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






                BREAST CANCER SCREENING RECOMMENDATIONS

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                            DECEMBER 2, 2009

                               __________

                           Serial No. 111-85









[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]








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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 L. 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             JOHN B. SHADEGG, Arizona
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
JANICE D. SCHAKOWSKY, Illinois       MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin             MIKE ROGERS, Michigan
MIKE ROSS, Arkansas                  SUE WILKINS MYRICK, North Carolina
ANTHONY D. WEINER, New York          JOHN SULLIVAN, Oklahoma
JIM MATHESON, Utah                   TIM MURPHY, Pennsylvania
JANE HARMAN, California              MICHAEL C. BURGESS, Texas
CHARLES A. GONZALEZ, 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
Hon. Roy Blunt, a Representative in Congress from the State of 
  Missouri, opening statement....................................     3
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................     3
    Prepared statement...........................................     5
Hon. John Shimkus, a Representative in Congress from the State of 
  Illinois, opening statement....................................     9
Hon. Anna G. Eshoo, a Representative in Congress from the State 
  of California, opening statement...............................     9
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................    10
Hon. Lois Capps, 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.....................................    17
Hon. Donna M. Christensen, a Representative in Congress from the 
  Virgin Islands, opening statement..............................    18
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................    19
Hon. Kathy Castor, a Representative in Congress from the State of 
  Florida, opening statement.....................................    20
Hon. Mike Rogers, a Representative in Congress from the State of 
  Michigan, opening statement....................................    21
Hon. Janice D. Schakowsky, a Representative in Congress from the 
  State of Illinois, opening statement...........................    22
Hon. John B. Shadegg, a Representative in Congress from the State 
  of Arizona, opening statement..................................    22
Hon. John P. Sarbanes, a Representative in Congress from the 
  State of Maryland, opening statement...........................    24
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................    25
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................    25
    Prepared statement...........................................    28
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, opening statement.......................................    30
    Prepared statement...........................................    32
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................    36
Hon. Sue Wilkins Myrick, a Representative in Congress from the 
  State of North Carolina, opening statement.....................    37
Hon. Tammy Baldwin, a Representative in Congress from the State 
  of Wisconsin, opening statement................................    38
Hon. Diana Degette, a Representative in Congress from the State 
  of Colorado, opening statement.................................    39
Hon. Zachary T. Space, a Representative in Congress from the 
  State of Ohio, opening statement...............................    40
Hon. Betty Sutton, a Representative in Congress from the State of 
  Ohio, opening statement........................................    41
Hon. Bruce L. Braley, a Representative in Congress from the State 
  of Iowa, opening statement.....................................    42
Hon. Ed Whitfield, a Representative in Congress from the 
  Commonwealth of Kentucky, prepared statement...................   149

                               Witnesses

Ned Calonge, M.D., M.P.H., Chair, U.S. Preventive Services Task 
  Force..........................................................    43
    Prepared statement...........................................    46
Diana B. Petitti, M.D., M.P.H., Vice Chair, U.S. Preventive 
  Services Task Force............................................    60
    Prepared statement...........................................    46
Otis Webb Brawley, M.D., Chief Medical Officer, American Cancer 
  Society........................................................    86
    Prepared statement...........................................    90
Jennifer Luray, President, Susan G. Komen for the Cure Advocacy 
  Alliance.......................................................   101
    Prepared statement...........................................   103
Donna Sweet, M.D., M.A.C.P., Member, American College of 
  Physicians' Clinical Assessment Efficacy Subcommittee..........   111
    Prepared statement...........................................   114
Fran Visco, President, National Breast Cancer Coalition..........   134
    Prepared statement...........................................   137

                           Submitted material

Letter of December 4, 2009, from the U.S. Preventive Services 
  Task Force to Members of U.S. Senate...........................    14

 
                BREAST CANCER SCREENING RECOMMENDATIONS

                              ----------                              


                      WEDNESDAY, DECEMBER 2, 2009

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:07 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, Eshoo, 
Green, DeGette, Capps, Schakowsky, Baldwin, Matheson, 
Christensen, Castor, Sarbanes, Space, Sutton, Braley, Waxman 
(ex officio), Shimkus, Shadegg, Blunt, Pitts, Rogers, Wilkins 
Myrick, Burgess, Blackburn, Gingrey and Barton (ex officio).
    Staff present: Ruth Katz, Chief Public Health Counsel; 
Purvee Kempf, Health Counsel; Sarah Despres, Health Counsel; 
Jack Ebeler, Health Advisor; Stephen Cha, Professional Staff; 
Anne Morris, Professional Staff; Bobby Clark, Professional 
Staff; Alvin Banks, Special Assistant; Elana Leventhal, 
Professional Staff; Katie Campbell, Professional Staff; Virgil 
Miller, Professional Staff; Andy Bindman, Robert Wood Johnson 
Fellow; Ryan Long, Minority Chief Health Counsel; Brandon 
Clark, Minority Professional Staff; and Chad Grant, Minority 
Legislative Analyst.

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

    Mr. Pallone. The subcommittee is called to order, and I 
will first recognize myself.
    The subcommittee is meeting today to review the new breast 
cancer screening recommendations issued by the U.S. Preventive 
Services Task Force just a few weeks ago. By now, I am sure 
everyone in this room is familiar with the new guidelines or at 
least we are familiar with the controversy surrounding them. 
From what I have heard from my constituents, friends, family 
members and academic institutions in my district, there are a 
lot of questions, frustration and confusion around these new 
recommendations. The controversy that was ignited by the report 
may be eclipsing what the report actually says, and this is the 
reason why I am holding this hearing today. It is time for all 
of our questions to be answered. We want a clear understanding 
of what the report did and didn't say and what others have to 
say about the report.
    We also want to understand the process used by the task 
force. Should they operate, for example, with more 
transparency? Do they get sufficient input from stakeholder 
groups? Do they consider different opinions? And I have invited 
the U.S. Preventive Services Task Force to speak directly about 
their work. It is my hope that we will all walk out of this 
room later today with a better understanding of how these 
recommendations came about, how they should be viewed and what 
exactly they mean. We want to get these answers. We want to 
know as much as we can because women and their doctors deserve 
to know what is best.
    I also want to hear from organizations, advocacy groups and 
medical experts. We don't want the task force's report to stand 
alone if there are different opinions. I know that some of the 
frustration is due to the fact that this recommendation was 
seemingly made with little input from these groups. That may be 
a problem with process as well as a problem with the substance 
of the report, and they will have a platform and a voice today.
    The United States is at the forefront of medical research 
and innovation. Investment in science has led to the 
development of early detection methods for certain cancers. It 
has led to treatments and cures for diseases once considered a 
death sentence, and it is important that all of this new 
medical information is used to empower physicians and their 
patients when making medical decisions. This information should 
be used to help patients and their doctors. It should not be 
used, and I stress, it should not be used as an excuse to deny 
needed care. Scientific studies enable patients and their 
physicians to make more-informed decisions about what is best 
for them in any given situation. These studies should be one of 
many tools. Patients and their doctors should have access to as 
much information as available. They should have informed 
conversations. But the decisions about mammography for women in 
their 40s should remain with women and their doctors.
    There is a lot of disagreement in the medical community 
about when exactly to begin using mammography screening for 
breast cancer. Studies have shown that mammograms save lives 
while at the same time others have highlighted the risks 
associated with the test. For example, an article published in 
the New York Times just yesterday cites a new study that 
indicated that the risks associated with yearly mammograms can 
actually put high-risk women at an even greater risk to develop 
breast cancer in their lifetime, though at the same time the 
study also cautions that more research is needed to make a more 
conclusive recommendation. And it appears to me that the 
takeaway message from all this is that more research is needed 
and there is already quite a bit of disagreement within the 
community as to what is best for the patient. But remember, our 
goal is to provide the best ways of preventing, detecting and 
treating breast cancer. All the studies, reports and 
recommendations should be used with that goal in mind. And I 
also believe that we do not want this study or any other study 
to be used as an excuse by insurance companies or others to 
deny mammograms or treatment that would help women. And again, 
the decision should be between the women and their doctors, not 
with the insurance companies. Essentially we want stakeholders 
today and the task force and all groups to be heard. We want 
people to understand whatever recommendations are made and what 
the implications are from these recommendations.
    So I want to thank the witnesses that are here today for 
coming on relatively short notice.
    At this time I would recognize our ranking member, our 
temporary ranking member, I guess, the gentleman from Missouri, 
Mr. Blunt.

   OPENING STATEMENT OF HON. ROY BLUNT, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MISSOURI

    Mr. Blunt. Well, I thank you, Mr. Chairman, and Mr. Deal 
will be here at some point during the hearing. I am glad to 
substitute for him in this chair for a little while today. I 
certainly thank you for holding this hearing on the recent 
recommendations on breast cancer screening. I think there will 
be large agreement from the committee and concern about those 
recommendations.
    These new guidelines or these new proposed guidelines have 
caused a great deal of confusion for women and their families. 
The U.S. Preventive Services Task Force no longer 
recommendations routine mammograms for women between the ages 
of 40 and 49 yet this group accounts for about one out of six 
instances of breast cancer. I believe it is a huge mistake to 
send a message to women and their families and health care 
providers that an early alert system is not beneficial or may 
not be beneficial. As a cancer survivor myself, I am very 
interested in hearing from members of the task force on why 
these recommendations were formalized, how they were finalized 
and then communicated to the public because I know how 
important screening was for me on two different cancers on two 
different occasions as part of my annual physical.
    As we all know, health care reform has been a hot topic for 
this Congress. In a time when we have been talking about 
encouraging more prevention in the health care arena, these 
recommendations run counter to almost every other discussion 
that we are having. I am also concerned about how these 
recommendations could be interpreted should the House-passed 
health care bill become law. I find it unlikely, or at least 
questionable that the government-run health benefits advisory 
committee would propose including services in the central 
benefits package that another government-appointed board has 
recommended are not necessary.
    Mr. Chairman, I think this is an important hearing. I 
congratulate you for holding it. I look forward to working with 
you and our ranking member, Mr. Deal from Georgia, on the 
subcommittee as we work to figure out how and why these 
confusing recommendations were made.
    Mr. Pallone. Thank you, Mr. Blunt.
    Next is our chairman, Mr. Waxman, the gentleman from 
California.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Waxman. Thank you, Chairman Pallone, for holding this 
important hearing.
    Today we are going to talk about an issue about which 
people have strong views: which women should be routinely 
screened for breast cancer and when. It is a question that 
resonates with every person in this room. We all know someone, 
a family member or friend, who has received a breast cancer 
diagnosis. In some instances, this may be a younger woman in 
the prime of her life. Indeed, just a few weeks ago, this 
subcommittee heard powerful testimony from a member of our own 
Congressional family, Representative Wasserman Schultz, about 
her diagnosis and treatment for breast cancer at age 40.
    The new guidelines for breast cancer screening that were 
recently issued by the U.S. Preventive Services Task Force have 
placed this issue front and center again. I emphasize the word 
``again'' because this is not the first time recommendations 
about the use of mammography and breast self-exams have been 
revisited by the task force or NIH or any number of cancer-
related research or advocacy groups. Just as we have seen with 
prostate cancer screening, immunization schedules and even last 
week cervical cancer screening as well as numerous other 
services, new information or new interpretations of old 
information often result in a change in what the experts tell 
us works at all or works most effectively at all, and this is 
how it is supposed to be. As the science of medicine evolves, 
so too should the recommendations on the best use of that 
science. I believe that is what the U.S. Preventive Services 
Task Force set out to do in making a review of its 2002 
mammography guidelines: to take a fresh look at what has been 
learned over the last several years and based upon that body of 
work to provide its best professional judgment on what doctors 
and their patients should consider when they are making 
decisions about breast cancer screening. While that judgment 
may be contentious, I have no doubt it was driven by science 
and by the interpretation of science and not by cost or 
insurance coverage or the ongoing health care reform debate. I 
am also confidence that these recommendations are just that--
recommendations, and that the task force would not expect them 
to be used to take the place of a considered opinion of a 
physician and a patient.
    As we will hear shortly, there is a deep divide about these 
guidelines among other experts that I believe together with the 
task force share the primary goal of ensuring the best possible 
care for women. We want to learn more about those differing 
views today and understand better exactly what the task force 
has proposed and why, but in the end, what must prevail is a 
set of recommendations that is evidence based, backed by 
science and supported by experts in the field. American women 
and their doctors deserve and are entitled to nothing less to 
inform their decisions, not to make them but simply but to 
inform them. I hope that will be our sole focus here today.
    I look forward to hearing from all of our witnesses and 
thank them in advance for their testimony. Thank you, Mr. 
Chairman.
    [The prepared statement of Mr. Waxman follows:]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



