standardized way of incorporating genetic 
information provides you the opportunity to put it into a field 
that is appropriately labeled so there will be no ambiguity 
here about whether this is something which ought to be 
protected by this particular nondiscrimination bill.
    As opposed to the current rather messy medical records 
system, where you might have to sift through many pages of 
hand-scribbled notes to even be quite sure what is in there 
that ought not to be used by a health insurance company in 
doing individual policy underwriting.
    So, my hope would be that if we have a system that can 
actually better incorporate and better label the information 
about each of us in our medical care, that will facilitate the 
process of avoiding the kind of discriminatory actions that 
otherwise could happen.
    Mr. EMANUEL. Mr. Chairman, I don't have any other 
questions. I do think that as we look at the notion of 
electronic medical IT, electronic medical records, this 
information, I think, will be very important in guiding us as 
we start to develop that piece of legislation, which I know has 
been a priority for you and something we discussed in the last 
congress.
    Chairman STARK. Thank you.
    Mr. Pomeroy, would you inquire?
    Mr. POMEROY. Thank you, Mr. Chairman. I have no questions. 
I just commend Dr. Collins for the wonderful presentation he 
gave the National Prayer Breakfast. I completely enjoyed it. I 
wish you had brought your guitar today; maybe you could have 
regaled some of this testimony in song. But you did a wonderful 
job and I have also enjoyed the testimony. I have no questions 
to add to it.
    Thank you.
    Dr. COLLINS. Thank you.
    Chairman STARK. Thank you. Have a safe trip. Don't forget 
your passport.
    Dr. COLLINS. I won't get very far if I do.
    Thank you all very much.
    Chairman STARK. Thank you, Doctor.
    We will now have a panel inform us about various aspects of 
this issue. Ms. Karen Pollitz, who is the project director at 
Georgetown University Health Policy Institute; Ms. Sharon 
Terry, who is the president and CEO of the Genetic Alliance; 
Mr. David Escher, formerly in the employ of the Burlington 
Northern of Reno, Nevada, and Dr. William Corwin, the Medical 
Director of Clinical Policy, the Harvard Pilgrim Health Care 
service on behalf of America's Health Insurance Plans.
    Why don't I ask you to testify in the order in which I 
called you.
    So, Karen, welcome back to the Committee. Why don't you 
proceed to enlighten us any way you would like.

   STATEMENT OF KAREN POLLITZ, PROJECT DIRECTOR, GEORGETOWN 
               UNIVERSITY HEALTH POLICY INSTITUTE

    Ms. POLLITZ. Thank you, Mr. Chairman, Mr. Camp, Members of 
the Subcommittee. I am Karen Pollitz, and I direct research on 
private health insurance at Georgetown University's Health 
Policy Institute. I am pleased to testify today about genetic 
discrimination in health insurance and about H.R. 493, also 
known as GINA, which would prohibit it.
    Congress and the states have already taken some steps to 
end genetic discrimination in health insurance but work remains 
to be done. For example, with HIPAA in 1996, Congress 
prohibited insurance companies in the small group market from 
denying coverage to any small employer based on any health 
status reason, including genetic information. HIPAA also 
limited the imposition of preexisting condition exclusion 
periods in all group health plans and prohibited pre-ex based 
on genetic information in all group health plans.
    However, HIPAA did not set any limits on what employer 
groups can be charged in terms of premiums based on the health 
status of members of the group.
    Congress has also limited medical underwriting in Medigap 
or Medicare supplemental insurance. Seniors who apply for 
Medigap policy within the first 6 months of Medicare 
eligibility cannot be turned down or charged more based on 
their health status.
    After this open enrollment period, however, seniors may 
face medical underwriting in the Medigap market. Federal law 
protections also do not apply to disabled beneficiaries under 
the age of 65, although more than 20 states do limit medical 
underwriting by Medigap insurers for these individuals.
    In the past, critics have questioned the need for Federal 
law prohibition of genetic discrimination in health insurance 
arguing that very few such instances of problems have yet been 
documented. However, it is important to remember, as Dr. 
Collins just said, that very few individuals have undergone 
genetic testing to date.
    For example, since genetic testing for hereditary breast 
and ovarian cancer became clinically available via the BRCA1 
and 2 tests in the mid-nineties, 75,000 individuals have been 
tested through the commercial lab that holds the patent on 
these genes and approximately 9,000 have received a positive 
test result. So, there aren't that many people yet to be 
discriminated against.
