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THE GENETIC INFORMATION

NONDISCRIMINATION ACT

HEARING

BEFORE THE

SUBCOMMITTEE ON HEALTH

OF THE

COMMITTEE ON ENERGY AND

COMMERCE

HOUSE OF REPRESENTATIVES

ONE HUNDRED TENTH CONGRESS

FIRST SESSION

ON

H.R. 493

MARCH 8, 2007

Serial No. 110–15

(

Printed for the use of the Committee on Energy and Commerce

energycommerce.house.gov

COMMITTEE ON ENERGY AND COMMERCE

JOHN D. DINGELL, Michigan, Chairman

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, JR., New Jersey

BART GORDON, Tennessee

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

DIANA DEGETTE, Colorado

Vice Chairman

LOIS CAPPS, California

MIKE DOYLE, Pennsylvania

JANE HARMAN, California

TOM ALLEN, Maine

JAN SCHAKOWSKY, Illinois

HILDA L. SOLIS, California

CHARLES A. GONZALEZ, Texas

JAY INSLEE, Washington

TAMMY BALDWIN, Wisconsin

MIKE ROSS, Arkansas

DARLENE HOOLEY, Oregon

ANTHONY D. WEINER, New York

JIM MATHESON, Utah

G.K. BUTTERFIELD, North Carolina

CHARLIE MELANCON, Louisiana

JOHN BARROW, Georgia

BARON P. HILL, Indiana

JOE BARTON, Texas

Ranking Member

RALPH M. HALL, Texas

J. DENNIS HASTERT, Illinois

FRED UPTON, Michigan

CLIFF STEARNS, Florida

NATHAN DEAL, Georgia

ED WHITFIELD, Kentucky

BARBARA CUBIN, Wyoming

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

VITO FOSSELLA, New York

STEVE BUYER, Indiana

GEORGE RADANOVICH, California

JOSEPH R. PITTS, Pennsylvania

MARY BONO, California

GREG WALDEN, Oregon

LEE TERRY, Nebraska

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

SUE WILKINS MYRICK, North Carolina

JOHN SULLIVAN, Oklahoma

TIM MURPHY, Pennsylvania

MICHAEL C. BURGESS, Texas

MARSHA BLACKBURN, Tennessee

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Staff Director

GREGG A. ROTHSCHILD, Chief Counsel

SHARON E. DAVIS, Chief Clerk

BUD ALBRIGHT, Minority Staff Director

(II)

(III)

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman

HENRY A. WAXMAN, California

EDOLPHUS TOWNS, New York

BART GORDON, Tennessee

ANNA G. ESHOO, California

GENE GREEN, Texas

Vice Chairman

DIANA DEGETTE, Colorado

LOIS CAPPS, California

TOM ALLEN, Maine

TAMMY BALDWIN, Wisconsin

ELIOT L. ENGEL, New York

JAN SCHAKOWSKY, Illinois

HILDA L. SOLIS, California

MIKE ROSS, Arkansas

DARLENE HOOLEY, Oregon

ANTHONY D. WEINER, New York

JIM MATHESON, Utah

JOHN D. DINGELL, Michigan (ex officio)

NATHAN DEAL, Georgia,

Ranking Member

RALPH M. HALL, Texas

BARBARA CUBIN, Wyoming

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

STEVE BUYER, Indiana

JOSEPH R. PITTS, Pennsylvania

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

SUE WILKINS MYRICK, North Carolina

JOHN SULLIVAN, Oklahoma

TIM MURPHY, Pennsylvania

MICHAEL C. BURGESS, Texas

MARSHA BLACKBURN, Tennessee

JOE BARTON, Texas (ex officio)

(V)

C O N T E N T S

Page

Baldwin, Hon. Tammy, a Representative in Congress from the State of Wisconsin, opening statement ................................................................................... 6

Capps, Hon. Lois, a Representative in Congress from the State of California,

opening statement ................................................................................................ 6

Cubin, Hon. Barbara, a Representative in Congress from the State of Wyoming, opening statement ..................................................................................... 9

Deal, Hon. Nathan, a Representative in Congress from the State of Georgia,

prepared statement .............................................................................................. 3

Engel, Hon. Eliot, a Representative in Congress from the State of New York,

opening statement ................................................................................................ 8

Eshoo, Hon. Anna G., a Representative in Congress from the State of California, opening statement ........................................................................................ 3

Green, Hon. Gene, a Representative in Congress from the State of Texas,

opening statement ................................................................................................ 4

Hooley, Hon. Darlene, a Representative in Congress from the State of Oregon,

opening statement ................................................................................................ 10

Murphy, Hon. Tim, a Representative in Congress from the Commonwealth

of Pennsylvania, opening statement ................................................................... 7

Pallone, Hon. Frank Jr., a Representative in Congress from the State of

New Jersey, opening statement .......................................................................... 1

Solis, Hon. Hilda L., a Representative in Congress from the State of California, opening statement ........................................................................................ 9

WITNESSES

Collins, Francis S., M.D., Director, National Human Genome Research Institute, National Institutes of Health, Department of Health and Human

Services ................................................................................................................. 11

Prepared statement .......................................................................................... 56

Corwin, William, M.D., medical director, Clinical Policy, Harvard Pilgrim

Health Care, Wellesley, MA, on behalf of the America’s Health Insurance

Plans ...................................................................................................................... 35

Prepared statement .......................................................................................... 119

Fishman, Burton J., Fortney & Scott, LLC, Washington, DC on Behalf of

the Genetic Information Nondiscrimination in Employment Coalition ........... 36

Prepared statement .......................................................................................... 77

Hudson, Kathy, director, Genetics and Public Policy Center, and associate

professor, Berman Institute of Bioethics, Institute of Genetic Medicine,

Department of Pediatrics, Johns Hopkins University, Washington, DC ......... 44

Prepared statement .......................................................................................... 108

Kuczynski, Christopher J., Assistant Legal Counsel and Director, Americans

with Disabilities Act, Policy Division, Equal Employment Opportunity Commission, Washington, DC .................................................................................... 14

McAndrew, Susan, Deputy Director, Health Information Privacy, Office for

Civil Rights, Department of Health and Human Services ............................... 16

Prepared statement .......................................................................................... 62

Pollitz, Karen, research professor, Georgetown University Health Policy Institute, Washington, DC .......................................................................................... 38

Prepared statement .......................................................................................... 132

Swain, Frank, senior vice president, B&D Consulting, Washington, DC ........... 40

Prepared statement .......................................................................................... 106

Terry, Sharon F., chair, Coalition for Genetic Fairness and president and

chief executive officer, Genetic Alliance, Washington, DC ............................... 32

Prepared statement .......................................................................................... 72

Page

VI

Trautwein, Janet, executive vice president and CEO, National Association

of Health Underwriters, Arlington, VA .............................................................. 41

Prepared statement .......................................................................................... 150

(1)

H.R. 493, THE GENETIC INFORMATION

NONDISCRIMINATION ACT

THURSDAY, MARCH 8, 2007

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC.

The subcommittee met, pursuant to call, at 1:00 p.m., in room

2123 of the Rayburn House Office Building, Hon. Frank Pallone,

Jr. (chairman of the subcommittee) presiding.

Members present: Representatives Gordon, Eshoo, Green,

DeGette, Capps, Baldwin, Engel, Schakowsky, Solis, Hooley, Deal,

Cubin, Wilson, Pitts, Rogers, Myrick, Murphy, and Burgess.

Staff present: John Ford, Jessica McNiece, Jesse Levine, Jonathan Brater, Ryan Long, Nandan Kenkeremath, and Chad Grant.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY

Mr. PALLONE. I am calling the meeting to order and today we are

having a hearing on H.R. 493, the Genetic Information Nondiscrimination Act of 2007. The bill would prevent the use of an individual’s genetic information from being used to discriminate

against them in obtaining health insurance coverage in the workplace.

As science continues to make rapid advancements in the area of

genetics, I can’t stress how important this bill is to every American

citizen. Genetic testing has increasingly become an integral part of

the American healthcare system, providing the possibility to develop better therapies that are more effective against disease and

allow individuals to take steps to reduce the likelihood that they

will contract a particular disorder.

However, along with the increasing prevalence of genetic testing

comes the growing fear of the potential misuse of this information

by way of discrimination in health insurance and employment. For

example, people known to carry a gene that may increase the likelihood of cancer may be denied health insurance coverage, since insurers have an incentive to identify and avoid beneficiaries who

will cost them more money than the average beneficiary.

Furthermore, many genetic conditions and disorders are associated with particular racial and ethnic groups and therefore members of a particular group may be stigmatized or discriminated

against as a result of their genetic information. There have been

several documented cases of genetic discrimination carried out by

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both insurers and employers. A 2001 American Management Association survey of U.S. companies found that a number of employers

were conducting tests that employers acknowledge might include

genetic testing, as well as requesting employees’ family medical

histories.

And the fear of genetic discrimination alone can have significant

societal cause. For example, many Americans may be reluctant to

undergo genetic testing because of such fear, thereby hindering essential genetic research and clinical practices. Many people may be

deterred to participate in biomedical research that studies gene

mutations associated with certain disease because of the fear that

their information could be used against them by insurers and employers.

And even more alarming, patients who could benefit from genetic

testing have often avoided testing out of concern for possible repercussions, therefore losing the opportunity to received monitoring

and preventive care for conditions in which they are at a higher

risk.

A 2004 Genetics and Public Policy Center survey showed that 92

percent of respondents thought employers should not have access

to their genetic test results and 80 percent opposed letting insurance companies have access to the results. And we think or I

should say I believe that current laws need to be strengthened to

protect against the possibility of genetic discrimination. While the

Health Insurance Portability and Accountability Act of 1996 created Federal protections against genetic discrimination, these protections are limited; I think very limited.

Under HIPAA, Congress established certain restrictions for

group health insurance use of health related information in terms

of coverage and setting premiums. However, these protections did

not apply to individual health insurance nor do they prevent insurers from denying an entire group coverage or setting higher premiums based on the results of genetic testing results from one of

its members.

Many States have also enacted genetic nondiscrimination laws,

yet these provisions vary widely in their approach, application and

degree of protection and therefore I believe that Federal legislation

is necessary to establish a national protection against potential genetic discrimination.

As knowledge of the human genome expands, a greater proportion of the population will likely be identified as carriers of

mutations associated with a greater risk of certain diseases, indicating that virtually all people are potential victims of genetic discrimination in health insurance. And we need to work in a bipartisan fashion to tackle this issue. I would point out that this legislation does have a lot of Republican, as well as Democratic support.

It actually passed the Senate twice, so it does have a lot of support

on both sides of the aisle already.

The president, President Bush, has also indicated that he supports the bill, so we have an opportunity to actually pass something here that will also pass the Senate and be signed by the

president and that is why I think that it is particularly important

that we act swiftly. There is absolutely no reason why we shouldn’t

work together to pass the bill and get it to the president’s desk.

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So in closing, I would like to thank the sponsor of this bill. I

know Representative Louise Slaughter has been pushing this for as

long as I can remember. She talks to me about it all the time and

of course, Anna Eshoo, the member of this committee, who has also

been not only a cosponsor, but a leader on this issue. They have

done a lot of work to put this bill together over the years and it

is immensely important. In my opinion, it holds a lot of promise.

So thank you.

I will now recognize our ranking member, Mr. Deal of Georgia.

Mr. DEAL. Thank you, Mr. Chairman. I am going to waive my

opening statement, but I would request unanimous consent that all

Members be allowed to insert their statements in the record.

[The prepared statement of Mr. Deal follows:]

PREPARED STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF GEORGIA

Mr. Chairman, I want to thank you for holding this hearing today on H.R. 493,

the Genetic Information Nondiscrimination Act. I realize the Committee has limited

time to act on this possibly far reaching legislation but I am glad we are taking this

opportunity to hear about the impact of this bill.

My primary concerns with this legislation are the definitions of ‘‘genetic test’’ and

‘‘genetic information’’. I fear these definitions are so broad that routine medical tests

and information may be covered by this bill. Many States including my own have

enacted their own genetic nondiscrimination legislation which include specific exclusions we do not find in H.R. 493. In Georgia’s law, the definition of genetic testing

focuses on tests for the purpose of identifying the presence or absence of inherited

alterations in genetic material which are associated with a disease that arises solely

as a result of the abnormality in the genes. It also includes specific exceptions for

routine physical measurements; chemical, blood, and urine analysis; tests for abuse

of drugs; and tests for the presence of the human immunodeficiency virus (HIV).

Yet, the definition of a genetic test we find in this bill goes so far as to include an

analysis which simply detects genotypes. Nor do we find clear exceptions for routine

tests or for the abuse of drugs. This broad drafting leaves open the possibility that

tests the authors of this legislation may have never intended to cover being included

in this bill.

I am also concerned with how this legislation may interact with the action 43

States have already taken on this issue. It seems that in this bill, we would be legislating in a sweeping manner; in an area the vast majority of the states have already

taken action. This could lead to a great deal of confusion in the states about which

regulations actually apply. I believe this bill uses a standard of stringency to determine which regulation, the State or Federal, should apply. Without a clear determination, this could make it difficult for employers and insurers to comply with this

bill.

I realize many of our witnesses today will testify about the need for this legislation to allay the public’s fears of being genetically tested and the important role genetic information may play in the delivery of health care in the future. I hope the

witnesses could also help guide the Committee to act in a specific way that would

limit the bill’s unintended consequences in the future.

Again, I am glad we are taking this opportunity today and I hope our witnesses

will be able to address some of my concerns and indicate the implications of this

important legislation.

Mr. PALLONE. Thank you, Mr. Deal. I next would recognize Ms.

Eshoo, who is the chief proponent of this legislation.

OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA

Mr. ESHOO. Thank you, Mr. Chairman, for having this legislative

hearing. It has been a long time in coming. I think this is a very

important and auspicious moment for the issue at hand and that

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is as the great discovery, I think the greatest discovery of the 20th

century, just before we started the 21st century, was the mapping

of the human genome project. But with that discovery came another one and that is that the wonder and the manifestation of

what that promise held would be withheld because of the fear of

being discriminated against, and that is why we are here today.

I want to salute our colleagues, Congresswomen Louise Slaughter and Judy Biggert, who have done a superb job on this. I am

proud to have played a role to help to build the coalition of very,

very important national organizations; some may be unlikely partners, but that makes the case even stronger for us to pass the bill.

And with Dr. Collins here today, I think you will remember when

I was the co-chair of one of the bipartisan retreats and of course,

the Speaker of the House was there, as well as the minority leader,

and I believe it was Speaker Hastert and Minority Leader Gephardt.

And they were sitting at tables next to each other, not together,

which is not atypical, right? But Dr. Collins and I were sitting together and he was a guest; he had been invited to come to the retreat to be instructive to all of the members about the challenge

that was before us. And I said to Dr. Collins you must go up to the

Speaker and the minority leader. I will try to get them to stand

next to you together so that you can address them together and

challenge them to take a hold of this and make sure that it happened.

Well, that was some time ago and although it didn’t happen

then, we have been helping to make it happen and I am very excited that we are on the threshold of this and that we will work

through the bill. If there are ways to improve it, we look forward

to that. If there are ways that will essentially kill it, I think that

there are enough of us that won’t allow that to happen. I think the

people in the country deserve a very good bill in this area and I

think that when this committee passes it, we will have distinguished ourselves in a very important way.

So thank you, Mr. Chairman. Thank you, Dr. Collins, for all that

you have done, and to the witnesses that are here today to talk

about the bill and answer the important questions that members

from both sides of the aisle will pose. Thank you.

Mr. PALLONE. Thank you. And thank you for all the work you

have done over the past few years in trying to move this. I recognize the gentleman from Michigan, Mr. Rogers.

Mr. ROGERS. I will waive for more questioning time, Mr. Chairman.

Mr. PALLONE. And next we have our vice chair, the gentleman

from Texas, Mr. Green.

OPENING STATEMENT OF HON. GENE GREEN, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

Mr. GREEN. Thank you, Mr. Chairman, for one, holding this

hearing and also, as vice chair, I would like to welcome our witnesses to the subcommittee and my colleague from California,

thank you for your efforts for many years. Some of us have been

cosponsors of this for six terms, it seems like. One of our subcommittee’s important responsibility is protecting the rights of paVerDate 11-SEP-98 09:47 Mar 27, 2008 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 Q:\DOCS\110-15 SCOM1 PsN: SCOM1
5

tients for their confidentiality and I hope we can address this important issue in a bipartisan and cooperative way.

Our society supports the idea that a person should be hired

based on their qualifications and ability to perform the job, instead

of characteristics out of their control, which have no effect on their

job performance. Racial, gender and other types of discrimination

is incompatible with merit-based economic systems that rewards

people for work and effort. Discrimination based on health conditions is also incompatible with our society and economy, so people

should not be fired because of their family history of a certain illness.

There should also be a consensus that people should not be

charged a higher price for health insurance based on their family’s

medical history. The recent advances in the field of human genetics

has brought these issues to the forefront because as usual, new

technologies bring new benefits but also, new opportunities for

harm. Genetic testing is proven to be extremely helpful in preventative medicine. It allows for individuals with risk of an illness to

take the precautionary steps ahead of time, which will help keep

healthcare costs to the minimum.

It is important that we continue to support genetic testing in

order to further scientific advancement while protecting Americans

from any negative impact due to their participation. There are over

15,500 recognized genetic disorders which affect millions of Americans. It would be unfair to penalize someone based on their genes

by using this information improperly. Under most circumstances, a

person should be allowed to refuse a genetic test without fear of

being fired.

Also, if an individual is taking a genetic test, the test should be

conducted in terms which they agree and the results should be released only if on the consent of that individual. These issues are

properly addressed in H.R. 493, which again, I co-sponsored along

with many supporters in the House. I believe President Bush has

made it evident he will also support these principles. This hearing

is an excellent opportunity for our committee to work together to

protect Americans from this discrimination based on health concerns. And I yield back the balance of my time.