    
    Mr. Pallone. Thank you, Chairman Waxman.
    Next is the gentleman from Illinois, Mr. Shimkus.

  OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF ILLINOIS

    Mr. Shimkus. Thank you, Mr. Chairman, and I hate to 
disappoint Mr. Waxman but this will not be our sole focus today 
because this is the canary in the coalmine. This is what we get 
when we have government intervention starting to dictate health 
care policy decisions and this will not be taken outside the 
context of H.R. 3962, which will then set up a government 
system and will eventually ration care, and when you have 
government commissions setting policy instead of a doctor and a 
patient relationship, you get this. So don't be surprised if we 
do not focus on how this is just one small example of how 
health care will be delivered in this country pretty soon, 
2013, and definitely in 10 or 15 years. We will be able to 
point out in H.R. 3962 the ratings of A and B in the essential 
benefits package and the highest rating of C, women would not 
receive access to regular mammograms until the age of 50. One 
estimate finds rationing of care like this would result in 
50,000 preventable deaths from women who go undiagnosed. H.R. 
3962 does give the Secretary the ability to add benefits but 
only after getting approval to do so from a new bureaucracy 
that is created called the Health Benefits Advisory Council. 
Will the new Health Benefits Advisory Committee take into 
account cost when making decisions? Will the committee make 
recommendations another government board like the task force 
has said shouldn't be covered? When mammograms and other 
services aren't covered by government, where will people turn? 
In Canada, we know those people can turn to the United States 
market. In the U.K., they are allowed to purchase their own 
private plan, this creating a two-tiered system.
    Under H.R. 3962, we create the same tiered system for the 
rich, one for the rich and one for the poor. The Secretary can 
approve additional benefits to be covered or enhanced and a 
premium plan is to be offered in the exchange. These plans will 
cost more money and in 2013, 2014, anyone receiving subsidies 
to help them afford insurance can only purchase a basic plan. 
How will these people receive coverage? So here is proof the 
government will have the ability to come between you and your 
doctor and that we won't need a single payer to get there. The 
government-run public option will allow them the same ability 
to ration care, and I yield back my time.
    Mr. Pallone. The gentlewoman from California, Ms. Eshoo.

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

    Ms. Eshoo. Thank you, Mr. Chairman, for holding this very 
important hearing today. I want to welcome the witnesses, the 
members of the task force, the National Breast Cancer 
Coalition, the American Cancer Society and the Susan Komen 
Foundation here today as well, and to thank you all for your 
work.
    I will place a full statement in the record, but there are 
a couple of points that I would like to make at this moment, 
and that is, number one, I think that if we wander away from 
science, from evidence-based science in our country, then it 
will be a march to folly. Sometimes we debate, and we should, 
and question the scientists and how they arrived at the 
conclusion that they have come to, but science is something 
that has been honored by the American people for a very, very 
long time. We have come through a period of time where science 
was not honored by the Congress. It was political science that 
drove it, and scientists within the government were muzzled and 
we paid a big price for it. Certainly the task force and coming 
out with their information, I wish there were maybe a better 
communications plan. I think a lot of people were simply not 
prepared all of a sudden to be hearing what the task force came 
out with. But now is the sober and the prudent time to examine 
what the task force has come out with and why and where that 
may take us.
    Now, on the issue of national health insurance, of course 
our Republican friends are going to try and drag this into that 
but I remember too many times where they were too slow to take 
up the call to reform, to bring services to women, especially 
poor women, in the fight against breast cancer. So today is a 
most important hearing and we need to remain, I think, devoted 
and dedicated to solid science in our country and to pay heed 
to that, and I think that that really drives to the core of 
what we are here today for and God help us if we don't. This is 
not about anybody's political science as much as members are 
tempted to drag that into it, and I might say that insurance 
companies, private insurance companies have long made decisions 
about who they want to insure and what they will cover, and 
women and their complicated bodies have been left out of so 
many of those decisions and not covered by them and that is why 
we have engaged in a whole new debate and hopefully we will be 
successful with our efforts to remain all of that.
    So, Mr. Chairman, thank you. Thank you for having the 
scientists, the experts that are here today for us to query, to 
understand better and their recommendations and that with that 
we will be far more confident about the discussion and the 
debate that they brought forward, so thank you.
    Mr. Pallone. I want to thank the gentlewoman.
    The gentleman from Texas, Mr. Burgess.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Dr. Burgess. Thank you, Mr. Chairman.
    I agree with the gentlelady's previous statement that the 
fight against cancer knows no ideological or partisan lines, 
and I am certain the doctors who will be testifying before us 
today would agree with that. Cancer is a disease that all 
Americans fear and one that is all too often very, very close 
to home. We have learned in this committee that cancer is a 
complex disease, still has no cure but efforts geared towards 
prevention, early detection and treatment have made significant 
gains. We start there because as we embark upon this hearing, 
we must remember not to embrace policies that would undo the 
successes that we have enjoyed. I agree, we should not make 
this partisan but the 2,000-page gorilla in the room is the 
bill that this House passed 2 weeks ago, and if things were 
just to stay as they are now, then the task force 
recommendations would be just that, recommendations. Doctors 
would be free to accept them or reject them. But what we have 
written in the legislative language may take some of that 
freedom away from doctors and may take some of that freedom 
away from patients as well.
    Cancer strikes roughly one-third of all women in the United 
States and 13,000 Texans are expected to be diagnosed with 
breast cancer this year, so we come to these new 
recommendations made by the United States Preventive Services 
Task Force and they have made some pretty dramatic statements 
regarding breast cancer screening. Now, the whole concept of 
not participating in a monthly self-exam, well, okay, maybe 
that is a good thing but I cannot tell you as a physician 
practicing obstetrics and gynecology for 25 years in north 
Texas the number of new cancers that were brought to my 
attention by the patient herself who found something on exam. 
In fact, the young OB/GYN physician learns very early in their 
course not to question the patient's clinical judgment when 
they come in and tell you something is wrong because very 
likely something is wrong. We are all happy when the tests show 
that in fact there was no problem but more often than not there 
is going to be something there that does deserve further 
scrutiny.
    Now, we had these task force recommendations come up 2 
weeks ago and I went home to Texas, and on my desk waiting for 
me was a periodical called OB/GYN News, not necessarily a peer-
reviewed scientific journal but articles of the day which are 
of interest to practicing OB/GYNs are discussed and they had a 
story that ironically was the day before the task force 
recommendation came out that said headline, breast cancer 
deaths higher without routine screening, and this was from a 
report given to the American Cancer Society out in San 
Francisco and a rather startling statistic that Dr. Katie 
reported to this group that 345 breast cancer deaths, which was 
nearly three-fourths of the total, were in women who were not 
regularly screened. Women who were regularly screened had 25 
percent of the cancer deaths. Women who did not have regular 
screening, 75 percent of the cancer deaths. I think that is 
trying to tell us something and I think again the 2,000-page 
gorilla in the room is this new brave new world of health care 
which Congress is going to dictate how things are happening and 
the recommendations of the United States Preventive Task Force 
now carry the weight of law, if you will, under the auspices of 
the Secretary of Health and Human Services or whoever the 
health care commissar is that they designate.
    So I thank you for having this hearing. I think it is 
extremely important. I think it is extremely timely. I look 
forward to the testimony of our witnesses. Dr. Brawley, always 
good to see you. And I will yield back the balance of my time.
    Mr. Pallone. Thank you, Mr. Burgess.
    The gentlewoman from California, Ms. Capps.

   OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mrs. Capps. Thank you, Chairman Pallone, for holding this 
hearing.
    I am so pleased that you and we all have responded quickly 
to the release of the task force's recommendation because there 
has been a lot of confusion underscoring the value of having 
hearings like this in our House of Representatives. I have just 
returned, as we all have, from our Thanksgiving break and I was 
with my family, and in fact as an aside, received my own annual 
mammogram during that time. I can assure you that the message 
is out there but I am afraid it is not necessarily the accurate 
one. So I am looking forward to hearing in great detail today 
how the task force arrived at its conclusions and what the 
recommendations really mean in a practical sense.
    Unfortunately, there are people who have completely twisted 
what the task force is, what the task force does and what its 
recommendations mean. The scare tactics I have witnessed since 
the release of the recommendations have been deplorable, quite 
frankly. The recommendations are based on scientific findings. 
This is so important to underscore. Now, we know there is not 
always consensus within the scientific community or within the 
advocacy community, both groups so important to us in setting 
public policy, but we in Congress owe it to our constituents 
and the public to listen to what a reputable group of experts 
in evidence-based medicine and prevention have to say.
    Furthermore, we owe it to them to refrain from engaging in 
partisan rhetoric about what these recommendations mean. The 
United States Preventive Services Task Force issues guidelines 
for a whole range of preventive services. They do not make 
coverage determinations for insurance companies, public or 
private, and ultimately all decisions should be made between 
patients and their health care professionals. The task force's 
website affirms that their purpose is to present health care 
providers with information about the evidence behind each 
recommendation, allowing clinicians to make informed decisions 
about implementation. At the end of the day, this is 
information that clinicians should use to make decisions in 
consultation with their patients and nothing more.
    So I look forward to hearing in greater detail what the 
task force concluded and how they arrived at these conclusions, 
and I hope we can stop with the false accusations.
    Before I yield back, Mr. Chairman, I ask unanimous consent 
to enter a letter from the Partnership for Prevention into the 
record. The partnership is a group of reputable organizations, 
the American Academy of Family Physicians, Nurse Practitioners, 
Physicians Assistants and on and on, there is about 10 of them, 
and they are calling attention to our committee on the three 
most common misstatements that have appeared in the media, one 
being that that the task force recommends that women age 40 to 
49 not receive mammograms, this is nowhere in the report, that 
the intention of the task force was to reduce cost, this is 
nowhere in their analysis, and that they are not qualified. 
These are some of the misstatements out in the public that this 
task force is not qualified to make recommendations or that 
they have other agendas in play, and I ask that the letter be 
made part of the record, and I yield back.
    Mr. Pallone. Without objection so ordered. Thank you, Ms. 
Capps.
    [The information follows:]


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    Mr. Pallone. Next is the gentleman from Georgia, Mr. 
Gingrey.

