    [House Hearing, 111 Congress]
    [From the U.S. Government Publishing Office]

    H.R. 1740, THE BREAST CANCER EDUCATION AND AWARENESS REQUIRES LEARNING
    YOUNG ACT OF 2009; H.R. 1691, THE BREAST CANCER PATIENT PROTECTION ACT
       OF 2009; H.R. 2279, THE ELIMINATING DISPARITIES IN BREAST CANCER
    TREATMENT ACT OF 2009; AND H.R. 995, THE MAMMOGRAM AND MRI AVAILABILITY
                                  ACT OF 2009

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

                                    HEARING

                                   BEFORE THE

                             SUBCOMMITTEE ON HEALTH

                                     OF THE

                        COMMITTEE ON ENERGY AND COMMERCE
                            HOUSE OF REPRESENTATIVES

                         ONE HUNDRED ELEVENTH CONGRESS

                                 FIRST SESSION

                                   __________

                                OCTOBER 7, 2009

                                   __________

                               Serial No. 111-69

          Printed for the use of the Committee on Energy and Commerce

                            energycommerce.house.gov
                                    _____

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                        COMMITTEE ON ENERGY AND COMMERCE

                     HENRY A. WAXMAN, California, Chairman

    JOHN D. DINGELL, Michigan            JOE BARTON, Texas
      Chairman Emeritus                    Ranking Member
    EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
    RICK BOUCHER, Virginia               FRED UPTON, Michigan
    FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
    BART GORDON, Tennessee               NATHAN DEAL, Georgia
    BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
    ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
    BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
    ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
    GENE GREEN, Texas                    STEVE BUYER, Indiana
    DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
      Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
    LOIS CAPPS, California               MARY BONO MACK, California
    MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
    JANE HARMAN, California              LEE TERRY, Nebraska
    TOM ALLEN, Maine                     MIKE ROGERS, Michigan
    JANICE D. SCHAKOWSKY, Illinois       SUE WILKINS MYRICK, North Carolina
    CHARLES A. GONZALEZ, Texas           JOHN SULLIVAN, Oklahoma
    JAY INSLEE, Washington               TIM MURPHY, Pennsylvania
    TAMMY BALDWIN, Wisconsin             MICHAEL C. BURGESS, Texas
    MIKE ROSS, Arkansas                  MARSHA BLACKBURN, Tennessee
    ANTHONY D. WEINER, New York          PHIL GINGREY, Georgia
    JIM MATHESON, Utah                   STEVE SCALISE, Louisiana
    G.K. BUTTERFIELD, North Carolina
    CHARLIE MELANCON, Louisiana
    JOHN BARROW, Georgia
    BARON P. HILL, Indiana
    DORIS O. MATSUI, California
    DONNA M. CHRISTENSEN, Virgin
    Islands
    KATHY CASTOR, Florida
    JOHN P. SARBANES, Maryland
    CHRISTOPHER S. MURPHY, Connecticut
    ZACHARY T. SPACE, Ohio
    JERRY McNERNEY, California
    BETTY SUTTON, Ohio
    BRUCE BRALEY, Iowa
    PETER WELCH, Vermont

                                      (ii)
                             Subcommittee on Health

                    FRANK PALLONE, Jr., New Jersey, Chairman
    JOHN D. DINGELL, Michigan            NATHAN DEAL, Georgia,
    BART GORDON, Tennessee                   Ranking Member
    ANNA G. ESHOO, California            RALPH M. HALL, Texas
    ELIOT L. ENGEL, New York             BARBARA CUBIN, Wyoming
    GENE GREEN, Texas                    JOHN B. SHADEGG, Arizona
    DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
    LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
    JANICE D. SCHAKOWSKY, Illinois       MARY BONO MACK, California
    TAMMY BALDWIN, Wisconsin             MIKE FERGUSON, New Jersey
    MIKE ROSS, Arkansas                  MIKE ROGERS, Michigan
    ANTHONY D. WEINER, New York          SUE WILKINS MYRICK, North Carolina
    JIM MATHESON, Utah                   JOHN SULLIVAN, Oklahoma
    JANE HARMAN, California              TIM MURPHY, Pennsylvania
    CHARLES A. GONZALEZ, Texas           MICHAEL C. BURGESS, Texas
    JOHN BARROW, Georgia
    DONNA M. CHRISTENSEN, Virgin
        Islands
    KATHY CASTOR, Florida
    JOHN P. SARBANES, Maryland
    CHRISTOPHER S. MURPHY, Connecticut
    ZACHARY T. SPACE, Ohio
    BETTY SUTTON, Ohio
    BRUCE L. BRALEY, Iowa

                                 C O N T E N T S

                                  ----------
                                                                       Page
    Hon. Frank Pallone, Jr., a Representative in Congress from the
      State of New Jersey, opening statement.........................     1
        Prepared statement...........................................     4
    Hon. Nathan Deal, a Representative in Congress from the State of
      Georgia, opening statement.....................................    10
    Hon. Roy Blunt, a Senator in Congress from the State of Missouri,
      prepared statement.............................................    11
    Hon. Jane Harman, a Representative in Congress from the State of
      California, opening statement..................................    12
    Hon. Phil Gingrey, a Representative in Congress from the State of
      Georgia, opening statement.....................................    35
        Prepared statement...........................................
    Hon. John D. Dingell, a Representative in Congress from the State
      of Michigan, opening statement.................................    36
    Hon. Michael C. Burgess, a Representative in Congress from the
      State of Texas, opening statement..............................    38
    .................................................................
    Hon. Kathy Castor, a Representative in Congress from the State of
      Florida, opening statement.....................................    41
    Hon. Donna M. Christensen, a Representative in Congress from the
      Virgin Islands, opening statement..............................    44
    Hon. Joe Barton, a Representative in Congress from the State of
      Texas, prepared statement......................................   157
    Hon. Bruce L. Braley, a Representative in Congress from the State
      of Iowa, prepared statement....................................   160
    Hon. Joseph R. Pitts, a Representative in Congress from the
      Commonwealth of Pennsylvania, prepared statement...............   163

                                   Witnesses

    Hon. Jerrold Nadler, Member of Congress..........................    45
        Prepared statement...........................................    48
    Hon. Rosa L. DeLauro, Member of Congress.........................    51
        Prepared statement...........................................    53
    Hon. Debbie Wasserman Schultz, Member of Congress................    56
        Prepared statement...........................................    59
    Stephen Taplin, M.D., M.P.H., Chief of the Applied Cancer
      Screening Research Branch, Division of Cancer Control and
      Population Science, National Cancer Institute, National
      Institutes Of Health...........................................    62
        Prepared statement...........................................    65
    Otis Webb Brawley, M.D., Chief Medical Officer, American Cancer
      Society........................................................    79
        Prepared statement...........................................    82
    Jennifer Luray, President, Susan G. Komen for the Cure Advocacy
      Alliance.......................................................    91
        Prepared statement...........................................    94
    Debra L. Ness, President, National Partnership For Women And
      Families.......................................................   107
        Prepared statement...........................................   109
    George W. Sledge, Jr., M.D., Ballve Professor of Oncology,
      Indiana University Medical Center, Cancer Pavilion.............   112
        Prepared statement...........................................   114
    Fran Visco, J.D., President, National Breast Cancer Coalition....   119
        Prepared statement...........................................   121
    Marisa C. Weiss, M.D., President and Founder, Breastcancer.org...   135
        Prepared statement...........................................   138

                               Submitted material

    Statement of United Jewish Communities...........................    13
    Statement of Lifetime Networks, submitted by Ms. Sutton..........   164

    H.R. 1740, THE BREAST CANCER EDUCATION AND AWARENESS REQUIRES LEARNING
    YOUNG ACT OF 2009; H.R. 1691, THE BREAST CANCER PATIENT PROTECTION ACT
       OF 2009; H.R. 2279, THE ELIMINATING DISPARITIES IN BREAST CANCER
    TREATMENT ACT OF 2009; AND H.R. 995, THE MAMMOGRAM AND MRI AVAILABILITY
                                  ACT OF 2009

                                  ----------

                           WEDNESDAY, OCTOBER 7, 2009

                      House of Representatives,
                                Subcommittee on Health,
                              Committee on Energy and Commerce,
                                                        Washington, DC.
        The Subcommittee met, pursuant to call, at 11:47 a.m., in
    Room 2123 of the Rayburn House Office Building, Hon. Frank
    Pallone, Jr. [Chairman of the Subcommittee] presiding.
        Members present: Representatives Pallone, Dingell, DeGette,
    Schakowsky, Baldwin, Matheson, Harman, Barrow, Christensen,
    Castor, Sarbanes, Space, Sutton, Braley, Deal, Whitfield,
    Shimkus, Blunt, Pitts, Wilkins Myrick, Burgess, Blackburn,
    Gingrey and Barton (ex officio).
        Staff present: Sarah Despres, Counsel; Anne Morris,
    Professional Staff; Elana Leventhal, Policy Advisor; Alvin
    Banks, Special Assistant; Allison Corr, Special Assistant;
    Aarti Shah, Counsel; and Chad Grant, Legislative Analyst.

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

        Mr. Pallone. We will start the hearing, and I do apologize
    for the delay.
        Today the Subcommittee is meeting to review four bills
    relating to breast cancer: H.R. 995, the Mammogram and MRI
    Availability Act of 2009, sponsored by Congressman Nadler of
    New York; H.R. 1691, the Breast Cancer Patient Protection Act
    of 2009, sponsored by Ms. DeLauro of Connecticut; H.R. 1740,
    the Breast Cancer Education and Awareness Requires Learning
    Young Act of 2009 by Congresswoman Wasserman Schultz from
    Florida; and H.R. 2279, the Eliminating Disparities in Breast
    Cancer Treatment Act of 2009 sponsored by our own Member,
    Congresswoman Castor also from Florida. And I want to thank all
    the sponsors of these bills for the hard work on raising
    awareness about these very important issues, and I should also
    point out that they have been spending some time over the last
    6 months trying to have this Subcommittee have this hearing and
    the reason for the delay was of course we were dealing with
    health care reform.
        Now, aside from the non-melanoma skin cancer, breast cancer
    is the most commonly diagnosed cancer in women. The NIH
    estimates that over 190,000 new cases of breast cancer will be
    diagnosed in women in 2009, and though we have seen breast
    cancer death rates decline since 1990, still approximately
    40,000 women will succumb to the disease this year. And that is
    the work of advocacy groups and the key sponsors of the bills
    today is so crucially important. We have made great strides in
    detecting and treating breast cancer but there is still much
    more to be done and much more to learn.
        Although all of these bills address concerns related to
    breast cancer, they all focus on different aspects of the
    disease from screening and early detection to treatment and
    quality improvement, and all they all raise very important
    issues with respect to how breast cancer patients or any other
    patients for that matter are being treated in the medical
    environment we live in today. Not every American has access to
    good preventive services. Not every American has the good
    fortune to have an insurance plan that covers the medical care
    they need, and that is why we are working hard trying to pass
    health reform legislation that will improve access to quality
    and affordable health care for every American. If enacted,
    health care reform legislation will dramatically improve our
    efforts in the battle against breast cancer.
        Particularly important are the insurance reforms. In
    drafting America's Affordable Health Choices Act, we took the
    same tack as Ms. DeLauro did in taking decision-making
    authority out of the hands of health insurers and putting it
    back in the hands of patients and their doctors where it
    belongs. In addition, the subsidies offered in the exchange and
    expansion of the Medicaid program under health care reform will
    cover childless adults and mean that many low- and middle-
    income women who might not have access to health insurance
    today will be covered in the future for the first time, and
    that means they will be able to access a doctor and receive
    treatment when they need it.
        A key component to winning the battle against breast cancer
    is effective and appropriate screening, which both Ms.
    Wasserman Schultz and Mr. Nadler's bill seek to address. Early
    detection of breast cancer has long been acknowledged as an
    effective way to improve outcomes. In fact, studies have shown
    that the 5-year survival rate in women who have received timely
    treatment due to early detection is at 98 percent, and that is
    why the U.S. Preventative Services Taskforce has recommended
    that all women over the age of 40 have a mammography screening
    every 1 or 2 years. Now, I agree with my colleagues that early
    detection and prevention is key to survival, and that is why in
    health reform we bolster the very important work that the U.S.
    Preventative Services Taskforce does by providing increased
    funding so that they can analyze more studies and make more
    prevention recommendations. The evidence-based recommendations
    that receive the highest ratings from the taskforce such as
    mammography screenings will be covered by all insurance
    carriers participating in the health insurance exchange and by
    Medicaid, and while Medicare already covers these services
    under health reform, beneficiaries would no longer face cost-
    sharing requirements to receive them.
        In addition in health reform, we must also improve the
    quality of care that is provided in this country as Ms. Castor
    is seeking to do with her bill. Tens of thousands of Americans
    die to preventable medical errors every year. Billions of
    dollars are wasted on low-quality care. We as a Nation must do
    better. Improving quality is a concept we picked up in health
    reform as well. We require the Secretary to establish national
    priorities for quality improvement and we also create a center
    for quality improvement. This center will develop and encourage
    the use of best practices for quality assurance and will
    provide implementation grants to those who are already doing
    innovative work to improve the quality of care. Using breast
    cancer as an example, we can and must do better to ensure that
    all Americans receive the highest quality care and that we
    collect data that will help us continuously improve as more
    information becomes known about the medical system and specific
    diseases.
        I want to thank all of our witnesses. I know we are going
    to start after opening statements with the Members' panel. I
    would say I guess it is clear from my opening statement that in
    many cases some of the things in these bills hopefully will be
    addressed in the larger health care reform bill but I don't
    mean to suggest that that takes away from the need for us to
    have this hearing today or to move forward with these bills. It
    may very well be that some things are included and some are
    not, and so this is a legislative hearing and the intention
    would be to move these bills, but we also have to see what is
    included in the health care reform as well.
        [The prepared statement of Mr. Pallone follows:]

        Mr. Pallone. So thank you, and with that I would yield to
    our ranking member, Mr. Deal.