Mr. PALLONE. Thank you. Dr. Burgess is recognized for an opening.

Mr. BURGESS. Thank you, Mr. Chairman. Thank you for calling

this hearing. In deference to the quality of witnesses we have

today, I will just submit for the record.

Mr. PALLONE. You are reserving your time for questions, OK.

The gentlewoman from Colorado, Ms. DeGette.

Ms. DEGETTE. Thank you, Mr. Chairman. As usual, Mr. Green

said it all and better than I could have, so I will waive my opening

statement.

Mr. PALLONE. Mr. Pitts.

Mr. PITTS. I will waive.

Mr. PALLONE. The gentlewoman from Wisconsin, Ms. Baldwin.

6

OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF WISCONSIN

Ms. BALDWIN. Thank you, Mr. Chairman, and thank you to our

witnesses today. I am truly delighted that this subcommittee is

taking up this very important bill. It is clear that the time has

come to extend nondiscrimination protections to include genetic information. This particular issue, genetic information discrimination, poses a unique challenge for us, but I think we are up to the

task. The scientific advancement that has been made in sequencing

the human genome is groundbreaking and I am excited that the

leading scientist involved with the Human Genome Project is here

today, as you have been in the past at our bipartisan conference

that I also had a chance to attend. I am glad you are here today

to share your expertise with us.

We have only just begun to understand how we can harness the

vast amount of information that is included in the genetic code to

benefit human health and longevity. We have yet to see the limits

of the ways that this information can benefit all of us. The ability

to predict disease will greatly increase our opportunities for early

treatment and prevention efforts and this can have a real impact

on people’s lives.

So we must not allow discrimination to prevent us from taking

full advantage of the important opportunities that genetic information provides. We need to provide strong protections that will prevent employers and insurers from denying health coverage or job

opportunities on the basis of predictive genetic information. This

important protection is necessitated by these incredible advancements in the science and we, members of Congress, are responsible

for making sure that our laws keep up with these scientific advancements so that we can fully realize the value of these discoveries.

I am proud to be an original cosponsor of this legislation and I

look forward to seeing these important protections extended to all

Americans. Thank you, Mr. Chairman.

Mr. PALLONE. Thank you. Mrs. Capps has returned, so I will recognize her.

OPENING STATEMENT OF LOIS CAPPS, A REPRESENTATIVE IN

CONGRESS FROM THE STATE OF CALIFORNIA

Mrs. CAPPS. I apologize. I did not want to miss this very special

moment. Thank you, Mr. Chairman, for holding this hearing. I

want to acknowledge my colleague, Anna Eshoo, and her partners,

Louise Slaughter and Judy Biggert for their work. There has been

a steady push to get to this day. After so many years and it is quite

an accomplishment here. And especially with our first witness;

well, with all of our witnesses, it will be a remarkable day. To have

Dr. Collins here with us today is very auspicious. This is a very appropriate time to have you and all of us remember when he first

showed us the charts of the completion of the Genome Project. And

now we have today’s topic to deal with.

We need this hearing today because we are paving the way for

consideration of legislation that, as I said, so many of us strongly

support. The identification of genetic markers for disease is one of

7

the most remarkable scientific accomplishments we have made.

With Dr. Collins at the helm, we are going to continue to see even

greater accomplishments in our understanding of genetics. As we

all know, we can never emphasize enough just how important preventive health care is to our wellbeing. The ability to identify risks

for certain conditions promises to enhance our ability to identify

and practice greater preventive healthcare in this country.

It is about quality of life, it is about saving life, but at the same

time, as with almost all great scientific advancements, we have

also opened the door to a whole slew of unintended consequences.

I fear that preventive healthcare is being put at risk when patients

decline genetic testing for fear of insurance or employment discrimination. I know we will hear from at least one witness today

about the juxtaposition of a public that is overwhelmingly optimistic about the benefits of genetic testing, but overwhelmingly pessimistic about their privacy being protected. What a shame.

We need to work together on ways to promote ethical genetic

testing with appropriate privacy protections and with measures in

place to prevent discrimination. This is our task. I believe we can

do it. We cannot continue with a system in place that leaves individuals who might be at risk for a disease to forego available genetic testing for fear of losing their job or their health insurance.

I am proud to be a strong supporter of the Genetic Nondiscrimination Act so that we can ensure that this will not occur

in the future. I look forward to hearing from all of you today.

Thank you very much for coming. I yield back.

Mr. PALLONE. Thank you. I recognize the gentleman from Pennsylvania, Mr. Murphy.

OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

Mr. MURPHY. Thank you, Mr. Chairman, and thank you for holding this hearing. This is a very, very important issue that has to

be addressed. I commend my colleagues, my friends, for putting

forth this bill. It is a very important issue to be dealing with in the

area of healthcare and a couple of areas. As it has been stated, we

are learning more and more about the genome in the role of genetics and what it can teach us about patients; in particular, as just

mentioned by my colleague, the issues of prevention.

I would like to see a day when we recognize that treatments

have become so sophisticated for patients that understanding their

own genetic makeup, that medications and treatments can be made

person-specific and come with much more effective treatment

plans, such as cancer and other diseases. However, we do need to

protect and make sure that patient does not fear losing their job

or losing their insurance because they complied or wanted to have

these things done.

I wanted to also make sure, and one of the things I hope that

perhaps some of our witnesses will be able to address today at the

level of expertise, has to do with electronic medical records, because I want to make sure there is no unintended consequence of

this bill that might prevent a business that might try and help its

employees by providing electronic medical records to be seen as

8

somehow gathering information that might be used in some discriminatory manner.

There are so many incredible potentials we have here for

healthcare and making it better with prevention and personal specific treatment. I hope we can get to that point and any of the other

concerns in this bill, I hope this committee will take care of. And

I yield back the balance of my time.

Mr. PALLONE. Thank you. Mr. Engel of New York.

OPENING STATEMENT OF HON. ELLIOT L. ENGEL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW YOR

Mr. ENGEL. Thank you, Mr. Chairman, for holding this very important hearing on the Genetic Information Nondiscrimination Act.

I echo what all of our colleagues said. The sequencing of the human

genetic code is unquestionably one of our greatest scientific accomplishments. A researcher’s ability to identify genetic markers for

diseases has given hope and promise to millions of people regarding

how to make more informed choices about their personal

healthcare.

The promise of this breakthrough is hindered, though, by wellfounded fears of how information may be abused in the employment and insurance industry. In one notable example in 2002, the

Burlington-Northern Santa Fe Railway agreed to pay $2.2 million

to 36 employees who said the company illegally tested their blood

samples to claim a genetic defect that caused their workplace injuries. A study noted by one of our witnesses, Dr. Collins, said that

68 percent of respondents would not bill their insurance company

if they chose to have genetic testing done regarding their risk for

cancer, colon cancer or breast or ovarian cancer. Twenty-six percent

said they wouldn’t feel safe getting tested unless they used another

name.

A 1998 joint report by the Department of Labor, Equal Employment Opportunity Commission of the Department of Justice stated

that Federal legislation was necessary to mandate more appropriate protections against workplace discrimination. While many

States, including mine, of New York, have laws which prohibit discrimination in health insurance and by employers based on genetic

testing and information, it is clear that they are not fully comprehensive and that Federal action is necessary. Fear should not

be a deterrent to knowledge. Disregarding available tests for fear

of discrimination prevents citizens from making smarter, personalized choices and being better informed about their own well-being.

Why wait until the standard age that everyone is recommended

to start getting mammograms and colonoscopies if one knows he or

she is at risk for these diseases? We know too much to subscribe

to one-size-fits-all medicine and once again, it should be our physicians, not our insurance companies, who influence our healthcare

decisions. I am proud to be an original cosponsor of this bill, it has

strong bipartisan support, and the President supports it, as it will

clarify how genetic information should be protected in both the insurance and employment setting.

So Mr. Chairman, I thank you again for convening this hearing

and I look forward the testimony and this is one thing that is not

9

political. As Americans, we deserve no less. Thank you. I yield

back.

Mr. PALLONE. Thank you. Recognize the gentlewoman from Wyoming, Mrs. Cubin.

OPENING STATEMENT OF HON. BARBARA CUBIN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF WISCONSIN

Mrs. CUBIN. Thank you, Mr. Chairman. The advent of genetic

technology holds tremendous promise in the healthcare field. Along

with the mapping of the human genome, researchers have identified genes associated with diseases such as Alzheimer’s disease,

cancer and diabetes. Genetic testing and the information it garners

can assess individual predisposition to these debilitating diseases.

Continued research may open the door to earlier disease prevention, new diagnostic tools, treatments and potentially, even cures.

Genetic technology could also play a role in making treatment

delivery more individualized and effective. As is the case with

many rapidly developing technologies, advances in the genetic field

are not without their pitfalls. Like a fingerprint, an individual’s genetic information serves as a unique personal identifier. The potential misuse of a person’s unique genetic information is an important issue to the general public and something that this committee

is right to address.

H.R. 493, the Genetic Information Nondiscrimination Act, is intended to prevent discrimination based on genetic information,

both in the workplace and in the context of health insurance coverage. As a long time advocate for healthcare privacy, I, too wish

to ensure that genetic technology does not become a tool for discrimination or limitation on access to healthcare. H.R. 493’s broad

definition of genetic information, however, in combination with its

sweeping ban on requesting or disclosing genetic information

should be looked at critically.

This bill stands to directly impact our Nation’s employers, law

enforcement and healthcare providers, making it imperative that

we root out unintended consequences before we move forward. In

the healthcare field in particular, H.R. 493’s new regulatory web

will have to interlock with the already extensive and complex privacy rules administered by the U.S. Department for Health and

Human Services. I am hopeful that our panelists will be able to

shed some light on the underlying issues of genetic discrimination,

as well as address concerns that this legislation may interfere with

the delivery of important and life saving healthcare services.

Thank you, Mr. Chairman. I yield back the balance of my time.

Mr. PALLONE. Thank you. Next is Ms. Solis.

OPENING STATEMENT OF HON. HILDA L. SOLIS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA

Ms. SOLIS. Thank you, Mr. Chairman, and good afternoon. I

want to thank you for holding this very important hearing and I

want to just express that I strongly believe that discrimination of

any kind, whether it is based on gender, race, disability or genetics,

is morally wrong and should not be tolerated. H.R. 493 is critical

10

in protecting communities that have historically faced discrimination, many of which are at great risk or perceive themselves to be

at risk of genetic discrimination.

A study done by Mt. Sinai School of Medicine found that Latino

participants believed that there were more disadvantages to genetic testing compared with other ethnic groups and they expressed

strong concern regarding testing abuses. Even though African

Americans were four times more likely to think that all pregnant

women should be genetically tested, a 2006 study published in the

Journal of the National Medical Association stated that African

Americans were also three times more likely to believe that genetic

testing would lead to racial discrimination.

The research participants were concerned that genetic testing results could lead to racially based population control or would block

access to health insurance and employment. Unfortunately, these

are the same communities which could benefit significantly from

genetic testing if only they were protected. Genetic tests can help

people determine if someone is at risk of breast, ovarian and other

cancers. Breast cancer, as you know, is the leading cause of cancer

among Latinos and African American women continue to have

higher rates of mortality from breast and cervical cancer.

Native Americans and Alaskan natives continue to have the

poorest survival form of all cancers combined than any other racial

group. Cancer has been the No. 1 killer of Asian American women

since 1980. We need to make sure our residents can access their

genetic information without fear that it will be used against them

by their insurers or employers. If we do not protect our residents

from genetic discrimination, preventable health disparities will continue to increase unnecessarily.

I believe this bill is long overdue and I look forward to hearing

from our witnesses today and working with my colleagues to see

that this bill moves forward. Yield back the balance of my time.

Mr. PALLONE. Thank you. I recognize the gentlewoman from New

Mexico, Mrs. Wilson.

Mrs. WILSON. Thank you, Mr. Chairman. I will waive my opening statement.

Mr. PALLONE. And next is Ms. Hooley, from Oregon.

OPENING STATEMENT OF HON. DARLENE HOOLEY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON

Ms. HOOLEY. Thank you, Mr. Chairman. I am proud to say I am

a long time supporter of the Genetic Information Nondiscrimination Act. I am hopeful that in the 110th Congress we will finally

be able to pass this important piece of legislation. The Health Insurance Portability and Accountability Act of 1996 was a first step

in protecting workers from genetic discrimination. However, in the

light of the rapid growth in scientific knowledge that has occurred

since 1996, it is well past the time that we take strong steps to

strengthen genetic nondiscrimination provisions.

Scientific advancements and sequencing the human genome provide exciting opportunities that may allow us to live longer and

healthier lives. However, the potential for inappropriate and the

discriminatory use of genetic information fosters fear in many people. We will not be able to benefit from the extraordinary scientific

11

achievements in genetics if people are afraid they will be discriminated against if they undergo genetic testing.

That is why GINA is not only an important privacy and consumer protection bill, but also a bill critical to improve the health

of Americans and foster increased scientific research. If people do

not trust the way genetic information is used, then the research,

itself, will almost certainly be stifled. It would be a tragedy to slow

research that holds a potential to provide such tremendous benefit.

GINA strikes the appropriate balance between the imperative of

protecting the privacy of workers and patients with the need to encourage future scientific advancements.

This legislation will accomplish both sets of goals so that we can

feel safe in taking advantage of the improvements in how

healthcare is delivered that genetic research allows. I am also encouraged that the president has expressed strong support for genetic nondiscrimination. Hopefully, this time, and I am an optimist,

we can get it through the House and the Senate and get it signed

by the president. It is the best for the American people. Thank you,

Mr. Chairman.

Mr. PALLONE. Thank you. And that concludes the opening statements by members of the subcommittee. Let me just say again that

every member has the right to submit their statement for the

record.

Let me welcome the panel and mention who we have here. First

is Dr. Francis S. Collins, who is director of the National Human

Genome Research Institute and the National Institute of Health.

Next is Mr. Kuczynski. He is assistant legal counsel and director

of Americans with Disabilities Act Policy Division for the Equal

Employment Opportunity Commission. And then we have Ms.

Susan McAndrew, who is Deputy Director for Health Information

Privacy, Office for Civil Rights, Department of Health and Human

Services.

Now, we will have 5-minute opening statements from each of the

witnesses. Those statements will be made part of the hearing

record. Each witness may, at the discretion of the committee, submit additional briefs and pertinent statements in writing for inclusion in the record. And I will now recognize Mr. Collins to begin

with his opening statement. You can proceed.

STATEMENT OF FRANCIS COLLINS, M.D., DIRECTOR, NATIONAL HUMAN GENOME RESEARCH INSTITUTE, NATIONAL

INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Dr. COLLINS. Thank you, Chairman Pallone, and good afternoon,

members of the subcommittee. I am Francis Collins. I am the director of the National Human Genome Research Institute at the National Institutes of Health. I am a physician and a scientist. I want

to express my thanks for the opportunity to be here today and my

congratulations to this committee for taking on this issue and moving it so quickly in the 110th Congress. Some of us had been waiting a dozen years to get to this point and it is gratifying, indeed,

to see this hearing being held this afternoon and to hear these

statements of strong support for the principles of the Genetic Information Nondiscrimination Act or GINA, H.R. 493.

12

We stand on the brink of a revolution in healthcare. The Human

Genome Project, which was completed ahead of schedule and under

budget in 2003, read out all of the three billion letters of our own

human DNA instruction book, providing a foundation for all of the

research that we need to do in the future to understand how environment and genetics work together to cause health or disease. In

an immediate follow-up at another project that I had the privilege

of leading, the International HapMap Consortium, laid out a map

of how the variable part of the genome, the 0.1 percent where we

differ, is organized across chromosomes and provided with the tools

to understand how it is that some of that variation plays a role in

risk of disease, be it diabetes, heart disease, Alzheimer’s or many

other conditions.

We are moving quickly towards the time where your genome

might be possible to determine, at high accuracy, for a thousand

dollars or less, because the technology is moving so quickly and so

there will be a major motivation to make that information a standard part of the medical record. Already, we see around us many

gene discoveries happening. More than a thousand genetic tests are

now available and discoveries are happening practically every day.

Just this week there were discoveries about genetic factors in cleft

lip and palate, other genetic factors in Alzheimer’s disease, even

something about panic disorder. And in the last year we have seen

discoveries about macular degeneration, a common cause of blindness, diabetes, prostate cancer, Crone’s disease.

NIH has a major investment now in trying to take this opportunity and move it forward at maximum speed so that we can identify other factors that play a role in virtually all hereditary diseases and frankly, all diseases have at least some hereditary contribution. I should say, therefore, personalized medicine, this hope

that we can use this information to individualize the way we approach medical problems and focus on keeping people healthy is

not for a few people, it is for all us. We all have glitches somewhere

in our instruction books that place us at risk for something. The

opportunity to discover those and to individualize our individual

plans of prevention is one of the major hopes that we have for reducing our healthcare costs and focusing on keeping people

healthy.

Yet, there is a cloud on the horizon and it is a cloud that has

been getting darker and more frightening over the course of the

last more than 12 years, since I have had the privilege of leading

the genome effort and worrying about this issue, and that is that

this kind of genetic information, as valuable as it is, might be used

against people. If I could see the one slide that I brought along, I

wanted to put a human face on this particular issue.

[Slide shown.]

So this is a particular family. You can see in the pedigree, that

some are drawn as males and some as females. You see a bright

red arrow pointing to the woman who first came to attention in one

of our research protocols at NIH, and she came to attention because, at the age of 36, she had already had cancer of both the

uterus and the colon. And it turned out her mother and her aunt

had also had both of those conditions. We recognize that this is a

condition that can be strongly inherited. It is called hereditary

13

nonpolyposis colon cancer and this is one of those conditions for

which the genetic basis has been identified.