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

    Dr. Gingrey. Mr. Chairman, I thank you.
    We have heard already some comments from the Democratic 
side regarding the danger of ignoring science if we go down 
that road. I don't think we are talking about Newton's third 
law here, by the way. We are not talking about exact science. 
We are talking, I think, about an opinion, a judgment that is 
made by the United States Preventive Services Task Force, 15 or 
so members, based on looking at a lot of studies. I will tell 
you as a practicing OB/GYN physician, like my colleague from 
Texas, Dr. Burgess, I have spent 26 years practicing medicine. 
In that specialty, I am a very proud member of the American 
College of Obstetrics and gynecology and a board-certified 
fellow, and we take our recommendations from that organization 
and from the standard of care in the community, my community, 
the greater Atlanta area, of what is best practices, and the 
American public and particularly the American women, they know 
who the American Cancer Society is. They know who the Susan G. 
Komen for the Cure organization is. So many of them help raise 
money for that organization but very few of them have ever 
heard of the United States Preventive Services Task Force or in 
what department they are embedded and how much power they have 
and how much authority they have, Mr. Chairman. They will find 
out pretty darn soon, and I would refer them to pages in both 
the House and the Senate bill, the Senate bill of course 
pending, the House bill 3962, and let them just connect the 
dots and to see the power that this organization, this U.S. 
Preventive Services Task Force, no matter what they call it, to 
tell physicians basically that this is not an A or B 
recommendation, this is a C recommendation. Well, Mr. Chairman, 
if the President had followed through, if the Congress had 
followed through on the President's recommendation of having 
meaningful medical liability reform in these pending health 
care bills, then maybe physicians like myself would not have to 
worry too much if we decide to follow the United States 
Preventive Services Task Force guideline and not order a 
mammogram for our patients between the ages of 40 and 49 or not 
recommend it to them that they do breast self-examination, and 
we miss a diagnosis of cancer and they died from that disease. 
Or on the other hand, if we decided to ignore the 
recommendation and we did the mammogram and a lump was detected 
or a suspicious marking on the mammogram, the patient had a 
needle biopsy, it turned out to be benign, but unfortunately, 
she developed a breast abscess and then the physician gets sued 
for not following the recommendations and doing something that 
is, quote, unnecessary. So you put doctors in an untenable 
position and you put their patients at risk of death.
    So I can't wait to hear from Susan G. Komen and from the 
American Cancer Society and obviously from the Preventive 
Services Task Force and the others on the panel. Mr. Chairman, 
with that, I will yield back.
    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, Chairman Pallone.
    Given the confusion and the uncertainty the updated 
recommendations on screening for breast cancer by the U.S. 
Preventive Services Task Force has elicited, this hearing I 
hope will bring some clarity which I feel is needed on both 
sides, and I thank you for holding it.
    I have only read the executive summary but I have several 
questions like why now. Did the task force not foresee the 
reaction that has occurred, and why was it just released as an 
article as important as it is and now in a briefing with press 
and stakeholder organizations. As an African American woman who 
has had friends and family diagnosed in their 20s, their 30s 
and 40s, many with no known risk factors, some with good 
outcomes and others who died because of the aggressive of their 
disease, and as a physician who knows the pain of caring for 
women who came with very late stage carcinomas like the 24 
black women who are going to be reported on shortly diagnosed 
in this city by Dr. Wayne Frederick, the head of the cancer 
center at Howard, in a recent 18-month period, 24. I am not 
pleased to say the least with the report not specifically 
addressing those of who die most often from this disease.
    Mammograms are not perfect and perhaps least so in the 40 
to 49 age group, but as part of the full armamentarium, it is 
the best we have today. We have never told women that 
mammograms are all that there is. As Dr. Frederick of Howard 
said, and Ms. Luray and Dr. Brawley will attest, in prevention, 
our main concern ought to be the gaps in outcomes and the lack 
of access of many women to mammograms, exams and other 
screening and diagnostic modalities, and while is most evident 
in the uninsured, copays create almost equal barriers to women 
with insurance, and neither is the federal government doing 
enough. As an example, the Virgin Islands scored very high on 
the breast and cervical cancer grant application but was never 
funded. There is inadequate funding to meet the need.
    Until every woman has access, you can well imagine that we 
will not welcome, I will not welcome, anyway, these kinds of 
narrow recommendations. What is next? Colonoscopy screening for 
cancer screening? It probably saved my life, and not having one 
has caused me to lose too many friends. The task force is 
independent, which I consider a good thing. It is also very 
important to base decisions and recommendations like these on 
science, but the task force is not as diverse as it needs to be 
to adequately and appropriately address the health care needs 
of all Americans. The recommendations may have been very 
different or at least more expansive if some of the 
recommendations that the American Cancer Society offered had 
been accepted. They are similar to ones that we recommended for 
H.R. 3962.
    But I welcome all of the panelists today and I look forward 
to the testimony.
    Mr. Pallone. I thank the gentlewoman.
    The gentleman from Pennsylvania, Mr. Pitts.

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Pitts. Thank you, Mr. Chairman, for convening this 
hearing.
    On November 16, the U.S. Preventive Services Task Force 
released its updated breast cancer screening recommendations 
for women in the general population. Several of the 
recommendations have since caused widespread confusion and 
concern, primarily its recommendations for women age 40 to 49. 
The task force recommended against routine screening 
mammography in women age 40 to 49 but did say that certain 
patients in this age range based on individual factors should 
be screened. This is a change from the task force's 2002 
recommendation that all women age 40 and older receive 
screening mammography every 1 to 2 years.
    The U.S. Preventive Services Task Force was first convened 
by the Public Health Service in 1984 and since 1998 it has been 
sponsored by the Agency for Health Care Research and Quality, a 
division of the Department of Health and Human Services. It is 
instructive, therefore, to pay attention to what the Secretary 
of Health and Human Services had to say about the task force 
recommendations. On November 19, Secretary Kathleen Sebelius 
said, ``My message to women is simple: mammograms have always 
been an important lifesaving tool in the fight against breast 
cancer and they still are today. Keep doing what you have been 
doing for years. Talk to your doctor about your individual 
history, ask questions and make a decision that is right for 
you.'' Basically she told women to ignore the task force 
recommendations. The good news for women age 40 to 49 is that 
they can talk to their doctors and determine whether or not 
routine mammograms are best for them. The bad news is that if 
the House-passed health reform bill, H.R. 3962, becomes law, a 
woman in that age range may not be allowed to have a mammogram. 
The House-passed reform bill renames the U.S. Preventive 
Services Task Force the Task Force on Clinical Preventive 
Services. As part of the bill's essential benefits package, 
preventive services including those services recommended with a 
grade of A or B by the Task Force on Clinical Preventive 
Services must be covered, but according to the task force's 
just-released recommendations, routine mammograms for women age 
40 to 49 received only a grade C. Should the health reform bill 
become law, the new task force will make recommendations to the 
Health Benefit Advisory Committee which will determine what is 
and is not covered in the essential benefits package. I think 
we should ask ourselves how likely it is that one government 
board, the Health Benefits Advisory Committee, will recommend 
including services in the essential benefits package that 
another government board, the task force, has recommended not 
be covered.
    It is important to note that all private plans in the 
exchange will have to meet the essential benefits package but 
they cannot exceed it. A private insurer cannot add additional 
benefits above and beyond what the government requires in the 
essential benefits package except to premium plus plans and 
then only if the added benefit is approved by the health 
benefits commission. So, for example, if the essential benefits 
package did not coverage routine mammograms for women age 40 to 
49, insurance plans would be forbidden from covering them. My 
State of Pennsylvania requires that all plans cover mammograms 
for women age 40 to 49. If this bill were to become law and the 
Secretary were to adopt these breast cancer screening 
recommendations as is as part of the essential benefits 
package, Pennsylvania would either have to change its benefit 
mandate law or reimburse the government for the added cost of 
screening this population. These recommendations should be a 
wake-up call that government-run health care will come between 
patients and their doctors.
    I look forward to hearing our distinguished witnesses. 
Thank you, and I yield back my time.
    Mr. Pallone. Thank you, Mr. Pitts.
    The gentlewoman from Florida, Ms. Castor.

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

    Ms. Castor. Thank you, Mr. Chairman, very much for the 
hearing today because it not only gives us an opportunity to 
further understand the recommendations as to breast cancer 
screening but it affords us an opportunity to raise awareness 
about the real issue involving women's health in America and 
that is access to care, plain and simple.
    For women in America, access to care, affordable health 
care, including screenings of all kinds, eclipses the debate 
over what age women and their doctors should begin routine 
mammograms. For millions of women across America, this debate 
has no application whatsoever. They are not receiving 
screenings at age 50, they are not receiving screenings at age 
60. They simply do not have access to affordable health care 
because our health care system in this country is broken.
    It is very basic. We know that if you do not have 
affordable health care you are less likely to receive the vital 
preventative screenings that women with insurance have. The 
American Cancer Society reports that in my home State of 
Florida, if you don't have health insurance, you are simply not 
going to receive any screening whatsoever. Women in this 
country just do not have access to affordable care. Maybe one-
quarter of women in the State of Florida that do not have 
health insurance will receive some mammogram during age 40 to 
60, and it is much worse if you are African American or Latina. 
The disparities in screenings, diagnosis and treatment exist 
and I think this is the critical issue that Donna Christensen 
has raised that really deserves a great deal of attention and 
debate and it is the proper place for our outrage over women's 
health in America because regardless of your insurance status, 
if you are African American, you are 1.9 times more likely to 
be diagnosed with an advanced stage of breast cancer than white 
women and Hispanic women are almost 1-1/2 times more likely to 
be diagnosed than white women.
    So the real concern here and the proper place for our 
outrage is access to care in and of itself. Our broken system 
prevents millions of women in America from even being part of 
this debate over screening. Fortunately, due to the efforts of 
many over the past year, we are on the road to correcting this 
problem, and I hope that we can focus on the true issues of our 
broken health care system in America that affects, yes, breast 
cancer screening but really is the heart of the problem in our 
fight to making America a healthier country. Thank you.
    Mr. Pallone. I thank the gentlewoman.
    Next is the gentleman from Michigan, Mr. Rogers.