    My colleagues at Georgetown and I recently completed a 
study on individual health insurance market underwriting 
practices with respect to genetic information. We asked 23 
individual health insurance companies to medically underwrite 
hypothetical applicants.
    Four pairs of applicants were presented. Within each pair, 
one applicant had received a positive genetic test result 
indicating higher risk of future disease. In seven instances, 
five of these 23 responding medical underwriters said they 
would take an adverse action based on genetic information. They 
would turn the applicant down, charge them more, or permanently 
exclude coverage for their preexisting condition, which was the 
genetic information.
    We also asked underwriters what action they would take 
based on an applicant's receipt of genetic services, which is 
mentioned in GINA. Specifically, we asked them to consider an 
applicant with a BRCA1 mutation whose doctor had discussed or 
recommended preventive surgery to reduce her future risk of 
cancer. Thirteen underwriters responded to this question. Of 
those, five said that they would take an adverse action based 
on even a discussion of risk reduction options and 10 of 13 
said they would take an adverse action if the doctor had 
recommended an intervention to reduce risk.
    Our research findings confirm that patient fears about 
genetic discrimination in health insurance are not unfounded. A 
Federal law prohibition on medical underwriting based on 
genetic information in all types of health insurance is 
reasonable and good public policy.
    Finally, Mr. Chairman, I would just note there was 
discussion earlier today and concern has been raised at prior 
hearings that H.R. 493 would prevent insurers from using 
genetic information for medical appropriateness review of 
claims. It does not.
    Current law, health privacy rules, expressly permit the use 
of personal health information including genetic information 
for medical appropriateness reviews and H.R. 493 does not 
disturb that authority. The bill does prohibit insurers from 
requiring an individual to undergo a genetic test. That's 
different. The decision to undergo a test is very personal and 
impacts not only the patient but potentially members of their 
family. As you heard Dr. Collins say, some people don't want to 
have the test. So, that decision under the bill rests with the 
patient.
    But once a patient has undergone testing, the information 
about the results of that test can be available for appropriate 
uses by insurers.
    Thank you very much for your time today.
    [The prepared statement of Ms. Pollitz follows.]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Chairman STARK. Thank you.
    Ms. Terry, would you like to proceed?

  STATEMENT OF SHARON F. TERRY, PRESIDENT AND CHIEF EXECUTIVE 
                   OFFICER, GENETIC ALLIANCE

    Ms. TERRY. Chairman Stark, Representative Camp, and Members 
of the Subcommittee, thank you for the opportunity to testify 
here. Representative Slaughter, Biggert, Eshoo and Walden 
demonstrate robust vision and courage to introduce again the 
legislation that will make it possible for Americans to benefit 
from new genetic tests and technologies.
    My name is Sharon Terry, and I am the president and CEO of 
Genetic Alliance, which is a coalition of more than 600 disease 
support groups. Mine is not a chosen profession, I have been 
assigned it, since my two children have a rare genetic disease 
for which there is no treatment and I long for the day that we 
can have many people enter research.
    I am also the chair of the Coalition of Genetic Fairness 
and I have worked on this legislation for 12 years myself, 
since Chairwoman 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 
members from every sector of society, disease support groups, 
health professional organizations, women's leadership groups, 
labor groups, academic, and most significantly companies like 
Affymetrix, IBM and Twentieth Century Fox. We have compromised 
and conceded a great deal during these years and I believe that 
the bill before you is fair and well balanced.
    Many Americans fear that genetic information may be used by 
insurers and employers to deny, limit or cancel their health 
insurance and/or to discriminate against them in the workplace. 
As more genetic tests become available, there is real concern 
that this genetic discrimination will increase. More than 40 
states have enacted legislation on discrimination and more than 
30 states have enacted it in the workplace health insurance in 
the first case.
    Despite the presence of these state laws, only 
comprehensive Federal legislation can guarantee that everyone 
in the United States will be protected. This legislation will 
prohibit the use of genetic information as a basis of charging 
more for health insurance, limit the collection of genetic 
information by employers and insurance, limit the disclosure of 
genetic information by employers and insurers and apply to 
individual health insurers except if covered by the portability 
provision.