      OPENING STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF GEORGIA

        Mr. Deal. Thank you, Chairman Pallone. Thank you for
    holding the hearing and thanks to our colleagues for appearing
    before us today and all the other distinguished witnesses whose
    testimony we will certainly look forward to hearing.
        All of us, I think, understand the importance of the topic
    that is before us today. Many of us have cosponsored many of
    the legislative agenda items that are before the Committee. I
    for one have cosponsored H.R. 1740 because I think it is
    important for early diagnosis and treatment of breast cancer as
    well as the continued effort to educate young women about this
    particular disease. Now, we have dealt with a variety of issues
    over the years and most recently highlighted by testimony from
    Ranking Member Barton about a constituent who in the midst of
    dealing with breast cancer had her policy canceled. The House
    has dealt with that when we passed H.R. 758 by an overwhelming
    vote of 421 to 2, so we have begun the process, I think, of
    dealing with many of the issues surrounding the treatment and
    diagnosis of breast cancer.
        But as we continue to deal with how we can best combat this
    disease, I believe that as stewards of the taxpayers' dollars
    that we must make sure that these dollars are being most in the
    most appropriate way, particularly those that are with the NIH
    and CDC. We must assure that these limited resources are
    appropriately expended to fight all diseases including breast
    cancer, and I have particular concerns about some of the
    expenditures in both NIH and CDC that would appear to be far
    beyond the normal pale of what people regard as important
    research for those two agencies to be supervising.
        So I look forward to the testimony and I welcome our
    colleagues on the first panel. I yield back.
        Mr. Pallone. Thank you, Mr. Deal.
        Let me mention to everybody, that is just a recess. We are
    not voting, just so you know.
        I recognize the gentlewoman from Colorado, Ms. DeGette.
        Ms. DeGette. Thank you very much, Mr. Chairman, and out of
    respect for our intrepid and courageous witnesses in our first
    panel, I will waive my opening statement and submit my very
    excellent statement that everyone will be able to read in the
    record. Thank you.
        Mr. Pallone. Thank you.
        Next is the gentleman from Missouri, Mr. Blunt.
        Mr. Blunt. Thank you, Mr. Chairman. I do have a statement.
    I will submit it for the record as well. I am pleased we are
    having this hearing. I am pleased to be a cosponsor of H.R.
    1740, the EARLY Act, with my good friend, Ms. Wasserman
    Schultz, and look forward to the hearing.
        [The prepared statement of Mr. Blunt follows:]

        Mr. Pallone. Thank you.
        The gentlewoman from California, Ms. Harman.

      OPENING STATEMENT OF HON. JANE HARMAN, A REPRESENTATIVE IN
                 CONGRESS FROM THE STATE OF CALIFORNIA

        Ms. Harman. Thank you, Mr. Chairman. I will be brief but I
    want to salute our colleagues but especially our colleague,
    Debbie Wasserman Schultz, for her courage, her passion and her
    example. Many of us wore pink today in solidarity with her. We
    are strong supporters of her bill. Hopefully we will find a way
    now that it is in acceptable form to Committee staff to include
    it in the health care bill with the robust public option that
    we are going to pass on the House Floor one of these days.
        Just briefly, I have a brother who is an oncologist. I
    couldn't have been prouder when he was given the Healer of the
    Year award by Marin County, California, for his work on breast
    cancer. Breast cancer attacks oldies, grandmas like me, but it
    also attacks beautiful young women like Debbie Wasserman
    Schultz and hopefully not my daughters, who are a bit younger
    than she is, and hopefully not my granddaughter, who is a lot
    younger then she is. So this is something we all have
    experience with. All of us know people who have breast cancer.
    Hopefully they all will be survivors and most of us are very
    responsive to the Susan G. Komen and other efforts to raise
    awareness.
        I just want to say that these bills are all good. I am
    rousingly enthusiastic about Debbie Wasserman Schultz's bill
    and in that context I would like to ask unanimous consent to
    insert in the record a statement by the United Jewish
    Communities in support of that bill.
        [The information follows:]

        Mr. Pallone. Without objection, so ordered. I guess I
    didn't get the memo to wear the pink. I see Jerry did. But I
    was given a pink bat in lieu of a gavel today, so maybe we will
    use that.
        Ms. Harman. Well, Jerry Nadler represents two of my kids on
    the west side of New York, one of whom is female, so it is a
    good thing that he has high awareness of this. I just want to
    add a couple of facts. One, advances in cancer research and
    treatments have greatly improved survival rates. In the 1960s,
    a woman diagnosed with breast cancer had only a 63 percent
    chance of living longer than 5 years. Now it is 89 percent.
    Hispanic and African-American women have a lower survival rate
    than the rest of the population, so clearly we have a lot of
    work to do on reducing racial disparities.
        And finally, next Friday, October 16, is National
    Mammography Day. It is a day when radiologists provide free or
    discounted screening mammograms, and hopefully the women in my
    district and all those can hear us at this hearing will take
    advantage of this. Breast cancer is a terrible opponent but it
    is a beatable one. I yield back, Mr. Chairman.
        Mr. Pallone. Thank you.
        Next is the gentleman from Georgia, Mr. Gingrey.

      OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF GEORGIA

        Mr. Gingrey. Mr. Chairman, thank you. I did have an opening
    statement I would like to give.
        Deaths from breast cancer among women have dropped more
    than 2 percent each year since 1990 due in large part to the
    intervention of improved treatments and early detection of the
    disease. A study published in 2008 found the United States has
    the highest rate of survival for breast and prostate cancers in
    the world. These statistics are just a small example of the
    quality that makes our health care system a leader throughout
    the world. Unfortunately, being the best is not the entire
    story. While our health care system is a benefit to many with
    breast cancer, the disease is still the second most common
    cancer that women are forced to deal with in the United States.
    It is estimated that 192,000 new cases of invasive breast
    cancer are expected to be diagnosed this year and roughly
    40,000 women are expected to die from the disease in 2009,
    40,000. These are sobering statistics that beg our thoughtful
    consideration.
        Therefore, I would like to commend the efforts of our
    panelists and all those who strive each and every year to bring
    attention and awareness to a disease that has impacted many of
    our friends and colleagues, some of whom are sitting here with
    us today as we well know. I applaud their efforts to raise the
    awareness and early detection of breast cancer among our
    Nation's patients, and I look forward to hearing their
    testimony today.
        However, we must also take a step back and look at the
    legislation before us in the context of the overall reform plan
    reported from this Committee at the end of July. From what I
    surmise, two of the bills before us today address federal
    requirements on insurance plans that would in essence I think,
    become moot because of H.R. 3200. If H.R. 3200 were to become
    law, this Congress would not be deciding what benefits
    insurance companies must contain or what measures should be
    used to ensure non-citizens cannot use taxpayer dollars to
    purchase health insurance. Those would be the purview of a
    political appointee with little regard for the will of the
    people.
        After the outpouring of concern and constructive criticism
    for the President's plan during the August recess, I had hoped
    to come back to these hallowed walls and found a new Congress
    open and willing to work in a bipartisan fashion for the
    benefit of our constituents. Today as we sit here with the
    specter of H.R. 3200 hanging over our heads, it is looking more
    and more that that hope to be a false one. Mr. Chairman, it
    seems the lessons of August have not been learned by some of my
    colleagues on the other side of the aisle. I yield back my
    time.
        Mr. Pallone. Thank you, Mr. Gingrey.
        Next is our chairman, Mr. Dingell.

    OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF MICHIGAN

        Mr. Dingell. Mr. Chairman, I thank you. Good morning.
        I would first like to thank you for holding this hearing.
    It is an important one and it is an opportunity to learn more
    about the four breast cancer bills before us today. Breast
    cancer is the second most common type of cancer amongst women
    in the United States so it is important for us to continue a
    vigorous examination of how to best prevent and treat this
    disease. In 2009, an estimated 192,370 new cases of invasive
    breast cancer will be diagnosed among women, and approximately
    40,107 of these women are expected to die from the disease. An
    additional 1,920 cases of breast cancer are expected to occur
    amongst men. In my home State of Michigan alone, there will be
    an estimated 6,480 new cases this year and 1,350 deaths. It is
    estimated that about $8.1 billion is spent in this Nation every
    year for the treatment of breast cancer. While real strides are
    being made against the disease, the 5-year survival rate is 98
    percent when detected early but too many women continue to lose
    the battle against breast cancer for want of proper treatment
    and proper early diagnosis.
        H.R. 995 would require a group health plan that provides
    diagnostic mammography for women over 40 to also cover an
    annual screening mammography and an MRI for high-risk women.
    The National Cancer Institute has recommended that women 40 and
    over should have a mammogram once every 1 or 2 years. Doctors
    and patients should make the decision whether to have a
    mammogram based on risk factors, not the cost.
        Another bill under consideration is H.R. 1691, the Breast
    Cancer Patient Protection Act, of which I am a sponsor. H.R.
    1691 would ensure that women undergoing mastectomies would be
    guaranteed 48 hours of hospital care unless the provider and
    the patient determine a shorter stay is appropriate. This is
    again aimed at dealing with the problem of drive-through
    mastectomies and other things of that character as provided by
    the health insurance providers of this country. The legislation
    would also protect physicians who provide quality care for
    breast cancer patients from retaliation by health maintenance
    organizations and other insurance companies seeking to maximize
    profits at the expense of patient care. This bill is of great
    importance to me because a member of my staff in Michigan was a
    victim of these unscrupulous insurance company practices when
    she was sent home after a mastectomy in considerable pain with
    no support to manage her condition. She ultimately succumbed to
    her cancer but the heartless way in which her insurance company
    treated her was an outrage. Guaranteeing that treatment
    decisions are made by the provider in consultation with the
    patient, taking into account the patient's unique medical
    needs, is the cornerstone of good, successful and, believe it
    or not, inexpensive or the least expensive medical care.
        H.R. 1740 would direct the CDC to develop and implement a
    national education campaign about the threat that breast cancer
    poses to young women of all ethnic and cultural backgrounds and
    the particular heightened risks of certain groups of our women.
    It is important that we examine the ways to educate our young
    women and medical professionals about breast cancer in young
    women.
        The final bill considered today, H.R. 2279, would address
    the disparities in breast cancer diagnosis and treatment by
    requiring providers to report their practices to encourage
    doctors to offer adequate care to all irrespective of race,
    income, age or health insurance status.
        Together these bills will protect women from drive-through
    mastectomies as well as advanced breast cancer protection and
    treatment amongst high-risk communities, young populations and
    minorities. This hearing coincides with National Breast Cancer
    Awareness Month and will shine light on issues of great
    importance to women and their families. I look forward to the
    testimony of today's witnesses and I commend you for the
    hearing, and I thank you, Mr. Chairman.
        Mr. Pallone. Thank you, Chairman Dingell.
        Next is one of the sponsors of the bill--oh, I am sorry.
    Next is the gentleman from Texas, Mr. Burgess.
        Mr. Burgess. Mr. Chairman, in the interest of time, and I
    know we have got votes, I will submit my statement for the
    record.
        [The prepared statement of Mr. Burgess follows:]

        Mr. Pallone. Thank you, Dr. Burgess.
        Next is one of our prime sponsors of the legislation, the
    gentlewoman from Florida, Ms. Castor.

      OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF FLORIDA

        Ms. Castor. Chairman Pallone, thank you very much for
    convening this timely hearing on breast cancer legislation
    during National Breast Cancer Awareness Month.
        Breast cancer is still a brutal killer in America but we
    are going to continue to fight and we are going to make
    progress, and we are going to make progress due in large part
    to the leaders who are here today, to my colleagues here on the
    Health Subcommittee but to these brave Members of Congress that
    represent hundreds of thousands of people and many, many women
    who have struggled with breast cancer. Congresswoman Rosa
    DeLauro, Congressman Jerry Nadler and my good friend from
    Florida, Congresswoman Debbie Wasserman Schultz. Congresswoman
    Wasserman Schultz has been a fine example of perseverance and a
    great role model for anyone that has been diagnosed with breast
    cancer, and I am proud to be a cosponsor of her bill.
        I am also eager to hear from the top experts in the field
    today on our latest legislation, and Mr. Chairman, our
    colleague, Congresswoman Dr. Donna Christensen, is my partner
    on my bill, H.R. 2279, the Eliminating Disparities in Breast
    Cancer Treatment Act, that we will consider today. I would like
    to thank her for all of her attention to disparate diagnosis
    and treatment that still plagues health care in America.
        It is not secret that quality health care in the United
    States is not equally accessible to all of our communities. As
    a Committee, we have worked diligently for the better part of
    this year to improve health care in America and to make quality
    care affordable and accessible for all, and we are closer to
    that than ever before but we still have these underlying issues
    of disparate diagnosis and treatment that must be addressed
    directly, and one of the most disturbing involves breast cancer
    in women of color. Overall breast cancer survival rates in the
    last two decades have improved with one exception: minority
    women. Women of color suffer from significantly higher death
    rates after diagnosis than white women. The American Cancer
    Society reports that delays in receiving care after breast
    cancer diagnosis are greater for African-American women than
    for white women. African-American women with breast cancer are
    less likely to receive standard therapy than white women.
    African-American and Hispanic patients are significantly more
    likely than white patients to be diagnosed at a more advanced
    stage of breast cancer. And regardless of insurance status,
    African-American women are almost two times more likely to be
    diagnosed with an advanced stage of breast cancer than white
    women and Hispanic women are about one and a half times more
    likely to be diagnosed with an advanced stage of breast cancer
    than white women. African-American women are 10 percent more
    likely not to receive tests to determine if breast cancer has
    spread to axillary underarm lymph nodes. This screening is
    essential to preventing the spread of cancer to other parts of
    the body. Health insurance status, race, income and educational
    background are directly linked to irregularity in administering
    this vital screening. Substantial disparities remain regarding
    cancer diagnosis and treatment.
        So in order to eliminate this unacceptable variance in
    treatment and quality care, it is necessary that we create real
    incentives and requirements for medical professionals to
    provide the best care. All patients should receive the most
    modern and high-standard treatment for their conditions. So our
    bill seeks to put an end to the inequities in treatment for
    breast cancer and will help ensure that every patient has
    access to the most appropriate care. The legislation will
    implement breast cancer treatment performance measures,
    requiring the Secretary of HHS to work with a national quality
    forum to develop standard best practices for breast cancer
    treatment. These measures will address patient outcomes, the
    process for delivering medical care related to breast cancer
    treatment, patient counseling and engagement in decision-
    making, overall patient experience, physician care coordination
    and then the Secretary will develop a 6-year breast cancer
    treatment quality performance initiative. In years 1 through 3,
    physicians will be encouraged to follow the new recommendations
    and report their practices on a voluntary basis. In years 3
    through 6 reporting will be required and the Secretary will
    evaluate the care that is furnished to patients. Low-quality
    treatment from providers will result in reduced Medicare
    payments for those physicians. Improvements in treatment will
    be recognized and payments will be scaled based on the care
    provided. The Secretary will be required to report to Congress
    so we can keep track of the progress.
        Mr. Chairman, this legislation will help eliminate
    disparities in the treatment of breast cancer. We must continue
    to use all of our expertise and modern tools to fight this
    brutal killer, improve diagnosis and improve treatment. It will
    save lives, it will save money and it will save heartache.
        Thank you very much. I look forward to hearing from the
    panels.
        Mr. Pallone. Thank you.
        The gentleman from Illinois, Mr. Shimkus.
        Mr. Shimkus. Thank you, Mr. Chairman. I want to welcome my
    colleagues here. They are all sincere and respected public
    policy experts, and I appreciate their attendance, and I yield
    back my time.
        Mr. Pallone. Thank you.
        The gentlewoman from Illinois, Ms. Schakowsky.
        Ms. Schakowsky. Thank you, Mr. Chairman. I will put my full
    statement in the record, but I do want to thank all of my
    colleagues, Debbie Wasserman Schultz and Rosa DeLauro and Jerry
    Nadler and Kathy Castor for the wonderful bills that I am proud
    to be a cosponsor of.
        I just do want to tell you that Chicago has one of the
    largest disparities in death rates as a result of breast
    cancer. A report released in 2007 showed that breast cancer
    kills minority women at a rate of 68 percent higher than white
    women, mostly because of inequities and access to quality and
    affordable care. And I want to give a shout-out to an
    organization. We are actually going to have a briefing with
    them next week. Pin-A-Sister is a Chicago-based organization
    started by Access Community Health Center. Every Mothers Day
    the organization coordinates an event in black and Latino
    churches. The women in the congregation are invited to place a
    pin on a sister to empower her to learn more about breast
    cancer and to show she is not alone in her experience with
    breast cancer. But they need help.
        These bills that you have sponsored and that I feel certain
    that will pass are really going to help them and all women,
    those facing breast cancer and potentially those who may face
    it in the future. Thank you very much. I yield back.
        Mr. Pallone. Thank you.
        The gentlewoman from Tennessee, Ms. Blackburn.
        Mrs. Blackburn. Thank you, Mr. Chairman, and I thank our
    colleagues for the good work that they have done and the
    attention that they have brought to this issue and we are
    delighted that you are here. I will place my full statement in
    the record.
        I do want to highlight some of our volunteers in Tennessee
    that have done exceptional work on the issue of breast cancer.
    Our Tennessee Breast Cancer Coalition really has taken the lead
    in Tennessee. We do know that the work we did last year on the
    Breast Cancer Environmental Research Center Act was very
    important. This is something the environmental pressures that
    come to bear on Tennessee women is something that has gained a
    lot of attention in our State and has caused a lot of concern,
    and we have several facilities that are doing a great deal of
    wonderful research--the UT Cancer Institute, the Vanderbilt
    Ingram Cancer Center and the Minnie Pearl, Sarah Cannon Center
    and so I highlight the good work that is being done there.
        In Tennessee, we have 3,970 new cases of breast cancer that
    will be diagnosed this year, and 910 women will probably end up
    losing their life to this disease. We note the legislation
    before us will help assist the good ongoing research equally in
    the manner that the legislation we passed last year did and we
    look forward to eradicating the disease and certainly making a
    difference in the lives of men and women that are affected by
    this, and I thank you for the hearing and yield my time.
        Mr. Pallone. Thank you.
        The gentleman from Utah, Mr. Matheson.
        Mr. Matheson. Thanks, Mr. Chairman. I will submit my full
    written statement for the record, but just very briefly, I
    would point out that it is appropriate we have four different
    bills today. This is a complicated issue and there are a lot of
    aspects in terms of addressing and trying to fight this disease
    that we should consider as a Committee, and I want to thank the
    lead sponsors, Representative Castor, Representative Nadler,
    Representative DeLauro and Representative Wasserman Schultz for
    championing this issue. Congresswoman DeLauro has been such a
    great advocate and I was an original cosponsor. I remember we
    passed this in the House last time and hopefully we get it
    across the finish line this time.
        You know, a lot of people point out different populations
    that are affected differently, and I would just highlight one
    interesting demographic in my home State where in Utah the
    incidence of breast cancer is actually much lower than the
    national average and yet the mortality rate is about the same,
    and that is because we have a problem where it is usually
    diagnosed at later stages. That is why Congresswoman Wasserman
    Schultz's bill is of particular interest to me that will help
    in my State. And it just points out that you hear these opening
    statements from people around the country with different
    constituencies and whatnot and there are so many ways we need
    to try to attack this issue.
        I commend the Committee for holding this hearing and
    bringing all these folks together. I look forward to advocating
    for all these bills. Mr. Chairman, I want to once again thank
    my colleagues for being here and I will yield back my time.
        Mr. Pallone. Thank you.
        The gentlewoman from the Virgin Islands, Ms. Christensen.

           OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A
           REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS

        Mrs. Christensen. Thank you, Mr. Chairman, and I thank you
    and the ranking member for holding this hearing on such an
    important issue and making, we hope, this Breast Cancer
    Awareness Month a decisive one in the fight against breast
    cancer. I would like to welcome my colleagues as well.
        With these bills, we not only expand access to mammography
    and other often lifesaving screening technologies but we
    protect and ensure the health care coverage for breast cancer
    patients, educate women earlier about breast cancer and
    eliminate the breast cancer disparities that have a disastrous
    impact on far too women of color. I would like to thank
    Representatives Nadler, DeLauro, Castor, with whom I worked on
    2279, and especially Congresswoman Debbie Wasserman Schultz,
    herself a breast cancer survivor, especially for your bill's
    emphasis on educating younger women earlier about breast
    cancer.
        It is unacceptable that today one in every eight women will
    have invasive breast cancer at some point in her life and that
    breast cancer remains the second leading cause of cancer death
    for women in this country, but as grim as these statistics are,
    they are even worse when you consider racial and ethnic
    disparities in breast cancer incidence and mortality and
    prevention. For example, while African-Americans have lower
    breast cancer incidence rates than their white counterparts,
    they are more likely to die from the disease. Latina, American
    Indian and Asian-American women are not only disproportionately
    more than likely than their white counterparts to not have a
    mammogram in the recent 2 years, but finally, while breast
    cancer death rates have been on the decline since 1990 overall,
    we find that that the 5-year breast cancer survival rate for
    American Indian women is lower than any other population group
    of women.
        So these statistics suggest that while we have made great
    progress in the fight against breast cancer much to the credit
    of the witnesses we will hear from today and continuing with
    the legislation before us. We have a long way to go and I look
    forward to today's testimonies and discussions and anticipate
    that this hearing will serve as the impetus needed to take our
    collective fight against breast cancer and every cancer really
    to the very next level, and I thank you. I yield back.
        Mr. Pallone. Thank you.
        The gentleman from Maryland, Mr. Sarbanes.
        Mr. Sarbanes. Thank you, Mr. Chairman. I will be very
    brief.
        These are all incredibly important measures, and I just
    want to salute our colleagues and my colleague, Kathy Castor,
    for their work on this. I am embarrassed, Debbie, that I am not
    wearing any pink today, but I am turning pink with
    embarrassment at that, so that will have to do.
        Anyway, congratulations on your work. We look forward to
    your testimony.
        Mr. Pallone. Thank you.
        The gentleman from Georgia, Mr. Barrow. I will mention to
    members that we have three votes, a 15--I am sorry, four votes.
    There is a 15 and then three 5s. Mr. Barrow, if you would like
    to make an opening, go ahead.
        Mr. Barrow. Thank you, Mr. Chairman. I would.
        It is estimated that one in eight women will develop breast
    cancer over their time and it is the leading cause of death
    among women age 45 and older. This disease is far too
    preventable and too treatable for these numbers to be so high.
    I know because my mother, who turns 89 years of age today, is a
    35-year survivor of breast cancer. Curing breast cancer is a
    huge challenge and it can only happen with good science,
    adequate funding, effective treatments and greater awareness
    and education.
        These bills we are addressing here today represent small
    but important steps along the way. October is National Breast
    Cancer Awareness Month. This gives us an excuse to come here
    today and work on this legislation but I look forward to the
    day when this month will not be a time to raise awareness but a
    time to celebrate how our collective efforts actually led to
    the eradication of breast cancer. I want to thank Chairman
    Pallone and Ranking Member Deal for addressing this important
    issue in our Subcommittee as well as Representatives Nadler,
    DeLauro and especially my colleagues, Congresswoman Wasserman
    Schultz and Congresswoman Castor, for introducing these
    critical bills that promote breast cancer prevention, research,
    treatment and quality of care. Thank you, and I yield back.
        Mr. Pallone. Thank you. I think that concludes our opening.
    Now, we could get a couple of you in. I don't think we can get
    all three of you. I will dispense with my remarks other than to
    say the three of you are wonderful, and two of you are cancer
    survivors. All three of you have been champions of this and
    other issues so effectively. If anybody can get anything done,
    it is the three of you, and I start with Congressman Nadler.

    STATEMENTS OF THE HONORABLE JERROLD NADLER, MEMBER OF CONGRESS;
      THE HONORABLE ROSA L. DELAURO, MEMBER OF CONGRESS; AND THE
         HONORABLE DEBBIE WASSERMAN SCHULTZ, MEMBER OF CONGRESS

                      STATEMENT OF JERROLD NADLER

        Mr. Nadler. Thank you, Chairman Pallone, Ranking Member
    Deal and the members of the Subcommittee. Thank you for
    convening this hearing and for inviting me to testify today
    about H.R. 995, the Mammogram and MRI Availability Act.
        I also want to thank the breast cancer advocacy groups for
    coming to testify about the work they do, the problems we face
    in the fight against breast cancer and the ways in which they
    and their organizations are helping to educate, screen, treat
    and care for women living with and at risk of developing breast
    cancer.
        We all know people near and dear to us who have battled
    breast cancer, my wife among them for the last 3 years. We all
    know the statistics. Breast cancer is the second leading cause
    of death of women in the United States, the leading cause of
    death of women age 40 to 49. This year alone, more than 40,000
    women in the United States will die from breast cancer. More
    than 192,000 new cases will be discovered.
        We also know that in addition to the need to find a cure,
    prevention is the difference between life and death. In 2005,
    the National Institute of Cancer Study confirmed that
    mammograms contributed to a pronounced drop in the number of
    breast cancer deaths. Study after study has found that yearly
    mammograms, annual mammograms done from age 40 on help find
    tumors at their smallest and most treatable stage. That is why
    the American Cancer Society and others recommend that women age
    40 and older should have yearly mammograms, and that is why I
    introduced H.R. 995, a bipartisan, commonsense bill to ensure
    coverage of annual mammograms for this population of women.
        While many insurance plans cover diagnostic mammograms,
    that is, mammograms used to diagnose whether an already known
    mass or tumor is cancerous, many insurance plans do not cover
    screening mammograms for the purpose of detecting tumors in the
    first place. Based on the research and what we know about
    breast cancer, this is simply unacceptable, and women and their
    families deserve better. We would save many, many lives if all
    plans covered annual screening mammograms for women of age 40
    and above.
        As we have learned, mammograms on their own do not detect
    every malignant tumor. For women at particularly high risk of
    breast cancer, women who have a strong family history of breast
    cancer where a woman's mother, grandmother, sister or daughter
    was diagnosed with breast cancer or those women with a BRCA1 or
    2 genes who have a genetic predisposition to developing the
    disease, MRIs help detect more tumors at their earliest, most
    treatable stages that mammograms cannot detect. For this
    population of women who are particularly susceptible and at
    high risk of developing breast cancer, the American Cancer
    Society recommends an annual mammogram and an annual MRI. As
    with coverage for mammograms, insurance companies do not
    routinely cover screening MRIs, even for this high-risk
    population of women.
        H.R. 995 would make these important screening exams
    available to the women who need them most. So, in other words,
    what this bill would do is to say that any health insurance
    plan that provides coverage for diagnostic mammograms must
    provide coverage for screening mammograms for women annually
    over 40 and for the high-risk population of women over 40 for
    MRIs annually as well. While women should consult a doctor
    before undergoing a mammography or MRI, nothing in this bill
    requires a woman to seek a doctor's referral prior to receiving
    one of these lifesaving screening exams nor does the bill
    require women to undergo any tests unless she chooses to do so.
        As the Subcommittee well knows, Congress is on course to
    pass historic health care reform bill this year. That
    legislation contains important provisions that would eliminate
    copays and deductibles for recommended prevention services.
    These recommendations should include screening mammograms.
    However, neither House of Congress has passed the legislation.
    Furthermore, even if passed, delays upward of 5 years or more
    could continue to limit women's access to these exams.
    Therefore, passage of major health reform won't necessarily
    prevent these women from continuing to fall through the cracks.
    Additionally, the prevention measures likely to be included in
    the final health care reform package do not currently include
    coverage for MRIs for high-risk women. Thus, the women most at
    risk, the women with a strong family history of the presence of
    breast cancer as well as those who are genetically predisposed
    to the disease will continue to be left without access to these
    lifesaving exams. Only passage of H.R. 995 either as a
    standalone bill or by inclusion of its provisions in the
    comprehensive bill that this Committee is helping to shape now
    will ensure that these women have the coverage they need on
    which their lives may very well depend.
        Mr. Chairman, with the passage of this bill or with its
    inclusion in the overall bill when that passes, women age 40
    and older as well as those women at particularly high risk of
    developing breast cancer will no longer continue to fall
    through the cracks. With this legislation, these women will be
    guaranteed coverage for life-saving screening exams. As we wait
    to find a cure, ensuring coverage for screening mammograms for
    all women age 40 or older and where indicated for the high-risk
    population of women over 40 for MRIs as well could mean
    tremendous benefits for many, many women and their families in
    the fight against breast cancer.
        Mr. Chairman, I thank you again for giving me an
    opportunity to discuss this bill, H.R. 995, the Mammogram and
    MRI Availability Act, and for holding this important hearing on
    women's health. I look forward to working with you as well as
    my colleagues on the Subcommittee to pass this legislation in
    one or the other form. Thank you very much.
        [The prepared statement of Mr. Nadler follows:]

        Mr. Pallone. Thank you.
        Congresswoman DeLauro.