  OPENING STATEMENT OF HON. MIKE ROGERS, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Rogers. Thank you, Mr. Chairman.
    You know, science is a whole host of disciplines and math 
is one of them, and when you look at what the task force 
recommendations have done, it is absolutely disingenuous to say 
cost didn't play a role in it. Let me quote you from the 
American Cancer Society: ``The task force says that screening 
1,339 women in their 50s to save one life makes screening 
worthwhile at that age yet the task force also says that 
screening 1,904 women ages 40 to 49 in order to save one life 
is not worthwhile.'' When you look at their executive summary, 
clinical breast examination specifically talks about costs. The 
principal cost of a CBE is the opportunity cost incurred by 
clinicians and the patient encounter. Clearly, cost is a 
consideration. They did it with digital mammography. Digital 
mammography is more expensive than film mammography and talks 
about the cost-benefit analysis of that as they work their way 
through. Magnetic resonance imagine--magnetic resonance imaging 
is much more expensive than either film or digital mammography. 
To say that cost was not a factor in this is not being honest. 
It is just not. It clearly was the reason, and to say, well, 
they don't have any authority. Wait until that insurance 
company comes out and says well, we based it on this task 
force, a government task force recommendation says I don't have 
to pay for mammography for a woman between the ages of 40 and 
49. That is where we are going.
    As a matter of fact, in your 2,000-page bill, that is 
exactly what you do. The Health Benefit Advisory Committee is 
created to do exactly that. And how do we know that? Because 
the National Institute of Clinical Effectiveness, the NICE 
board in Great Britain, is the very organization that limits 
things like Pap smears. They raised it from 23 to 25 for young 
women. Why? Why did they do it? Because science told them? No, 
to save money. And what the math part of your science equation 
is, we think that we are willing to accept that more women will 
be diagnosed later on in later stages of cancer. We are willing 
to accept a higher mortality rate to save money. That is what 
this report says and that is what we are getting ready to foist 
on the American people. That is not a scare tactic. That is 
reality, and it happens in Great Britain and it happens in 
Canada and it happens in France, and what we are saying is, we 
can and should do better.
    I am a cancer survivor because of early screening. I know 
Mr. Blunt is a cancer survivor because of early screening. Why 
we would foist this kind of an ugly system and hide behind the 
fact that we will have more deaths, more mortality because of 
cancer because of it is beyond me. What we are saying is, this 
2,000-page bill and its 118 new boards, commissions and other 
government agencies that will dictate your health care policy 
is wrong and we can and we should by these women in their 40s 
do much better, and I would yield back the remainder of my 
time, Mr. Chairman.
    Mr. Pallone. Thank you, Mr. Rogers.
    Next is--I am having a hard time seeing who is here. The 
gentlewoman from Illinois, Ms. Schakowsky.

       OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 
     REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS

    Ms. Schakowsky. Thank you, Mr. Chairman, for moving so 
quickly to convene a hearing on the recommendations of the U.S. 
Preventive Services Task Force. I appreciate it.
    This committee has talked a lot about the need for 
evidence-based science over the last year but it is important, 
particularly when it comes to something as critical as breast 
cancer screenings that we do look carefully into the 
justification for these recommendations and their ramifications 
for individual women. Many of my constituents have questions, 
as do I, and I look forward to asking them. But I do want to 
say right now that this is not something that should become a 
political football or, in my view, an attack on the need for 
health reform that guarantees access to comprehensive health 
care for women. We all want to ensure women, especially women 
threatened with life-threatening diseases like breast cancer 
and make sure that they have access to the health care that 
they need without preexisting-condition exclusions, gender 
rating denials that exist today.
    But among the questions that have been asked is, how do we 
reduce the number of unnecessary screens while ensuring that we 
do not provide disincentives for mammograms that will save 
women's lives? How do we empower women to ask for a screening 
when they suspect a problem? How do we build on what we know 
today to ensure that are getting the research and science 
around breast cancer prevention and treatment right? What 
improvements are needed to obtain more accurate screens? How do 
the grades provided by the task force mesh with its 
recommendation that doctors and their patients be allowed to 
make individual choices, particularly when it comes to high-
risk women? And how do we make adequate insurance coverage or 
high cost sharing don't prevent barriers to screening and all 
appropriate follow-up care? Women across the country are 
concerned about getting access to mammograms and other 
essential services, and women's groups across the Nation have 
endorsed comprehensive health reform for this very reason: 
because they know that millions of women's lives depend on it.
    I am eager to hear from our witnesses and discuss the task 
force's recommendation and again, Mr. Chairman, thank you for 
having this hearing. I yield back.
    Mr. Pallone. Thank you.
    The gentleman from Arizona, Mr. Shadegg.

OPENING STATEMENT OF HON. JOHN B. SHADEGG, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF ARIZONA

    Mr. Shadegg. Thank you, Mr. Chairman, and I want to also 
thank you for holding this hearing so quickly on this important 
topic. I believe I have mentioned to this committee before that 
my older sister is a 20-year breast cancer survivor so I have a 
keen interest in this topic.
    The breast cancer treatment guidelines released on November 
16th by the U.S. Preventive Services Task Force have created a 
firestorm across the country, giving rise to concerns about 
women's access to lifesaving screening. Some have commented 
that these recommendations are merely guidelines for insurance 
companies and government officials trying to assess the 
relative value of mammography, clinical breast exams and breast 
self-exams. In a written statement, Health and Human Services 
Secretary Kathleen Sebelius said the guidelines had caused a 
great deal of confusion and worry among women and their 
families across this country and stressed that they were issued 
by ``an outside, independent panel of doctors and scientists 
who do not set federal policy and don't determine what services 
are covered by the federal government.'' I am here to tell you 
today and to tell every women in America that under this bill, 
H.R. 3962, which has already passed this Congress, that 
statement will not be true. Indeed, under this bill, the 
recommendation of this task force would become binding law, and 
if so, it would be devastating to access to mammograms and 
nothing short of catastrophic for women's health in this 
country.
    In their recent report, mammograms for women age 40 to 49 
were given a grade of C. Under this bill, any procedure given a 
grade of less than A or B cannot be covered by the public plan. 
So the women that my colleague worried about who have no access 
to care today for mammograms could not legally get mammograms 
once this bill becomes law. The panel also found insufficient 
evidence to determine it is worth screening over the age of 74. 
Again, because the grade was neither an A nor a B, it was an I, 
insufficient, under this bill those women could not get 
mammogram screening legally under any public plan.
    But it is important to understand precisely how far this 
bill goes. Because it does not just prohibit mammogram 
screening if this were the finding of this same task force 
after H.R. 3962 becomes law, it would prohibit private 
insurers, make it illegal for private insurers to provide 
mammogram coverage to women in these age groups. That is what 
the law says. Let me explain. Under the House bill, private 
insurers can offer four plans: one, a basic plan; two, an 
enhanced plan; three, a premium plan; and four, a premium plus 
plan. Under section 303 of H.R. 3962, women purchasing 
insurance under the first three categories, basic, enhanced or 
premium, would not be allowed to purchase because the insurance 
company would not be allowed to offer a policy covering 
mammogram services. That is right, it would be illegal for a 
private insurance company in any one of those first three 
categories, basic, enhanced or premium, to offer coverage for 
mammograms because mammograms were not given either an A or a B 
rating.
    With regard to the top category, premium plus, an insurance 
company could offer coverage for mammograms but if and only if 
the health choices commissioner specifically allowed the policy 
to cover mammograms. Now, I don't suspect that many of my 
colleagues on the other side of the aisle understand that 
aspect of this bill and I hope that before this bill or 
anything like it were to become law, they would study it 
closely and recognize what is wrong with it. Certainly having 
the government prohibit people who choose to be able to buy 
mammogram coverage is not what was intended by the authors of 
this legislation but in fact that is what the bill does. The 
government would prohibit millions of women from buying 
coverage for mammograms. The government would forbid private 
plans from offering mammogram coverage to millions of women. 
Poor and middle-class Americans by force of law would be 
prohibited from getting mammogram coverage under the insurance 
exchange----
    Mr. Pallone. The gentleman is 2 minutes over.
    Mr. Shadegg [continuing]. Created in this bill.
    I thank the gentleman for his indulgence and hadn't 
realized I had gone over time. Thank you.
    Mr. Pallone. Thank you.
    The gentleman from Maryland, Mr. Sarbanes.

OPENING STATEMENT OF HON. JOHN P. SARBANES, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MARYLAND

    Mr. Sarbanes. Thank you very much, Mr. Chairman, for 
holding this hearing. I expect we are going to hear a lot about 
rationing today from the other side. To me, the discussion 
today isn't about rationing, it is about being rational in 
looking at all of the evidence that is available to us and 
making smart decisions about what kind of treatment we should 
deploy and what kind of coverage there should be, and I think 
the jury is out on this. That is why we are having the hearing. 
There have been recommendations that have been put forward. 
They appear to me to be based on very extensive studies, 
research and science, and I think we ought to approach them 
with an open mind.
    I am glad we are having this hearing. I think this is 
exactly the kind of thing we should be doing, and the fact of 
the matter is that as science advances, it causes us to revisit 
treatment, and that is a good thing. Now, there may be other 
considerations at play here. One of them is clearly the high 
attention that there is to mammography screening and the 
education effort that has gone on with women across this 
country to make them more sensitive to this as a screening 
tool, so all of those considerations ought to be fed into the 
mix and I would expect that the Secretary of HHS will be 
considering all of those things going forward. But to put our 
head in the sand and not look at the science, it seems to me 
would be a serious mistake. So we ought to review these 
recommendations with a sober and dispassionate consideration. I 
think that is what we are called upon to do. I would assume 
that that is what the Health Benefits Advisory Committee would 
do in receiving recommendations from any other government body. 
The notion that one--we have this theme again as well today, 
the notion that one government body will accept without any 
kind of independent judgment or review the recommendations of 
another government body, I don't think makes any sense. I think 
the Health Benefits Advisory Committee will look at all the 
factors in determining what ought to be the policy when it 
comes to treatment.
    So I think that this is a good conversation to be having 
and I thank the commission for putting the recommendations 
forward, for basing them on science, and now we are going to 
have to consider those in the light of many, many factors in 
judging how to move forward. So I look forward to the testimony 
of the witnesses and I yield back my time. Thank you.
    Mr. Pallone. I thank the gentleman.
    The gentlewoman from Tennessee, Ms. Blackburn.