    In 1997, following a number of papers, some by Dr. Collins 
and others, and symposia calling attention to genetic 
discrimination, Chairwoman Slaughter and Senator Snowe 
introduced companion bills in the House and Senate. Over the 
next few years, there were several senate hearings, 
reintroduction of the bill in both chambers.
    President Clinton first endorsed the legislation and then 
signed an executive order to prohibit discrimination. Meanwhile 
the Secretary's Advisory Committee on then Genetic Testing and 
the Coalition for Genetic Fairness among other bodies called 
for the passage of the legislation.
    In 2000, Dave Escher and others experienced discrimination, 
which he will tell you about after me.
    At the start of the 108th Congress, the bill was radically 
overhauled. We, the proponents of the legislation, were told 
that if we could give up the strong protections and remedies in 
the bill, it would move. The new bill narrowed the definition 
of genetic information, specifically excluding protections for 
genetic tests related to manifest disease. In addition, it 
required claimants to exhaust administrative state and Federal 
EEOC procedures before seeking court damage and limit the 
amount of punitive damages that can be awarded.
    The new compromise version, heavily compromised, passed the 
U.S. Senate in 2003 by a vote of 95 to zero but was never taken 
up in the House.
    In the 109th Congress, the Genetic Nondiscrimination Act of 
2005 passed 98 to nothing in the Senate. It was introduced 
again in the House in March of that year and the bill was 
referred to the three Committees, yours being one. It saw no 
action. President Bush released a statement of administrative 
policy supporting the legislation twice.
    The bill has again, this Congress, 110th, been introduced 
in both chambers. The Senate Committee on Health, Education, 
Labor and Pensions has approved it and the Senate will bring it 
to the floor for a vote soon. As you know, the other two 
Committees of jurisdiction here, and yours, have taken swift 
action which we appreciate.
    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 families, their 
jobs, their insurance. Men, women and children, families from 
communities all across this country have told us their stories 
and in some cases pleaded for us to help them.
    In 2003, Heidi Williams of Kentucky suffered discrimination 
when her children were denied health insurance from Humana 
because they are carriers of alpha-1 antitrypsin deficiency. 
Her third grade daughter wrote to her representative here in 
the house: Please help my mom stop people from treating others 
unfairly.
    Aren't health and disease enough to worry about? We cannot 
afford to also worry about discrimination based on our 
mutations, silent mutations with no signs or symptoms. This is 
simply about preventing the misuse of genetic information.
    This is also about special interests. Let us put the 
special interest of all Americans above all else. Every one of 
you and each of your loved ones is at risk for some disease. We 
cannot yet easily reduce that risk, as Dr. Collins has said, 
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 it was elucidated. I have faith that you 
will relieve our burdens, your burdens, all our burdens, and I 
look forward to your good work. Thank you.
    [The prepared statement of Ms. Terry follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Chairman STARK. Thank you, Ms. Terry.
    Mr. Escher, would you like to tell us about your 
experiences, please?

            STATEMENT OF DAVID ESCHER, RENO, NEVADA

    Mr. ESCHER. Yes. Thank you. My name is Dave Escher. I am 53 
years old, and I had been employed by Burlington Northern Santa 
Fe Railroad for over 26 years, as well as a member of the 
Brotherhood of Maintenance of Way during that time.
    I was born and raised in Herndon, Kansas, a small 
northwestern town in Kansas, with a population of 200 people. I 
graduated from high school in 1972 and began my career with 
Burlington Northern in 1976 and had that career abruptly end in 
2002.
    I married my wife, Deb, in 1986. I have three daughters, 
Kelsey, Kara and Kristyn. We now live in Reno, Nevada, after 
relocating three-and-a-half years ago from McCook, Nebraska.
    My jobs within the company during that 26 years included 
such positions as laborer, truck driver, assistant foreman, 
machine operator and foreman. I was appointed to the Division 
Safety Committee and continued to serve on that Committee for 
over 12 years. I held such positions as maintenance of way 
representative, vice Chairman, and safety and health 
facilitator up to the time of my departure from the company.
    I was also selected as the McCook Division Safety Employee 
of the Year in 1994. I had always had a great working 
relationship with all my coworkers as well as those in upper 
management levels.