                      STATEMENT OF ROSA L. DELAURO

        Ms. DeLauro. Thank you very much, Mr. Chairman, and thank
    you, Ranking Member Deal, for hosting this effort today. I also
    want to say thank you to this Subcommittee and to the full
    Committee on a bipartisan basis that have supported the Breast
    Cancer Patient Protection Act, and I appreciate that as the
    women around the country do. Also, my colleagues, Jerry Nadler,
    Debbie Wasserman Schultz, all of whom have--Kathy Castor, Donna
    Christensen, try to come to grips with what is a singularly big
    health issue for women around the country, and I would just say
    to Debbie that her courage and her tenacity in this effort is
    well known, and she clearly is a voice for young women. To all
    of the advocates who are here today, thank you. We can't do
    this without you. It is an honor to work with you and your
    efforts again also keep us strong and determined to make sure
    we pass good legislation.
        It was 13 years ago that Dr. Kristin Zarfos, who is a
    Connecticut breast surgeon, told me that HMOs were forcing her
    to discharge her patients before they were ready, sometimes
    just hours after a mastectomy. She testified before this
    Subcommittee last year that insurers suddenly refused to pay
    for reasonable hospital stay regardless of any underlying or
    complex medical problems that patients might have--diabetes,
    heart disease. This is still happening. Patients continue to be
    discharged with no consideration for adverse reactions to
    anesthesia, postoperative pain or even when they are awake
    enough to understand their discharge instructions. At the
    Subcommittee hearing last year that was convened, we had a
    breast cancer patient, Alva Williams. She testified she had a
    mastectomy on March 6, 2006, was sent home several hours after
    surgery. The insurance company would not cover an overnight
    stay. The family didn't receive proper training on how to care
    for her. She developed an infection in the incisions and
    recovering from that infection caused Ms. Williams'
    chemotherapy treatments to be delayed 6 weeks. Arizona--a
    woman's story on Lifetime TV website: ``I had a double
    bilateral mastectomy in June of this year. I was discharged
    within 2 hours after surgery. I had severe complications that
    later resulted in being readmitted to the hospital within the
    first week post surgery.'' The stories go on, and my testimony
    has been submitted. There is a woman in Kansas City whose
    husband was a physician and she found that it was difficult
    even with a caregiver who was a physician.
        So this is happening across the Nation, which is why in my
    view we need to pass the Breast Cancer Patient Protection Act.
    It says that simply, very simply, adequate recovery time in the
    hospital should not be negotiable. The last thing that any
    woman should be doing at this time is fighting with their
    insurance company. The bill does not mandate, it does not
    mandate a 48-hour hospital stay. If a patient chooses to go
    home sooner, fine. Nor does it set 48 hours as a maximum amount
    of time a woman can stay in the hospital. It says that any
    decision in favor of shorter, longer hospital stay would be
    made by a patient and her doctor and not by an insurance
    company.
        I have been in the hospital many months, and let me just
    tell you, it is not for everyone. It is not where you want to
    spend your time. But it is important to know that successful
    outpatient mastectomy programs have been extremely careful to
    empower their patients through education, monitoring outcomes
    and working intensely to minimize complications.
        Last year, 421 Members of Congress voted to enact this
    legislation, bipartisan support. We introduced it this year, my
    colleague, your colleague, Joe Barton. Mr. Dingell has spoken
    out on it. Lifetime Television has a petition calling for the
    Breast Cancer Patient Protection Act's passage. Nearly 24
    million people have signed on to this petition. We have 236
    cosponsors. Senator Snowe, Senator Landrieu, 17 cosponsors in
    the Senate. We are ready to do this. We need to move forward.
    We have a number of supportive advocacy groups out there.
        I will just conclude by saying to you that let us do this.
    Let us do this for the women of this Nation. What happened on
    the Senate side to us last year was the insurance companies. We
    passed it 421 votes. That tells you something about the need.
    It tells you something about the support. Let us do it again in
    the House and let us make sure that our Senate colleagues do
    the same thing. Thank you so much for letting me speak to you.
        [The prepared statement of Ms. DeLauro follows:]

        Mr. Pallone. Thank you, and thank you for your passion,
    really.
        We only have about a minute left. I was going to suggest we
    come back, if that is okay. All right. We will reconvene after
    those votes with Congresswoman Wasserman Schultz. The Committee
    is in recess.
        [Recess.]
        Mr. Pallone. The Subcommittee will reconvene, and we had
    our Members' panel, and you ended up last, I guess. I apologize
    for that, Congresswoman Wasserman Schultz. But let me say,
    since we have a little time, thank you so much. You are like a
    hero. You really are. Or heroine, I guess, is the word. I mean,
    I don't know all the details but I remember the speech when you
    came to the Floor that one day and it was just amazing. All
    that you do, I don't know how you find the time, but thank you.

                 STATEMENT OF DEBBIE WASSERMAN SCHULTZ

        Ms. Wasserman Schultz. Thank you so much, Mr. Chairman. I
    am happy to bat cleanup today for the Member panel, and
    Chairman Pallone and Ranking Member Deal when he comes back and
    the distinguished members of the Subcommittee that are here
    with us, it really is an honor to be here and to testify in
    front of the Health Subcommittee of Energy and Commerce, and
    Mr. Chairman, thank you very much for holding this hearing
    during Breast Cancer Awareness Month. I think that is a
    particularly important symbol. It is fitting that we review
    what is needed in the fight against breast cancer during this
    special month when, although we pay special attention to breast
    cancer awareness during the month of October, it is important
    that we focus on that awareness and help women pay attention to
    their breast health throughout the year.
        Before I go further, I really want to give my deepest
    gratitude and thanks to the efforts of three of my colleagues,
    Sue Myrick, Rosa DeLauro and Donna Christensen, who embraced
    this legislation months ago before I publicly shared my own
    battle with breast cancer, and it was an honor to testify by
    the side of my friend and colleague, Rosa DeLauro, and Sue, you
    are just superhuman. I think there was one day when you got 45
    cosponsors for this bill in one small series of votes. It is
    hard for me to express how much I appreciate your support for
    me and the fact that I was able to share my story and talk to
    you about our mutual experience before I shared it with
    everyone else. Thank you very, very much. You have been there
    for me every step of the way.
        Breast cancer strikes women from all backgrounds, all
    races, all ages and all ethnicities. It strikes black and
    white, rich and poor, those with access to quality health care
    and those without. But many women, too many women do not know
    their specific risk factors or their family history, and this
    is especially true with young women who see breast cancer as an
    older woman's disease. Many young women think breast cancer
    will never happen before they turn 40 but we know that young
    women can and do get breast cancer. In fact, each year nearly
    24,000 women under 45 are diagnosed with breast cancer in the
    United States. While incidence rates of breast cancer are much
    lower in young women than older women, young women's breast
    cancers are generally more aggressive, they are diagnosed at a
    later stage and they result in higher mortality rates. After
    talking with many health care professionals, advocates in the
    breast cancer community and the Centers for Disease Control and
    Prevention, it became clear that there was an urgent need to
    help build awareness among this often overlooked group. These
    conversations led to H.R. 1740, the Breast Health Education and
    Awareness Requires Learning Young Act, or the EARLY Act. This
    bill will empower young women to learn the facts, know their
    bodies, speak up for their health and embrace support. The
    truth is, we all need to be better informed about our own
    health. We must empower each other to know and reduce our
    risks.
        Recently I learned I had more personal risks than I was
    aware of. Almost 2 years ago, as most of you know now, only 6
    weeks after a clean mammogram, I found a lump in my breast
    while doing a routine self-exam. My doctor diagnosed me with
    breast cancer when I was only 41. As a legislator, I have been
    in the fight against breast cancer for a long time. In Florida,
    I was the lead sponsor of the drive-through mastectomy law, the
    focus of Rosa's bill. I never dreamed I would need its
    protection myself. I thought I knew all of my risk factors.
    That is why I chose to perform self-exams and saw my doctor
    regularly. But after I was diagnosed, I learned I had more risk
    factors than I was aware of. I had no idea, for example, that
    as an Ashkenazi Jewish woman, I was five times more likely than
    the general population to have a BRCA1 or BRCA2 gene mutation.
    I didn't know that that mutation gave me as much as an 85
    percent chance of developing breast cancer during my lifetime.
    Too many young women are unaware of their risk.
        The EARLY Act will give all young women the tools and
    information they need to take more control of their health. It
    will raise awareness of their personal risks and the importance
    of paying attention to their breast health. It will encourage
    young women to be familiar with the look and feel of their
    breasts. By knowing what feels normal, a young woman has a
    better chance of knowing when something feels different, and I
    can tell you that that is how it was for me. Because I did
    self-exams on a fairly regular basis, I was familiar enough
    with what my breasts normally felt like so that when I felt
    that lump, I knew it didn't belong there. The EARLY Act will
    teach young women and medical professionals about the
    importance of family history, warning signs of breast cancer
    and predictive tools such as genetic testing that can help some
    high-risk women make informed decisions about their health. It
    will also provide grants to organizations dedicated to
    supporting young women diagnosed with breast cancer. These
    grants will help young women tackle the unique challenges that
    they face like fertility preservation, body image and self-
    esteem as well as help them manage and understand their risks.
    And again, when a young woman is diagnosed with breast cancer,
    I mean, at 28 years old, for example, if they don't even have a
    boyfriend and they are faced with breast cancer and having a
    double mastectomy and dealing with chemotherapy and facing
    their own mortality, on top of that having to think about how
    to preserve their fertility, that is a unique challenge that
    young women who are diagnosed with breast cancer face that
    older women simply do not, and younger women have to face many
    more years as survivors which presents in and of itself unique
    challenges.
        So we have 371 cosponsors in the House including nearly all
    members of this Subcommittee and 34 cosponsors in the Senate.
    The EARLY Act has garnered broad public support from more than
    40 advocacy and health organizations, many of whose
    representatives are behind me here today, and I just cannot
    thank these groups enough for their support, for their
    expertise and their guidance in helping to craft this
    legislation, but also for their personal support of me because
    it has just been very moving and special for me.
        Some say that we shouldn't be talking to young women about
    breast cancer at all because it might scare them. Well, I find
    this quite simply patronizing. Young women and providers can
    handle the truth. They can and should be empowered with the
    knowledge that while only 15 percent of breast cancer cases are
    in women under 45, eight of these women die every here in
    America. Having no information when you are 35 about breast
    cancer and finding a lump in your breast, that is what is
    really scary.
        Over the past year I have met with oncologists and other
    health care professionals that work with breast cancer
    patients, whether at MD Anderson Cancer Center in Houston, the
    Dana Farber Cancer Institute at Harvard or the Cancer Center at
    Memorial Regional Hospital in my district in Florida, the
    message is clear: too often a diagnosis of breast cancer is
    delayed or missed in young women. A Harvard study of young
    women with breast cancer found 26 percent delayed seeking
    medical attention and 27 percent experienced a delay in
    diagnosis after seeking medical attention. This means that more
    than half of young women are not receiving the timely treatment
    that they need. We must do better. By encouraging young women
    to know their bodies and their family history and by teaching
    young women how to effectively talk with their doctors and
    their doctors with them, we can transform how we approach the
    fight against breast cancer.
        Every young woman that I know has the goal of becoming an
    old woman. With the passage of the EARLY Act, we can help more
    young women in America reach their goal and give them powerful
    tools to take control of their own health for a lifetime. Thank
    you very much.
        [The prepared statement of Ms. Wasserman Schultz follows:]

        Mr. Pallone. Thank you so much. Really, you know, even now
    you have given me a lot more insight into what needs to be done
    and what we need to do, and I just want to stress again, I know
    that there has been some discussion today about what is in the
    health care reform bill and how some of these bills relate and
    some parts of them actually are included, but as I said
    earlier, this is a legislation hearing and so we do intend to
    move the bills, and we will look and see what is in the health
    reform and what isn't and take that all into account.
        Ms. Wasserman Schultz. Mr. Chairman, I have been a
    legislator for a long time. Any which way this bill becomes law
    is fine with me. Thank you very much, and thank you to the
    Committee staff because they have been an incredible source of
    support and guidance as we move through the process too. Thank
    you.
        Mr. Pallone. Take care.
        Now, what we are going to do with our second and third
    panel is that the panelists have agreed, actually on their own
    initiative, to put the two panels together, so we are just
    going to have one panel. This way we can save time and have a
    series of questions that way. So I would ask the second and
    third panel members to come forward, if you would. Welcome. Let
    me say that the normal practice is that Administration
    witnesses have a separate panel, which is why Dr. Taplin from
    NIH would normally have had the second panel, so I want to
    thank you for suggesting that you be with the other panel, but
    I don't want anyone to think that that prejudices what we do in
    the future. We understand that the Administration is normally
    not part of another panel.
        So let me introduce everyone. Starting on my left is Dr.
    Stephen Taplin, who is chief of the Applied Cancer Screening
    Research Branch, Division of Cancer Control and Population
    Science for the National Cancer Institute, which is part of the
    National Institutes of Health. Then we have Dr. Otis Webb
    Brawley, who is chief medical officer for the American Cancer
    Society; Ms. Jenny Luray, who is president of the Susan G.
    Komen for the Cure Advocacy Alliance; Debra L. Ness, who is
    president of the National Partnership for Women and Families;
    Dr. George W. Sledge, Jr., who is Ballve Professor of Oncology
    at Indiana University Medical Center in the Cancer Pavilion;
    Ms. Fran Visco, who is president of the National Breast Cancer
    Coalition, and finally, Dr. Marisa C. Weis, who is president
    and founder of Breastcancer.org. So thank you all for being
    here, and I think you know we have 5-minute opening statements
    that become part of the record. I would like you to try to keep
    your comments to the 5 minutes if you could. You may get
    questions from the panel that you have to get back to later in
    writing too, but we would like you to try to answer the
    questions today.
        So we will start with Dr. Taplin from NIH. Thank you.

       STATEMENTS OF STEPHEN TAPLIN, M.D., M.P.H., CHIEF OF THE
     APPLIED CANCER SCREENING RESEARCH BRANCH, DIVISION OF CANCER
      CONTROL AND POPULATION SCIENCE, NATIONAL CANCER INSTITUTE,
     NATIONAL INSTITUTES OF HEALTH; OTIS WEBB BRAWLEY, M.D., CHIEF
       MEDICAL OFFICER, AMERICAN CANCER SOCIETY; JENNIFER LURAY,
    PRESIDENT, SUSAN G. KOMEN FOR THE CURE ADVOCACY ALLIANCE; DEBRA
        L. NESS, PRESIDENT, NATIONAL PARTNERSHIP FOR WOMEN AND
      FAMILIES; GEORGE W. SLEDGE, JR., M.D., BALLVE PROFESSOR OF
     ONCOLOGY, INDIANA UNIVERSITY MEDICAL CENTER, CANCER PAVILION;
    FRAN VISCO, J.D., PRESIDENT, NATIONAL BREAST CANCER COALITION;
           AND MARISA C. WEISS, M.D., PRESIDENT AND FOUNDER,
                            BREASTCANCER.ORG