All of the people that you see in yellow, therefore, are at high

risk of having the same condition, but the good news is that knowing you are risk for this condition allows you to undergo medical

screening, such as colonoscopy, beginning at an early age; 35 is

often recommended. And then one can find the evidences of an

early tumor while it is still easily treated, by a surgical procedure.

However, in this family, the fear of genetic discrimination made it

very difficult for these family members to decide what to do. Ultimately, the woman with the arrow was tested; she was found to

have a mutation.

Other family members were offered the chance to find out their

status. Her four sisters, as you can see there, given that information, still decided not to be tested because of their fear that this

might be used against them. And they are out there somewhere

without having life saving information because of this very specific

issue, an issue which you all can help us with by getting this legislation passed this year.

This in not a partisan issue, of course. Let me give you one other

example. You can take that slide down. Health professionals are

not immune to this risk, as well. I am aware of a physician who

lives in Chicago who is in a family with a lot of breast cancer. She

decided to undergo BRCA1 testing. She decided to do this under a

false name because of her concern about this being used against

her. What are we doing here? Asking people to use a false name

to have a genetic test that might be useful? The test was——

Mr. PALLONE. Dr. Collins, I am going to ask you to summarize,

because we do have votes.

Dr. COLLINS. Sure.

Mr. PALLONE. And then I will indicate what we are going to do.

If you could wrap up.

Dr. COLLINS. Certainly. Her test was positive. She didn’t get that

into her medical record. An ultrasound that was done later for another purpose was not looked at carefully because of that consideration. A year later, she was diagnosed with ovarian cancer. It could

have been diagnosed if that information had been known.

So let me finish. We remain deeply concerned about the impact

of potential genetic discrimination on both research and clinical

practice. Unless Americans are convinced this information will not

be used against them, this era of personalized medicine may never

come to pass. The result will be a continuation of our current onesize-fits-all medicine, ignoring the evidence that genetic differences

among people help explain why some of us benefit from a therapy

while others do not. This is an issue of equity. It is an issue of justice.

Twenty-four out of the 33 members of this subcommittee are cosponsors of this bill, which I am delighted to note. And the president, in his visit to NIH last month, again called on Congress to

pass such a bill, so we are delighted to see this issue being taken

up so early in this Congress and are hopeful this will be the year

when the American people are given a gift that is long overdue,

protection at the Federal legislative level against genetic discrimination.

14

Thank you, Mr. Chairman. I would pleased to answer any questions.

[The prepared statement of Dr. Collins appears at the conclusion

of the hearing.]

Mr. PALLONE. Thank you. Let me explain what we are doing. We

have one vote, then we have 10 minutes on the motion to recommit

for debate and the we will have three more five-minute votes, so

I think, since there is only about 7 or 8 minutes left, we should

break now, rather than hear from the next speaker, so figure

about, I don’t know, half an hour, maybe even 45 minutes. And

those are the last votes of the day, so we will break and then we

will come back after that. Thank you.

[Recess.]

Mr. PALLONE. The committee will reconvene and we will start

where we left off, with Mr. Christopher Kuczynski. I am sorry for

the delay, but that is what happens around here. We will have no

further delays because we are done voting.

CHRISTOPHER KUCZYNSKI, ASSISTANT LEGAL COUNSEL AND

DIRECTOR, AMERICANS WITH DISABILITIES ACT POLICY DIVISION, EQUAL EMPLOYMENT OPPORTUNITY COMMISSION

Mr. KUCZYNSKI. Thank you, Mr. Chairman, and members of the

subcommittee. I am pleased to be here today on behalf of Chair

Naomi Earp to answer your questions concerning H.R. 493, the Genetic Information Nondiscrimination Act. Since February 1997, I

have been Assistant Legal Counsel and Director of the Americans

with Disabilities Act Policy Division at the United States Equal

Employment Opportunity Commission. In this position, I oversee

the development of agency policy on the ADA, counsel EEOC field

and headquarters offices that are investigating and litigating ADA

charges of discrimination, and provide technical assistance on the

law to a wide range of stakeholders.

In the late 1990’s, I was part of an inner-agency working group

that developed what ultimately became Executive order 13145,

which prohibits Federal agencies from discriminating in employment on the basis of protected genetic information, and I provided

substantial input on the policy guidance that EEOC issued in July

of 2000 to implement that Executive order. Peter Gray, of EEOC’s

Office of Legal Counsel, who is with me today, also worked on the

inter-agency working group that developed the Executive order and

was the primary drafter of the EEOC policy guidance on that

order.

As this subcommittee is aware, the administration has issued a

Statement of Administration Policy supporting Senate passage of a

similar bill in the 109th Congress, and former EEOC Chair, Cari

Dominguez, on February 13, 2002 expressed this agency’s support

for legislation prohibiting employment discrimination on the basis

of genetic information.

Now basically, my understanding is title II H.R. 493 would do essentially three things. First, with carefully defined exceptions, it

would prohibit employers from obtaining genetic information about

job applicants and employees that would indicate a predisposition

to or increase risk of acquiring a condition in the future. Consistent

with limitations that the ADA imposes, employers would still be

15

permitted to conduct medical examinations of applicants and employees to detect conditions that actually exist and that may affect

their ability to perform their jobs.

Second, the bill would prohibit employers from using genetic information indicating that a job applicant or employee has a predisposition to or increased risk of acquiring a condition in the future to deny someone a job or other equal employment opportunities. And in this way, the law is consistent with other laws that

the EEOC enforces, such as title VII of the 1964 Civil Rights Act,

the Age Discrimination in Employment Act and the ADA, which

prohibit discrimination on the basis of some protected status.

Finally, title II of H.R. 493 requires that employers keep genetic

information about applicants and employees confidential with limited exceptions. In this respect, the law is similar to the Americans

with Disabilities Act, which itself contains confidentiality provisions about medical information that employers acquire.

I know that issues have arisen concerning the relationship of

some of H.R. 493’s requirements regarding the collection and confidentiality of genetic information to requirements in the Health Insurance Portability and Accountability Act, HIPAA. The EEOC will

need to work with the Department of Health and Human Services,

the agency responsible for interpreting and implementing HIPAA,

assuming that GINA is enacted with current provisions, requiring

EEOC to promulgate regulations. We would work closely with

other agencies, including the Departments of Labor and the Treasury, who have responsibility for issuing regulations under HIPAA’s

current nondiscrimination provisions and title I of GINA, as necessary to ensure consistency in the interpretation of terms such as

‘‘genetic information’’ and ‘‘genetic tests’’ that appear in titles I and

II. We have well-established procedures for doing this type of coordination.

Additionally, we would have the benefit during the notice and

comment period prior to issuance of final regulations, to hear from

the public, other Federal agencies, employers and a wide range of

stakeholders on the proposed regulations.

Additionally, if EEOC’s experience with enforcing and implementing the ADA is any indication, compliance with the requirements of the confidentiality provisions of the GINA should not

present insurmountable problems. For example, the ADA allows

employers to collect medical information about employees as part

of voluntary wellness programs and requires that the information

gathered be kept confidential. We have no data to suggest that employers have been deterred from establishing wellness programs because of concerns about the ADA. Indeed, wellness programs seem

to be more popular than ever before.

The ADA also allows employers to obtain medical information

about applicants and employees in other situations, such as during

a medical examination conducted after a job offer has been made,

but before employment begins, when an individual with a non-obvious disability requests a reasonable accommodation or when an

employer reasonably believes that a current employee’s medical

condition prevents him or her from performing a job or from performing it safely.

16

Again, we have not observed that employers are either reluctant

to obtain medical information they need or that the applicability of

the ADA to some of this information is causing serious compliance

problems.

Thank you for the opportunity to appear before you today. I look

forward to your questions.

Mr. PALLONE. Thank you, Mr. Kuczynski. Ms. McAndrew.

SUSAN MCANDREW, DEPUTY DIRECTOR FOR HEALTH INFORMATION PRIVACY, OFFICE FOR CIVIL RIGHTS, DEPARTMENT

OF HEALTH AND HUMAN SERVICES

Ms. MCANDREW. Thank you, Mr. Chairman and members of the

subcommittee. My name is Susan McAndrew. I am the Deputy Director for Health Information Privacy in the Office for Civil Rights

in the Department of Health and Human Services and as such, I

am responsible for the administration and enforcement of the Privacy Rule that was issued pursuant to the Health Insurance Portability and Accountability Act of 1996. I thank you for this opportunity to testify on the role that the Privacy Rule plays in the protection of genetic information today. I will just start with some

brief background material on the Privacy Rule and then turn to the

provisions that will be of most interest to this committee.

The Privacy Rule establishes, for the first time, a set of national

standards to protect health information, but it is not universally

applicable to health information wherever it resides. The standards

apply to health information that is individually identifiable and we

call that information protected health information. But it only protects that information when it is being held and maintained by

what we call covered entities. These entities are health plans,

healthcare clearinghouse and those healthcare providers that engage in electronic transactions for which the HIPAA legislation required the Secretary to adopt standards for the electronic exchange

of information, most commonly, how they go about billing for their

services.

The Privacy Rule protects the information, largely by establishing limitations on how that information is to be used and disclosed,

and puts the individual in control to the extent feasible, by requiring that the information only move outside of the entity with the

individual’s written authorization. The rule does make clear that

there are exceptions to when that written authorization is required

and these permitted uses and disclosures are largely or primarily

focused on the core functions of the health industry that is—the

need for this information to treat the patient and to get that treatment paid for in a prompt and accurate manner, as well as to allow

healthcare providers and health plans to conduct normal health-related business practices.

There are a limited number of other exceptions that the rule recognizes where public interest may require that this information be

disclosed without first obtaining the individual’s written authorization. The Privacy Rule also establishes a Federal floor of privacy

protections thus allows State and other Federal law to provide

more protection as well as business entities to adopt practices that

are more protective of privacy

17

With regard to this legislation, I want to focus on three things.

First, individually identifiable genetic information is protected

health information under the Privacy Rule today, but we protect

this information as we would any other individually identifiable

health information. There are no special rules in the Privacy Rule

that would add heightened protections because this is genetic information. What the legislation would do, if it is adopted in its current form, would be, for the first time, to introduce a definition of

genetic information into the Privacy Rule and apply different protections to this information.

Second, with regard to health plans, currently, the Privacy Rule

permits a health plan to use protected health information, and this

includes genetic information, for their core business practices; that

includes determining enrollment and eligibility for benefits under

the plan, as well as underwriting premium rating and the activities

related to the creation, renewal or replacement of a contract for insurance. Under this legislation, the health plan would be prohibited from using genetic information for these activities. And the

rule also currently allows health plans to condition enrollment or

eligibility for benefits under a plan on obtaining an individual’s authorization for the release of protected health information if that

request is made prior to the enrollment. This is so the plan can get

the necessary health information in order to make a determination

about enrollment. However, under this legislation, to the extent the

information sought pursuant to this type of authorization was genetic information as defined by the bill, that would no longer be

permitted.

In addition, for the first time, not only would the bill, title I,

make these activities a discriminatory practice for the health plan,

similar to what title I of HIPAA does today in some circumstances,

but——

Mr. PALLONE. I am just going to ask you to summarize a little,

because we are a minute over.

Ms. MCANDREW. OK. I am sorry. The other point that should be

made is that the Privacy Rule does not govern a business simply

because it is an employer. However, the rule protects the information if the business is involved in healthcare, from flowing from the

healthcare side of the business to the employer’s side for employment activities that that business would need. And that largely

would be the topic of title 2. And I appreciate your having us here

today and we look forward to answering your questions.

[The prepared statement of Ms. McAndrew appears at the conclusion of the hearing.]

Mr. PALLONE. Thank you. Thanks a lot. I am going to start by

recognizing myself for 5 minutes for questions and I will start with

Dr. Collins. I have a couple questions for Dr. Collins.

More than a thousand genetic tests are now available, but most

of them are for rare diseases. How rapidly is the science of genetic

testing progressing from more common conditions?

Dr. COLLINS. Very rapidly, indeed. With the success of the

Human Genome Project, with this follow-after effort called the

HapMap Project that has allowed us to really get a sense of a landscape of genetic variation, that 0.1 percent of our DNA where we

differ, we now have the tools to be able to scan the entire genome

18

and identify subtle variations that increase the risk of diseases like

diabetes, Alzheimer’s disease, prostate cancer, Crohn’s disease.

All of the diseases I just mentioned, in fact, have had those discoveries made within the last year and a half and you can anticipate now with these tools in place and with the advances in technology that now make this kind of laboratory work much cheaper

than it used to be, you will see a profusion of these discoveries coming out in the course of the next 2 or 3 years. We will discover the

major hereditary factors in the common diseases that fill up our

hospitals and clinics in the relatively near future.

Mr. PALLONE. So basically, we will see it in the mainstream practice of medicine, would you say?

Dr. COLLINS. We have already seen, in some instances, such as

the example of hereditary colon cancer that I presented in my

opening statement, an opportunity to integrate this kind of testing

for a common disease in a way that saves lives.

Mr. PALLONE. Now, are there any other barriers, though, that

would exist for bringing it into the mainstream? Is there anything

Congress should be doing to remove barriers or would just move it

along fine?

Dr. COLLINS. The main barrier is the one we are here to talk

about this afternoon, is this fear of discrimination and which is not

an unreasonable fear.

Mr. PALLONE. OK.

Dr. COLLINS. Obviously, we also need to be sure we have supported the medical research to know the answers as crisply as possible so that people who get this information can be given accurate

information and that is what NIH and our fellow agencies supporting medical research are committed to doing.

Mr. PALLONE. Let me ask this. I mean, basically, I think you

have answered even my second question because you say that doctors are already testing whether some of us carry gene mutation.

Well, you stated before that doctors can already test whether some

of us carry gene mutations that increase our risk for disease and

that more research will expand that capability. But how far can

you go with this? Can you offer a guess regarding what proportion

of the population would someday be able to learn about their own

inherited risk of disease?

Dr. COLLINS. I think ultimately, all of us, because we all carry

these risks. Some of us can guess what some of those are from our

family history, but not all that accurately. As we learn more and

more precisely about the DNA variance that convey those risks, we

will be able to offer much more specificity. I would see a time, if

this legislation successfully passes and if the research moves at the

rate that it seems clearly to do, where each of us, in perhaps as

little as 5 years would have the opportunity to find out what our

future risks are based on extensive DNA analysis and to be able

to alter our lifestyle, our medical surveillance, our diet, our exercise

plan to reduce the risks of the things that are highest on our list,

instead of doing this in a one-size-fits-all approach, which is our

current strategy and which sometimes works and sometimes

doesn’t.

Mr. PALLONE. And everybody has at least one gene mutation, so

everybody is going to be impacted?

19

Dr. COLLINS. Everybody has dozens of these.

Mr. PALLONE. OK.

Dr. COLLINS. There are no perfect specimens, not even in the

halls of the United States Congress.

Mr. PALLONE. So that is why this discrimination issue affects us

all and why we have to deal with it.

Dr. COLLINS. It absolutely does. We are all at risk unless we

solve this problem.

Mr. PALLONE. All right, then let me ask Ms. McAndrew; well,

this is what I wanted to ask. I know you deal with the privacy

issue. The Bush administration has issued two Statements of Administration Policy in response to the Senate passing this bill. In

both of those cases, the administration said that they favor an Act

of legislation to prohibit the improper use of genetic information in

health insurance and employment, and as recently as January 17,

President Bush said, and I quote, ‘‘I really want to make it clear

to the Congress that I hope they pass legislation that makes genetic discrimination illegal.’’

In other words, if a person is willing to share his or her genetic

information, it is important that that information not be exploited

in improper ways and Congress can pass good legislation to prevent that from happening. What I want to ask, with regard to

GINA, am I correct in assuming that you or your office agree with

President Bush and support the legislation before us today? I know

you mentioned a little bit about it, but if you could just answer

that.

Ms. MCANDREW. Yes, we are in support of the nondiscrimination

provisions of this bill and they really are beyond the scope of the

Privacy Rule, to effect, and we are in support of this legislation to

address those problems.

Mr. PALLONE. Thank you. Thank you. I yield to the gentleman

from Georgia, Mr. Deal.

Mr. DEAL. Thank you, Mr. Chairman. I am going to ask a series

of questions, Mr. Kuczynski. I am going to start with you. And I

think they lend themselves to rather short answers and I would

like to get through as many of these as I possibly can.

Under title II of H.R. 493, can the practices, actions or communications of in-house healthcare be a basis for violations under

202(a), 202(b) and 206(b) of the Act? To clarify, I mean providers

employed by an employer covered by the bill to provide healthcare

services as a benefit for employees. Examples, of course, being inhouse clinics, hospitals or universities that provide health services

to employees as a benefit of employment.

Mr. KUCZYNSKI. Yes, I think that if the employers providing

health services as a benefit of employment, that benefit of employment would be subject to nondiscrimination requirements of title

II, as it would be with respect to all of the other—it is the same

principle as would apply under any of the civil rights laws that we

enforce.

Mr. DEAL. Would the same rule apply if the employer contracted

with a doctor to provide healthcare services to an employee? In

other words, could the practices, actions or communications of such

a provider be the basis of a violation under sections of the Act?

20

Mr. KUCZYNSKI. Again, if the employer is contracting with a

third party to provide health services on its behalf, the employer

has to ensure that that provider is conducting itself and providing

those services in a manner that does not discriminate under GINA.

Again, the same is true under the Americans with Disabilities Act,

where we have said that an employer can’t do, through a third

party, what it could not do directly, so the employer would be liable.

Mr. DEAL. That would be yes, they would be considered violations of 202(a), 202(b) and 206(b) of the Act?

Mr. KUCZYNSKI. Yes, the employer could be responsible for those.

Mr. DEAL. OK. I understand that the uniformed military service

is exempt from the bill. Would the actions or communications of a

healthcare provider employed or contracted to by NASA, the FBI,

the Border Patrol or State governments be covered under the Act?