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF TENNESSEE

    Mrs. Blackburn. Thank you, Mr. Chairman, and I want to say 
thank you so much to our witnesses for being here. I am really 
appreciative of the opportunity for us to have this hearing 
today and I have a formal statement I will submit for the 
record, but I do want to make a few comments as we begin this.
    This is an issue of tremendous concern to me. I think that 
all of us are concerned about the welfare and the health of 
women. We are concerned about what you all as the task force 
brought forward. Sure, we are concerned about the science, and 
I want to discuss with you that science, where you drew that 
from and your process. I also want to explore with you your 
task force structure and look at the linkages that you bear and 
what would happen if H.R. 3962 were to be passed and read into 
law. You all have a portfolio of 105 topics. That gets to the 
heart of the issue because when you start reading on H.R. 3962 
on page 1,296 in Title 3 and you look at section 2301 of this 
bill, the decisions you make do end up having the weight of the 
law placed behind them, and when you read specifically on pages 
1,317 and 1,318, you see exactly what is going to happen with 
your recommendations. And then you go in and you look at how it 
becomes the standard of the law, so I encourage everyone to 
take this bill then and read it and read that title. Look at 
section 3101. Look at section 2301. Go back and look on pages 
110 to 112 at how what you do and how you give priority and 
preference to certain treatments and certain categories is 
going to carry the weight of law.
    Now, it is concern to me when I hear statements made by 
Members of Congress that we are going to deploy certain 
treatments or certain health care. That ability should rest 
with the patient and their physician. We do not need a 
bureaucrat in that exam room. And yes, indeed, when you read 
this bill, we do have concerns that it will lead to rationing 
because the decisions appear that they are being made on cost 
and not on health care.
    So I welcome you all. I appreciate your time. We are going 
to have a lengthy number of questions. And Mr. Chairman, I 
yield the balance of my time.
    Mr. Pallone. I thank the gentlewoman.
    Chairman Dingell, the gentleman from Michigan.

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

    Mr. Dingell. I flew back this morning from Michigan hoping 
to have a rather informed hearing on a very important point. I 
find that I have come back to listen to some fairy tales coming 
from the other side of the aisle and I find myself offended by 
the lack of attention that my Republican colleagues have given 
to the health bill and I find myself very much offended to 
listen to the kind of distorted logic and reasoning with which 
I am being afflicted as I enter this room. I have great 
affection and respect for my friends on the other side of the 
aisle and I am willing to assume that their behavior this 
morning in making the comments I am hearing about these 
recommendations and how they will play with the bill is 
bottomed on a lack of attention, study, knowledge or diligence 
in understanding either the bill or the recommendations of the 
U.S. Preventive Services Task Force.
    It has been a little bit like listening to the fairy tales 
of the Brothers Grimm, but to set the record straight, I want 
my colleagues to understand the bill does not in its provisions 
behave as my Republican colleagues would have us believe. It 
does not use these kinds of recommendations to suppress 
treatment or interfere with the relationship between the 
patients and the doctors. This is the kind of scare tactics 
that I have heard from that side of the aisle always with great 
personal offense. They talked about how we are going to pull 
the plug on Grandma, how we are going to push euthanasia 
forward, how we are going to deny health care to deserving 
people because of this legislation. These recommendations that 
we are going into this morning are recommendations, nothing 
more, and to say anything different than that is either to 
transmit the grossest kind of carelessness or, and I hope this 
is not the case, just plain outright deceit.
    It is time for us to look at these recommendations are they 
are: the recommendations of a scientific panel created to make 
advice on what is the best medical practice and how we can see 
to it that we best protect our women with regard to things like 
Pap smears and mammograms.
    Now, I will yield to no one on either subject because this 
committee and the Oversight Subcommittee when I was chairman of 
each were responsible for seeing to it that both mammograms and 
Pap smears were made in the safest way for the benefit of 
patients. I lost my mother to cervical cancer and I lost lots 
of friends to breast cancer and other things, and I am grossly 
affronted by the statements that I have heard coming from the 
other side in which they tell us how these recommendations and 
the health bill on which we are working so hard are going to 
deny women mammograms, proper mammography and Pap smear and 
other needed services. That is offensive. It is just plain 
wrong. It is absolutely false. And I would urge my friends on 
the other side to take a look at the bill, to read it 
carefully, and if they need any assistance in understanding 
what the bill does, I will be happy to volunteer to provide 
time so that they may come to have a better understanding of 
what the bill does and they may then make more-informed 
statements on these matters.
    We need to deal with our health problems in a responsible 
way. We need to see to it that we address the honest defects 
which are in the bill but not to manufacture a lot of fears and 
faults which do not exist. I am affronted, Mr. Chairman, and I 
hope that this record and this hearing will correct some of the 
unfortunate misapprehensions and misstatements that have been 
flowing thickly from the other side of the aisle this morning. 
I ask unanimous consent to revise and extend my remarks.
    [The prepared statement of Mr. Dingell follows:]


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    Mr. Pallone. So ordered. Thank you, Mr. Chairman.
    Our ranking member, the gentleman from Texas, Mr. Barton.

   OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Barton. Thank you, Chairman Pallone, for holding this 
hearing.
    I listened with great affection and with great interest to 
my good friend from Michigan, former Chairman and current 
Chairman Emeritus Dingell's opening statement. I think it goes 
without saying the personal esteem and professional respect 
that I have for him. Having said that, there are no fairy tales 
being told on this side of the aisle this morning. Here is the 
bill that passed the House. In this bill on page 1,762, the 
U.S. Preventive Services Task Force is given the authority, and 
I quote ``to determine the frequency, the population to be 
served and the procedure or technology to be used for breast 
cancer screenings covered under the Indian Health Service.'' 
Section 303 of the legislation states, and I quote, ``The 
commissioner shall specify the benefits to be made available 
under the exchange participating health plans.'' In plain 
English, Mr. Chairman, what this means is, the new health 
choices commissioner will determine what preventive services 
including mammography are covered under the health insurance 
that is in this bill.
    Now, we also know that the U.S. Preventive Services Task 
Force is an outside independent counsel of doctors and 
scientists who make recommendations. They do not set federal 
policy and they don't determine what services are to be covered 
by the bill but their recommendations are going to be seriously 
listened to.
    Now, I have an aunt who passed away in her early 50s as a 
consequence of breast cancer. I have a sister who was diagnosed 
with breast cancer in her 30s, luckily received proper 
treatment, had a mastectomy and so far in the last 10 years is 
cancer-free. I have a wife, beautiful wife who is under the age 
of 50 and she has annual mammograms every year. I have a good 
friend who was just diagnosed with breast cancer who is in her 
mid 40s. Again, she's undergoing treatment. Hopefully she is 
going to have a good outcome.
    To have a task force make the recommendation that has been 
made and to have in this bill the authority that is given to 
various unelected bureaucrats to make health care decisions 
including coverage and frequency in my opinion is wrong. Now, 
on a bipartisan basis, this subcommittee and the full committee 
repeatedly has passed bills increasing and supporting the early 
detection of breast cancer, the prevention, the research. I 
mean, we do it almost every Congress. So we are starting down a 
path in my opinion of socialization of medicine in this country 
with the passage of this bill out of this committee, with its 
passage on the House floor, it is waiting approval in the 
Senate. This is an excellent time to hold this hearing. I 
appreciate the subcommittee chairman and the full chairman's 
personal attendance, but let us don't talk about fairy tales. 
Let us talk about the facts, the plain English of these bills. 
And if we continue to agree rhetorically, then we need to begin 
to make substantive changes in the legislation to prevent what 
we all say we oppose. We don't want rationing of health care in 
America, we don't want to intervene between the doctor-patient 
relationship, we don't want young women or for that matter more 
mature women over the age of 74 developing breast cancer 
because they are not allowed a mammogram. My good friend to my 
right, Mr. Rogers of Michigan, had an amendment that was passed 
at committee that explicitly prevented the rationing of care 
and it mysteriously disappeared in the bill that got reported 
out of the Rules Committee. In the dark of the night some 
staffer on the Majority side or maybe a Member, I don't know, 
decided that the will of the committee didn't mean anything. It 
disappeared. Maybe we need to put that back in. I don't know.
    So I have great respect for this committee. I have great 
respect for the leadership on the committee. But let us not 
talk about fairy tales when we can read these bills. Now, I am 
not saying the bill is a fairy tale but I will say the bill is 
not reflective of the policy that members on both sides of the 
aisle say they support.
    With that, Mr. Chairman, I yield back.
    [The prepared statement of Mr. Barton follows:]


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    Mr. Pallone. Thank you.
    Next is the gentleman from Texas, Mr. Green.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Thank you, Mr. Chairman, and I appreciate the 
opportunity you have in so quickly dealing with this.
    First of all, I want to thank the chairman emeritus for his 
offer, Chairman Dingell willing to conduct a class on remedial 
health care comprehension, and my only question is, is it going 
to be mandatory or permissive. And hearing my colleagues on the 
other side talk about unelected bureaucrats, unelected 
insurance companies do this every day right now, and I will 
give you an example. When I moved to be a Member of Congress, 
my wife had been getting annual mammograms and yet our new 
insurance in Congress refused that after the first year, and 
she was a survivor. Her mom was a 40-year survivor of breast 
cancer and she so fit the exception, and it took me as a Member 
of Congress--I can't practice law, but believe me, I will file 
suit against our carrier if they continue not to pay for those 
mammograms. You have to fight for the care that you want. And 
to say that the House bill that passed would set up this 
unelected group to do it, it all rests on our shoulders and I 
think that decision ought to be made by elected officials.
    Now, this group will take recommendations from everyone but 
ultimately it is going to be our decision and we will continue 
to provide legislation to have minimum benefits, and the 
statement I have, in 2002 the task force changed their breast 
cancer screening to a grade B to recommend mammograms every 1 
to 2 years for women 40 to 75. That was only 7 years ago. And 
yet now the task force is making a change. Two weeks ago they 
revised it and made a grade C, and that's the issue I think 
that my colleagues are talking about, that women at the age of 
40 would not be automatic but should not be denied. And again, 
it does go back to the doctor and the patient's decision. And I 
have in fact doctors on both sides. I have doctors tell me all 
the time that they have battles with insurance companies saying 
we need to do this and the insurance company won't allow it, 
and they are the ones that are practicing medicine and that is 
a battle that has to be fought every day no matter what happens 
if we pass a national health care bill. But to use this 
opportunity to pick at the national health care bill I think is 
interesting because the task force will be given the 
opportunity to clarify their statements and I am glad we have 
the testimony here today.
    The adverse reactions to the poor wording of the task force 
recommendations obviously have not gone unnoticed by our 
committee and the members of the committee. In fact, I have 
been contacted by a number of constituents in my district 
including M.D. Anderson Cancer Center in Houston about the 
recommendations. They were very public. They are opposed to the 
task force recommendations. They will continue to recommend it 
along with many, many other groups. And luckily the State of 
Texas has a mandate that all private insurers must cover annual 
breast cancer screenings beginning at the age of 40 but these 
new screening recommendations will cause some access problems 
for women.
    The topic is also especially sensitive because the reform 
bill 3962 states that the U.S. Preventive Services Task Force 
recommendations A and B are mandated benefits and the bill also 
includes report language saying A and B recommendations are a 
floor for benefits, not a ceiling. The A and B are a floor. So 
the task force recommendation will be considered that but the 
decision could be made still no matter what the task force 
says. So that is what we are here today to talk about. I have 
concerns about jeopardizing access to preventive screenings for 
women, especially since I represent a majority Latino district 
that is medically underserved, and I worked for years in 
Congress to expand the coverage of mammograms in our community 
for primary and preventive care services. I like the fact that 
the task force is an independent commission and is designed to 
keep politics out of medical recommendations because I can be 
an expert for 30 seconds on anything but I do depend on the 
experts to be able to make those decisions.
    Again, I look forward to the testimony, Mr. Chairman, and I 
ask unanimous consent that my full statement be placed into the 
record.
    [The information was unavailable at the time of printing.]
    Mr. Pallone. Without objection, so ordered. Thank you, Mr. 
Green.
    Next is the gentlewoman from North Carolina, Ms. Myrick.