                      STATEMENT OF STEPHEN TAPLIN

        Dr. Taplin. Thank you, Mr. Chairman Pallone, and Committee
    members. Thank you for the opportunity to speak today. I have
    also provided a written document that elaborates on my
    testimony with greater detail. As you have heard, I am Dr.
    Stephen Taplin, the chief of the Applied Cancer Research Branch
    at the National Cancer Institute. Before coming to NCI, I spent
    20 years as a practicing family physician while also managing
    an organized breast cancer screening program and conducting
    screening research at Group Health Cooperative, an integrated
    health plan in Seattle, Washington.
        There is more than 50 years of research in breast cancer
    screening and treatment that is now having a positive impact on
    the lives of women. Research shows that the breast cancer
    incidence increases markedly. Each year among 100,000 women,
    1.4 cancers are diagnosed in the age group 20 to 24, but as you
    can see here in figure 1, the rate rises to a peak of 454 in
    women ages 75 to 79. The benefit of research for these women is
    that breast cancer death has fallen across all age groups since
    1975. Since 1990, the rate of decline has accelerated and the
    annual percent reduction in mortality has been a fairly
    consistent 2 to 3 percent per year over the last 10 years.
    However, let me be clear that I understand it is not the
    research that changed the lives, it is the choices women are
    making and the changes in therapy that physicians that are
    implementing that have had the impact. The key is those changes
    are guided by evidence from research.
        The mortality reduction we are seeing is due to both
    improvements in treatment and improvements in screening. An
    elegant set of modeling studies demonstrated approximately half
    the reduction in mortality among women ages greater than 40 is
    due to screening, that in fact screening has become a large
    part of health in the United States since evidence from
    randomized trials showed that mortality reductions were
    possible. However, the integration of screening into care has
    not been simple because the evidence was sometimes ambiguous.
    The results from breast cancer screening trials show less
    benefit for women ages 40 to 49. Furthermore, the benefit
    appears much later in the lives of these women. Ultimately,
    however, the results of randomized trials led to national
    recommendations and increases in breast cancer screening among
    average-risk women in the United States beginning at age 40.
    The U.S. Preventative Services Taskforce, as you have heard,
    suggests considering screening every 1 to 2 years starting at
    age 40. Screening rates are at about 66 percent within the last
    2 years in the United States today.
        It is clear that not everyone is at average risk. As our
    knowledge of the genetic determinates of cancer has grown,
    there has been increased concerning regarding the high-risk
    populations. The ACS has provided recommendations that women at
    greater than 25 percent lifetime risk for breast cancer should
    consider magnetic resonance imaging. This is about 1 to 2
    percent of women. These recommendations are based on
    observational studies showing that technology has a higher
    sensitivity in dense breast tissue. Unfortunately, it also
    shows more false positive tests than occur with mammography. We
    need national work to show that use of MRI in high-risk women
    actually affects mortality. NCI is sponsoring studies on how to
    reduce the false-positive testing with MRI but it continues to
    be a limitation. One approach around the problem is to examine
    biomarkers and biomarker profiles that may identify the lethal
    cancers or become a screening test.
        Access across most races and ethnicities including whites,
    women in lower socioeconomic groups are less likely to be
    screened, in large part because they do not have access to
    preventive care. People with less than 12 years of education
    are one of the groups in the United States who have not seen a
    significant drop in breast cancer mortality. The Centers for
    Disease Control and Prevention has managed a program to
    encourage access to screening among low-income populations.
    That is a step towards addressing access. Access to medical
    care is critical to screening because it is a process, not a
    test. The screening process has multiple steps as shown in
    figure 2, and these steps are managed in clinical trials but
    not necessarily in usual practice in the United States.
        To achieve the full potential of screening in the United
    States, we must consider how to improve the entire process. We
    must also consider the effects of the process on all the women,
    even those who will not get cancer. Some have argued that
    healthy people should be very skeptical of screening because
    most people will not have cancer even with a positive test.
    Improving the screening process means finding better tests and
    better diagnostic procedures. NCI is supporting research in key
    areas relevant to optimizing the screening process for breast
    cancer including risk estimation using biomarkers as a genetic
    profile, comparative effectiveness studies to evaluate MRI, 3D
    ultrasound and emerging technologies and the comparison of
    alternative screening and diagnostic strategies.
        In closing, I want to emphasize three points, that fewer
    women have died of breast cancer because research has led to
    progress in breast cancer screening and treatment, that the
    research provides evidence for women and their physicians to
    choose wisely among options they face but it is their behavior
    that changes care and improves outcomes, and three, that we
    have much more research to do to understand the screening
    process, how to affect behavior, to identify biomarkers of
    risk, cancer progression and treatment response and to use all
    of this information to begin to personalize screening.
        Thank you for the opportunity to testify.
        [The prepared statement of Dr. Taplin follows:]

        Mr. Pallone. Thank you, Dr. Taplin.
        Dr. Brawley. I see your nametag says ``Brawler'' but it is
    Brawley, right? It is Brawley.
        Dr. Brawley. It is correct on this.
        Mr. Pallone. Thank you.

                     STATEMENT OF OTIS WEBB BRAWLEY

        Dr. Brawley. Thank you, Mr. Chairman, and good afternoon,
    distinguished members of the Committee. I am Dr. Otis Brawley,
    the chief medical officer of the American Cancer Society. I am
    a medical oncologist by training and a practicing physician,
    and I am professor of hematology, medical oncology, medicine
    and epidemiology at Emory University. On behalf of the 11
    million cancer patients and survivors in America today, the
    American Cancer Society thanks you for your continued
    leadership in the fight against cancer and commitment to
    enacting comprehensive health care reform this year.
        I greatly appreciate the opportunity to testify today on
    federal initiatives to help fight breast cancer in the United
    States. Dr. Taplin's comments were quite wise, by the way.
    Breast cancer is an amazingly devastating disease. It is also a
    very complicated disease. Too often we do a disservice to women
    who we want to help by simplifying the concepts of this disease
    with very simple messages. Sometimes simple messages actually
    end up doing harm. This year, breast cancer will take the lives
    of approximately 40,000 women in the United States. This is
    particularly disheartening because we know that if every woman
    had access to accurate information about the disease, good
    science-driven early detection and quality and timely
    treatment, more of them would survive this disease.
        Members of the Committee today quoted a lot of American
    Cancer Society-generated statistics. One statistic generated by
    the same ACS epidemiologist that I would like to quote is the
    fact that with halfhearted approaches to breast cancer from
    1991 to 2005, 55,000 to 60,000 women's lives or deaths were
    averted. We averted 55,000 to 60,000 breast cancer deaths by
    really in essence halfheartedly approaching this disease and
    not getting serious about it. At a time when at least a third
    and indeed in the 1990s perhaps 50 percent of women who should
    have been getting screened were not getting screened, and even
    today a substantial number of women who were screened and found
    with an abnormality get less than good treatment for the
    disease. Unfortunately, not all women have access to adequate
    health coverage with the public health programs that have been
    proven to help save lives. The consequences can be devastating
    in terms of prognosis.
        My testimony today will highlight four priority areas that
    are essential to improved breast cancer outcomes in the United
    States. Priority one: You must ensure access to quality health
    care for all Americans. Our current health care system fails to
    meet the needs of far too many people. Research has made clear
    that lack of health insurance can be deadly. Studies have
    documented that uninsured breast cancer patients are more
    likely to be diagnosed at a later stage of disease and have
    lower survival rates than women who are privately insured. That
    is a polite way of saying the uninsured are more likely to die.
    Continued progress against breast cancer requires that we give
    all cancer patients an equal opportunity to battle this disease
    by making sure they have access to quality and timely medical
    care.
        Priority two: We need to ensure that we apply what we know
    about evidence-based prevention and early detection and make
    these services available to all Americans. Breast cancer is one
    of the few cancers early through evidence-based screening
    tests. Absent these screenings, women are at risk of being
    diagnosed at later stages of the disease when it has spread and
    become more difficult and more expensive to treat and chances
    of survival drop precipitously. Now is the time to transform
    our current sick care system into one that also focuses on
    prevention and wellness. This requires making evidence-based
    and early detection services affordable and accessible to all
    populations. Ironically, not doing so increases our Nation's
    overall health care costs.
        Priority three: Clinical decisions must be patient-centered
    and made through strict rational and orthodox interpretation of
    the most current scientific evidence. This is particularly
    important in the context of a serious illness like breast
    cancer or any cancer. As practitioners, we need to strive to
    consistently do a better job of explaining the evidence and the
    options for screening treatment and care as understandably as
    possible to help patients make informed decisions together with
    their health care teams.
        Priority four: Finally, we must do a better job of
    addressing the health disparities that exist in our Nation.
    Recent studies have shown differences in quality of care
    provided among certain populations that are of particular
    concern. For example, Congresswoman Castor actually quoted a
    study that I published together with colleagues last year that
    showed that black women were five times more likely to
    experience huge delays in starting breast cancer treatment
    compared to white women. We also found that black women were
    significantly less likely to receive appropriate surgery. Seven
    and a half percent of black women and 1\1/2\ percent of white
    women with a locally staged potentially curable breast cancer
    did not get breast surgery, research completed by Halstead in
    1903 that was not practiced in the year 2006. It is well
    documented that insurance status and poverty are principal
    determinates in cancer disparities. We simply must do a better
    job in providing access to appropriate early diagnosis and
    cancer treatment services for all women.
        In closing, it is gratifying that since 1990 we have been
    seeing a rise in the number of women surviving breast cancer
    each year, and as I said, 55,000 to 60,000 deaths averted. But
    that success is not enough. All women must have access to
    accurate information, existing and future early detection
    methods and quality treatment and care. The number of deaths
    averted if all women who should have gotten screening and
    should have gotten accurate diagnosis and should have gotten
    accurate treatment, the number of deaths averted would have
    easily doubled over that 55,000 to 60,000.
        The Society appreciates the leadership and commitment of
    the Energy and Commerce Committee in helping eliminate
    suffering from breast cancer through the work that will be
    described today and through health care reform. My colleagues
    at the American Cancer Society Cancer Action Network, ACS CAN,
    and I look forward to working with you as we look ahead to help
    create a world with less cancer.
        Thank you again for inviting me here today. I would be
    happy to answer your questions, sir.
        [The prepared statement of Dr. Brawley follows:]

        Mr. Pallone. Thank you, Dr. Brawley.
        Ms. Luray.

                      STATEMENT OF JENNIFER LURAY

        Ms. Luray. Mr. Chairman and members of the Committee, thank
    you for the opportunity to testify today about the four breast
    cancer bills before your Committee. My name is Jennifer Luray
    and I am president of the Susan G. Komen for the Cure Advocacy
    Alliance and vice president of Government Affairs and Public
    Policy for Susan G. Komen for the Cure.
        This year marks the 25th anniversary of National Breast
    Cancer Awareness Month. It is an opportunity to reflect on what
    we have accomplished and to work even harder to fight the war
    on breast cancer. Before the Nation celebrated breast cancer
    awareness, we practiced denial. We didn't talk about breast
    cancer, didn't understand it, did little to find out how to
    prevent and treat it. This was the world that Susan Komen lived
    in when she heard those dreaded words at age 33: ``You have
    breast cancer.'' Her sister, Nancy Brinker, founded Susan G.
    Komen for the Cure, and a promise made between two sisters to
    end breast cancer forever has become the promise of millions.
    Thanks to events like the Race for the Cure, we have invested
    almost $1.5 billion in cutting-edge research and community
    programs and have pledged another $2 billion over the next
    decade. The Komen Advocacy Alliance, the sister organization
    that I am proud to lead, mobilizes a network of 250,000
    advocates, men and women, at the State and national level to
    promote important policy change. Our promise is to leave few
    scientific opportunities or community needs untouched.
        Yet, to make the most of these investments, we need to
    first empower women to be advocates for their own health,
    second, to expand access to health care, and third, to improve
    the quality of care that women receive, and we need the help of
    Congress to do that. That is why I am so pleased to be here
    today, because of these bills before the Committee helps us to
    move closer to these goals.
        I will first discuss the Breast Cancer EARLY Act, H.R.
    1740. The Komen motto is that information empowers women to be
    their own best advocates yet too many don't receive information
    about breast cancer until their doctor recommends their first
    mammogram at age 40, and that is just too late for information.
    Each year, 25,000 women in this country under age 45 are
    diagnosed with breast cancer, and sadly, almost 3,000 under age
    45 will die. That is approximately 10 percent of all breast
    cancer diagnoses this year, certainly not a trivial number. A
    carefully targeted, evidence-based public health effort will
    inform young women and importantly their providers that
    unfortunately breast cancer does occur in young women. It will
    help women to establish good lifelong breast health habits like
    regular exercise and to be empowered to seek care when they
    suspect that something is wrong. It will also prevent fewer
    young women with breast cancer from being overlooked by the
    medical system and left undiagnosed until their disease is
    tragically advanced. We have had an outpouring of support from
    young women around the country for this bill. We are working
    with the bill's sponsor to ensure that funding for the EARLY
    Act won't come from existing funds for the CDC's breast and
    cervical cancer program.
        Let us now turn to the Breast Cancer Patient Protection
    Act, H.R. 1691. To be truly empowered, women also need to the
    ability to impact decisions. That is why the Komen Advocacy
    Alliance has consistently supported this bill by
    Representatives DeLauro and Barton. Decisions concerning a
    women's care after a complicated medical procedure should be
    made between the woman and her doctor and not dictated by an
    insurance company.
        H.R. 995, the Mammogram and MRI Availability Act,
    introduced by Representative Nadler, brings us closer to the
    second goal I mentioned, which is expanding access to health
    care. At Komen, we believe that all women should have access to
    recommended screenings including cancer survivors who need
    follow-up testing and surveillance. Guidelines recommended by
    the American Cancer Society and the National Comprehensive
    Cancer Network state that women at high risk should receive
    annual screening mammograms and an MRI every year. Importantly,
    women undergoing screening tests should do so in conjunction
    with their doctor. When we talk about improving access to care,
    we mean quality care for all women, our third goal. So we
    commend Congresswoman Castor and Congresswoman Christensen for
    their attention to the issue of disparities in breast cancer.
    Low-income women should have access to the same quality care as
    higher-income women so that they can benefit from the same
    positive outcomes. Improving the quality of cancer care across
    income, race and ethnicity has long been a focus of Komen. We
    recently joined with the American Society of Clinical
    Oncologists to collect data that can be used for quality
    improvement. This type of data collection is needed for any
    performance or quality-based payment system.
        In addition to these bills specific to breast cancer, we
    want to thank Congresswoman Capps for her leadership on two
    comprehensive cancer bills, one to revamp research and the
    other to improve care. The Komen Advocacy Alliance also
    strongly supports the insurance reforms in H.R. 3200 that would
    prevent patients from being denied coverage due to preexisting
    conditions, protect patients from high out-of-pocket costs and
    dramatically improve access to mammograms. Before Congress
    reconvened this fall, we asked our advocates to share their
    personal experiences. Nearly 60,000 women and men from around
    the country contacted their representatives. Their heart-
    wrenching stories call out the need for health care reform.
    Breast cancer patients turned down for insurance turn destitute
    after paying for their care and turn sicker because they
    couldn't afford screening or treatment.
        In conclusion, I want to thank you again for the
    opportunity to testify before your Committee. As we mark the
    25th anniversary of National Breast Cancer Awareness Month, we
    take a hard look at what we have accomplished and where we need
    to be. The stigma surrounding breast cancer in our country is
    largely gone, a fact that makes us the envy of women the world
    over. In the United States, more women are being screened and
    living longer as a result, and we have made progress on key
    scientific fronts. Yet, if we are one day to end the suffering
    and death from breast cancer, we must continue to make
    investments across the entire cancer spectrum to prevent and
    better detect and treat the disease, and we must always trust
    the women to be our partners in this fight. Information
    empowers women to be their best advocates.
        We look forward to working with you and our partners in the
    cancer community as we continue this important race forward.
    Thank you, Mr. Chairman.
        [The prepared statement of Ms. Luray follows:]

        Mr. Pallone. Thank you.
        Ms. Ness.