    Prior to my departure from the company, I began 
experiencing numbness, pain, and tingling sensations in my 
right hand. When the numbness began to move through my hand and 
up into my arm and upper bicep, I went to see a doctor, who 
referred me to a specialist. It was determined that I had 
developed work-related carpal tunnel syndrome, for which 
surgery was necessary.
    After meeting with the operating surgeon, I received a 
letter from corporate headquarters stating that they were not 
satisfied with the initial test results and that they required 
further testing. In a subsequent visit to a neurologist, I once 
again had my hands X-rayed and another nerve conductor study 
was performed. The results again confirmed that I had carpal 
tunnel syndrome and that surgery was required and that the 
condition was work-related.
    Within 3 weeks of surgery, I received another letter from 
management demanding that I undergo more extensive testing and 
that an appointment was already set for me. Included in this 
letter was the requirement of a safety rule S-26.3, which gives 
the medical department the authority to require an employee to 
meet all requirements set forth by the medical department and 
that everyone must comply with these instructions or face the 
consequences of disciplinary action for being an insubordinate 
employee.
    After receiving this letter, I immediately contacted the 
company medical case manager with whom I had been dealing and I 
reminded her that I had already seen four medical 
professionals, undergone two nerve conductor studies, had 
received six separate X-rays of each hand, and now the company 
was demanding that I see yet a fifth doctor and undergo yet 
another nerve conductor study, with more X-rays. When I pressed 
for an explanation, I was told that as far as she understood, 
more information concerning my medical condition was needed.
    I went to the appointment as I had been ordered. During the 
procedure, seven vials of my blood were extracted, and the 
doctor once again confirmed that I did suffer the effects of 
carpal tunnel syndrome and that the condition is work-related.
    In a matter of a few days, I would learn from a co-worker 
who had refused to submit to that same order, and who also had 
been diagnosed with carpal tunnel syndrome, that I had been 
subjected to a genetics test through the blood which had been 
taken from me at that clinic. This was done without my 
knowledge and without my consent.
    I found myself in a state of disbelief and humiliation. I 
could not believe or accept what had just occurred. I 
experienced stages of denial, disbelief, depression. I felt 
totally violated and devalued as a person. I had just been used 
as a laboratory rat in a carefully devised scheme where my 
employer would benefit greatly by trying to prove that carpal 
tunnel syndrome was a genetic disorder rather than a work 
environment-related condition. They could relieve themselves of 
all the financial obligations to their employees who suffer 
work-related injuries within the workplace.
    This was a very difficult concept for me to accept. My 
attitude toward the company became very negative. My moods of 
anger and depression resulting from the constant stress and 
uncertainty of my job situation affected my family, as well. I 
became despondent to the needs and the concerns of my wife and 
daughters as I tried to work through this seemingly 
uncomfortable and endless situation.
    I was also fearful of the fact that no one could tell me 
where all the vials of my blood had been dispersed. What 
information was being learned about me, who was going to 
receive this information, and how it could be used to 
discriminate against not only myself but my family when they go 
out into the workplace? The constant worries, where would I go 
to find another job at this point in my life, and would I be 
able to obtain insurance for my family, seemed to me 
insurmountable. It was a very trying time in my life.
    One of the most heart-wrenching moments occurred when my 
little seven-year-old daughter Kristyn began crying one night 
because she was scared her dad was going to lose his job and 
her little world would be turned upside down. How do you 
explain to a young child that you could lose your job not 
because of what you have done but because of what your employer 
has done to you?
    I feel that this new science of genetic information is a 
great asset when left in responsible hands. But it can also be 
very devastating when put into the hands of the wrong people.
    I am fearful of the power that corporations, including 
insurance companies, would have if they were allowed to subject 
their employees and policyholders to genetic testing and then 
make decisions based on what is learned in those tests.
    We have laws to protect us from people wiretapping our 
phone, stealing our mail and defrauding our bank account. How 
can we allow employers to steal the blood of their employees 
and use it to discriminate through the predispositions 
discovered through the information learned from the genetic 
studies?
    It is my personal belief that individuals are hired on the 
basis of their abilities and their capability to do the job, 
not on the basis of their genetic makeup or their genetic 
history.
    It has now been 5 years since I had the opportunity to 
testify before the Health, Education, Labor and Pension 
Committee in regard to genetic testing. To this day, I have 
never received confirmation of what happened with the five 
vials of blood taken from me. I have been denied health 
insurance since I am on a railroad occupational disability, and 
there are still no laws protecting individuals from an employer 
demanding an employee be genetically tested.