OPENING STATEMENT OF HON. SUE WILKINS MYRICK, A REPRESENTATIVE 
          IN CONGRESS FROM THE STATE OF NORTH CAROLINA

    Mrs. Myrick. Thank you, Mr. Chairman. Thank you for holding 
the hearing today.
    I understand that scientifically and statistically this 
report information is not new, and I know that mammography is 
not perfect by any stretch of the imagination, but I want to 
talk to this whole report from the preventive side because to 
me it is sending the wrong message to women. It is saying you 
don't have to be vigilant, you don't have to take care of 
yourself, you don' have to do preventive care, and the reason 
that concerns me is, I am a 10-year breast cancer survivor. I 
am one of those who persevered literally to find, you know, my 
own cancer because I knew something was wrong with my body and 
I had good doctors who helped me. But because of that, I am 
here today, and we all know that earlier detection means longer 
survival. I mean, that is a no brainer. So many women really 
say to me I don't want to get a mammogram, it hurts, you know, 
or whatever, I just don't want to do it. I heard that over and 
over again ever since I started to get active on this issue. 
And then a lot of women have told me I don't want to know, you 
know, I really don't want to know if I have cancer. Well, my 
point whole in this is, you know, you better find out sooner 
rather than later because of what I said before.
    So I am very concerned that we are saying hey, you don't 
have to take care of yourself. Women look for an excuse not to 
do this anyway and not to do self-exams, and especially, you 
know, younger women today. There are so many younger women in 
my area that are in their 20s and 30s getting breast cancer, 
they have their own support group and that never used to 
happen. So when we talk about what we need to do, I hope that 
we will very seriously consider, you know--and I am glad the 
panel is going to be here to explain why they did what they 
did. But I know that some of the groups are going to continue 
to recommend they do the same thing and with digital 
mammography now, things have changed, especially with younger 
women.
    So, Mr. Chairman, I appreciate this opportunity very much 
and just look forward to hearing the recommendations from the 
panel.
    Mr. Pallone. Thank you.
    The gentlewoman from Wisconsin, Ms. Baldwin.

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

    Ms. Baldwin. Thank you, Mr. Chairman. I appreciate your 
calling this hearing of the Health Subcommittee to discuss what 
is both a deeply personal and deeply political issue for myself 
and as you have heard many of our colleagues in this room.
    The U.S. Preventive Services Task Force was authorized by 
Congress to deliver recommendations regarding the efficacy of 
clinical preventive services. Ideally, these recommendations 
will be used to inform primary medical care. On November 16, 
the task force delivered new recommendations regarding breast 
cancer screenings incorporating the most extensive scientific 
evidence available. Among their more controversial findings 
were the grade C recommendation for mammography in women over 
40, which means that because the science does not point to any 
significant harm or tremendous benefit, that the provision of 
the services should be a decision between an individual and her 
doctor. An independent, rigorous examination of the science 
behind clinical preventive services is an essential part of 
delivering effective health care. The task force was doing its 
job. And as they may admit today, they could have done much 
more around such a sensitive topic by educating and explaining 
their recommendations to women across the country. They could 
have engaged community and advocacy groups to be messengers of 
this information rather than combatants. Moving forward with 
additional recommendations in sensitive areas, I would 
encourage them to do just that.
    I came away from this report and the surrounding 
controversy with two additional thoughts that I would like to 
quickly share. First, we clearly need better screening and 
diagnostic tools. Mammography is not a precise enough tool. We 
need advancements in technology that can help us understand 
what conditions require further tests, what requires treatment 
and how we can best help women live long and healthy lives. 
Some of these advancements in technology are being developed in 
my home State of Wisconsin, tools to help us identify types of 
issue with more precision, improving the efficacy of an X-ray 
screening for breast cancer.
    My second point is that we urgently and desperately need 
health care reform. We must ensure that every woman and every 
American has access to a regular source of care. If the best 
approach is to discuss the option of mammography or other 
screening with your doctor, you have to have a doctor. The 
villain here is the lack of coverage and access to care. 
Otherwise women who are shut out of the health care system 
whether by stigma or lack of resources or even abusive and 
discriminatory insurance industry practices, these women have 
the potential of dying of breast cancer or other conditions 
before we even have a chance to intervene.
    Again, Mr. Chairman, thank you for allowing us this venue 
to discuss and clarify this critical topic. It has bearing not 
only on the health of women but the health of all Americans.
    Mr. Pallone. Thank you.
    The gentlewoman from Colorado, Ms. DeGette.

 OPENING STATEMENT OF HON. DIANA DeGETTE, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Ms. DeGette. Thank you very much, Mr. Chairman. I will 
submit my full statement for the record.
    I just want to say that as Mr. Sarbanes said, we have got 
to look at science here and we have got to look at the 
recommendations based on science which, you know, sometimes I 
feel revolutionary in Congress saying that, but that is what we 
need to look at. All of this excitement on the other side of 
the aisle about how these recommendations are going to be 
implemented, first of all, Mr. Green said, it is not a ceiling, 
it is just a floor, but secondly, even if they were 
implemented, most of them probably we wouldn't object to. The 
recommendations say, number one, the decision to initiate 
regular screening mammography in women age 40 to 49 years 
should be an individual one accounting for patient context and 
values rather than a population-wide recommendation for routine 
screening. That makes sense to me. Number two, biannual 
screening mammography for women age 50 to 74 years. Number 
three, insufficient evidence to assess the additional benefits 
and harms of screening in women over 75 years or old, and then 
the others.
    So really, if you actually look at the recommendations, 
they probably do make some sense from a scientific standpoint 
but I have got to say, it is no wonder why the women of America 
are unbelievably confused as to what these recommendations are 
saying because what they are saying is, most women need to talk 
to their care provider and they need to figure out for 
themselves based on their health and their family history what 
is appropriate for them. It is not a one-size-fits-all testing. 
That makes sense to me. But if you look at the 24-hour news 
cycle, that is not what is being said to people. They are 
scared, they are confused. And when you add the misinformation 
that we hear from some of my friends on the other side, they 
are triply confused and scared because they think now when we 
have a health care plan that applies to everybody, suddenly 
they are going to be told that they can't have tests that they 
need, and that is simply not the case.
    So, Mr. Chairman, that is why I came down and sat through 
all the opening statements and am looking forward to the 
testimony because I think we really need to clear it up. What 
is it that we are saying should be done with mammography and 
testing for women and what is it that women need to be talking 
to their physicians about. Ultimately it is going to be the 
decision of the physician and the woman what they need and they 
need to figure that out and then they need to feel secure that 
they are getting the level of testing that they need. Thank 
you, Mr. Chairman.
    Mr. Pallone. I thank the gentlewoman.
    Next is the gentleman from Ohio, Mr. Space.

OPENING STATEMENT OF HON. ZACHARY T. SPACE, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF OHIO

    Mr. Space. Thank you, Mr. Chairman, for taking the time to 
hold the hearing on this very important issue.
    Cancer is a terrifying specter for all Americans and almost 
all of us have had a loved one or a friend who has been 
affected by it. It certainly is a disease that strikes fear in 
the heart of all of us, and I want to preface my remarks by 
saying that I have heard some things from the other side of the 
aisle that have made a lot of sense, and I specifically point 
to Congresswoman Myrick's comments, and I find them very 
consistent with those just provided by my colleague from 
Colorado, Congresswoman DeGette. But we have heard some things 
from the other side of the aisle today that I think cause us or 
certainly cause me considerable concern. I think that it is 
wrong to use that fear that we all share of cancer to 
intimidate the people of this country into fear of 
comprehensive legislation that as some of our witnesses will 
testify today is good for people with cancer.
    In following up with some of the remarks made by Chairman 
Dingell, there are some things this bill does not do that need 
to be clarified. These task force recommendations will not lead 
to rationing care. That is simply not true. You know, I think 
it is tactics like these that weaken the faith of the American 
people not in any one particular party but in the institution 
of Congress. Nothing in this legislation prohibits insurers 
from covering mammograms. In fact, the legislation gives the 
Secretary leeway to add to the minimum benefits package as 
needed. I think it is disingenuous to on the one hand defend 
the status quo which sees the insurance industry every day 
making decisions about the lives of their insureds based on 
strictly financial considerations and then on the other hand 
condemn a system because you speculate that these kinds of 
recommendations will lead to the rationing of care.
    Second, what this bill does do is, it provides the benefit 
of insurance to millions of Americans that don't have it and 
then following on what Dr. Christensen mentioned earlier, it is 
not just those Americans that don't have insurance that would 
benefit from this bill when it comes to preventive care and 
access to mammograms, it is those who have insurance but can't 
afford the copayments, specifically those who are indigent or 
middle-class Americans. That makes a difference for them. This 
bill makes preventive care a basic and fundamental right for 
every American. That means again that my constituents, the 
65,000 of them that have no access to coverage right now and 
tens of thousands more who can't afford copays will now have 
access to things like mammograms when they wouldn't have 
otherwise had that.
    These are questions that we all should be asking: what is 
the net benefit of this legislation to our constituents. Rather 
than jumping to irrational conclusions, adding confusion to the 
public and politicizing an issue which should transcend 
politics, we should be asking these rational questions, again 
as my colleague from Maryland indicates, based on reason and 
science.
    With that, Mr. Chairman, I thank you once again for calling 
this hearing and yield back.
    Mr. Pallone. Thank you.
    The gentlewoman from Ohio, Ms. Sutton.