                       STATEMENT OF DEBRA L. NESS

        Ms. Ness. Good afternoon, Chairman Pallone, members of the
    Subcommittee. Thank you for this opportunity to testify.
        The National Partnership for Women and Families is a
    nonprofit, nonpartisan organization with more than three and a
    half decades of experience working on issues important to women
    and families. Over the years we have brought together a wide
    range of consumer voices to push for health reform that would
    expand affordable coverage, help us get costs under control,
    improve quality and reduce disparities. We are very pleased to
    support the efforts of this Subcommittee to enact comprehensive
    health reform this year. This is truly a historic moment. For
    the first time in decades, Congress is poised to enact
    comprehensive reform that would vastly improve the lives and
    well-being of America's women and families.
        We are pleased to endorse H.R. 3200 for many reasons. It
    provides meaningful financial assistance to help low- and
    moderate-income families purchase insurance. It ensures
    adequate coverage and scope of benefits. It creates a health
    insurance exchange with strong patient protections. It prevents
    insurers from denying or dropping people from coverage because
    of their health status or raising rates based on gender. Very
    importantly, it charts a pathway for real delivery system
    reform. This pathway is key to ensuring that the reforms we
    enact today are meaningful and sustainable for the long haul. I
    believe H.R. 3200 lays the groundwork for a system that over
    time will deliver better care to patients and enable us to get
    more value for our health care dollars. It does this by shoring
    up primary care and encouraging better coordination through new
    payment models and it creates the necessary foundation for
    those models through things like comparative effectiveness
    research, workforce development, better data collection and
    quality measures and improvements.
        It is the development and use of quality measures that I
    want to particularly focus on today, not just for breast cancer
    care but for our system as whole. The use of measures to
    generate performance information about provider performance is
    critical to getting us to a system that at some point delivers
    on the promise of the right care to the right patients at the
    right time for the right reasons. Without measurements, we
    can't know if the new models we are putting in place are
    actually resulting in better patient care. We can't assess
    whether we are really eliminating disparities. Without
    measurement, we can't tell if we are using our health care
    dollars effectively. We can't transition to a system that is
    based on value rather than volume. Without good measures and
    good measurement and the quality improvement that they enable,
    we simply cannot achieve the high-quality, effective and
    equitable care that patients need and deserve.
        Congresswoman Castor, you have clearly recognized the
    importance of measurement in your bill, H.R. 2279, and we
    applaud your commitment and leadership on women's health
    issues. We share your goals of rewarding value over volume, of
    incentivizing quality, of improving the patient's experience of
    care and eliminating disparities, and we particularly
    appreciate the provisions of your bill that move us toward
    quality measurement and public reporting at the individual
    provider level and that help us begin to align our payment
    system so that we have incentives that encourage better quality
    and practice that lives up to the best standards of care. These
    elements are essential to building a more effective delivery
    system and they should be integral not just to care for breast
    cancer but to the broader reforms that we all seek. We stand
    ready to work with you and your colleagues to implement a
    pathway for these reforms but we also urge that we do this in a
    way that benefits all patients no matter what their condition
    or diagnosis and in ways that are going to generate
    accountability for all providers across all settings. It is
    this vision that led the national partnership to work with the
    Stand For Quality Coalition, which is a broad group of about
    200 health care stakeholders that include consumers, purchasers
    and providers to issue a set of recommendations that are now
    largely embodied in H.R. 3200. These recommendations call for a
    national comprehensive strategy that includes setting
    priorities for quality improvement and measurement, developing
    good measures and then endorsing and maintaining those measures
    as national standards, collecting and analyzing measurement
    data and then using that data for quality improvement, for
    public reporting and for payment. This broad coalition of
    stakeholders also called for a multi-stakeholder consultative
    process to provide input and make recommendations so that the
    implementation of this strategy would engage in reflective
    perspectives of all of us who have a stake in health care.
        So in closing, I want to say how pleased we are that H.R.
    3200 has incorporated these recommendations and I thank the
    members of this Subcommittee for their leadership in
    recognizing that a comprehensive quality strategy is the
    critical foundation for health reform that is meaningful,
    equitable and sustainable over the long term. Thank you.
        [The prepared statement of Ms. Ness follows:]

        Mr. Pallone. Thank you.
        Dr. Sledge.

                   STATEMENT OF GEORGE W. SLEDGE, JR.

        Dr. Sledge. Mr. Chairman Pallone, members of the
    Subcommittee, thank you for the opportunity to submit testimony
    today. My name is Dr. George Sledge. I am a medical oncologist
    from Indianapolis who specializes in the treatment of breast
    cancer. I also serve as professor of medicine at Indiana
    University's Simon Cancer Center, and I am president-elect of
    the American Society of Clinical Oncology. ASCO's mission is to
    ensure that the highest quality, evidence-based care is
    delivered to all people with cancer during all stages of their
    disease. We are especially pleased to speak at today's hearing
    as it focuses on the cornerstones of ASCO's mission: cancer
    prevention, quality, access to care and education.
        Many of us have been touched by breast cancer either
    personally or through family members' or friends' experiences.
    ASCO supports the underlying goals of all four bills being
    discussed today and we urge this Committee to ensure the
    resulting legislation is grounded in sound scientific evidence.
    In today's testimony, I will focus on three areas that span the
    continuum of cancer care: patient access to appropriate
    screening, patient education and public awareness, and quality
    measurement in cancer care.
        The first is patient access to appropriate screening.
    Studies have shown the value of cancer screening, particularly
    mammography in women over the age of 40. ASCO supports
    provisions that prohibit health plans from establishing
    policies or barriers to medically appropriate testing. While
    MRI is a highly sensitive test, we should not overlook the
    potential risk of overdiagnosis that lead to additional
    diagnostic tests including biopsy. Tests and procedures cause
    anxiety and can lead to harms so we should be very clear about
    the associated costs, risks and benefits. The greatest utility
    for MRI appears to be for women who are at high risk for breast
    cancer such as individuals who have a strong family history.
    For women at high risk, detection of abnormalities is less
    likely to result in false positive findings. However, all women
    undergoing screening MRI should be informed about the odds of
    false positive findings and the potential adverse consequences
    of those findings.
        The second issue I will discuss is patient education and
    public awareness. With respect to educating young women on the
    causes and risks of breast cancer, such an endeavor must be
    evidence based. An informed patient has a critical advantage in
    cancer care treatment and the American Society of Clinical
    Oncology has directed considerable resources and expertise to
    informing patients through our cancer.net website.
        Finally, I would like to address quality measurement and
    reporting, which is at the very core of ASCO's mission. More
    than 500 oncology practices throughout the country participate
    in ASCO's Quality Oncology Practice Initiative, or QOPI, a
    system for practicing oncologists to submit clinical data where
    practice-specific comparative data reports are generated. QOPI
    allows oncologists to systematically assess the quality of care
    they provide and engage in data-driven practice improvement
    activities. The majority of the 80 quality measurements in QOPI
    are applicable to breast cancer patients and 14 are specific to
    breast cancer treatment. QOPI together with the breast cancer
    registry pilot made possible by generous support from the Susan
    G. Komen For the Cure will provide tremendous insight into how
    breast cancer patients receive care, where improvements are
    needed and strategies for breast cancer care. A project that
    tests well-designed quality measures in breast cancer would
    move the field forward. However, such a project must remain
    flexible, especially with respect to public reporting of
    quality information. Studies of quality performance suggest
    that the most important element is the very active measuring
    and sharing outcomes with physicians. Value-based purchasing
    that reduces payment for low-quality providers rather than
    rewarding high-quality providers may have the unintended
    consequence of further stressing systems that are already
    struggling. The development and testing of quality measures
    would benefit from ASCO's long history of work in this area.
    Some measures developed by ASCO have already been endorsed by
    the National Quality Forum but the number of NQF-endorsed
    measures for cancer is quite limited. Significant work will be
    required to expand this portfolio so that it includes the full
    range of measures required in H.R. 2279. ASCO would be
    delighted to provide its expertise in this area.
        In closing, ASCO appreciates the tremendous thought and
    attention the Subcommittee and sponsors of the four bills have
    devoted to the care of women with breast cancer. We look
    forward to working with you and our partners throughout the
    cancer community to achieve the important goals set out in
    these bills. Thank you very much.
        [The prepared statement of Dr. Sledge follows:]

        Mr. Pallone. Thank you, Dr. Sledge.
        Ms. Visco.

                        STATEMENT OF FRAN VISCO

        Ms. Visco. Thank you. Thank you, Chairman Pallone, members
    of the Subcommittee. I appreciate very much the opportunity to
    testify today on behalf of the National Breast Cancer
    Coalition.
        I am a 22-year breast cancer survivor. I was diagnosed when
    I was 39 years old. My son, David, was 14 months old. I was a
    partner in a law firm in Philadelphia and I was fortunate that
    I became involved with a group of women who launched the
    National Breast Cancer Coalition and I soon left my law
    practice to devote my life to our mission to eradiate breast
    cancer.
        We are a coalition of organizations from across the
    country. Our board of directors is a board of 25 of these
    organizations representing the diversity that is breast cancer
    from the Women of Color Support Group, to Nueva Vida, to the
    Alamo Breast Cancer Coalition, to the California Alliance of
    Breast Cancer Organizations. Our national grassroots network
    consists of representatives of many different organizations. We
    set priorities. We educate our members to understand the
    language and the concepts of science. We know that women are
    quite capable of understanding these issues, of accepting the
    truth no matter how difficult that may be, and of speaking up
    for themselves. We critically analyze information. We
    critically analyze public policies before we set our priorities
    and before we take positions, and we have but one agenda and
    that is to eradicate breast cancer.
        I know the Committee today is focusing on a number of bills
    specific to breast cancer and we have submitted analyzes of
    some of those bills to members, and I will submit them for the
    record. But what I want to focus my remarks on today is our
    number one priority, and that is the bill that we believe will
    have the largest impact for all women at risk of and all women
    who have received a diagnosis of breast cancer and that is
    guaranteed access to quality health care for all. We followed
    our process of research of critical analysis. We spent several
    years educating our grass roots, looking at various health care
    systems, reading the literature, researching the system, and we
    developed our framework which was submitted with our written
    testimony to support guaranteed access for all, educated
    patient participation at all levels of the system, shared
    responsibility and benefits based on evidence. We strongly
    support comparative effectiveness research because we believe
    that it is necessary to help ensure quality and affordable
    health care for all. We need a high level of evidence for
    doctors and patients to choose which care is appropriate, for
    whom and under what circumstances. In addition, our framework
    calls for a significant number, and that is 25 percent of
    educated patient and consumer member on all committees,
    commissions and boards involved in health care including those
    established to review and assess the best evidence-based
    treatment options.
        We commend the Committee for its work on H.R. 3200, which
    achieves many of the benchmarks set forth in our framework, and
    we are pleased to endorse that bill and we look forward to
    working with you to ensure that all individuals have access to
    the comprehensive quality care they deserve, quality care they
    need. Everyone should have access and it must be affordable,
    not just for the federal budget but to people. It must be
    affordable to individuals. We very much appreciate your
    interest and support of our shared goal to save lives and to
    end breast cancer. You have the power to make a real difference
    for all of us, and we know how complicated these issues are,
    how difficult your task is. We know how complex breast cancer
    is and how careful we all have to be to make certain that what
    we are doing is the right thing in terms of women's lives.
        There are too many unfortunate examples of policy messaging
    and beliefs that have taken hold when there was in fact no real
    evidence behind it, and these actions resulted in harm to
    women. My written testimony describes them from bone marrow
    transplants to breast self-exams and hormone replacement
    therapy to the misuse of statistics by opponents to health care
    reform that are looking inappropriately at survival statistics
    that are outdated from different countries. All of that has
    been submitted with my written testimony.
        I know firsthand the horror of breast cancer and I see that
    horror over and over again for too many women of all ages, all
    races, all walks of life. That is why we are so firmly
    committed to the evidence-based approaches, to our passionate
    commitment to eradicating breast cancer.
        I want to take a moment to talk about Carolina Hinestrosa,
    a strong, passionate, unbelievable activist. She was the
    executive vice president of the National Breast Cancer
    Coalition. She founded Nueva Vida, a national support group for
    Hispanic women with breast cancer. She was diagnosed 15 years
    ago at the age of 35 and then again 6 years ago. She died in
    June of a soft-tissue sarcoma, a result of her treatment for
    breast cancer, not breast cancer, her treatment for breast
    cancer, just one more story of how complex this disease is, how
    complicated the issues are. I dedicate my testimony and my work
    to her memory, and I thank you again.
        [The prepared statement of Ms. Visco follows:]

        Mr. Pallone. Thank you, Ms. Visco.
        Dr. Weiss.