Mr. KUCZYNSKI. They would be as they are under the other civil

rights laws.

Mr. DEAL. If an employer offered to provide a service to provide

for and maintain electronic personal health records, would that activity be subject to sections 202(b) and 206(b) of GINA?

Mr. KUCZYNSKI. If that involves the provision of health services

under GINA, then the individual would have to give a prior knowing, written, voluntary consent to the provision of their services,

but yes, the employer would have to make sure that those services

were provided in a way, including maintaining the confidentiality

of that information that was in compliance with GINA.

Mr. DEAL. I take your answer, then, to be yes?

Mr. KUCZYNSKI. Yes.

Mr. DEAL. Would the same rule apply if the employer contracted

with a private company to maintain personal health records in a

storage service for their employees? If the employer provided family

medical history, for example, to be placed in such personal health

records stored at the private company, is that fact alone a disclosure and violation of section 206(b) even if the company agrees to

keep such material confidential?

Mr. KUCZYNSKI. I don’t think I understood the last part of the

question. If the employer is contracting with a third party to maintain the electronic records and there is a disclosure that would violate GINA?

Mr. DEAL. Yes. Is the fact that they are storing it, even though

they agree to make it confidential?

Mr. KUCZYNSKI. I think that the fact that they are storing it, I

don’t think would be. I think the violation would be if the information was disclosed. Again, this is assuming that the individual has

given prior knowing, written and voluntary consent to the provision

of the health services. They have done that. They can be stored, if

they are disclosed in violation of section 206, that would be a violation.

Mr. DEAL. Would the fact that they are being stored by an outside contractor make any difference?

Mr. KUCZYNSKI. No, but the responsibility for and the violation,

the liability would be the employer’s liability. The Act, as I understand it, doesn’t regulate so much the practices of the provider, be

it a healthcare provider or an entity that is storing the records, it

21

is regulating the conduct of the employer and it is saying to the

employer you are responsible for making sure that entities with

whom you contract are carrying out their functions in a way that

is consistent with the requirements of this Federal law.

Mr. DEAL. So if they contract with a private company, then any

practices, actions or communications of that private company could

be the basis for a violation under section 202(a), 202(b) and 206(b)

of the Act, is that right?

Mr. KUCZYNSKI. Well, communications that violate 206, I mean,

to the extent that there are communications that are conducted in

the normal course of business, sharing information, be it the provider of storage, if an entity is storing records or if an entity is providing health services, I think that they would be permitted to exchange information to the extent necessary to provide those health

services or to the extent necessary to store the information.

Mr. DEAL. But that would only be to the extent allowed under

206(b), is that right?

Mr. KUCZYNSKI. Well, I mean, I think there is a question as to

whether this law really is intended to disrupt the manner in which

providers of health services carry on their business. I don’t think,

for example, that it would be a violation if, in order to provide services to an individual who has agreed to have them provided, that

information was shared, let us say, from a doctor to a lab that

needed to have that information in order to carry out the health

services to which the employee had already consented. I don’t think

that GINA is inconsistent with that type of sharing of information.

Mr. DEAL. Under title II, assuming there was not a section

209(2)(b), could the practices, actions or communications of a

health plan, administered or sponsored by an employer as an employee benefit, be the basis of violations under title II?

Mr. KUCZYNSKI. When employers contract with providers to offer

health insurance, for example, on behalf of the employer, the employer is again liable if that benefit is being provided in a discriminatory way. The same would be true under title VII. For example,

if higher rates were charged to women than to men, it would be

sex discrimination or fewer benefits were offered to African Americans than to whites.

Mr. DEAL. So I take that to be a yes, then?

Mr. KUCZYNSKI. Yes.

Mr. DEAL. I would like your interpretation of section 202(b)(5)(b).

Assume that genetic monitoring is not required by Federal or State

law and the business nonetheless feels that safety requires such

monitoring. If the employee says that he does not want to be subject to such monitoring, does the employer still have the right to

reassign him away from the position that the employer feels needs

monitoring or must the employer allow the employee to continue

without the monitoring?

Mr. KUCZYNSKI. I think the monitoring under the section that

you cited has to be consented to voluntarily and if a condition of

submitting to that monitoring, if you don’t submit to the monitoring the result is going to be that your employment is going to be

adversely affected, then I think it would render the monitoring not

voluntary and would render it a violation of the section concerning

22

voluntary monitoring. Again, the same would be true in an analogous situation with the wellness program under the ADA.

The ADA says employers can offer voluntary wellness programs,

but we have said that in order to be truly voluntary, the program

can neither require participation nor penalize individuals for nonparticipation. I think in this case, if the person’s employment status was adversely affected as a result of non-consent to the monitoring, then it would be a violation of GINA.

Mr. DEAL. Dr. Collins, a reading of this statute, reference is

made to detecting a genotype. Does that reference to detecting a

genotype cover pharmacogenetic tests?

Dr. COLLINS. Pharmacogenetic tests or sometimes called

pharmacogenomic tests is one that analyzes whether an individual

has a variation that might predict whether a particular drug is

going to be beneficial, whether it would fail to help them or whether it might even cause a toxic side effect, we are learning how to

do that increasingly for an increasingly long list of drugs. This is

a test of a genotype.

Mr. DEAL. So it would qualify?

Dr. COLLINS. It would be covered under the language that is

present in GINA.

Mr. DEAL. Does the definition also cover forensic DNA identification tests, tissue typing for organ donation and paternity tests?

Dr. COLLINS. To the extent that those tests are conducted in a

way that detects genotypes, mutations or chromosomal changes,

they would qualify as genetic tests and to the extent that they were

contemplated as being used to make decisions about health insurance coverage or employment, then they would be protected under

the provisions of this bill.

Mr. DEAL. One very quick last one. My understanding is that if

someone is determined to have O or AB blood types, it also detects

that that person is an O or AB genotype. Do you agree?

Dr. COLLINS. I do. That is a circumstance where the analysis of

the AB or O protein is actually a direct correlate with the genotype

of that individual, so it is making a very precise prediction about

genotypes, so in that instance, yes, you have a circumstance where

a protein directly detects the genotype and therefore it would qualify and be protected under the provisions of this bill. I might add

that ABO blood type can be a risk factor for disease. That is not

widely known. The very first association ever reported between a

genetic variation and a disease was ABO blood type and Hodgkin’s

disease.

Mr. DEAL. Thank you, Mr. Chairman.

Mr. PALLONE. Thank you. I recognize the gentlewoman from

California, Ms. Eshoo.

Ms. ESHOO. Thank you, Mr. Chairman. I am sorry I have had to

try and divvy up my time between here, obviously the Floor and

some other things. Again, thank you to everyone that is testifying

today. We need you, we are grateful to you, and what you tell in

this part of the record is a very important part of this effort.

Dr. Collins, your testimony has cited several studies demonstrating that people are afraid of discrimination on the basis of their genetic information. In many ways, you are one of the parents of this

effort, because you pointed this out a long time ago. Can you fill

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that out and instruct the committee about the frequency of it, the

number of people refusing the opportunity to take a genetic test?

Has this grown since the mapping took place? And also, how the

fear manifests itself relative to doctors that provide the appropriate

preventive care? Because this is another area, I think, where it is

affected and at any rate, can you fill that debate out and give us

more about it? It will broaden and deepen our understanding of it.

Dr. COLLINS. I would be happy to.

Ms. ESHOO. Thank you.

Dr. COLLINS. And I should say that in the second panel, because

I have looked at the statements, Dr. Hudson will present you with

new statistics just collected in the last week or so about this public

concern based on a statistically valid survey indicating that, in

fact, something like 80 percent of the members of the public are

deeply concerned about this issue of genetic information being used

against them, particularly in health insurance, but also in employment. And that is a consistent response that we have been seeing

now over the course of some 10 years since those surveys have

been taken. I see no evidence that there is any diminution in that

concern and that is despite the fact that many States have passed

genetic nondiscrimination legislation.

Ms. ESHOO. How many States, Dr. Collins?

Dr. COLLINS. More than 40 States have either a health insurance

or an employment provision or both, but again, I think people who

have looked at that realize that there are loopholes and you never

quite know what State it might end up in a few more years. And

if you really want complete protection in this country, it ought to

be at the Federal level. So the concerns, as I mentioned, are largely

about the anxiety about health insurance in the workplace.

When you look at what this means on the ground, in terms of

how people are facing the possibility, not hypothetically, but in

their own lives about having such a genetic test, the best data we

have comes from studies we do at NIH. We invite people who have

had a strong family history of a particular condition to participate

in a research study that will involve some genetic testing. We have

done this particularly for breast cancer and we have done this for

colon cancer in families like the one I mentioned in my opening

statement.

And it is actually quite consistent and quite disturbing that

roughly one-third in each of the studies that we have done of people who otherwise wish to go through the testing, wish to have the

data, were convinced it would be useful to them to know if they

were at high risk ultimately decide not to take the test because of

this concern that the information might leak out. And this is despite our assuring them that we try to keep careful records, that

we have certificates of confidentiality and so on. This goes deep

enough that that is not reassuring.

The family I told you about is still walking around out there,

with many individuals, at high risk for colon cancer, untested because of this concern and at serious risk of having a very bad outcome and here is a condition that we know how to prevent, knowing you are at risk, getting into a screening program with

colonoscopy is life saving. In terms of what it means with health

professionals——

24

Ms. ESHOO. Can I just inject something?

Dr. COLLINS. Yes.

Ms. ESHOO. I think my colleagues, that what Dr. Collins has just

referred to, that is an extraordinary amount of fear, to not act on

the diseases that he just mentioned. I mean, imagine; people knowing that they have it, have something very serious and not exercising to do something about it because of this fear. So I just kind of

wanted to highlight that.

Dr. COLLINS. Another example of how this plays out in a very

disturbing way in medical care is individuals who decide they do

want to go through with the test but are fearful about this may do

so by using a false name. To get the results back, they may have

to tell their health provider, ask their health provider not to put

it into the record because then it might find its way into an insurer’s database and so you have a patient asking their health provider to not tell the truth about information that may be critical

for their future medical care.

What is wrong with our system if it encourages that kind of very

distressing behavior which, need I say, is bad for medical care, as

in the example I briefly mentioned in the opening statement of a

physician who ended up with metastatic ovarian cancer which

might have been detected earlier, except her provider and the radiologist who was doing the study of a particular pelvic ultrasound

didn’t know she was at high risk because she had been tested

under a false name. What a strange and sad situation.

Ms. ESHOO. Thank you very, very much.

Mr. PALLONE. Thank you. Dr. Burgess.

Mr. BURGESS. Thank you, Mr. Chairman. Dr. Collins, I am going

to assume you have genetic counselors talking to these patients?

Dr. COLLINS. Yes. And genetic counselors are absolutely critical

to convey this very complex information.

Mr. BURGESS. I don’t know. I am just internalizing this conflict

for myself. I think my fear of colon cancer would far outweigh my

fear of discrimination at any level, but that is——

Dr. COLLINS. And I agree with you and I am startled by those

statistics, as well.

Mr. BURGESS. Would your understanding of the bill that we have

before us, the bill that we are discussing, would it cover the different mutations, the chromosomal changes that would be present

in tumors, if you got, say, receptors on the breast cancer, this type

of study would be covered under this Act, is that correct?

Dr. COLLINS. So again, the way the language is written, as far

as the definition of a genetic test, this, if it is related to a manifested disease, which in this case would be a breast cancer, this

would not cover a measure on that particular thing that was of proteins or metabolites, but it would if it was a DNA test. So if you

did a per 2 analysis that was based on DNA or RNA, that would

be protected information according to the language of the bill.

Mr. BURGESS. And just to take one step back to Chairman Deal’s

question about the blood types, would the Rh factor also be protected information?

Dr. COLLINS. It would be protected information in the sense that

it detects, even though it is done as an antibody test, it detects,

specifically, the presence of a particular genotype.

25

Mr. BURGESS. I realize it is a little bit of circular logic, but would

someone be in violation of the law by putting a charge of RhoGAM

on a patient’s super bill, thereby the inference is they must have

had an RH negative blood test, but thus we have disclosed genetic

information?

Dr. COLLINS. I think one should pay close attention to this rule

of construction which says nothing in this bill should be construed

to limit the authority of a healthcare professional who is providing

healthcare services with respect to an individual to request if such

an individual or a family member of such individual undergo a genetic test, which would mean it would be entirely appropriate to

know whether a woman is, in fact, RH negative as part of their

routine OB and GYN care, which I know you are very much in

charge of, as a physician.

Mr. BURGESS. Correct, but is the act of charging for the

RhoGAM, is that an unauthorized disclosure of that patient’s RH

negative status?

Dr. COLLINS. Disclosure to whom? I am not sure I am following.

Mr. BURGESS. To the insurance company, to Sigma, Aetna, Medicaid, whoever is the third party payer.

Dr. COLLINS. Well, surely if you have any kind of genetic testing

that you are expecting the third party payer to cover, which we certainly expect third parties should cover, otherwise the advantages

of all these discoveries aren’t going to happen, that cannot very

well be a violation of this bill. The insurance company cannot request or require, but they can certainly see the information in

order to arrange for reimbursement.

Mr. BURGESS. So the insurance company would not be able to say

we need verification that patient was RH negative.

Dr. COLLINS. Yes, they can ask for proof of that, but they could

not demand or require or request it if it had not already been medically indicated. Again, I hope, in this regard that I am not treading

into territory that I, as a non-legal expert and not precisely——

Mr. BURGESS. Don’t worry about it. I do it every day.

Dr. COLLINS. All right, I will do my best.

Mr. BURGESS. It never stops anyone here. Let me just be sure

that I do, before we leave this side, let me just be sure I understand. You have the bill in front of you?

Dr. COLLINS. I do.

Mr. BURGESS. Page 15, down about at the bottom quarter of the

page where it starts out, ‘‘In general,’’ we get into the definition of

a genetic test and the language, ‘‘There is the occurrence of a disease or disorder in a family member of the individual,’’ not to be

limited to heritable genetic disease. So would that include infectious or contagious diseases within family members that would be

the subject of this legislation, as well?

Dr. COLLINS. I am not sure I have the same version, but I think

I see where you are referring to.

Mr. BURGESS. Bottom of 15, top of 16.

Dr. COLLINS. In my version it is more like 9, but anyway, I think,

yes, I am looking at the version which is offered by Mr. George Miller of California, which is the substitute to H.R. 493 that came out

of the previous committee. So the intention, certainly, of this bill

is to include family history as part of genetic information. Let me

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explain why that needs to be, because there has certainly been a

good deal of discussion about that and some of the State provisions

do not include family history.

At the present time, most genetic tests that are offered to people

in terms of giving them a risk of future illness prediction are triggered by the discovery of a family history. The family I told you

about with colon cancer wouldn’t have been offered a test, except

that there were a number of affected individuals.

If family history is not included in the definition of genetic information, then you can imagine a circumstance where a test is positive, but the family history is used as the reason to discriminate

and that would rather destroy the purpose of the whole provision

in the first place, so I think most of us who have looked at this over

now 12 years of talking about these definitions would agree that

family history absolutely has to be part of the definition. But then,

you are asking family history——

Mr. BURGESS. But what about a contagious or an infectious disease?

Dr. COLLINS. So again, infectious diseases do have hereditary

contributions in terms of potential risk. Interesting anecdote. In

those individuals in Asia, for instance, died of avian flu, there are

some examples where in one household more than one individual

has dies. You have yet to see an example where both spouses have

died, but there are many instances of a child or siblings. That tells

you there is some genetic contribution to susceptibility to flu. We

know that is true of many other infectious diseases.

So I don’t think it is possible to absolutely draw a bright line between what is an infectious disease with no genetic component and

what is a genetic component for another type of disease, so I think

the language that is in here basically covers the circumstances. I

can’t imagine, although, if you were interested looking at a circumstance where an infectious disease was placing an individual at

risk because it was occurring around them, but you would limit

that examination to family members.

Mr. BURGESS. Just one last question on this subject. Would that

meant that data would have to be segregated from the balance of

the patient’s clinical data?

Dr. COLLINS. No, the only segregation, as I understand it in this

bill, of separate information relates to employer records.

Mr. BURGESS. OK. Ms. McAndrew, let me ask you a couple of

questions, if I could. Currently, health plans in the country are

subject to the Privacy Rules under HIPAA, is that correct?

Ms. MCANDREW. That is correct.

Mr. BURGESS. And the HIPAA Privacy Rule recognizes that there

are a number of important uses and disclosures of information by

health plans that are necessary for payment purposes and to conduct normal business operations. Fair statement?

Ms. MCANDREW. Yes.

Mr. BURGESS. Does title I of H.R. 493 alter in any way the ability

of the health plans to use and disclose information, including genetic information for normal payment and normal business operations purposes?

Ms. MCANDREW. We would need to take a close look. It would not

appear that, with regard to claims processing, that there is any afVerDate 11-SEP-98 09:47 Mar 27, 2008 Jkt 000000 PO 00000 Frm 00032 Fmt 6633 Sfmt 6633 Q:\DOCS\110-15 SCOM1 PsN: SCOM1
27

fect on title I, from title I on that activity. It does, however, prohibit the use of genetic information for other types of activities for

which the Privacy Rule currently allows a health plan to engage in

with regard to other types of protected health information, such as

premium rating, enrollment and determination of eligibility for

benefits. Those would become discriminatory uses under title I and

prohibit the use of genetic information with regard to those particular purposes.

Mr. BURGESS. So it would prohibit the disclosure of that information?

Ms. MCANDREW. It would prohibit the use of, by the health plan,

of genetic information for those purposes.

Mr. BURGESS. OK, just going back to my RhoGAM example, is

that a concern here?