    There have been many important events that have occurred in 
this time period, most notably 9/11 and the aftermath which 
followed. As important an event that this has been in our 
Nation's history, I still strongly believe that the need for 
the passage of legislation that protects all Americans from 
genetic discrimination is as important today as it was 5 years 
ago.
    Mr. Chairman, through the tactics of deception, 
intimidation, lying and stealing, the company to which I had 
given 26 years of my life took from me something they can never 
give back, and that is the very essence of my being, my genetic 
makeup.
    In conclusion, if employers, insurance companies, and the 
like are able to have this type of power and control over their 
employees and clients, then who will be able to have a job or 
affordable insurance, if any insurance at all?
    I thank the Committee for the opportunity to testify and I 
urge enactment on legislation to protect American citizens from 
genetic discrimination. Thank you.
    [The prepared statement of Mr. Escher follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Chairman STARK. Thank you very much.
    Dr. Corwin . . .

STATEMENT OF WILLIAM CORWIN, MEDICAL DIRECTOR, CLINICAL POLICY, 
 HARVARD PILGRIM CARE, ON BEHALF OF AMERICA'S HEALTH INSURANCE 
                             PLANS

    Dr. CORWIN. Thank you, Mr. Chairman, Mr. Camp, Members of 
the Subcommittee. My name is Dr. William Corwin. I'm a 
physician, a medical director for clinical policy at 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 number one health plan 
in America for three consecutive years, 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 representing nearly 1,300 health insurance plans, 
providing coverage for more than 200 million Americans.
    Health insurance plans work on a daily basis to promote 
appropriate use of medical and genetic tests, to help 
clinicians and patients make informed health care decisions and 
improve health outcomes. We agree with the sponsors of H.R. 493 
that health care consumers should not face discrimination on 
the basis of their genetic makeup and that genetic makeup 
should be protected from unauthorized disclosure. Our policies 
and programs reflect this belief.
    We have submitted written testimony that focuses on three 
broad areas. First, examples of how health insurance plans are 
promoting the appropriate use of genetic tests to improve 
patient care. Second, opportunities for improving H.R. 493. 
Third, our support for strong protection with respect to 
nondiscrimination in the confidentiality of genetic 
information.
    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 enrollees receive the highest 
quality evidence-based care possible. I also will briefly 
comment on H.R. 493.
    Through early detection, disease management programs and 
other improvement initiatives, we are working to identify 
individuals who can benefit from early intervention and the 
evidence based treatments for specific illnesses and diseases. 
Genetic information including the results of genetic tests is 
just one more very sophisticated source of data that clinicians 
and health insurance plans are using to ensure that patients 
receive appropriate preventive care, coordination of services 
and very early treatment for their medical conditions.
    I would like to highlight two specific examples of how 
genetic tests are being used to improve patient care.
    In February of this year, in 2007, the Food and Drug 
Administration approved a new genetic test called MammaPrint, 
which indicates whether a woman with breast cancer is likely to 
have a relapse. This test allows physicians to tailor therapy 
for individual patients, as Dr. Collins mentioned, 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 
should not be subjected to risky and costly treatment.
    Another test, the Cytochrome P450 enzyme, 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 medications, adjust the doses 
intelligently, and avoid any of the potential adverse drug 
reactions in patients who either metabolize a drug too quickly 
or do not metabolize this drug at all. 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 or treatment 
to ensure the appropriate evidence-based care is being provided 
to meet the patient's individual needs.
    Health insurance plans are also using genetic test results 
to promote preventive screening and disease management 
programs. These programs can help to improve health care 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 a gene for the familial form 
of colorectal cancer, as we heard described earlier, can 
receive coverage for more frequent preventive screenings.
    As scientists acquire a greater understanding of the role 
that genes play in disease and develop more targeted therapies, 
more targeted treatments and possibly even cures, preventive 
screening and disease management programs can be tailored to 
improve the outcomes for these individuals. These therapies 
will become even more important in the future.
    We appreciate the interest many Subcommittee Members have 
shown in passing additional legislation addressing 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 ensure that new legislation does not 
unnecessarily restrict the use of information needed to promote 
appropriate health care decisionmaking.