                      STATEMENT OF MARISA C. WEISS

        Dr. Weiss. Thank you, Chairman Pallone, Subcommittee
    members and other panelists. It is a true privilege for me to
    be here today to talk about breast health and breast cancer
    issues that have been my core professional focus and driving
    mission for over 20 years, but more importantly, these issues
    directly affect about half the United States population and the
    rest of us who care for them.
        My name is Dr. Marisa Weiss. I am a breast oncologist and
    founder and president of the nonprofit Breastcancer.org. We are
    the world's most utilized online resource for breast health and
    breast cancer information, reaching 8 million people annually.
    As a doctor, I have had the honor taking care of thousands of
    women with breast cancer and have seen up close its devastating
    effects, and our laws govern how I can best care for the unique
    needs of each individual that comes to me.
        Everyone here knows how much is at stake. The breasts are
    the favorite place for cancer to occur in women, often in their
    prime of their lives and when these women are most
    indispensable to so many. The bills before the Committee today
    represent critical ongoing efforts to improve diagnosis and
    patient care. I would like to start with the EARLY Act. I
    believe this legislation will do much to advance public health
    efforts and combat the threat of breast cancer, and I commend
    Congresswoman Wasserman Schultz for her leadership. There are
    concerns that outreach to young women will produce more harm
    than good by creating the fear of breast cancer, but what we
    have found is that fear already widely exists. Information
    about breast cancer is pervasive. Young women like the rest of
    us are bombarded by breast cancer messaging aimed at adult
    women. To better understand the impact, Breastcancer.org
    conducted a research project with 3,000 girls ages 8 to 18
    across the country. Consistently, nearly 30 percent of girls
    feared that they may have had breast cancer. It was triggered
    by breast pain, a diagnosis in someone close to them, or
    mistaking the changes of normal breast development for signs of
    breast cancer. Over 70 percent of girls have someone close to
    them who has been diagnosed, a mother, grandmother, best
    friend's mom, teacher or neighbor, and when breast cancer
    diagnosis strikes this close to home, their fears were
    magnified. Many young women think breast cancer messages in the
    media targeted to mature women directly apply to them as well,
    but they simply don't have the resources to understand the
    meaning and relevance of these critical issues nor do they have
    the dialog skills or opportunities to discuss their fears or
    clarify breast cancer misinformation. Only 47 percent of the
    girls had talked to a parent, 40 percent to a doctor.
        To resolve unrealistic fears, young women in this era need
    accurate information and reassurance that age-appropriate and
    scientifically grounded education can arm them with the facts
    of what is normal and what is not, empower them to take charge
    of their breast health. It is these girls during the ages of 8
    to 18 and into their 20s that are using what they eat, what
    they drink, what they breathe in, medicines they take, personal
    products that they use to build their breast tissue, laying
    down the foundation of their future breast health. It is at
    this early point also that young women are establishing their
    lifelong behavioral patterns.
        Concerns have been raised about the value of education
    outreach to low-risk populations in the absence of modifiable
    risk factors, and we know how complex a disease breast cancer
    is with multiple causes, but most of these risks for breast
    cancer don't begin at age 45. Rather, they accumulate over a
    lifetime beginning at conception. There are periods when breast
    cells are hypersensitive to internal and external environmental
    insults: the first trimester of pregnancy, the 4 to 10 main
    years of breast organogenesis between adolescence and the 20s,
    as well as the stretch of time leading up to a woman's first
    full-time pregnancy when breast cells are highly active and
    immature. So the behaviors of women under age 45 impact not
    only their own breast health but the future breast health of
    their daughters through pregnancy and modeled behaviors. Some
    risks are modifiable and some are not but even the tiny risks
    can combine and really add up, particularly during these
    sensitive times. An example of a modifiable risk factor is the
    obesity epidemic across the United States associated with an
    increase in risk of breast cancer in adult women. Extra fat
    makes extra hormones that could stimulate extra breast cell
    growth. In addition, fat stores hormonally active pollutants
    that are lipophilic such as bisphenol A, atrazine, dioxins,
    nonylphenols, which could potentially stimulate unhealthy
    breast cell growth. And moreover, obesity in childhood predicts
    for obesity in adults and obese mothers are more likely to
    raise obese daughters. And contrary to the claim that proven
    breast cancer risks can't be modified, our obesity epidemic is
    doing just that, by accelerating the age of menarche. Early
    education and behavioral modification that increases athletic
    activity and health weight management early enough could
    postpone the onset of puberty, and lessons learned from the
    EARLY Act programs will benefit current and future generations
    since it is the women under the age of 45 who are in their
    prime childbearing and parenting years.
        Another example is the opportunity to provide breast cancer
    risk reduction strategies to high-risk women. In the EARLY Act,
    the 5 to 10 percent of breast cancers due to an inherited
    breast cancer genetic abnormality, over 13,000 per year, would
    more likely be identified, giving these women a greater chance
    to reduce the risk of breast cancer by as much as 90 percent
    with prophylactic mastectomies or 50 percent with anti-estrogen
    therapies.
        It is important that we impart this knowledge along with
    what we, the scientific and medical community, know are not
    risk factors for breast cancer. Fear certainly breeds myths,
    and in our survey many young women believe that only their
    mother's family history is important and that breast cancer
    skips generations. They also were fearful that they could have
    caught breast cancer from their mothers during pregnancy and
    breastfeeding. Education can change attitudes, knowledge and
    behaviors. We do a disservice to this and future generations by
    neglecting to provide this information and facilitate this
    dialog.
        I am also here today in full support of the Breast Cancer
    Patient Protection Act, the Mammogram and MRI Availability Act,
    and Eliminating Disparities in Breast Cancer Treatment. I am
    prepared to answer any questions about the medical content.
        And in conclusion, I thank the chairman, the Subcommittee
    and the panel for giving me the opportunity to speak to you
    today. Thank you.
        [The prepared statement of Dr. Weiss follows:]