Ms. MCANDREW. To the extent that information was submitted

to the health plan for a payment purpose, it would not appear to

be an impermissible use under this bill, but if it were——

Mr. PALLONE. Doctor, we have got to move on. We are over almost——

Mr. BURGESS. Mr. Chairman, let me, if possible, since this is so

important that we get this legislation, because I told Dr. Collins he

is moving really fast with his science, and I am glad he is, and we

move really slow up here and anything we——

Mr. PALLONE. Twelve years, to be specific.

Mr. BURGESS. Anything we do is going to be that way for the rest

of our natural lifetimes, so would it be permissible to submit questions in writing?

Mr. PALLONE. Oh, absolutely.

Mr. BURGESS. OK.

Mr. PALLONE. Any Member can submit questions.

Mr. BURGESS. Thank you, Mr. Chairman.

Mr. PALLONE. Thank you. Mr. Green.

Mr. GREEN. Thank you, Mr. Chairman. I want to follow up my

colleague from Texas’ question, Ms. McAndrew, although, Dr. Collins, I have questions for you, too, but following that line of questioning, it would be impermissible use. My concern is if the information is available, it is very difficult to find out why they denied

someone coverage and maybe some States, because my experience

in dealing with health insurance in the State of Texas, for example,

if you are denied coverage for an individual policy, now, group policies have protections, but for individual, but if it is even provided,

there might be some other reason they would deny coverage. Is

there a concern on that?

Ms. MCANDREW. As I understand the way this is structured, I

don’t think it would be any different than the current HIPAA title

I prohibitions with regard to the use of genetic information for

some health plans and to prohibit discrimination and discriminatory policies with regard to that. That does not bar the health plan

from obtaining this information and much of this information, as

was indicated earlier, may need to come to the health plan in order

for them to adequately, to pay for the services that these individuals need in getting these genetic tests. I think the proper limitation is on the misuse of that information for this nondiscriminatory

practice.

28

Mr. GREEN. But again, the misuse of it, how do you prove that

in a court of law or if you even get to the court? Because in so

many cases if a claim is denied and they happen to know that information that your genetic background is diabetes, for example,

and the claim is denied, maybe, because that was a preexisting

condition, but that is my concern and I share Dr. Burgess’ concern

about that.

I am concerned about disclosing it, period, because I think families who have the fear of the disclosure would say well, it is hard

for me to get insurance, anyway, and if that information is available, no matter what they use; they may use something else. We

are not underwriting in your zip code or you are blocked or something like that, that is not discriminatory.

Mr. Chairman, I want to make sure that our final draft, whatever comes out, that we look at that issue—that disclosure is a concern not just that they are prohibited from using that information.

I think it ought to be prohibited use, but I also think the disclosure

is something that families will still be afraid of disclosing that to

health plans.

Dr. Collins, some people express concern that the legislation singles out genetic information as being fundamentally different than

other types of health information. This is called genetic

exceptionalism. What is the justification for treating genetic information differently than some other health condition?

Dr. COLLINS. That is a very appropriate question because obviously, we don’t, by doing something that is really needed here. We

try to provide protection for something the public is quite concerned about, mainly genetic discrimination. We don’t want to

somehow set genetic information into this area that sounds even

scarier than any other type of medical information and yet, it is

different in certain ways.

I have this mantra of the six P’s that make genetic information

separate from other types of medical information. No single one of

these would qualify, but you put all six together and you can see

there is something different here, so let me try my six P’s out on

you. What is it about genetic information? It is predictive. It says

something about what might happen in the future while you are

still well. It is prejudicial. It is the kind of information that can be

used against you. That is why we are all here this afternoon. It is

permanent. Your DNA is going to be your DNA while you are here.

It is not like your blood cholesterol or your serum sodium that

might change next week. It is what it is.

It is, this is a littlie bit of a stretch, pedigree relevant. That is

to say it affects not only you, but your relatives and what you find

out about yourself may shed light on your kids or our parents or

your siblings. It is, in the view of most people, personal. There is

something about DNA, our own instruction book, that is a little different than saying well, my white blood count today is 5600.

And finally, and attached to that personal is most people think

it should be private. It is not the sort of thing you want on the

Internet or the front page of the Post. So you take those six things

together and you can see that genetics fits into all of those and

other types of medical information doesn’t quite create that same

29

sense of specialness and hence, the appropriateness, I think, of trying to provide special protection.

Mr. GREEN. Thank you. Mr. Chairman, I know I have run out

of time, but I have just one question I would like to throw out to

take a yes or no to Mr. Kuczynski of the EEOC. I know the previous chairman of the EEOC expressed support for this legislation.

Is the current chairman, Naomi Earp, is she also in support of this

legislation from the EEOC?

Mr. KUCZYNSKI. I believe that the chair is in support of legislation that would prohibit the type of genetic discrimination that I

have described in my opening statement, yes.

Mr. GREEN. OK. Thank you, Mr. Chairman.

Mr. PALLONE. Thank you. Mrs. Myrick.

Mrs. MYRICK. Thank you, Mr. Chairman. And my question is for

Dr. Collins and first of all, thank you for the fine work you have

done. It really is very exciting and we have all come a long way

because of it. But I wanted to ask about clinical trials because I

understand one of the goals of the bill is to try and remove unnecessary barriers to participation in clinical trials and I know a lot

of times that scientists have told me they have trouble getting people to participate in clinical trials; it is difficult.

As you mentioned, people are scared that some of their genetic

information about disease will be made known to their insurer or

their employer and so I am curious why the bill doesn’t explicitly

mention that genetic disease related clinical trials are covered

under the nondiscrimination umbrella and I wanted to ask you if

you see this as a potential problem?

Dr. COLLINS. So certainly, we would not want anyone who is contemplating participating in a clinical trial to have this fear of discrimination to be a deterrent. We depend on people’s generosity

with their time, with their very lives, to take part in these trials

so that we can advance the course of medicine. I think when it

comes to this specific area of genetics, however, the provisions of

this bill largely make that a non-issue in specific ways, because the

bill does, after all, comment upon whether, in fact, one may allow

the use of genetic services, the request or receipt of genetic services, to be used to discriminate and the bill specifically says no.

H.R. 493 says that is not permitted. Genetic services are defined

in the bill as (A) a genetic test; (B) genetic counseling; and (C), genetic education. Those three things are all part of the kinds of clinical trials that we currently conduct that involve genetics, so anyone who is part of such a trial has essentially, then, received genetic services and those may not be used, according to the language

in this bill, as a means of discrimination. So I grant you, the larger

question of clinical trial participation may need attention, but in

the specific instance of genetics, the language that is in this bill appears adequate to cover that situation.

Mrs. MYRICK. So you feel it is covered, without question, in the

bill, that people are protected?

Dr. COLLINS. The genetic component of clinical trials, yes.

Mrs. MYRICK. OK. Thank you very much. Ms. McAndrew.

Ms. MCANDREW. Yes.

30

Mrs. MYRICK. A couple questions here. For entities that are covered by HIPAA Privacy Rule, how long is the list of permitted disclosures?

Ms. MCANDREW. We have, first, identified those disclosures that

are core to the business of providing treatment and getting that

treatment paid for and as I mentioned, the first carve-out from the

need for an individual written authorization in order to use information or disclose it to others is for treatment, payment and

healthcare operation purposes. And that permits the ready use of

this information for its intended purpose, to treat the individual,

get that treatment paid for. Outside of that, we do have a number

of other public purpose disclosures.

Mrs. MYRICK. Like what? I mean, what would you——

Ms. MCANDREW. We have, for instance, we would permit a disclosure as required by other law. We would permit a disclosure of information for public health purposes. There is an exclusion for

health oversight activities. There is an exclusion for judicial and

administrative proceedings. There is an exclusion for research.

Now, all of these come with their own separate list of conditions

and other protections before an entity is permitted to release identifiable information for any of these purposes. But the basic balance is that the need for the information for these important public

purposes overrides to one degree or another the necessity to get the

individual’s prior written permission before that disclosure is made.

Mrs. MYRICK. Well, if we enacted a broad prohibition on the use

and disclosure of information by employers, in your experience with

implementing HIPAA rules, do you foresee any issues that would

arise from the obstruction or the routine flow of information? Is

there anything that would be a potential problem?

Ms. MCANDREW. Well, I think the balances would need to be

worked out. I don’t have any particular expertise with regard to

what the normal practices would be in an employment setting. The

HIPAA balances were all structured in the healthcare delivery and

healthcare payments study and were really restricted, in particular, to that need for the information and the collection of health information in the first place. And so looking at any other sector,

whether it is the business sector, and I think employment may be

particularly complicated only because of such a wide range of businesses that would, that are employers whose need and legitimate

need for the information would need to be weighed and balanced.

Mrs. MYRICK. I appreciate it. Thank you, Mr. Chairman.

Mr. PALLONE. Thank you. Mrs. Capps.

Mrs. CAPPS. Thank you, Mr. Chairman, and thank you to each

of our witnesses for their testimony. Many of us are here in this

hearing because of our concern that the public’s fear of getting tested for genetic conditions may interfere with taking full advantage

of what genetic testing has to offer in terms of prevention, early detection, early treatment. Perhaps, however, we assume that the

public understands exactly what this is and what it might involve.

To start us off, Dr. Collins, you are a physician as well as a geneticist. You gave some compelling illustrations of colon cancer and

understanding the gene in the role that it could play. Perhaps, for

the record, you would start us off with just briefly mentioning a

31

couple of other situations that might indicate the purpose for this

hearing.

Dr. COLLINS. I appreciate the opportunity to do so. So certainly,

the colon cancer example is one where we already know that interventions can be life saving. That list, though, is growing. Certainly,

with breast and ovarian cancer, the BRCA1 and BRCA2 genes,

which, if misspelled, can confer a rather high risk of both of those

cancers, are now at the point where there is clear evidence that

knowing your status can, in fact, improve your likelihood of longterm survival and that has now been implemented in the hands of

many healthcare providers.

And yet, I just read a report that came from this past weekend’s

Society of Gynecological Oncology, that only a tiny fraction of

women who are at risk, based on their family history, are actually

taking advantage of that test, a really frighteningly small number

are doing so. That particular study did not investigate why, but I

know from everything we have been able to document at NIH, that

discrimination and the fear of it has certainly been a major factor

in that.

Other types of tests, certainly we are learning more and more

about this business of how to identify risks of a bad drug reaction,

which could be, in fact, very important in preventing some of those

outcomes. There is a particular drug that is used to treat children

with leukemia, six-mercaptopurine. If you are one of those one in

300 kids that has a particular misspelling of the gene that coats

for the enzyme that metabolizes that, then this drug, instead of

helping cure your leukemia, could actually be fatal.

We now know how to test for that and so it is possible to do so

before administering the drug. In fact, produces even better than

that. Those kids that have that particular situation can still receive

the drug, but at one-tenth the dose and they still have a very high

likelihood of being cured of their disease. You can imagine that

that kind of test might be seen by some as a risk factor, might

therefore end up being utilized in ways that we all would find inequitable and unjust.

And there are other examples in terms of drug testing. The drug

that is given for blood clots, something that we have been reading

about in terms of a high number of the administration this week,

warfarin, which is used in millions of people, is also one of those

that has a lot of side effects. We are on the brink of figuring how

to predict those and being able to offer a test prior to administering

the drug to reduce that risk. Other tests for diabetes are coming

along fairly quickly. A lot of things happening there in terms of understanding hereditary risks.

Mrs. CAPPS. Thank you. And we could go on and on, I know.

Dr. COLLINS. I probably would if you didn’t stop me.

Mrs. CAPPS. In the next 1 minute and 45 seconds, I want to get

to people not getting tested. This also has a effect on their own

healthcare. But mention, if you would, some ways that it would

also inhibit biomedical research and clinical trials, because it

means fewer people will volunteer for clinical research and individuals there will not be tested for preventable disease. And if you

have a second at the end, if you would, talk about the need to include family members, as well as the individual patient.

32

Dr. COLLINS. Great questions. Already at NIH, this is a serious

issue. We are at this point in medical history where we have the

opportunity to discover what really are the genetic and environmental causes of illness. In order to do that, we need to have individuals willing to volunteer to have their environment studied and

their genetics studied. And if fully a third of the people who otherwise want to participate walk away, then we have lost out. We

have lost out in a way that is bad for them and bad for us.

And especially, as you say, in circumstances where you are trying to look especially at heredity, you are very interested in enrolling families so that you can see how a particular genetic variation

has passed through the family and conveyed a risk or sometimes

a protection against disease and if even some members of the family are afraid of discrimination, then the whole family may end up

not participating and we lose out. We lost out, as a country, on the

opportunity to learn more. We could take care of that. Thomas Jefferson’s words on the Jefferson Memorial over there, ‘‘Our laws and

institutions should keep pace with the progress of the human

mind.’’ Here is the opportunity to make that happen.

Mrs. CAPPS. What a wonderful statement. Thank you very much.

Dr. COLLINS. His words.

Mr. PALLONE. What a great way to conclude this panel. Thank

you, Doctor. Thanks to all of you. I think we have finished with the

questions, but this really was a fascinating exercise to listen to all

of you and obviously made the case very well for why we need to

move legislation, so thank you again. I appreciate it.

I would ask the next panel to come forward.

There are seven of you, so we are going to ask you to try to keep

your comments to the 5 minutes,if you see the red light, please try

to summarize and end because otherwise, we will be here all night.

Let me welcome you all and introduce all of you to the committee.

We have Ms. Sharon Terry, who is the chair of the Coalition for

Genetic Fairness and president and CEO of the Genetic Alliance.

We have Dr. William Corwin, who is medical director, Clinical Policy for Harvard Pilgrim Health Care. And then we have Mr. Burton

Fishman, who is with Fortney and Scott. And then we have Ms.

Pollitz, who is a research professor at Georgetown University

Health Policy Institute; Mr. Frank Swain, senior vice president,

B&D Consulting and former chief counsel, Advocacy at the United

States Small Business Administration.

Ms. Janet Trautwein, executive vice president and CEO of National Association of Health Underwriters. And last, Dr. Kathy

Hudson, who is director of the Genetics and Public Policy Center

and associate professor of the Berman Institute of Bioethics of the

Institute of Genetic Medicine, Department of Pediatrics at Johns

Hopkins University.

Thank you all for being here and we will start with Ms. Terry.

STATEMENT OF SHARON TERRY, CHAIR, COALITION FOR GENETIC FAIRNESS, AND PRESIDENT, CHIEF EXECUTIVE OFFICER, GENETIC ALLIANCE, WASHINGTON, DC

Ms. TERRY. Chairman Pallone, Representative Deal, and members of the subcommittee, thank you for bringing us to this moment

and for the opportunity to testify here. Representatives Eshoo,

33

Slaughter, Biggert and Walden demonstrate robust vision and

courage to introduce again the legislation that will make it possible

for Americans to benefit from new technologies and tests. My name

is Sharon Terry. In some way, I am the least qualified person to

appear before you. I don’t have the professional qualifications of

those who testified today. And in other ways, I am the most qualified. I represent millions of Americans affected by genetic conditions.

I am president and CEO of Genetic Alliance, a coalition of more

than 600 disease support groups and I am the chair of the Coalition for Genetic Fairness. Mine is not a chosen profession. It is a

vocation thrust upon me when my children were diagnosed with a

genetic condition that will rob them of their vision in the prime of

their life. Quite poignantly, the Genetic Information Nondiscrimination Act of 2007 will not protect my children nor the millions I officially represent. They all have manifest disease and this

bill appropriately does not protect them. This is a critical point

often obscured in many of the arguments against the legislation.

The bill is not about those who already have signs or symptoms

of disease, but rather about those who carry a genetic mutation

which increases their chances to develop a disease. Though my

family will not benefit, I have worked on this legislation for 12

years, since Congresswoman Slaughter first introduced it. With

others present here, I founded the Coalition for Genetic Fairness

to support this legislation and we have had a long and uphill battle. We are several hundred organizations strong and include many

sectors of our society, including disease support groups, health professional organizations, women’s leadership groups, labor groups

and most significantly, companies like Affymetrix, IBM and 20th

Century Fox. We thank them and those of you, who year after

year, have supported this legislation. We have compromised and

conceded a great deal during these years and we believe the bill

before you is fair and well-balanced.

My passion for more than a decade has been fueled by the faces

and the voices of the hundreds of individuals who have contacted

us, fearing for their children, their lives, their jobs, their insurance;

men, women and children, families from communities all across

this country, who have told us their stories and in some cases,

pleaded for us to help them.

In 2003, Heidi Williams of Kentucky called me when her children

were denied insurance by Humana, Incorporated. Heidi has alpha–

1 antitrypsin deficiency, an autosomal recessive genetic disease.

Humana rejected the children’s application stating that the children were carriers and so they could not cover them. With our

help, Heidi explained in an appeal that carriers are not affected,

but Humana again denied the insurance. I called a reporter from

a prominent national newspaper, they called Humana and that

night Heidi’s children were covered retroactively.

Some families are not lucky enough to have a connection with

our coalition or a reporter to help them. This year, Heidi’s daughter

wrote a letter to her Congressman.

Dear Congressman Ron Lewis, My name is Jayme Williams and I am in the fifth

grade and live in Cecilia, Kentucky. My brother and I are carriers of alpha–1

antitrypsin deficiency, a defective gene in our DNA that can be passed on to our

34

future children. While my brother and I have only one defective gene, my mother

was given two and her lungs are very sick. My brother and I were denied health

insurance because we carry these mutations. My mom tells our story because other

people are too afraid to tell theirs. Discrimination makes people very afraid. When

people are discriminated against, they are sometimes told they will lose something

they need if they speak out against the people causing the discrimination. My mom

says that everyone is created equal and deserves to be fairly treated. Please help

my mom.

Let resonate these heart-felt words from a young woman who

cannot imagine that carrying a mutation in the gene makes her uninsurable. I assured her that we will continue to work hard for her.