    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 ensure 
appropriate coverage decisions and design targeted disease 
management programs to improve the quality of patient care.
    We do not oppose the bill and 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, the Health 
Insurance Plans would like to encourage the Subcommittee 
Members to ensure that the statutory language clearly reflects 
your intent for enacting this legislation.
    In conclusion, I want to emphasize that the Health 
Insurance Plans are strongly committed to ensuring that genetic 
information is used to help clinicians and patients make 
informed health care decisions, at the same time maintaining 
strong protections in the area of nondiscrimination and 
confidentiality.
    We appreciate the opportunity to testify, and I am open to 
questions. Thank you very much.
    [The prepared statement of Dr. Corwin follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Chairman STARK. I want to thank all of you. My assumption 
is that the first three witnesses are in support of the bill 
and that Dr. Corwin is in support of the bill with conditions. 
I guess I would just like to figure out whether we're in a 
general hearing nit picking or whether there are some major 
issues here.
    You guys are hooked up with Harvard, right?
    Dr. CORWIN. In name only.
    Chairman STARK. In name only? All right.
    Dr. CORWIN. Separate entity. It used to be part of the 
Harvard Community Health Plan way back.
    Chairman STARK. Okay. I don't suppose there are any laws 
now--and I don't know what the Massachusetts health bit--if I 
come in and you tell me that I have to have a colonoscopy and I 
say I don't want to, you are not going to kick me out of the 
plan, are you?
    Dr. CORWIN. No, sir, we are not. It's your choice.
    Chairman STARK. I mean, you are not going to send me to 
jail.
    Dr. CORWIN. No, sir.
    Chairman STARK. So, wouldn't the same thing prevail if you 
told somebody, well, we think the indication is you have this 
condition or that condition, and I think in your testimony you 
said maybe you want to get an extra 30 days of treatment that 
could be identified as necessary with genetic testing. Was that 
yours?
    Dr. CORWIN. That is ours.
    Chairman STARK. Okay, that was your testimony.
    Dr. CORWIN. Yes, sir.
    Chairman STARK. Wouldn't medical ethics say to you if I 
said, no, you think I probably would need the 30 days, but I 
ain't going to take the test, wouldn't medical ethics say well 
you ought to go ahead and give me the extra 30 days of 
treatment just in an abundance of caution?
    Dr. CORWIN. What our concern is, sir--this is a very good 
question, first of all.
    What our concern is, that when Dr. Collins's future 
research becomes even more sophisticated, that we will soon be 
at a point in time where what is called pharmacological genetic 
signatures, or pharmacogenetics, will allow us to take a look 
at a panel of chemotherapeutic agents on one side and a panel 
of genetic interpretation on the other side of a grid and help 
predetermine which chemotherapeutic agent is most likely to be 
able to help you in your treatment.
    It is our understanding and our concern that, in the 
wording of this bill that, as it stands at this point in time, 
that requesting or requiring someone to undergo that kind of 
testing as a health plan, to help guide their therapy to the 
most appropriate level, to ensure they get the most appropriate 
medication and not the most--best guess, which is not good 
medicine at this point in time and not evidence based, that we 
wouldn't be able to do that.
    Chairman STARK. Okay, now, I think you hit on the operative 
word. I don't know as there is anything in the bill, although I 
must say I would have to read it more carefully than I have, 
that would stop you from requesting it. But as to requiring it, 
I don't know that there are any tests that you can require 
anyway, and I don't know that, under law. I guess you could say 
you withhold certain treatments.
    I don't know, I certainly wouldn't want to see anything in 
this bill that would interfere with the delivery of the best 
medical care that your physicians could determine for your 
beneficiaries. I do see the exciting prospects of being able to 
be much more accurate in determining what kinds of 
pharmaceuticals should be used. We get in a big fight with 
Amgen about EPO. How much EPO should you give somebody in 
dialysis. I think I know, but I think it is determined more by 
money than it is by medical science.
    But be that as it may, I don't want to get in the way. If 
there are specific issues, then I think you are going to have 
to, and I hope you will, sit down with our legislative counsel 
and your lawyers and see if we can come to some kind of an 
agreement that----
    Dr. CORWIN. We are more than willing to work with you on 
this and we would love to do that.
    Chairman STARK. Because if we could work those sorts of 
things out, you guys would favor the bill.
    Dr. CORWIN. Yes, sir.