        Mr. Pallone. Thank you, Dr. Weiss.
        Now we will have questions from the members, and I will
    start myself, and I wanted to ask Dr. Taplin some questions
    initially.
        In fiscal year 2007, the National Cancer Institute invested
    nearly $600 million in breast cancer research. I understand the
    Institute devoted roughly the same amount of resources towards
    research on this topic in 2008. Can you describe, Dr. Taplin,
    the activities that NIH is supporting, understand how women can
    actually prevent breast cancer in the first place and how is
    NIH investing in research into improved breast cancer screening
    as well as into treatment of breast cancer once it has been
    diagnosed, in less than 2 minutes? Whatever you can do.
        Dr. Taplin. There are many studies related to breast cancer
    at NCI. As you have already noted, we had $572.6 million and
    2,146 studies at NCI in fiscal year 2008. Those are
    concentrated in several areas but the ones relevant to your
    question are prevention, early detection and treatment. We
    spent approximately $27 million on prevention, $54 million on
    early detection and $169 million on treatment studies, so all
    of those are relevant to your question. I think probably the
    most interesting piece, and there are several, and many places
    we can go among the 2,146 studies we did. The most important, I
    think, is the Breast Cancer and Environmental Research Act,
    which came from you folks and resulted in a center, a set of
    centers to look at basic--the relationship between environment
    and biology of young women's breast development, and so there
    are biologic studies in women, there is epidemiology study in
    young women and there is also a group of people looking,
    academicians and educators, looking at how you communicate
    these issues to women and to young women especially so that we
    can begin to adapt those message to the population that we are
    targeting. Those are some of the areas we are working on.
        Mr. Pallone. All right. Thank you.
        Dr. Brawley, I wanted to ask you, the U.S. Preventative
    Taskforce recommends that women over 40 have annual or biannual
    mammograms. Your organization recommends annual mammograms for
    women over 40 and clinical breast examinations for women in
    their 20s or 30s. So unless a woman under 40 has an identified
    risk factor, there is no recommendation that she get a
    mammogram. Obviously, you know, this relates to Congresswoman
    Wasserman Schultz's legislation. Would you elaborate on the
    challenges for women under 40 and what can we do for these
    women to detect their cancers as early as feasible?
        Dr. Brawley. Yes, sir. Thank you for the question. Part of
    the answer to your question is mammography is a terrible test
    for women who have younger breasts and denser breasts. It is a
    terrible test for two reasons. Number one, it is very difficult
    for the radiologist to actually make an interpretation of that
    X-ray because of the breast density, and number two, radiation
    does cause some cancers and causes cancers in young breasts
    that are more active in terms of biology. So if you actually
    were to give radiation to the breasts of, say, 10,000 women who
    are under the age of 20 and do it on an annual rate, there are
    some people here--I am not one of them--but they can calculate
    how many breast cancers we will ultimately manufacture. Now, in
    randomized clinical trials of women who are older, in their
    40s, 50s and 60s, we have evidence that mammography clearly
    saves lives in screening, so what we like to do is, if a woman
    has a mass and she is in her 20s or 30s, if she finds the mass
    or if someone finds it on clinical exam, a clinician, be it a
    nurse practitioner or a physician, then perhaps doing a
    mammogram is appropriate in that one particular individual. If
    you have someone who is at very high risk, perhaps the
    mammogram is appropriate or perhaps an MRI is, but to do
    mammography, mass mammography in the United States in younger
    women, it would be literally public health malpractice because
    we would actually manufacturing some breast cancers.
        Mr. Pallone. Okay. I was going to ask a third question but
    I don't have that much time left, so I will move to other
    members. The gentleman from Georgia, Mr. Gingrey.
        Mr. Gingrey. Mr. Chairman, thank you, and I will ask all of
    the panelists, and I thank you for being here, the same
    question, and I will start with Dr. Taplin. Some have said that
    this bill will spread fear of breast cancer among women who
    shouldn't be concerned at such a young stage of their life. As
    physician, I believe that arming patients with medical
    information is a good practice as long as the message is, of
    course, well crafted and well delivered. Do you have any
    concerns that keeping this demographic well informed will cause
    more harm than good?
        Dr. Taplin. That is an excellent question. I think the
    problem is that we don't have the evidence to give you the
    answer. The problem is that there is some evidence out there
    that there is a U-shaped curve, that there is a perfect amount
    of fear. A little bit of fear may be helpful. A little bit too
    much fear may be harmful, and we don't really know where the
    balance is between those things and we don't know enough about
    messaging from my standpoint to know what the answer is to the
    question you are posing, so that is part of why we are
    sponsoring the study that I have already mentioned.
        Mr. Gingrey. Dr. Brawley.
        Dr. Brawley. Dr. Gingrey, part of the American Cancer
    Society's early concern about this bill was that it wasn't
    clear who was going to create the messages that were going to
    be conveyed to the population. Now that it is very clear that a
    committee of scientists appointed by the director of the CDC
    will be those that craft the messages that should be conveyed,
    we feel very comfortable with educating the population because
    we have some assurances that the messages will be created by
    experts. So yes, I am agreeing with you and I think that the
    messages that would be conveyed through the EARLY Act would be
    message that would be scientifically valid. Now, you are
    correct that the messaging to individuals, be they youth or be
    they people in their 50s, is sort of like a T1 line. The more
    health messages that you put forth, you diminish all the other
    health messages. Currently, the EARLY Act, as I see it, allows
    for messages about diet, messages about exercise and nutrition,
    and it actually may be more than a breast health act, much more
    a health act because it is going to--if the messages are
    received appropriately, it is going to prevent diabetes and
    heart disease which actually, by the way, kill more people in
    their 30s and 40s, females in their 30s and 40s, than breast
    cancer.
        Mr. Gingrey. Ms. Luray.
        Ms. Luray. Congressman, we agree with Dr. Brawley. We are
    pleased how the bill has evolved over time. One study of young
    survivors found that 40 percent didn't believe that young women
    could even get breast cancer, so part of what we are looking
    for is a very targeted campaign that lets women know that while
    it is a very small risk, it is possible so that if they feel
    that lump, they don't ignore it, or if they go into their
    doctor's office and they say I feel like I have a lump and the
    doctor says oh, it is just dense breast tissue, don't worry
    about it, they can't pursue their concern, and again, based on
    factual information pulled together by the appropriate sources.
        Mr. Gingrey. Ms. Ness.
        Ms. Ness. I will just reinforce what my colleagues here
    have said. I think we can't underscore enough the importance of
    basing what we do on evidence, and we need the research to tell
    us what makes us both in terms of medical practice but also in
    terms of how we educate and increase awareness.
        Mr. Gingrey. And Dr. Sledge.
        Dr. Sledge. Well, I think we all agree that knowledge is
    power, but it is only powerful to the degree to which it is
    accurate and we can act on it, and I think careful evidence-
    based data is actionable. The problem in younger women, to be
    honest, is that a lot of what we don't know exceeds what we do
    in terms of prevention for young women in terms of early
    diagnosis, in terms of the health habits for these women. So I
    think physicians and all of us need to be very careful about
    pretending more than we currently know.
        Mr. Gingrey. Ms. Visco.
        Ms. Visco. Well, I couldn't have said it better than Dr.
    Sledge did. I think it is very important that message that we
    give out are based on evidence, that are factually correct and
    that there is something you can actually do about that
    information, but I want to make clear that the evidence of
    harms that some people are concerned about and we are concerned
    about certainly with giving messages about breast cancer to
    millions and millions of healthy women, the vast, vast majority
    of whom will never get breast cancer, is also the distinct and
    clear possibility that has been shown in clinical trials of
    unnecessary biopsies, that young women are going to feel things
    in their breasts, they are going to have biopsies. Those
    biopsies can result in infections and in further harm. So it is
    not just the issue of anxiety. That is why it is so incredibly
    complex.
        Mr. Gingrey. Dr. Weiss, before you respond, and as a breast
    cancer surgeon and having treated many, many patients, how
    young do you think we really should give this information to
    young women? At what age do you start doing that?
        Dr. Weiss. Well, this information becomes--it is important
    to deliver it when it is most relevant, and we find that girls
    are going through puberty earlier and earlier these days and
    their breasts are very much on their minds. I think the power
    of education is not just delivering education along the way but
    correcting this massive misinformation that is out there. Our
    surveys have shown that over 20 percent of girls think that
    antiperspirant use, getting bumped in the breast, infection,
    drug use, drinking coffee, wearing a bra, an underwire bra,
    increase the risk of breast cancer, and without the correct
    information that is well established today. So I do think that
    when you replace myths with facts that you do free these girls
    of some of the anxiety they have about growing up and going
    from a big girl to a young woman and a young woman to a mature
    woman, and I think that that is going to make them more engaged
    in proactive healthy behaviors through their life, and while
    they are in high school and college, they are in educational
    institutions, they are within a system where knowledge delivery
    is----
        Mr. Gingrey. So educating them as teenagers but not
    necessarily preteens?
        Dr. Weiss. Well, we have found that a lot of
    misinformation, fears and questions present themselves upon
    adolescence, and whether or not you want to go back that early
    is a question that has to be studied, but those questions
    certainly exist, and they are inadequately addressed right now
    in current health classes within middle schools and high
    schools.
        Mr. Gingrey. Mr. Chairman, thank you very much, and thank
    all the panelists. I appreciate your response.
        Mr. Pallone. Thank you.
        Ms. Castor.
        Ms. Castor. Thank you, Mr. Chairman, and thank you all.
    Your testimony was very insightful, everyone.
        Ms. Luray, I would like to thank you and the Susan G. Komen
    for the Cure Advocacy Alliance for extending your support to my
    Eliminating Disparities in Breast Cancer Act since it was first
    introduced last Congress, and I would like to return the thanks
    and commend you all for everything that you have done to raise
    awareness about disparities in access, access to screening,
    access to quality care and treatment. The work you have done
    both with the American Society of Clinical Oncologists and the
    Metropolitan Chicago Breast Cancer Taskforce to reduce
    disparities is very commendable. Could you discuss what you
    believe we can do further to educate women about the types of
    treatment that they should look to receive after diagnosis so
    that women are not in the dark and are empowered to take
    control of their health and diagnosis? And please explain how
    moving forwards towards rewarding providers for quality care
    and ensuring that providers are not rewarded for inadequate
    care will help to reduce disparities in treatment.
        Ms. Luray. Thank you, Congresswoman, and we appreciate your
    leadership as well. I would like to take a minute just to talk
    briefly about our partnership with the Metropolitan Chicago
    Breast Cancer Taskforce because I think it is partnerships like
    this that will give us the data that then can be modeled by
    other community-based programs to promote the type of quality
    breast cancer care you are talking about across common and
    racial ethnic lines. In Chicago, the breast cancer mortality
    rate for African-Americans is even worse than in the rest of
    the country. African-American women in Chicago have a 68
    percent higher mortality rate than white women do, and the
    taskforce that we are involved in and are supporting developed
    an action plan for three main causes of the disparity, and it
    is almost like a tragic Rube Goldberg image because first of
    all, they have to get access to mammography, and that is either
    physical, where it is, how do you get there, and economic, can
    they afford it. But then they have to make sure that is of high
    quality, and we as providers and advocates need to make sure
    that that mammography is of high quality. And then they have
    inadequate access to treatment, and then you have to ask the
    same questions about their treatment, is the treatment that
    they are getting at the same level of evidence and the same
    level of quality that higher-income women are getting. So
    again, there are so many barriers that need to be addressed in
    terms of ensuring that this disparity in care does not continue
    in communities. But we are very hopeful that what we are doing
    in Chicago and what we are funding in communities across the
    country can help to promote a very high-quality breast cancer
    treatment program.
        Ms. Castor. Have you targeted other communities besides
    Chicago?
        Ms. Luray. Yes, we have, and I would be happy to share that
    information with your staff.
        Ms. Castor. Terrific.
        The American Cancer Society found in 2007 that certain
    additional screenings after diagnosis and initial treatment are
    not equally administered among patients, particularly tests to
    ensure that cancer has not spread to nearby lymph nodes. Maybe
    Dr. Brawley, can you share with us, have you found that
    additional screenings after treatment that are considered
    essential are not always accessible? I think you testified to
    that account.
        Dr. Brawley. Yes, ma'am.
        Ms. Castor. To what do you think that we can attribute the
    fact that some providers simply are not universally screening
    patients for potential spread of their cancer to other areas of
    the body?
        Dr. Brawley. I think the likelihood--I don't have a study
    that I can quote for you but I can tell you as someone who has
    practiced medicine, the likelihood is that there can be a
    couple different reasons, and what we are talking about there
    is follow-up exams after treatment to see if the disease has
    come back. Sometimes the physicians simply forget, which is
    unfortunate on the part of the physicians. Sometimes the
    patients are advised to get the test or it is prescribed and
    they don't go and get the test. Sometimes, and this is the more
    common problem, there is an affordability problem, copays and
    other things that people are just unable to come up with, even
    if insured, and I am actually much more concerned very
    frequently about the insured individual who doesn't have very
    good insurance than even the uninsured individual because quite
    a few people today--I just saw a figure, more than 60 percent
    of personal bankruptcies are due to health care costs. Quite a
    few individuals with breast cancer who need to get a chest X-
    ray or even just a simple liver function test that might cost
    $80 simply can't afford the continued copays over time so they
    don't get those therapies.
        Ms. Castor. Thank you, Mr. Chairman.
        Mr. Pallone. Thank you.
        The gentlewoman from Ohio, Ms. Sutton.
        Ms. Sutton. Thank you, Mr. Chairman. Before I begin, I
    could ask unanimous consent to enter into the record testimony
    from Lifetime Networks.
        Mr. Pallone. Without objection, so ordered.
        Ms. Sutton. Thank you. And before I turn to the panel, Mr.
    Chairman, if I could, I would also just like to recognize Kathy
    and Lee Giller, who are here from Akron, Ohio, my district, and
    they are town for the 3-day Susan G. Komen Walk, and Kathy was
    the number one fundraiser from Cleveland this year, and we are
    proud to have her here with us.
        As for the panel, thank you very, very much for your
    testimony, and it is hard to sit here without thinking about
    the people that we have known in our lives who have suffered
    from breast cancer, some who have been lost, some who are
    fighting the fight now, and of course, wondering about those
    who may encounter this battle in the future. Several of you in
    your remarks and in your testimony, you stress the need for the
    access to quality, affordable health care. Ms. Visco, you talk
    about quality, affordable health care for all. I appreciate
    that, and I concur. Dr. Brawley, you also talked a lot about
    the need to get health care for women. And Dr. Weiss, one of
    the things that you said that was striking to me and I think it
    is important is, you talked about the unique needs of patients
    because not always does one size fit all on this issue. And as
    I sit here, one of the people who comes to mind was a woman who
    I knew 10 years ago when I was working on these issues in the
    State legislature, and her name was Linda. She had breast
    cancer. Her mother had had breast cancer, her aunt. It was very
    pervasive in her family. Her doctor wanted to treat her
    aggressively because of the family history, a doctor attached
    to an institution that is of high renown when it comes to
    treatment, and the insurance company said no, we are not going
    to pay for coverage of that treatment. Her treatment was
    delayed because she had to raise money for the treatment. She
    ultimately succumbed to cancer. I went to her funeral and I
    listened to her young daughter get up and give a report about
    an essay that she wrote in school about how her mom was her
    hero because not only did she fight against breast cancer, she
    fought against the insurance company to try and make things
    better for other people in the future.
        So my question, I guess, is, that was a decade ago, is it
    better now? Are the treatments that the doctor is asking for,
    are they covered? Dr. Brawley, would you like to respond?
        Dr. Brawley. Yes, and I get in trouble for just saying the
    flat-out truth. There have been instances where the insurance
    companies have been wrong and there have been instances where
    the patients have been wrong and there have been instances
    where physicians have been wrong. Ms. Visco talked about bone
    marrow transplant for breast cancer. Very quickly, the
    thumbnail history of that, in the early 1990s many people
    thought high-does chemotherapy with bone marrow transplant
    would be beneficial for women at high risk for relapse of
    breast cancer. Many hospitals started these bone marrow
    transplant programs as a way of making money. Ten State
    legislatures passed laws saying that insurance companies had to
    pay for them. Many women sued their insurance companies because
    they didn't want to pay for it. There was no scientific
    evidence to support it. Ultimately, this delayed the NCI
    studies that ultimately showed that bone marrow transplant in
    breast cancer was more harmful than helpful. This is when
    people stop being scientific and start practicing--you know,
    earlier I said in my statement that one of the problems with
    this disease is, it is a complex disease and we all want to
    make it very simple and we all want to have very simple
    messages. That is a darn good example of how the simple
    message, more chemotherapy must be better, actually killed
    women. It wasn't that it was just a waste of money. It actually
    killed women.
        Ms. Sutton. I appreciate your answer, and I think that
    again goes back to the point of, it isn't simple. It is all
    very multi-faceted and there are unique considerations in every
    story right, so it is very difficult to--
        Dr. Brawley. But Congresswoman Sutton, the answer to your
    question is what you described does happen where people want to
    get the right therapy and someone in an insurance company or
    others somehow decides that they should not get the right
    therapy. That does happen.
        Ms. Sutton. It is one thing to make a determination based
    on health needs and it is another thing to make a determination
    based on money.
        Ms. Luray. And Congresswoman, if I may add, there is the
    issue of access to experimental treatment and how that access
    is granted and whether or not it is based on scientific
    evidence but there is also access to ongoing treatment that
    many of our patients experience. There was a young woman here,
    Anna van Lear, who had to fight her insurer after being
    diagnosed with breast cancer, had to fight to get her MRI
    because of her age, and that occurs again an again, so the
    experimental treatments are one issue but it is the ongoing
    need for surveillance care, side effects, et cetera and having
    to battle the insurer every day, and of course the economic
    loss that they experience too because of the high out-of-pocket
    expenses.
        Ms. Sutton. Thank you.
        Dr. Weiss.
        Dr. Weiss. The cost of negotiating with the insurance
    companies throughout each clinical day has lengthened my day by
    2 hours and it has slowed down the urgent feeling a patient--
    you know, her ability to get what she needs when she needs it,
    and we have doubled our office staff just to get enough people
    on the phones to get the authorizations for tests or for
    treatment or see a new doctor or to get a second opinion and
    maybe even a third opinion in a complex case. So in terms of
    the cost of health care, I don't think that these barriers are
    saving us money, I think that we need these laws today to give
    the physicians the ability to deliver the optimal care in terms
    of early detection, treatment and surveillance of women beyond
    their initial treatment.
        Ms. Sutton. Thank you.
        Mr. Pallone. Thank you.
        The gentleman from Iowa, Mr. Braley.
        Mr. Braley. Thank you, Mr. Chairman.
        Dr. Brawley, I want to follow up with your observation
    because you might find it interesting to note that I used the
    exact example that you were describing in an earlier markup we
    were having on health care in this same conference room, and
    one of the things we can't ignore is sometimes the political
    implications of important public policy decisions we are making
    that involve academic research, scientific research, medical
    research and most importantly people. Because the story I used
    was from a book by Shannon Brownley. It was given to me by a
    family practice doctor, ``Overtreatment'' and this exact
    scenario that you were describing is mentioned at length in
    that book, and this very conference room was filled with women
    who were getting high-does chemotherapy with bone marrow
    transplants and the person who developed that treatment
    methodology was sitting in these witness chairs and turned with
    his back to members of Congress and had all those women stand
    up and then said to the members sitting in this hearing room,
    ``Fifty percent of these women will be dead if you don't
    approve funding for this treatment.'' So we are really talking
    about a high-stakes poker game here, and I think what all of us
    want to get to is a health care delivery system that is based
    upon evidence-based decision making that makes sense for the
    greatest portion of the population.
        I had the opportunity before I came to Congress to
    represent a retired swimming coach who was diagnosed with
    prostate cancer, and the treatment of choice that he decided
    upon was not covered by Blue Cross/Blue Shield through an
    employer-sponsored health care plan, and after a lot of
    research and investigation, we determined that Blue Cross/Blue
    Shield was also the administrator for Medicare in the State of
    Iowa and covered that form of treatment as non-experimental. So
    when we are talking about making health care available to women
    who have been diagnosed with breast cancer, we all need to know
    the best evidence available and we also need to eliminate these
    bizarre distinctions between coverage options so that no woman
    who has been diagnosed with breast cancer is faced with the
    difficult decision of deciding how she is going to pay for
    treatment under one program that she could get if she was old
    enough to be covered under Medicare or something else.
        And so one of the things I would like to ask the panel
    about is why this particular class of women, younger women who
    do not fit traditional theories of who is most likely to be
    diagnosed with breast cancer, why are they more vulnerable than
    other segments of the population, if they are, and what types
    of attitudes do they bring to their treatment that make them
    more challenging as a group, if they are, than other groups of
    women?
        Dr. Brawley. If I could start first, sir, and thank you. I
    truly do believe that adequate health care reform includes
    reforming how we consume health care. We have to all learn to
    be more scientific and appreciate the science and the evidence.
    One aspect of the EARLY bill which I think is important is, it
    actually puts aside some money to address the very questions
    that you just addressed: what is different about younger women,
    how can we help younger women who have this disease. That is
    actually some of the most important parts of the EARLY bill.
    The ACS had some difficulty with the bill early on because some
    of the messages that were in it were not messages that we
    thought we could support. We wanted evidence-based good
    messages. Now we have scientists and survivors in a committee
    coming up with what the evidence-based messages should be, but
    one thing this bill always had was research to look at the
    quality of life needs of women with breast cancer, women who
    have been diagnosed who are in their 20s, 30s and 40s. That has
    always been a very good part of this bill.
        Mr. Braley. Yes?
        Ms. Visco. I would say that we don't know very much about
    breast cancer in any age group. There are some data that
    younger women are more likely to be diagnosed with triple
    negative breast cancer, a specific type of breast cancer, for
    which we have treatments for estrogen receptor-positive breast
    cancer that work well. We have treatments for HER2
    overexpressing breast cancer that works well. For triple
    negative, we don't yet have targeted therapies that work well.
    So more research into looking at that type of breast cancer,
    although there are a number of new possibilities in clinical
    trials now.
        There is also the issue of fertility. I was 39 when I was
    diagnosed. I had chemotherapy. I did go into premature
    menopause. I didn't have the opportunity to have more children.
    There are side effects with treatment no matter how old you
    are. That is a side effect of treatment for younger women. It
    is something we need to do more research on. But we just don't
    have the information. We just don't know enough about breast
    cancer and certainly not enough about breast cancer in younger
    women.
        Dr. Sledge. I can only add a little, but these women are
    vulnerable in many ways. One is, as Fran has just mentioned,
    they are biologically vulnerable. They tend to have much more
    aggressive cancers than do older women, cancers that grow
    rapidly, cancers that are more likely to spread to other parts
    of the body at an earlier point in time, cancers that are less
    targetable in terms of hormonal therapy or HER2-targeted
    therapy, so they are biologically vulnerable. They are
    economically vulnerable. These are women who by and large are
    less likely to have insurance just because they are at an
    earlier point in their life and they are not as far along up
    the chain that would allow them to have a good health care
    ability to cushion any blows. Economically, they can't cushion
    the blows because they don't have any money in the bank.
    Socially, they are vulnerable because they perhaps just started
    their family or just got married. They have to worry about
    these fertility issues that a woman who is 20 or 30 years older
    would not have to worry about. So across the board,
    Congressman, they are far more vulnerable than our older
    patients.
        Mr. Braley. Are the criteria that the AJCC staging manual
    is using for breast cancer adequate to try to delineate any of
    these specific concerns that you have mentioned here today or
    are they using broad groupings of women that don't allow us to
    have the ability to drill down and define criteria that would
    be more age-appropriate for different segments of the
    population?
        Dr. Brawley. Sir, I can only give my opinion as a physician
    who treats breast cancer patients. I think the AJCC which does
    the stating manual has done a good job although it actually
    being reevaluated right now as we speak. I think one of the
    great problems we have in breast cancer is, our definition of
    what cancer is actually comes from some German pathologist in
    the 1840s, and we have not actually brought the definition into
    a molecular or genetic age. We are still using the same
    science, looking at it under a microscope with a glass to say
    this is cancer that we used 160 years ago, and one of the
    challenges to us in science is to find a genetic way to look at
    a tissue and say that this particular tissue in this woman's
    breast is going to behave in this particular way over the next
    20, 30, 40 years and that is how we ought to treat it. This
    particular tissue is going to be very aggressive so we need to
    treat it aggressively. This other woman's breast cancer is
    going to be less aggressive so we will treat it or maybe even
    watch it and be less aggressive. We have not gotten there but
    that is where hopefully the science is going to take us. That
    is hopefully where the sequencing of the human genome is going
    to take us, and maybe 20 years from now we will be talking
    about those tests.
        Mr. Braley. Thank you.
        Dr. Weiss. I would just also add that in the care of any
    woman who has been diagnosed with breast cancer who is also a
    mother, one of her biggest concerns is, what does my diagnosis
    mean for the women in my family, and that question comes up all
    the time and so that is an area of research that I know we are
    all involved in that deserves much better answers because if
    you don't deal with that profound fear and concern for her, you
    haven't really taken care of the whole woman or her whole
    family.
        Mr. Braley. Thank you very much.
        Mr. Pallone. Thank you all. I know it has been a long day.
    We had a delay and had votes and all that, but I thank you for
    bearing with us, and this was very enlightening in terms of the
    whole issue. As I said earlier, this was a legislation hearing
    so we are going to have to sift through all this and figure out
    what is in the health care reform and what isn't, but we do
    intend to try to move the bills that were considered today. And
    let me just mention that members can still submit written
    questions to you. They are supposed to submit them within 10
    days and then the clerk notifies you, so we may ask you to
    respond in writing to some additional questions. But thanks
    again, and without objection, this meeting of the Subcommittee
    is adjourned.
        [Whereupon, at 4:00 p.m., the Subcommittee was adjourned.]
        [Material submitted for inclusion in the record follows:]