  OPENING STATEMENT OF HON. BETTY SUTTON, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF OHIO

    Ms. Sutton. Thank you, Mr. Chairman, for holding this 
extremely important hearing on the recommendations from the 
U.S. Preventive Services Task Force on mammograms for women in 
their 40s.
    As we have all heard and has been discussed here, the task 
force is no longer recommending routine mammograms for women in 
their 40s, and as someone who cares deeply about women's 
health, I like others was surprised by this change. Breast 
cancer is, to say the least, a terrible disease. It is the 
leading cause of death for women between ages 20 and 59. We all 
know people who have been touched by breast cancer, people that 
we love and care about, and we all know people who have 
benefited from early detection.
    So this is such an important hearing and I look forward to 
hearing the discussion of the panel, and what the 
recommendations basically are is that a woman should talk to 
her doctor and make decisions accordingly for their care but 
many women as has been pointed out don't have doctors and many 
women don't have access to health care and women who should get 
mammograms either under the old recommendations or the new 
recommendations do not get the mammogram. In 2007, only 70 
percent of the women in the country who should have been 
screened for breast cancer were screened for breast cancer, and 
part of the reason women, whether they are 40 or they are 60, 
are not screened is because they do not have insurance and 
because they don't have insurance they don't have access to the 
care that they need when they need it including preventive 
care.
    So let us be clear, that providing access to health 
insurance means providing access to preventive care which means 
saving lives. So what is important is that patients and doctors 
are able to consult and access the care that that patient needs 
when that patient needs it and that the patients and doctors 
together will decide the best course of care whether that 
includes a mammogram but in order to do that, people have to 
have access to doctors. Women of all ages under the health care 
bill that has been passed by this House will have improved 
access to coverage. That should not be lost and it certainly 
should not discussions otherwise representations otherwise 
should not be used as we debate and discuss this very important 
issue to derail efforts to give women access to the health care 
that they need in this country. I don't think that that serves 
women well. I don't think that serves our country well, and 
frankly, I find it outrageous, and I yield back.
    Mr. Pallone. Thank you.
    The gentleman from Iowa, Mr. Braley.

OPENING STATEMENT OF HON. BRUCE L. BRALEY, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF IOWA

    Mr. Braley. Thank you, Mr. Chairman, and thank you for 
holding this important hearing.
    I also want to commend my colleague, the gentlewoman from 
North Carolina, for her eloquent and thoughtful statement on a 
very important topic, and while I disagreed with what some of 
my colleague from Georgia said, I have great respect for his 
real-world experience on women's health issues and appreciate 
the concern he brought to this hearing.
    But I also want to talk about the comments that were made 
by the chairman emeritus and others on this committee. If 
people don't believe that rationing takes place right now in 
our private insurance system every day and every State in every 
Congressional district, they are sorely misguided. It does 
happen every day under the current system, which is failing to 
meet the needs of the American people. I will give you a good 
example of a friend of mine who was diagnosed with prostate 
cancer and conferred with his physician on treatment options 
and agreed that proton beam therapy was the best choice of 
treatment for him, and he went to his private insurance 
company, which also is the Medicare administrator in my State 
of Iowa, and his treatment was denied on the basis that it was 
experimental. Well, guess what? Under the Medicare plan that 
that same private insurance company administered, it was 
considered non-experimental, and even though he was eligible 
for Medicare because of his age he was still covered by a 
private plan through his employer and was denied coverage for 
the same treatment he would have gotten if he had been a member 
of Medicare. That is what is wrong with our broken health care 
delivery system and that is why comparative effectiveness 
research is such a critical part of a rational discussion about 
health care policymaking.
    In an earlier hearing in this same subcommittee, I talked 
about a hearing that took place in this very room years ago 
when a researcher advocating high-does chemotherapy with bone 
marrow transplant for metastatic breast cancer patients was the 
only path to cure for those women, even though it had not been 
tested by rigorous academic research. Then years after that, we 
came to the realization that many women were actually harmed 
and died because of being subjected to that treatment.
    And that is why, by the way, it is so important that the 
plain language amendment that I put in the health care bill be 
implemented in people dealing with health care issues. I think 
that in its position paper, the U.S. Preventive Services Task 
Force highlights why that is so important. They indicate on one 
page of their statement that the problem was a matter of 
communications because they did not say what the task force 
meant to say that the communication of the mammography 
screening recommendations was poor. Well, I agree with that, 
and all you have to look at is the next two sentences to find 
out why. This is what two of the sentences say, ``The we said 
is that screening starting at age 40 should not be automatic 
nor should it be denied.'' That doesn't make sense. The next 
sentence says, ``What we are saying is that a decision to have 
a mammogram for women in their 40s should be based on a 
discussion between a women, her doctor.''
    If you don't communicate for your intended audience in 
language that they can comprehend easily, these barriers of 
communication between highly technical scientific and medical 
information will be a problem but the debate we are having is a 
healthy debate and what the most effective use and treatment 
for breast cancer patients is and that is what we need to focus 
on going forward, and I yield back my time.
    Mr. Pallone. I thank the gentleman.
    Next is the gentleman from Utah, Mr. Matheson.
    Mr. Matheson. Thank you, Mr. Chairman. I will be brief 
because I am looking forward to hearing from our two panels on 
this topic.
    In my State of Utah, the incidence of breast cancer is 
lower than most States, however, our mortality rate is high 
because women in Utah are diagnosed in cancer's later stages. 
As a witness on our panel notes in his testimony, the recent 
recommendations provided by the U.S. Preventive Services Task 
Force November 16th have sparked concern and disagreement among 
providers, patients, families as well as sparked a public 
discourse that has led to further confusion and anxiety. As we 
can see from the testimony before this committee, there is not 
consensus on screening protocols but there does seem to be 
consensus that any screening and treatment discussion is an 
individual one between a provider and a patient.
    So I hope today's hearing can provide concrete information 
on the evidence-based decision-making processes of the task 
force but I am also interested to hear from the cancer 
community and medical providers on their next steps for 
outreach and patient education on the benefits and limitations 
of mammography screening.
    Thank you, Mr. Chairman. I yield back my time.
    Mr. Pallone. Thank you.
    I believe that concludes the opening statements by members 
of the subcommittee, so we will now turn to our witnesses, and 
if our first panel would come forward, I would appreciate it. 
Thank you.
    We have two witnesses both from the U.S. Preventive 
Services Task Force. To my left is Dr. Ned Calonge, who is 
chair of the U.S. Preventive Services Task Force, and next to 
him is Dr. Diana Petitti, who is vice chair of the U.S. 
Preventive Services Task Force. Now, I will just mention as I 
think you know that we have 5-minute opening statements from 
you. They become part of the record, and each of you may in the 
discretion of the committee submit additional statements in 
writing for inclusion in the record, and I would now recognize 
first Dr. Calonge.

STATEMENTS OF NED CALONGE, M.D., M.P.H., CHAIR, U.S. PREVENTIVE 
 SERVICES TASK FORCE; AND DIANA B. PETITTI, M.D., M.P.H., VICE 
           CHAIR, U.S. PREVENTIVE SERVICES TASK FORCE

                    STATEMENT OF NED CALONGE

    Dr. Calonge. Good morning, Mr. Chairman and distinguished 
members of the committee. On behalf of our fellow task force 
members, we thank you for the opportunity to discuss the task 
force and our work.
    Our recently published recommendations on breast cancer 
screening have drawn a remarkable amount of attention. We 
recognize the communication of what the recommendations say was 
poor and the timing of the release was unfortunate. We wish to 
explain the process and timeline for creating these 
recommendations and to clarify what we intended to say to 
clinicians and women.
    The health care clinician scientists on the task force 
fully understand, most through personal experience, the impact 
of breast cancer on the lives of women and their families. Our 
job, though, is to rigorously review scientific evidence. 
Politics play no part in our processes. Costs were never 
considered in our considerations. We voted on these 
recommendations long before the last Presidential election. The 
timing of the release of the findings last month was determined 
not by us but both the publication schedule of the medical 
research journal which peer reviewed our work.
    The current task force was created by Congressional mandate 
as an independent body with the mission of reviewing the 
scientific evidence for clinical preventive services and 
developing evidence-based recommendations for the health care 
community. Our primary audience for recommendations remains 
primary care clinicians. The task force has 16 volunteer termed 
members representing a diverse array of expertise in primary 
care and preventive health-related disciplines including adult, 
child preventive and behavioral medicine, women's health, 
nursing and research methods. The AHRQ director appoints 
members from the chair's recommendations developed from a 
public nomination process. Given the scope of topics covered, 
subspecialists who consult on or care for those identified 
through screening by primary care clinicians may not 
necessarily be recruited as members but instead are consulted 
to review and comment on our work at critical points in the 
process.
    Our current portfolio includes a broad array of 105 
clinical preventive services that are listed on our website. We 
strive to update topics every 5 years, which is what prompted 
the new breast cancer recommendations. To address a topic, 
designated task force work group members and scientists at an 
evidence-based practice center collaboratively develop an 
analytic framework and pertinent key questions. A structured, 
systematic review of evidence for each key question is 
conducted and a draft evidence report is created with working 
group consultation. Based on the evidence review and explicit 
methodology, the work group drafts a recommendation statement 
and at an in-person meeting the evidence and the draft 
statement are presented and discussed and the task force votes 
on the recommendation.
    There is careful attention to conflicts of interest such 
that members with potential conflicts are recused from 
discussion and vote or otherwise restricted in participation. 
Representatives of 24 partner organizations including all 
primary care specialties, key federal agencies and other key 
stakeholders specified in our written testimony and on our 
website are invited to participate in the discussion. At three 
key points in the process, work products are sent for review 
and comment by the partner organizations by subspecialty expert 
consults from the relevant disease area such as oncologists and 
by other stakeholders such as subspecialty professional 
organizations and advocacy groups. These products include the 
analytic framework and key questions, the draft systematic 
evidence review and the draft recommendation statement as voted 
on. All comments are considered in creating the final products. 
Final recommendation statements and evidence reviews are 
published in peer-reviewed medical journals.
    Recommendations are expressed as letter grades based on two 
factors only: the magnitude of net benefit or balance of 
benefits and harms of providing the service and the scientific 
certainty about whether the service works. Cost and cost-
effectiveness are not addressed in our deliberations and making 
a recommendation. Over the past several years we have discussed 
whether cost should ever influence a recommendation and we have 
repeatedly said no.
    For A and B recommendations, they are sufficient net health 
benefits such as that primary care clinicians are recommended 
to provide these services for all appropriate patients. If 
there is no net benefit or there is net harm, we assign a D 
recommendation indicating to not provide the service. If gaps 
in the evidence prevent net benefit from being determined, we 
assign an I statement reflecting insufficient evidence, 
indicating that more research is needed.
    Finally, a C recommendation is assigned when there is a 
small net benefit. For C recommendations, we recommend the 
patient be informed about the potential benefits and harms and 
then be supported in making his or her own informed choice 
about being tested. The specific C language that we recommend 
against routine provision was intended for consideration by 
primary care clinicians, but unfortunately as played out in 
unintended ways in the public interpretation of the breast 
cancer recommendation.
    Congress through Public Law section 915 mandates that AHRQ 
convene the task force to address our mission. The role of AHRQ 
in the process is to support our activities and processes of 
AHRQ staff and the director of AHRQ do not vote or otherwise 
influence our decisions.
    I will have to admit to the committee that breast cancer is 
of particular concern to me. I lost both my mother-in-law to 
breast cancer and my sister is currently undergoing therapy. I 
fully understand this issue and have to rely on the science as 
we provide our recommendations.
    With that, I would like to turn testimony over to Dr. 
Petitti to testify specifically about the breast cancer 
screening recommendation.
    [The prepared statement of Drs. Calonge and Petitti 
follows:]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]




    Mr. Pallone. I am sorry. I just wanted to thank Dr. Calonge 
and now ask Dr. Petitti to begin.