I am also reminded of Becky Fisher, who shares a mutation for

inherited breast cancer with many in her family. Having watched

her mother, aunts and cousins die of breast cancer and she, herself,

a survivor, she thinks only of her daughter, who is brave enough

to be tested and says of her, ‘‘One of the not-so-good things of having a documented genetic mutation makes her more vulnerable to

more than devastating disease. She also faces the burden of never

knowing when she will legally be asked to take a genetic test as

a condition of employment or lawfully fired from a job because of

high costs of medical care or denied health insurance.’’

We are all Heidi and Becky’s children. We all carry mutations for

dozens of diseases and we are all vulnerable. Aren’t health and disease enough to worry about? We cannot afford to also worry about

discrimination based on these mutations, silent mutations with no

signs or symptoms. This is simply about preventing misuse of genetic information, that which makes up every one of us, our shared

inheritance, and that which makes us unique.

This is also about special interests. Let us put the special interests of health of all Americans above all else. Every one of you and

each of your loved ones is at risk for some disease or another. We

cannot yet easily reduce that risk, but it is in your hands to reduce

the risk of discrimination associated with that information. At the

end of the day, we are relying on you to make it possible for individuals to use their genetic information for the health purposes for

which it was intended.

Some might say that Dr. Collins and his colleagues have done

the hardest work, but we understand that balancing the policy

needs of the Nation is difficult. You are pushed and pulled in many

directions. Please measure your decisions by what truly matters

when voting in committee and the full House floor in the next

weeks. Please remember that neither you nor any of us have any

choice over our ancestry, our different abilities, our genetic makeup. As a nation, we do have a choice.

Every American is affected by this legislation and beyond the

health insurance companies, the trade associations and the employers’ needs, all those who carry genetic mutations, they did not ask

are asking you to take the necessary measures to alleviate the burden of discrimination that this places on our nation. I have faith

and hope that you will choose to relieve their burdens, my burdens,

your burdens. I look forward to your good work in the weeks ahead.

Thank you.

[The prepared statement of Ms. Terry appears at the conclusion

of the hearing.

Mr. PALLONE. Thank you, Ms. Terry. Dr. Corwin.

35

STATEMENT OF WILLIAM CORWIN, M.D., MEDICAL DIRECTOR,

CLINICAL POLICY, HARVARD PILGRIM HEALTH CARE,

WELLESLEY, MA

Dr. CORWIN. Mr. Chairman, Mr. Deal, members of the subcommittee, my name is Dr. William Corwin. I am the medical director for Harvard Pilgrim Health Care, which is a not-for-profit

health plan that provides insurance plan options to more than a

million members in Massachusetts, New Hampshire and Maine.

Harvard Pilgrim has been named the No. 1 health plan in America

for 3 consecutive years. This is according to a joint ranking by the

U.S. News and World Report and the National Committee for Quality Assurance. I appreciate this opportunity to testify on behalf of

America’s Health Insurance Plans, which is a national association

for representing nearly 1300 different insurance plans providing

coverage to more than 200 million Americans.

Health insurance plans are working on a daily basis to promote

the appropriate use of genetic tests to help clinicians and patients

make informed healthcare decisions and improve health outcomes.

We agree with the sponsors of H.R. 493 that healthcare consumers

should not face discrimination on the basis of their genetic makeup

and that genetic information should be protected from unauthorized disclosure. Our policies and programs reflect this belief. We

have submitted written testimony that focuses on three broad

areas: examples of how health insurance plans are promoting the

appropriate use of genetic tests to improve patient care; opportunities for improving H.R. 493; and our support for the strong protections with respect to non discrimination, confidentiality of this genetic material.

In the next few minutes I would like to provide some examples

of how health insurance plans are promoting the use of genetic information to help our enrollees receive the highest quality, evidence-based care possible. And I also will briefly comment on H.R.

493.

Through early detection that we have heard about earlier, disease management programs and other quality improvement initiatives, we are working to identify individuals who can benefit from

early intervention and evidence-based treatment for these specific

illnesses and diseases. Genetic information, including the results of

genetic tests, is just one of the more sophisticated sources of data

that clinicians and the health insurance plans are using to ensure

that our patients receive appropriate preventive care, a coordination of services and early treatment for these medical conditions.

I would like to highlight two specific examples of how genetic

tests are being used to improve patient care. In February 2007, the

Food and Drug Administration approved a new genetic test called

a MammaPrint, which indicates whether a woman is likely, with

breast cancer, to relapse earlier than otherwise predicted. This test

allows physicians to tailor therapy for individual patients and administer chemotherapy to only those patients who would benefit.

At the same time, the test allows physicians to identify patients

who would not benefit from chemotherapy and avoid unneeded

chemotherapy or risky and costly treatment.

Another test that we heard about earlier, the Cytochrome P450

enzymatic test is genetically coded. The identification of the presVerDate 11-SEP-98 09:47 Mar 27, 2008 Jkt 000000 PO 00000 Frm 00041 Fmt 6633 Sfmt 6633 Q:\DOCS\110-15 SCOM1 PsN: SCOM1
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ence or absence of this genomic marker enables a physician to

evaluate a patient’s ability to process many different kinds of medications, adjust doses intelligently, and to avoid potential adverse

drug reactions in patients who either metabolize a drug too quickly

or do not metabolize that drug at all well. This test also is used

to determine how children with certain forms of leukemia will respond to various doses of chemotherapy. Health insurance plans

may request that this test be performed before authorizing a course

of therapy to ensure that the appropriate care, evidence-based care,

is being provided to meet the patient’s best individual patient centered needs.

Health insurance plans are also using genetic test results to promote preventive screening, disease management programs and

other programs to help improve healthcare for individuals who

have tested positive for a genetic disease or who have a family history of a specific disease or condition. For example, individuals who

have the gene for the familial form of colorectal cancer, can receive

coverage for more frequent preventive screenings. Physicians can

receive reminders that these screenings need to be done.

As scientists acquire a greater understanding of the role genes

play in disease and develop more targeted therapies and treatments and possibly even cures, preventive screening and disease

management programs can be tailored to improve outcomes for our

individual members. These therapies will become even more important in the future. We appreciate the interest many subcommittee

members have shown in passing additional legislation addressing

the use and disclosure of genetic information. As you do so, we urge

you to fully evaluate the implications of any additional requirements or prohibitions and to ensure that the new legislation does

not unnecessarily restrict the use of information needed to promote

appropriate healthcare decision making.

Working with AHIP, our industry association, we have reviewed

H.R. 493 and identified several areas where we believe changes are

needed to ensure that genetic information is available to health

plans so we can continue to assure appropriate coverage decisions.

Mr. PALLONE. Dr. Corwin, I know you still have a lot left, so if

you want to summarize a little bit? OK, thanks.

Dr. CORWIN. Targeting the programs to improve quality of patient care. We do not oppose the bill. We agree with its intent.

However, once enacted, there will be a variety of interpretations

about the bill and how its requirements would apply in various settings. To avoid any confusion, health insurance plans would like to

encourage the subcommittee members to assure that statutory language clearly reflects your intent for enacting this legislation.

Thank you.

[The prepared statement of Dr. Corwin appears at the conclusion

of the hearing.]

Mr. PALLONE. Thank you, Doctor. Mr. Fishman.

STATEMENT OF BURTON FISHMAN, FORTNEY & SCOTT, LLC,

WASHINGTON, DC, ON BEHALF OF THE GENETIC INFORMATION NONDISCRIMINATION IN EMPLOYMENT COALITION

Mr. FISHMAN. Chairman Pallone, Ranking Member Deal, distinguished members of the subcommittee, present and absent, thank

37

you for this opportunity to testify on H.R. 493 and the issue of genetic nondiscrimination in the workplace. I am honored to be here.

My name is Burton Fishman. I am of counsel to the Washington,

DC law firm of Fortney & Scott, and I appear before you on behalf

of the Genetic Information Nondiscrimination in Employment Coalition, the GINE Coalition, mainly of employers.

Let me be clear. The coalition strongly supports genetic nondiscrimination and confidentiality and believes that employment

decisions should be based on an individual’s qualifications and ability to perform a job and on characteristics that have no bearing on

job performance. As a result, the coalition supports the goals of this

bill. We commend the help of the subcommittee for the important

changes it has made and we hope to continue working with this

subcommittee, with all Members of Congress, to make genetic discrimination legislation effective, administratively efficient and

practical. I have submitted a lengthy statement and I do not intend

repeating it and I will focus my comments on the few issues the

coalition regards as significant.

When testimony was given on a prior version of this bill in 2004,

it was noted, at the time, over 30 States had passed genetic discrimination laws covering scores of millions of people. At that time,

not a single case had been brought under any of those laws, let

alone a violation being formed. That is still true today. Mr.

Kuczynski should have pointed out that the Burlington Northern

case was vigorously and successfully enforced under current existing law. We believed then and now that this bill is a remedy in

search of a problem.

In light of that and because of the breadth of its definitions and

the unintended intrusions this bill will impose on employees, employers, healthcare providers and health insurers, we ask you first

to do no harm. We do not want a law that imposes real burdens

and actual costs based on distant, contingent eventualities or the

inadvertent and innocent conduct of any employer. We share the

concerns of Representative Cubin, that we do not want a law that

makes knowledge illicit rather than one focused on illicit conduct.

We do not want a bill that regulates the flow of information rather

than the misuse of information. And I raise these points because

the proposed bill could be improved by greater attention to the implications of its various provisions.

As currently drafted, H.R. 493 creates protections for genetic information that far exceeds those for personal health information

under HIPAA. We do not understand why information relating to

distant, contingent eventualities requires protections greater than

those for existing medical problems. We do not understand why a

separate protective program needs to be invented and mastered

after employers have labored so long to put HIPAA and privacy

programs into place.

Further, the protective program of H.R. 493 does not promote

sound public policy. As we have heard, unlike the HIPAA privacy

regulations, there is no general exception for disclosures for treatment or disclosures to private and treating physicians, to unfolding

police investigations, to identify a victim of a crime or a criminal,

to Government officials investigating something other than compliVerDate 11-SEP-98 09:47 Mar 27, 2008 Jkt 000000 PO 00000 Frm 00043 Fmt 6633 Sfmt 6633 Q:\DOCS\110-15 SCOM1 PsN: SCOM1
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ance with this law; you can’t even talk to your own litigating counsel under GINA. These exceptions should be incorporated here.

As we have heard again, from Dr. Burgess and others, the definition of genetic information in H.R. 493 dispenses with predictive

genetic information or even a relation to an inheritable disease. In

its place, we have a definition that is so broad as to, and I quote,

‘‘The occurrence of a disease or a disorder in family members of the

individual.’’ That’s unquote, without any limitation. We share Dr.

Burgess’ concern that Congress did not intend to have colds, flus,

upset stomachs and chicken pox as part of this bill, but as it is

written, it does. The definition of genetic information should be

limited to predictive genetic information associated with the disease that is not symptomatic at the time of testing.

In the bill, genetic information acquired pursuant to some laws

is permitted, whereas that same limitation does not occur for others. For example, you can get information from FMLA certifications

or Workers’ Comp, but you can’t do so from ADA accommodation

or helping people get their health insurance, which are far more

likely sources of that information. There should be an exception

permitting the acquisition of all such information, if collected pursuant to law and retained in confidential files. As our position is

the information should not be the issue, the misuse of the information should. I know I have run out of time, so I will end here,

thanking you again for this opportunity. I am looking forward to

answering your questions.

[The prepared statement of Mr. Fishman appears at the conclusion of the hearing.]

Mr. PALLONE. Thank you, Mr. Fishman. Ms. Pollitz.

STATEMENT OF KAREN POLLITZ, RESEARCH PROFESSOR,

GEORGETOWN UNIVERSITY HEALTH POLICY INSTITUTE,

WASHINGTON, DC

Ms. POLLITZ. Thank you, Mr. Chairman, Mr. Deal. It is a pleasure to be here today. I am Karen Pollitz and I am an adjunct professor of public policy at Georgetown and I direct research on private health insurance at Georgetown’s Health Policy Institute. And

I would like to focus my remarks today on the insurance provisions

of H.R. 493 of GINA and say a word about what genetic discrimination in health insurance means. If you haven’t yet, I would encourage you to read the appendix to my friend, Janet Trautwein’s testimony. It is very excellent, it is very thorough and it explains how

health insurance works and how it is provided and the whole process of applying for it. And as you read through that, it is pretty

lengthy and complete, you won’t see the word discrimination in

there. You will see words like correct pricing of policies and accurate assessment of risk. And that is because certain practices that

GINA would prohibit are legal today and commonly employed, especially in the individual health insurance market.

A key concept in medically underwritten health insurance is really a deal between consumers and the health insurer. The consumer

promises to pay a premium and in return, the health insurer promises to protect the consumer against the costs associated with unknown future medical risks. And the medical underwriting process

is the process that insurers use to sort out what are the risks that

39

are already known and that won’t be covered under the policy.

Medical underwriting is somewhat controversial. Janet and I have

had some good fights about it over the years. Some people think

it is justified and some people would rather see it go away.

Gradually, the States and the Federal Government have limited

medical underwriting practices, much more so in group coverage,

much less so in the individual market. But I would make a prediction that it is safe to say its days are numbered. As Dr. Collins

has testified, eventually all of us are going to know what our future

risks of medical and health problems are going to be, so the concept

of unknown future risk is eroding and eventually we are all going

to be uninsurable. So then I think we are going to have to figure

out something else.

For today, though, GINA would protect discrimination in health

insurance based on genetic information and for all the good reasons

that you have heard today. I want to tell you a little bit just about

how medical underwriting works and how insurers could come to

discover this information and of course, people applying for coverage and then tell you about the results quickly of a research

project that my colleagues and I just completed.

In the individual market, first, not that many people have individual health insurance. On any given day, most of us get coverage

at work and then the next largest source of coverage for people

under the age of 65 is the Medicaid Program. So only about 5 percent of the population in any given year has individual health insurance. But we move through it a lot as we are ineligible for those

other more common sources of coverage, so over a 3-year period,

one in four adults will try to get individual health insurance. They

won’t all succeed because, for many reasons, but including the fact

that it is medically underwritten.

When you apply for medically underwritten health insurance,

you have to fill out an application and answer a lot of questions

about your health status and depending on how you answer them,

the insurer may ask for additional information about you and investigate more carefully your medical history. All applications for

individual health insurance has a waiver that you must sign that

gives a complete and total access to any and all medical records

about you to the health insurer, so if you answer yes to a question

have you ever had this or has someone in your family had that, the

insurer may then ask for your medical records and begin to dig a

little more.

And it is in the course of this digging for additional information

that insurers may come across your genetic information because

there it is in your medical record. Underwriters tell me that, on average, about 20 percent of applications involve a request for additional information and looking through your medical records. So

this is information that is discoverable today by health insurers.

We, as I said, studied medical underwriting practices in the individual market in response to genetic information. It is hard to examine in practice because not that many people have undergone

testing, so what we did, in our project, was we asked individual

health insurers to medically underwrite some hypothetical applicants and we presented them with four pairs of applicants. And the

pairs were pretty much identical, except one in each pair had unVerDate 11-SEP-98 09:47 Mar 27, 2008 Jkt 000000 PO 00000 Frm 00045 Fmt 6633 Sfmt 6633 Q:\DOCS\110-15 SCOM1 PsN: SCOM1
40

dergone genetic testing and gotten a positive result, so that we

were trying to sort of separate how would you behave with respect

to this applicant based on this one thing that is different, their

positive genetic test results.

In seven instances, five of the 23 responding companies said that

they would take an adverse action based on genetic information.

They would deny coverage or they would surcharge premiums or

they would exclude coverage permanently, using an exclusion rider

for the genetic information and basically call that a preexisting

condition. We then went back and asked underwriters what actions

they would take based on an applicant’s receipt of genetic services.

The GINA legislation also protects genetic services, which includes

counseling of patients about what steps they might be able to take

to reduce the risks that they learn that they have inherited.

Specifically, we asked the insurers again, would they consider an

applicant who had a BRCA1 mutation whose doctor had discussed

or——

Mr. PALLONE. Ms. Pollitz. I am sorry.

Ms. POLLITZ. I will wrap it up.

Mr. PALLONE. Yes.

Ms. POLLITZ. I just wanted to let you know that 13 underwriters

responded to this question. Five said that they would take an adverse action based on this woman having been told about risk reduction options and 10 out of 13 said if her doctor had recommended any, that they would turn her down, charge her more

or exclude preexisting conditions.

I would just conclude by saying that Congress and 43 States

have already acted to limit discrimination based on genetic information to some extent, but the protections that are out there vary,

they are not complete and a comprehensive Federal law that addresses all three of the ways that insurers can discriminate based

on genetic information is important to have. Thank you.

[The prepared statement of Ms. Pollitz appears at the conclsuion

of the hearing.]

Mr. PALLONE. Thank you very much. Mr. Swain.

STATEMENT OF FRANK SWAIN, SENIOR VICE PRESIDENT, B&D

CONSULTING, WASHINGTON, DC

Mr. SWAIN. Thank you very much, Mr. Chairman, Mr. Deal. I appreciate the invitation. This is a piece of legislation that I have

been interested in and involved with for only about 21⁄2 years now,

so in the history of this project, I am a relative newcomer. I would

ask that my statement be received into the record and I would like

to summarize a couple of points. I suppose one reason I am here

is because I have some experience, professional experience, and it

is a matter of personal interest, as well, worrying about the burdens on small business.

I have had a career that has had stops at the NFIB and I was

President Reagan’s chief advocate at the Small Business Administration, so I am not going to plunge into anything that I really

think is going to be a burden for small business. And after listening to Mr. Fishman’s comments, I thought well, maybe I am here

for the wrong reasons, but I must gently disagree with some of his

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densome for business and I do think that as the scope of available

genetic information accelerates, as it most certainly will and it is

doing, that business, in particular, needs the certainty and the predictability of how to handle this information and how to handle it

in a way in which they know that as they go about their normal

business practices, normal personnel practices, normal insurance

practices, that they will not be subject to criticism.