    Chairman STARK. Well, I will assure you that we will do our 
best to see that we don't get in the way of physicians 
practicing the best medicine they know how. Now I can't assure 
you that I am going to be able to put something in this bill 
that is going to pound sense into the heads of your patients, 
who may often choose not to listen----
    Dr. CORWIN. My patients have been refusing to listen to me 
for a long time about a lot of things.
    Chairman STARK. I can lead that horse to water, okay, but 
that is about as far as I think we could get.
    So, I appreciate you raising those issues and I hope that, 
with your forbearance and cooperation, we could take care of 
those. As long as you see them as technical corrections.
    Dr. CORWIN. We feel they are technical corrections, yes, 
sir.
    Chairman STARK. I think that that we could handle.
    I want to especially thank Mr. Escher for raising concerns. 
I know it is difficult, when we talk here in generalities of 
people not wanting to release private information. It is even 
more difficult, often, to come in a public forum such as this 
and talk about your family and your personal involvement. But 
it is important, and so you are to be thanked for the 
inconvenience and however you feel about our invading your 
personal privacy. But by being willing to step forth, you do us 
all a service and I want to thank you, in particular.
    Ms. Terry and Ms. Pollitz, I thank you for your help and 
support in this. We may have as we try and move this along--we 
have to report this by the 23rd?--we are on somewhat of a time 
schedule to see if we can report this out by the end of the 
month. So, we may want to call on all of you, if we can, over 
the next week or two to see whether we can wrap this up into a 
form that will have broad support.
    With that, I would like to recognize Mr. Camp for any 
inquiries he would like to make.
    Mr. CAMP. Thank you, Mr. Chairman. Again, thank you for 
holding this hearing.
    I want to thank you all for coming and taking the time to 
do that, especially Mr. Escher. Again, it is difficult to come 
and talk about personal issues. Hopefully, we won't make you 
come in another 5 years, we will have resolved this issue. Ms. 
Terry, after 12 years of effort, I hope we can.
    Dr. Corwin, I did want to just point out, there is a 
limitation on genetic testing in the bill, but it does say an 
insurance plan shall not request or require an individual or a 
family member of such individual to undergo a genetic test. So, 
it looks as though they can't even request it.
    But then you go further down in the rules of construction 
and it seems to go the other way and says in the rules of 
construction that a health care professional who is employed 
and is providing health care services may notify an individual 
of the availability of genetic testing. So, there is a bit of a 
construction problem here that I think--I would think the rule 
of limitation overplays the rule of construction, so I don't 
know if you want to comment on that, Ms. Pollitz?
    Ms. POLLITZ. Actually, if you continue on, the bill also 
protects health care professionals to request that they 
undergo, they just also can't require as well.
    Mr. CAMP. Under the rules of construction.
    Ms. POLLITZ. Yeah.
    Mr. CAMP. Yes. Oh, no, I understand that and I mentioned 
that.
    Dr. Corwin, there is a limitation on insurance companies 
requesting, but in the rules of construction they say that 
physicians and professionals employed by an insurance company 
can notify individuals of the desire for a genetic test.
    What does that do in terms of your understanding?
    Dr. CORWIN. I am not a lawyer, so I would have to defer to 
my colleagues who have helped me try to understand this bill as 
best as possible. My understanding is that the health insurance 
plans would be prohibited from requesting and then requiring.
    Again, we do not employ physicians. Physicians are merely 
the end product of the delivery of health care. The----
    Mr. CAMP. I am sorry.
    Dr. CORWIN [continuing]. The testing that we would be 
requesting.
    So, again, we get into the situation within our plan where 
we are trying to help improve the long-term, evidence-based 
process, decrease the variation in the practice of medicine. To 
your point earlier in terms of getting to that wonderful state 
where we have electronic medical records that do all the 
reminding for us, it is a great future place to be.
    But at this point in time, health plans have a very 
significant component in terms of filling gaps in care in the 
busy office practice in terms of reminders, both to patients 
who don't want to have their colonoscopies done for obvious 
reasons, not a comfortable procedure to undergo. If they have 
to be done more frequently, it is less comfortable to have to 
undergo those procedures.
    In the same token, we like to be able to remind physicians 
that they have panels of patients who require these tests. 