So this is extraordinarily important legislation because business

does need the predictability. I would absolutely agree with the

points that have been made that there has not been excessive litigation to this point over these issues. Of course, I could turn that

logic around and say indeed, although there are 41 or 43 States

that have this legislation on the books, it apparently has not been

overly burdensome for business in those States, because indeed,

there has been not much litigation. But be that as it may, the issue

is probably not so much where there is litigation or not.

The issue was amply demonstrated by the prior panel; apprehension and fear about engaging in these tests in the first place, and

as individuals have that apprehension and fear, I admit it is irrational in many cases, but medical advances and appropriate treatments will not be accelerated or promoted. We need to have a formula, a set of protections that is predictable for employers and also

for individuals so that there is not that factor of apprehension.

I do think that it is important to note that the bill has been adjusted, to some degree, in the prior committee and I think that the

proponents of the legislation are not adverse to making specific adjustments that might improve the bill. However, I think it is very

important to recognize that protections for genetic information are

important for all the reasons that Dr. Collins stated and for one additional reason. Indeed, my genetic information is what it is and

if it were published here today, I am not sure I would be too upset

about that. But it doesn’t just tell anyone looking at it about me,

it tells them about my children, as well.

And that is an additional responsibility that I think that I have

in not disclosing that information and that anyone that comes

across that information has, as well. So that would be, I submit,

one additional reason that this particularized, admittedly greater

protection for this type of information and other information, that

would be one important reason that I would encourage the committee to move this legislation and report it to the Congress. Thank

you.

[The prepared statement of Mr. Swain appears at the conclsuion

of the hearing.]

Mr. PALLONE. Thank you, Mr. Swain. Ms. Trautwein.

STATEMENT OF JANET TRAUTWEIN, EXECUTIVE VICE PRESIDENT AND CHEIF EXECUTIVE OFFICER, NATIONAL ASSOCIATION OF HEALTH UNDERWRITERS

Ms. TRAUTWEIN. Good afternoon, Chairman Pallone and Ranking

Member Deal. My organization is the National Association of

Health Underwriters. We are a 20,000 member association of insurance professionals who work with employers and individuals all

across America to help them find high quality and affordable

health insurance. We do appreciate this opportunity to present inVerDate 11-SEP-98 09:47 Mar 27, 2008 Jkt 000000 PO 00000 Frm 00047 Fmt 6633 Sfmt 6633 Q:\DOCS\110-15 SCOM1 PsN: SCOM1
42

formation today on the effect that well-intended genetic discrimination legislation could have on the costs of health insurance, as well

as the cost impact on employers who are providing benefits such

as health insurance to their employees. We believe that health insurance affordability is the most important component of access to

healthcare.

In light of advances in the field of genetic research, some people

expressed concern about whether their genetic information might

be used improperly to prevent them from obtaining health insurance or by employers for hiring or firing purposes, and I want to

emphasize today that NAHU believes that health insurance or employment discrimination based on genetic information of an otherwise healthy individual should be prohibited, provided that the definition of the prohibited information is carefully, clearly and narrowly defined.

We have talked a lot today about HIPAA and I just want to point

out a couple of things that I don’t think that anyone else has

brought up today. HIPAA legislated many new protections for

health insurance consumers and among those protections was a

provision stating that group health plans cannot consider any individual employee’s genetic information in a group setting in the underwriting process unless that genetic information has already resulted in a diagnosis.

We have talked about HIPAA several times today, but primarily

from a HIPAA privacy standpoint. And I want to point out that

HIPAA has some other very important provisions. One of them is

this HIPAA nondiscrimination provision and another one is a

HIPAA portability provision and this is one I do want to bring

forth. We have heard a lot about the fear factor which greatly concerns me because many of the people who we have been talking

about today probably already had insurance and what I heard

other people testifying say is that they were concerned that their

coverage would be cancelled.

HIPAA portability laws provide for guaranteed renewability of

contracts and the things that they are afraid of are already illegal.

And so I am concerned that we haven’t done a good enough job of

educating about that and I am going to take that into consideration, go back to our members about that. I wanted to point that

out.

When we talk about people already being subject to nondiscrimination provisions in the group market, unless they already

have a diagnosis, what we mean is that if a generally healthy person had some genetic tests run to see whether or not they had

markers for a particular illness, that information is already prohibited from use. However, as we have heard earlier, that provision

does not apply in the individual health insurance markets and we

currently don’t have any specific genetic provisions relative to employment discrimination.

Many people at some point in their lives are going to be purchasers in the individual health insurance market and I just want

to point out, as Karen said, I did enclose a lot of information about

the underwriting process as an addendum to our testimony, only

because I want people to understand why it is important relative

to the affordability of health insurance coverage. Underwriting in

43

the individual market is much more difficult for a number of reasons that I have outlined in my written testimony than it is for employer sponsored plans and the ability to use health status in the

way that we can use it legally today is very important to keep policies affordable.

In States that have extremely limited the costs or the information that can be used in the underwriting process, the cost of coverage is significantly higher than it is in the States where there is

a realistic underwriting process and so I wanted to point out, that

is why we care about what this definition is.

Just to move forward, as we look at the issue at hand today,

what we want to do is make sure that the information we restrict

is really not information that is critical to that underwriting process because using too broad of a definition will prevent normal underwriting procedures. The main issue is what is considered genetic information?

As I stated earlier, HIPAA already prohibits discrimination for

any individual within a group in the absence of a diagnosis. And

I would like to point out one other thing. During the 108th Congress, Representative Slaughter sponsored H.R. 1910 and that particular bill had some language in it that specifically excluded from

the definition of protected genetic information, information about

the physical exams of the individual and other information that indicates the current health status of the individual, and this exclusion is not present in the current version of the bill and I would

hope that you would consider including that in there because information about current health status is critical to the evaluation of

applicants in the individual health insurance market and that information is critical to keeping those policies affordable.

We also would hope, believe that the definition of genetic information should be limited to DNA or related gene testing for the

purpose of predicting risk of disease in asymptomatic or

undiagnosed individuals and that it should clearly exclude, as it

does, such items as age and gender, but an additional exclusion

should be information for physical exams and lab work, including

items like cholesterol tests that all of us have on a regular basis.

Mr. PALLONE. Ms. Trautwein, again, if you could summarize.

Ms. TRAUTWEIN. I would just summarize by saying that good underwriting is important to affordability of health insurance. The actions that Congress takes relative to this legislation are going to

have an impact for many years to come and we are supportive of

the concept of this legislation, but we would hope for a few minor

adjustments to make this workable so that we don’t price people

out of health insurance coverage. Thank you.

[The prepared statement of Ms. Trautwein appears at the conclusion of the hearing.]

Mr. PALLONE. Thank you. Again, I would mention to you again

that your written testimony is all going to be part of the record.

Dr. Hudson.

44

STATEMENT OF KATHY HUDSON, DIRECTOR, GENETICS AND

PUBLIC POLICY CENTER, ASSOCIATE PROFESSOR, DEPARTMENT OF PEDIATRICS, JOHNS HOPKINS UNIVERSITY

Ms. HUDSON. Mr. Chairman, Congressman Deal, Dr. Burgess, I

appreciate the opportunity to testify this afternoon and regret that

I am the only thing standing between you and happy hour. I might

just share my thoughts on H.R. 493 and the results of a survey

that we completed this week about Americans’ attitudes about genetic testing. You heard from Dr. Collins this morning his incredible enthusiasm about the future of genetic medicine. The American public shares his enthusiasm. In our survey, we found that

more than 90 percent of Americans support the use of genetic testing by doctors to identify a person’s risk of future disease or to determine a patient’s risk of having a bad reaction to a particular

medicine.

This enthusiasm extends to genetic research with again, more

than 90 percent supporting research use of genetic testing and twothirds trust researchers to have access to their genetic information.

But growing uncertainty and fear threaten public confidence and

the future of genetic medicine. More than 90 percent of Americans

are concerned that the results of their genetic tests could be used

in ways that are harmful to them. As a result, patients may pass

up genetic testing that could benefit their health or go to great

lengths to keep genetic information out of their medical records

and out of insurers’ hands.

While people trust their doctors and they trust genetic researchers, they simply do not trust health insurers and employers to safeguard their genetic information. In our survey, 93 percent said that

health insurers should not be able to use a person’s predictive genetic information to deny or limit insurance or charge higher prices

and a similar number said they feel employers should not be able

to use this information to make decisions about hiring and promotion. Researchers need to be able to reassure research volunteers their genetic information will not be used to discriminate

against them and today researchers can’t provide such assurances.

This week I was in Philadelphia conducting focus groups about

how ordinary citizens would feel about participating in large population study to understand the genetic, environmental and lifestyle

contributors to health and disease. And we heard substantial enthusiasm about this study in hopes that the study would benefit

others in the future, but their enthusiasm and altruism was overshadowed by concerns about privacy of genetic information and its

misuse.

I want to say just a word about H.R. 493 would affect the conduct of research. The bill would explicitly allow researchers, for the

first time, to tell research participants that it is simply against the

law for health insurers or employers to use genetic information to

discriminate. The impact of this legal change would be substantial.

Some are concerned that the mere fact of participation in genetics

research could be construed by insurers or employers as indicating

a heightened genetic risk and might therefore be used to discriminate them. H.R. 493 would prevent this, as the bill prevents insurers and employers from using information about individuals’ reVerDate 11-SEP-98 09:47 Mar 27, 2008 Jkt 000000 PO 00000 Frm 00050 Fmt 6633 Sfmt 6633 Q:\DOCS\110-15 SCOM1 PsN: SCOM1
45

ceipt of genetic services. Therefore, participation in genetics research would be protected and could not be used to discriminate.

Turning to the clinical context, some opponents of H.R. 493 have

suggested that the bill would make it hard for healthcare providers

to collect family history information, to request or recommend genetic testing and to use this information to provide the best possible care. This is simply not the case. H.R. 493 very clearly states

that the bill does not limit the ability of healthcare professionals

who are providing healthcare to request that a patient undergo a

genetic test. Dr. Corwin’s example earlier of MammaPrint, he is

correct. The plan cannot request or require that the patient take

this test because that is really not a plan’s role. That is the provider’s role.

In conclusion, H.R. 493 prevents the misuse of genetic information while protecting the ability of healthcare providers to collect

and use the information that they need to take the very best possible care of their patients. H.R. 493 also protects individuals who

participate in research from having their information or even the

fact of their participation used in harmful ways. More than threequarters of the respondents in our survey believe that there should

be a law that prevents employers from using results of genetic tests

to make decisions and three-quarters also believe there should be

a law to prevent insurers from using results from predictive genetic

tests to deny or limit insurance or charge higher prices.

The message is clear. The need for Congress to act grows with

every new test developed in every patient who decide to forego or

delay testing because of discrimination. Thank you for taking up

consideration of H.R. 493. And I beat the red light.

[The prepared statement of Ms. Hudson appears at the conclusion of the hearing.]

Mr. PALLONE. You did, indeed, and I thank you for that. Although we are not going to happy hour. I yield myself 5 minutes

to ask some questions and I will start with Dr. Corwin.

In your testimony you talk about opportunities to improve the

legislation. Specifically, you cite the need to allow health insurance

plans to request genetic tests to promote preventative screening

and disease management and you also note that Congress should

include a more precise definition of genetic information. In my

hand here, though, I have a memo which I would like to insert into

the record, from the Blue Cross Blue Shield Association to their

congressional relations coordinators regarding legislation introduced in the Senate during the 109th Congress, which is identical

to the bill before us today.

And this memo states, and I quote, ‘‘The definitions of genetic information and genetic tests included in the final bill are narrow

and the final version includes insurers and group health plans to

use and allows insurers and group health plans to use and disclose

genetic information without special consent for treatment, payment

and healthcare operations, such as for determining medical necessity, paying claims, detecting fraud and conducting quality management programs.’’ That is the end of the quote.

Mr. PALLONE. Doctor, could you explain to me why you are calling for these changes when it would seem, at least from this memo,

that the current provisions of the bill should already sufficiently

46

address the concerns that you listed? Obviously there is a discrepancy and I would just like you to explain that. I don’t know if you

have the whole memo, but I think that that section pretty much

describes it.

Dr. CORWIN. Thank you for the question. I am obviously not

privy to what the Blue Cross memo says.

Mr. PALLONE. Well, you know what? Why don’t I give it to you

while you are sitting there, but I will be honest with you, that

doesn’t really add anything from what that paragraph is.

Dr. CORWIN. Our concern is that the health plans be allowed to

request tests when they advocate for the better health care of our

patients and our members. Health plans design programs on a

basis to help address some of the variation that occurs in

healthcare. There is a tremendous amount of variations, I am sure

you are aware, in healthcare across the country and that that leads

to inferior and less competent care in many circumstances.

And as we heard earlier in some of the testimony from Dr. Collins about some of these great tests that are going to be available

to us in the very near future, being able to design programs to

make sure that our members get the care that they need is going

to be very, very critical in terms of helping control these costs and

making sure that our members actually get those tests that will

help them prevent these unfortunate diseases from progressing.

Be that as it may, that everything is not ideal, the medical care

system is not perfect, that people don’t always follow up on tests,

being able to help direct our membership to those tests and make

sure that they get those important follow-up diagnostic examinations on the periodic intervals that are indicated would be very important to health plans.

As the bill is currently worded, our concern is around the fact

that it prohibits us from being able to do that at this point in time

and deliver evidence-based care or ensure that evidence-based care

is given to the patients in a timely fashion. I hope that addresses

your question. If it doesn’t, I will take this back, take a better read

of it and then respond to you off-line.

Mr. PALLONE. Well, you are free. No, I appreciate your response

but also feel free to look at that and get back to me, if you like.

Thank you. Ms. Pollitz, insurers have testified before that they do

not currently ask about genetic information on applications or medical underwriting questionnaires. If that is true, then how do insurers obtain information about an applicant’s genetic status?

Ms. POLLITZ. As I mentioned, the underwriting process asks an

initial set of questions and about half of applications, the industry

tells me, are decided based on how applicants answer those first

sets of questions. But the other half of the insurers say I don’t

know, so a red flag has gone up somewhere and they need to get

additional information. Sometimes that is as simple as calling the

patient and asking for clarification. You said you are taking this

drug; what was the dose, when did you stop? Sometimes it is more

in-depth and there is a call to the physician or there is a request

for medical records.

Once the records are delivered to the underwriter, even if they

didn’t ask for the whole thing, even if they just asked for part of

it, they are obliged, I mean, they will be fired if they won’t, to go

47

through and read everything that is in that medical record so that

they can say that they did a thorough job of evaluating the risks.

So when we asked the participating underwriters who worked with

us on our study how often or have they ever seen or encountered

genetic information in that way, most of them said they had at

least once. So they do come across it.

Mr. PALLONE. OK, thank you. I yield to the gentleman from

Georgia, Mr. Deal.

Mr. DEAL. Thank you, Mr. Chairman. I want to pick up on the

Blue Cross Blue Shield letter that you are talking about. Obviously, this is a comment that this one particular company made

with regard to legislation in the last Congress, but they are pointing out parts that they think legislation should include that are important and they referenced it to last year’s version.

For example, they point out the definitions of genetic information

and genetic tests included in the final bill are now focused on predictive genetic tests and family history. The definitions do not include current health status or information from routine blood tests

that are critical for underwriting and et cetera. In that regard, Ms.

Terry, my understanding is that your objective is to cover predictive tests that are for the purpose of identifying genetic markers

for genetic disease and that it is not your objective to cover

genotypes or forensic DNA tests or other markers that are not

markers for future disease. Is that correct?

Ms. TERRY. Not exactly. Our intent is to cover genetic information so that it is not misused in insurance or employment.

Mr. DEAL. Well, let us talk about that, then. And maybe you are

not the one I have to ask, since you are not the doctor. Let me ask

the doctor next to you, then. Doctor, don’t we think that at some

point there is a correlation between genetic information and being

able to treat patients properly?

Dr. CORWIN. Easily answered in a yes. We do believe that there

is a need for genetic information to treat people in a predictive way

and that would get to the ability to address the preventative measures I talked about earlier.

Ms. TERRY. And also, although I am not a doctor, I do know that,

in fact, the bill does allow the practice of medicine that is not impacted and we are talking about insurers and employers.

Mr. DEAL. All right, let us get specific about that, then. And Doctor, that is what I want to ask you. Do you think a doctor can tell

a patient that he won’t treat that patient unless they undergo a genetic test? And would that be prohibited under this legislation?

Ms. HUDSON. A doctor can request and a doctor can strongly recommend that a patient undergo a genetic test and could decide

that it is not medically appropriate to go forward with the specific

line of treatment in the absence of that genetic test result. That

would be within the practice of a standard practice of medical care.

Mr. DEAL. So there are situations, then, when knowing what the

genetic test might show would be important to the treatment of

that patient, is that right?

Ms. HUDSON. That is absolutely correct and I think we heard a

number of examples this morning of drugs where there are adverse

reactions and unless you know what the genotype of the patient is,

48

the doctor, not the health plan, the doctor needs to know that genetic information before prescribing that medication.

Mr. DEAL. And are you saying, then, that your interpretation is

that a doctor can refuse to treat a patient and it be not in a violation of this statute?

Ms. HUDSON. There is no restriction on medical practice, at all,

in this bill.

Mr. DEAL. What about if the doctor was an employee of the employer of the patient?

Ms. HUDSON. The rule of construction in the bill, as I read it,

does not have any, is not limited by who the employer is of the

healthcare provider that is providing the care. The relationship between the provider and the patient is not affected by who employs

that particular physician, whether it is an insurance company,

whether it is——

Mr. DEAL. My understanding is that that restriction is not in

title II. I guess we can clarify that later. Back to Ms. Terry again.