Being able to encourage that and use this information in that 
way that if it is available in a generic way at some point in 
the future, to the Chairman's comment, at some point in time 
there will be tests that will be available that will help us 
with this.
    Mr. CAMP. Yes, I would be happy to yield.
    Chairman STARK. As another nonlawyer, what I am hearing 
here, some from my staff and some from--that there are some 
legal differences and niceties between saying, if you recommend 
to me to take the test, that is okay. But if you request it and 
I don't, then I might be in danger of being kicked out of the 
club. That I don't want.
    So, I mean, those are terms of legal differences that I 
think we have to work out, because I am happy to have you 
recommend to me, even be a pest and remind me. But I don't want 
to lose my health insurance.
    Dr. CORWIN. We don't disagree with that interpretation.
    Chairman STARK. Those are--okay.
    Mr. CAMP. I agree with the discussion, the way it is going. 
I mean, obviously, on the whole concept of the bill, I think we 
have general agreement on. We just want to make sure that as we 
look to the future--and I thought Dr. Collins was pretty 
eloquent in his statement that we do need to personalize health 
treatment. That that can be a real help to the future in terms 
of addressing health care needs and costs and other things, and 
obviously making sure people get the care they need.
    But the word request is okay with doctors, it is notify 
with insurance providers, it is request or require up in other 
language. I think we just need to get together and find out 
what the commonality should be so that we don't have an 
unintended consequence later when maybe this becomes a very 
hopeful tool in helping people.
    But the main purpose of the bill is to protect people from 
the misuse of this information, which I think is the real 
concern initially. We don't have the technology to really use 
it as a health care preventive measure right now as much as we 
would like. But as Dr. Collins also testified, that is coming, 
and we don't know how soon that will come.
    So, I appreciate all of your testimony. Thank you very 
much. Thank you, Mr. Chairman.
    Chairman STARK. Thank you.
    I just had one other question of Dr. Corwin, and maybe 
Karen could answer. In Dr. Collins's testimony, I asked him 
about how much it cost, and he indicated that there are 
services out there that would be glad to accommodate me and 
also recommend Herbalife and a lot of other good things for me 
to take if they found something that didn't seem quite right.
    Are we going to be opportuned by, quote, services who want 
to get out and sell this kind of program to the public and then 
come and ask us to have Medicare pay for it? Are there any of 
those services that are valid? Or do we have to wait a while 
until they are more developed? Can you comment on that?
    Dr. CORWIN. I would be glad to, and it is an excellent 
question. I don't know the future answer to that, but currently 
there are some, for lack of a better term, fly by-night 
services that do offer those things.
    There are many very good companies who are offering genetic 
tests at this point in time. But as Dr. Collins indicated, 
these are companies that have patented certain components of 
the human genome which have raised the price. To answer your 
question about the pricing, they can be anywhere from, 
depending on how good your contracting people are, from a 
couple hundred dollars up to $5,000. Many of these companies 
hold the patent on specific tests which limit the access to 
that one company, so there is a lack of competition and that is 
an issue for us on the payer side in keeping the overall cost 
of medical care down. So, I think that is a future concern.
    We will have to sort through the latter part of your 
question, which is how do we decide if these programs are 
really very good and whether they really do offer anything. It 
would be our hope that we would be able to use the evidence of 
science to help us determine what tests are appropriate, when 
they are appropriate, how they should be best utilized and 
hopefully keep them in the realm of the primary care practices 
of our specialists and our primary care physicians and away 
from people who may take advantage of other people's concerns, 
which is obviously something that does happen, unfortunately.
    Chairman STARK. Is it in the public interest to patent this 
stuff?
    Dr. CORWIN. I think that is a politically hotbed question. 
I would say with all due respect to our private enterprise 
system that as long as it is competitive, we may be able to 
keep those prices down. Right at the moment, it does not feel 
like a competitive environment.
    Mr. CAMP. Mr. Chairman, we do have--and this is fairly off 
the subject, but we do have patenting of tax advice, which we 
have held hearings on in the Committee on, so we have got some 
real extensions of patent law that are occurring out there.
    Chairman STARK. Do you suppose they could patent 
politicians?
    Mr. CAMP. I think that would be a very scary thought.
    Chairman STARK. I want to thank all of you again, and we 
will conclude the hearing. Thanks very much.

    [Whereupon, at 3:37 p.m., the hearing was adjourned.]

                                 
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