If I understand your policy, if a disease has manifested itself, you

don’t believe that the restrictions in the bill need to apply to genetic information related to that disease, is that right?

Ms. TERRY. So again, what we are looking for is making sure

that genetic information is not misused by the employer or the insurer.

Mr. DEAL. You made a distinction in your testimony between

manifest and not manifest. So your policy is that we are talking

about the not manifest diseases that these tests might disclose, is

that right?

Ms. TERRY. So my policy is that when we give examples like

MammaPrint or Hepatitis C, et cetera, that those are manifest disease and that in the course of treatment, doctors might, indeed,

highly recommend, as Kathy said, a genetic test and that is certainly part of the usual course of medicine.

Mr. DEAL. OK. Mr. Fishman, let me ask you this. As you read

this bill, does it focus on discriminatory misuse of genetic information or does the language focus more on the flow of information?

Mr. FISHMAN. Well, one of our concerns is, I hope and I guess I

failed to articulate properly, is that it seems to us, it seems to my

coalition and to me, personally, that the focus of this bill is, in fact,

not on the misuse of information or the discriminatory use of information, it is on the acquisition, including the innocent acquisition,

and the flow of that information. I think that, inevitably, any bill

that is directed at the flow of information rather than the abusive

use of the information, inevitably will have unintended consequences and we have heard of a couple.

I have tried to identify a couple. I think Dr. Corwin has identified a couple. I think that the purposes of this bill and the goals

of this bill can be achieved if you direct your attention to the conduct that you wish to prohibit, rather than hope that people who

have hundreds of motives will or will not take tests, may or may

not take tests, will or will not have insurance. This committee and

this Congress should focus on the abusive conduct that you wish

to penalize and make that the focus of the bill.

Mr. PALLONE. Thank you, Mr. Deal. Dr. Burgess.

49

Mr. BURGESS. Mr. Fishman, perhaps you could continue with

that line for just a moment, because I am concerned about the unintended consequences. I do think that some protections are necessary. I think the promise of genomic medicine is enormous and

will benefit, perhaps not those of us in our generation, but certainly, our children and our children’s children, and we want to be

certain that it is done correctly, so could you detail for me a little

bit more, flesh that out a little bit more about what you are concerned about?

Mr. FISHMAN. Well, I will try to. I think that many of my colleagues on this end of the prior panel’s over-expansive in their denials about what this bill covers. I think the bill is, I think the definition is over-expansive and I think some of the exclusions are

under-exclusive. For example, in section 210 there is a provision

that attempts to exclude manifest ailments from the reach of this

bill, but it says that only medical information that is not genetic

information can be disclosed.

So we have the bizarre situation of let us say, a company nurse

who is treating someone who has collapsed and during the triage,

would say oh, it is probably my heart because my dad had a heart

problem, too. Under GINA and because she has now just learned

family history, which is genetic information, that nurse could possibly tell a treating physician I have a patient who has collapsed

but could not say oh, by the way, it may be a heart problem because his dad had a problem. And that is simply a drafting problem

that I think comes from over-inclusiveness because the direction of

the bill is directed at the flow of information rather than the abusive use of the information.

That is one of the reasons that my oral testimony and a good

deal of my written testimony is devoted to thinking about including, as part of the text of this statute, the exceptions and exclusions that are included in the HIPAA regs for the privacy parts

where treatment is the first exception under HIPAA where there

should be an exception for treatment. That nurse should not have

to wonder whether the mere utterance of oh yes, I know that his

dad had a heart attack is a potential problem that could lead to

a jury trial and punitive damages under the enforcement scale of

title II.

I mentioned in my oral testimony the definition of a disease that

occurs in a family member that is not an inheritable disease, that

is not an asymptomatic disease, that is not even a disease that is

genetically related. There ought to be some focus on what the purpose, what is the goal of the bill? You have heard my co-panelists

talk about discrimination in insurance and employment. You

haven’t heard of a single employment discrimination case but one

and yet, we are going to have an entire legislative scheme devoted

to what nobody has yet been able to demonstrate even exists.

My clients, large and small, have difficulty finding employees

who can do the job and can come to work regularly, they don’t particularly care much about your genomes. Most of them don’t even

know what it is and I am one of them. Let us focus on the abusive

conduct and craft a bill that is narrowly directed to achieve the

goal that we all share, which is nondiscrimination in employment

50

and insurance and let us not focus on our hopes and our prayers

for how medicine can develop in 2030.

Mr. BURGESS. I thank you for your candor. Dr. Corwin, I was

particularly intrigued by the comments you had for improvements

to 493, and under one of the bullet points that medically indicated

testing should be encouraged to promote consumer access to appropriate coverage and treatment. And I think we heard from someone

else on the panel that these are decisions that actually should be

made by the doctor, not the insurance company. Would you care to

expound upon that?

Dr. CORWIN. Thank you very much. It is a great question. From

my perspective, and with all due respect to my colleague, I would

disagree with her on that point. I think that health plans do have

a role for requesting and requiring certain genetic testing to be

done for the purpose of treatment. With all due respect to all my

colleagues, there are times that evidence-based medicine is not

practiced in a timely way and if we know that individuals are going

to need pharmacogenomic testing for the purpose of delivering the

best possible care to them and to be able to decide what is the best

possible chemotherapeutic protocol for non-small cell lung cancer,

which is a devastating disease, and within a very short period of

time, we will have this type of genomic information available to

help decide what is the best possible test. It is not inappropriate

for the plans to be able to request that kind of testing to be done

to ensure that the patient gets the best possible care. If it is not

done, one is using the best guess scenario once again. I would hope

that in every case that wouldn’t be necessary, but in some cases,

it may be.

Mr. BURGESS. Well, I always resented it when insurance companies would challenge my clinical acumen, but it was probably appropriate in other doctors’ cases.

Dr. CORWIN. I would totally agree.

Mr. BURGESS. Well, I think you referenced somewhere in here

the Cytochrome people are, as being another area where this may

have some applicability.

Dr. CORWIN. In Dr. Collins’ example about the leukemic children,

that is very true and it is also going to be true for a number of

other drugs, specifically some of the newer antimicrobial agents

that are being developed for fighting infections will not work as

well in some people, but will work extra well in other people and

dosage adjustments will become much more difficult without having testing ahead of time and having that information available, so

it would be appropriate to require that kind of testing in those situations.

Mr. BURGESS. Thank you. Once again, Mr. Chairman, just reserve the right to submit written questions.

Mr. PALLONE. We are also going to do a second round now, so

if you want to stay, you can ask questions again. I will yield to myself for 5 minutes. I don’t know if I will use the whole five, but I

just wanted to ask Ms. Trautwein a question. We heard, in Dr.

Corwin’s testimony that AHIP does not oppose GINA and I am just

curious to know whether or not NAHU supports or opposes the enactment of GINA.

51

Ms. TRAUTWEIN. Well, that is a great question. I was very curious about the Blue Cross letter, because we actually worked very

closely with the people on the Senate side, as well, coming to the

language that was there. Sometimes on the other side things are

a little different than they are over here.

Mr. PALLONE. That is for sure.

Ms. TRAUTWEIN. And I think that many of us thought that that

possibly might have been the best thing that we could get out of

there rather than coming up with something worse, so I would just

state that for the record. Now, relative to the consideration over

here, I think you guys might be able to improve on their work a

little bit. And I think it is not broad-scale adjustments we are talking about. Some minor adjustments to the definitions could make

this a truly good piece of legislation. And so I would say that we

support it with a few caveats there, that we think that you could

make it a little bit better and you have an opportunity to do that

and I would hope that you will.

Mr. PALLONE. Thank you. Ms. Pollitz, is providing healthcare

limited by this bill, as Mr. Fishman seemed to suggest? If you

would just comment on that.

Ms. POLLITZ. Actually, I think Dr. Hudson was correct, that the

bill doesn’t limit the way physicians practice medicine and it

doesn’t even prohibit health insurers from asking about the results

of a genetic test. It just says that a health insurer can’t tell a patient to undergo a genetic test. Dr. Collins talked about the six P’s

of genetic testing and you could add profound to that. I think this

is an incredibly personal and profound decision to undergo genetic

testing and people may not want to. Not just because they fear it,

they may not want to for other reasons and if they don’t there may

be other consequences that come from that and we have heard

about them today, that they may be foregoing treatment options

and so forth, but nobody can tell somebody to take a test. Doctors

can recommend it, but the health plans need to stay out of that.

They can ask, for purposes of medical appropriateness review and

so forth, if a test was taken, what was the result, but they can’t

force a patient to take a test.

Mr. PALLONE. OK, thank you. I wanted to go back to Dr. Hudson,

actually, and ask if Congress failed to take action on genetic nondiscrimination legislation, how do you believe scientific research

would suffer as a result? In other words, if Congress were able to

pass this legislation, how do you believe scientific research would

benefit?

Ms. HUDSON. We are at a stage now where we can do the research to uncover those weak genetic contributors that are interacting with environmental factors and with lifestyle factors to common

diseases, which you really haven’t had the power to explore before

and in order to do that, we are going to have to do massive studies

that include hundreds of thousands of people who actively participate and share not only their genetic information, but their environmental exposures, their lifestyles, et cetera. That is sort of the

next big push in medicine and medical research and if we don’t

pass this bill, we won’t get people to sign up and we won’t understand how genes and environment and lifestyle work together and

how we can intervene to reduce our risks of disease.

52

Mr. PALLONE. OK, thank you. And then from your survey data,

it is clear that the public is concerned about who has access to

their genetic information, but in terms of protections from genetic

discrimination, what do you think the public expects and wants

and do you think that that this bill will address those concerns?

Ms. HUDSON. I think the public clearly wants legal protections at

the Federal level against misuse of genetic information and I disagree with some of my colleagues here. I think that the bill does

include very specific and concise prohibitions on the use of genetic

information, not just how it travels, but how it is actually used and

I think those are appropriate restrictions on the use of genetic information both in title I and in title II. I think we are going to have

a very big job ahead of us when this bill passes and I believe it

will pass. When this bill passes, we have a very big job to then educate the American public that they are now protected and they can,

with confidence, take a genetic test that is appropriate for them or

participate in biomedical research. There is a lot of suspicion out

there that we will have to overcome with the right information

about the protections that will be put in place by H.R. 493.

Mr. PALLONE. Thank you. Mr. Deal.

Mr. DEAL. Thank you. The reason I think some of us are asking

very specific questions is that this is the kind of legislation that

has profound consequences and many times the direct opposite consequences of what was intended by the legislation, if it is not carefully crafted, and that is the reason that some of the questions that

I am asking and others are asking are being posed. And let me just

take a few more shots at it. I am looking at a chart comparing permitted uses and disclosures under HIPAA rules versus the same

thing under this legislation and some of it goes directly to the

issues we have already talked about. HIPAA, for example, has a

business associates disclosure permission.

It says it has to be related to the delivery of the health functions.

It has an exception for treatment, payment, healthcare operations.

We don’t see a similar provision in this legislation. So I guess my

question would be am I correct that the 202(c) appears to say that

even if you are providing a health service, you are still subject to

the prohibitions of section 206(b) and if so aren’t we creating a

huge problem if there is no treatment or operations exception built

into this legislation like is built into HIPAA? Mr. Fishman, this is

sort of a lawyer’s question, I guess.

Mr. FISHMAN. I am not sure it is, but I will give it a shot. I think

it is correct and that is really the core of my testimony this afternoon. It is an odd situation that I find myself in. My clients don’t

collect this information and they don’t use this information. There

is no evidence that they even care about this information. But they

are going to be included in a privacy regimen that is both, we

think, over-inclusive and needlessly burdensome and seems to ignore the highly reticulated privacy program that the HIPAA regulations created after months of regulatory oversight with reams of

public comment.

I cannot, for the life of me, understand why this committee or

why this lobby would want to ignore the kind of effort that HHS

underwent to learn, from public comment and from survey of the

very same people that you are trying to include here, and not inVerDate 11-SEP-98 09:47 Mar 27, 2008 Jkt 000000 PO 00000 Frm 00058 Fmt 6633 Sfmt 6633 Q:\DOCS\110-15 SCOM1 PsN: SCOM1
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clude the kinds of learning that they discovered would make

HIPAA, the HIPAA privacy regs, meaningful and useful. For my

purposes, and as I said, this is almost tangential, because my clients, members of my coalition, don’t gather genetic information,

don’t do genetic testing, don’t use genetic information in employment decisions and don’t want to.

But it seems we are going to get dragged into a privacy regimen that is additional to the one they spent about $10 billion and a

hundred million hours trying to learn. It is highly, highly structured, it is highly directed to meet particularized needs and for the

life of me, I, as someone who used to be in a regulatory agency,

I can’t understand why this body wouldn’t want to use the benefits

of all of the efforts and all of the learning that HHS has proffered

in creating the HIPAA regs.

Mr. DEAL. Back to the specific, a doctor who is employed, is he

under the prohibitions that you read into this bill?

Mr. FISHMAN. As I said, in 210, I hope it is a drafting error and

all I can do, like most of you folks, I live in an imperfect world and

I can’t make the language that I read into something other than

what I honestly read. In 210 there is an exception that is supposed

to be for medical information that is not genetic information, which

means, to me, that genetic information is still regulated and if I am

a doctor employed by an employer covered by GINA, I have to be

concerned with whether the information I am relating, even for

treatment purposes, to another physician or to anyone else, is included as regulated in 210. And if it is regulated in 210 and I violate it, I am in the enforcement soup of title VII, which is what you

have included in this bill. I don’t think that is what you intended.

I hope you can correct it, but as currently drafted in this imperfect

world, that is what I read.

Mr. DEAL. Thank you, Mr. Chairman.

Mr. PALLONE. Thank you. Dr. Burgess.

Mr. BURGESS. Well, Mr. Fishman, let me just ask you. The Mayo

Clinic, for example, where all of the doctors are not independent

contractors, they are employees of the Mayo Clinic system, would

that system be at risk in what you are concerned about in 210?

Mr. FISHMAN. Well, it is not only that. One of the members of

our coalition is CUPA HO, which is ‘‘College and University Professional Association.’’ That means all of those medical schools and all

of those universities, they are included, too, and have to face this

problem. It may not be a problem if they don’t convey the information, but if they do convey the information, why would you want

to introduce the possibility of raising that doubt and causing that

delay? Why isn’t the exception here the same as PTO in HIPAA?

Why would you even want a physician at the Mayo Clinic or at

the University of Texas to have to worry about wait a minute, I

now know genetic information. This exclusion, which appears to be

intended to help me treat manifest ailments, it is not that I am

only covered for medical information that is not genetic information. Why should that poor person have to pause, to hesitate to try

to figure this out when it seems that it was not the intent of Congress to want to cover that sort of a situation. And that is where

I am. I am not a physician, two doctorates, but neither one in medicine, so there I am.

54

Mr. BURGESS. Well, and I thank you for your frankness and your

candor. I was on the outside looking in when Congress, in ’96 or

’97 passed, as part of the Health Insurance Portability and Accountability Act, what we now know as the HIPAA privacy regulations. It seems like it was a fairly short section of that KennedyKassebaum bill and many years later delivered to my doorstep, was

an enormous cost compliance that didn’t seem to do a whole lot to

further patient care. I never felt like I was the problem in the first

case.

Mr. FISHMAN. Well, I think there are something like 1,275 pages

of HIPAA regs, so you are not responsible for that.

Mr. BURGESS. I do understand why you are concerned about

what would seem to be a fairly narrow provision in this and in the

field of unintended consequences and I know we have gone a long

time today, Mr. Chairman. I see you holding your forehead and I

am sensitive to that fact and I appreciate the fact that we can submit written questions, but Ms. Trautwein, before we finish up

today, you mentioned concern about affordability of health insurance and I will just tell you that that is the one thing that is always on my mind, the decisions we make here, are they helpful or

hurtful as far as the average middle class family affording their

health insurance. Do you have some further thoughts on that?

I remember when this, and I wasn’t here when this body went

through the discussion of patient bill of rights, but I do remember

hearing about the for every dollar cost increase there is, we knock

so many people off of the rolls of the insured. Do you have any

thoughts about what the effect of this legislation will be?

Ms. TRAUTWEIN. Well, I think if we make some needed changes,

it is not going to impact things too much at all, other than to provide some protections that are obviously needed. I think we do

need to look at the definitions that are there because right now

they are broad and I am very concerned that a regulator, some

point down the road, people who would be under compliance with

this would not be clear on what it was that they were or were not

supposed to do and what Congress intended. And so my suggestion

is that we just get really clear and very specific on what is and is

not protected information and don’t leave it to someone else to figure out. Let us be specific. If we don’t mean current health status,

let us say that. If we don’t mean routine exams and lab work, let

us say exactly what we mean and that way we can underwrite appropriately and particularly in the individual health insurance

market, given what we have today and given what Karen Pollitz

said, that things will change; of course they will, but right now, we

don’t want to price people out of coverage now and create a problem that is much worse than what we started with by causing

many more people to become uninsured because they are priced out

of coverage. And so I think we can do this, we can tighten this up

and make it better, but I think it needs a little bit of work.

Mr. BURGESS. Well, Mr. Chairman, I am going to surprise you

and yield back 16 seconds. I do thank the panel for their forbearance today. I know it has been a long day, but this is important

legislation and I appreciate you all participating.

Mr. PALLONE. Thank you very much. I want to thank all of you.

I thought it was very thoughtful and useful discussion today, so I

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really thank you. It really wasn’t that long, it was just because we

had the hour that we were voting, I think. Let me just remind the

Members that you may submit additional questions for the record

to be answered by the relevant witnesses and they should be submitted to the committee clerk within the next 10 days. And without

objection, this meeting of the subcommittee is adjourned. Thank

you, everyone.

[Whereupon, at 5:20 p.m., the subcommittee was adjourned.]

[Material submitted for inclusion in the record follows:]

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