                 STATEMENT OF DIANE B. PETITTI

    Dr. Petitti. I am Diana Petitti. I am the vice chair of the 
U.S. Preventive Services Task Force. I am a physician and an 
epidemiologist. I have spent my entire 32-year career as a 
scientist working on issues of women's health. I published on 
the topic of mammography screening. I served as vice chair of 
the National Cancer Policy Board and I have expert in evidence 
synthesis, systematic review and med analysis. I participated 
in this process from the very beginning. I would not sign off 
on any recommendation that I did not believe reflected the best 
possible use of evidence for the benefit of women.
    I appreciate the opportunity to clarify for members of this 
subcommittee the task force recommendations and the evidence 
and weighing of the evidence that led to these recommendations. 
In specific, the task force recommends the following: women age 
50 through 74 should have mammography every other year. The 
decision to start regular, biannual screening mammography 
before the age of 50 should be an individual one and take the 
patient context into account including the patient's values 
regarding specific benefits and harms. That is, the task force 
is saying that screening starting at 40 should not be automatic 
nor should it be denied. Many doctors and many women, perhaps 
even most women, will decide to have mammography screening 
starting at age 40. The task force supports those decisions.
    The task force acknowledges that the language used to 
describe its C grade recommendation about breast cancer 
screening for women 40 to 49 did not say what the task force 
meant to say. The task force communication was poor. The task 
force is committed, really committed to improving its 
communication.
    The task force first addressed the screening mammography 
topic in 1989. At that time the task force recommended 
screening women 50 through 75 every 1 to 2 years. With regard 
to screening younger women, the task force stated it may be 
prudent to begin screening at an earlier age for women at high 
risk of breast cancer. In its 1996 guide, the task force 
recommendation was in favor of screening women 50 to 59 every 1 
to 2 years. Mammography screening for women 40 to 49 was given 
a C grade. At that time the C grade recommendation meant 
insufficient evidence. In 2002, the task force recommended 
screening women 40 to 69 every 1 to 2 years, stating that the 
benefits were smaller and took longer to emerge for women who 
were first screened in their 50s.
    On November 16th, as this committee knows, the task force 
issued its updated recommendations on breast cancer services. I 
wish for us to clarify that the timing of issuance of these 
recommendations. In late 2006, discussion of a plan for 
updating recommendations began. The breast cancer topic came up 
for review at the regularly scheduled time. Work on the topic 
started in 2007. When the recommendation statements came up for 
a vote in November 2007, the members could not come to 
agreement about what to recommend because agreement about what 
to say about the balance of benefits and harms. In this 
context, the task force asked for additional evidence from its 
evidence-based practice center. The task force considered this 
evidence at its July 14-15 meeting.
    In making its final recommendation, the task force 
considered evidence identified in a systematic review of 
evidence for six key questions, the results of an analysis from 
the breast cancer screening consortiums and the results of a 
study commissioned by the task force and conducted by the 
cancer intervention and surveillance modeling network. The 
systematic review identified almost 3,000 studies, and 550 of 
these were used to make the recommendation. The final 
recommendations were made based on a weighing of the benefits 
and harms of screening mammography. The task force concluded 
from the evidence that screening mammography for women 40 to 64 
has a benefit in reducing death due to breast cancer. The 
benefit is larger in older women than in younger women, and I 
would like to speak specifically to the issue of harms in this 
net benefit equation.
    Preventive services are provided to asymptomatic 
individuals for the sole purpose of preventing or delaying 
morbidity, delaying functional decline or postponing death. The 
promise of service delivery is net benefit, benefit minus 
harms. The benefits of mammography have been easy to 
communicate. The harms and potential harms have been difficult 
to communicate. The easily identifiable and commonly used 
definition of harm is physical injury. These physical injury 
direct harms are very, very small but the task force considers 
the harms of a screening test not just physical harms but 
psychological harms.
    A great deal of the controversy has centered on the task 
force use of consideration of anxiety and psychological 
distress as a harm of a false positive test. In particular, the 
psychological distress has been ridiculed. To understand the 
consequences of false positive tests, it is necessary to 
consider how women enter the screening cycle, what happens and 
what might happen to a woman who has a positive test. No matter 
how hard the concept of screening is explained, a positive 
mammogram screening test means cancer until cancer is proven 
not to exist. For some women who have a positive test, the time 
between a positive test and a statement there is no cancer is 
mercifully short. For other women, the follow-up involves more 
than one additional test, perhaps a clinical breast examination 
along with a test, a trip to a surgeon over a period of time 
that is not always short and over a period of time it is 
unpredictable and not within the control of the woman. Some 
women eventually need a biopsy. Cancer is a terrifying 
prospect. It carries special emotional weight because of the 
consequences of the diagnosis have in the past involve not only 
death but the prospect of mutilating surgery. Anxiety and 
psychological distress in women who have had positive screening 
tests is amply documented in the evidence. The task force wants 
only that screening mammograms be done with full knowledge of 
these potential harms, the frequencies of these harms and what 
is to be gained by being screened at an earlier compared with a 
later age. False positive tests are more frequent in younger 
than in older women.
    Other harms of mammography include ones that are less well 
documented. Some women are diagnosed in their 40s with cancer 
that could have been treated just as well if diagnosed later. 
These women may have unnecessarily been exposed to the harms of 
treatment including surgery, chemotherapy----
    Mr. Pallone. Doctor, I didn't want to stop because it is so 
important, but you are 2 minutes over, so keep going but----
    Dr. Petitti. I am going to say that--my final statement. 
Mammography starting at 40 should not be automatic. The task 
force recommends that women in their 40s decide on an age to 
begin screening that is based on a conversation with their 
doctor and is individual, and I apologize for going over.
    Mr. Pallone. I am going to apologize for trying to stop you 
because it is so important that you clarify a lot of these 
things, and I appreciate that.
    Our procedure now is that we have questions from the 
members of the panel--I mean from the Members of Congress, and 
I will start with myself.
    Let me say that you have actually clarified some of the 
questions I was going to ask very well but I still want to kind 
of review this if I could in my own mind, and if I say anything 
you disagree with, tell me, but I do want to ask you some 
questions as well. There are a lot of myths out there that have 
been spread both today and certainly in the last few weeks 
since you came out with your recommendations, and the way I 
understand it, the current task force uses these A, B, C 
ratings. These are the same kind of ratings that would be used 
under the different task force that is in the legislation, the 
larger health care reform legislation that we passed. In other 
words, you are the U.S. Preventive Services Task Force. The new 
task force in the bill that we pass has a different name, 
Clinical Preventive Services, but the A, B and the C ratings 
are the same or similar.
    But right now these A, B and C ratings have no force. They 
are just recommendations. And what some of my colleagues have 
said is that these insurance companies now don't have to cover 
A, B or C, they don't have to cover anything, and in fact what 
we are getting is that a lot of insurance companies right now 
don't prefer to cover any screenings because if you do a 
screening and they have to pay for treatment, it costs them 
money, which they try to avoid. And so what I see right now is 
that in some cases, States have required certain screening like 
my own State, but on the other hand we heard the gentleman from 
Utah talk about Utah where my understanding is, they don't 
require any screenings.
    So the point I am trying to make is that the big advantage 
of the health care reform bill that we pass is that H.R. 3962 
will for the first time create minimum standards for requiring 
preventive benefits. So private insurers would be required 
under that bill to cover services with a grade A or B 
recommendation. Right now they don't have to cover anything. 
What we're doing in the bill is basically saying that at a 
minimum if you or your successor task force says that this is 
an A or B, it has to be required, which it is not now. The 
other thing that we do in the bill is that we say that the 
Secretary could require a C rating also be covered under both a 
public option or private insurance plans. In fact, my 
understanding is that the new task force--I mean the Secretary 
under the bill could even require a C rating under the basic 
benefit package. Now, that is contrary to what some of my 
colleagues have been saying on the other side of the aisle, and 
my whole point here is to say that the truth is that if enacted 
into law, H.R. 3962 would result in a lot of people who are not 
getting mammograms, Pap smears, colonoscopies, a lot of people 
don't get that at all now because insurance companies basically 
don't have to do it unless the State requires it. Now under 
this bill, they would have to do anything that you rate as an A 
or B and the Secretary could even require the C either in the 
public option or in the private plan under the basic benefit 
package.
    Now, I mention this because the bottom line is that women's 
ability to continue to obtain mammograms increases in these 
House and Senate bills that are being passed, and when I look 
at the Republican bill on the other side, it sets no floor 
whatsoever. There would be no minimum required benefits for 
insurance to provide under the Republican bill. Essentially it 
would just like the status quo that we have now. So I listen to 
the debate that we have had today and the bottom line is that 
the bill that we passed in this House provides a lot more 
coverage, has a lot more guarantees. The status quo doesn't 
provide any guarantees at the federal level nor would the 
Republican alternative that we have been given on the other 
side.
    Now, my question is, again, you mention that when you 
recommend a C, it says that it has a small net benefit and 
women are supposed to make their own decisions so you made it 
quite clear today that even if it is a C, there is some net 
benefit and the Secretary could decide under the new bill to 
say okay, that is going to be required as well. So you are not 
in any way with the C recommendation saying that this screening 
is not a good thing. In fact, you are actually saying there is 
a net benefit but you would like individual women to make that 
decision with their doctor because it is only a small net 
benefit. Is that accurate?
    Dr. Petitti. Mr. Chairman, I am going to speak to the 
science.
    Mr. Pallone. Absolutely.
    Dr. Petitti. And the science is that a C recommendation 
does mean a small net benefit, and we map that C recommendation 
through advice that women make the decision with their doctors 
about whether or not to undergo screening. I think this 
committee is dealing with incredibly complicated issues about 
health reform and coverage but the task force is not a coverage 
and health care reform and policy committee; we are scientists.
    Mr. Pallone. But the bottom line is--and I will end with 
this--is that even when you recommend a C you are saying there 
is a small net benefit, so again, let us not talk about today 
but let us talk about if the bill that we passed in this 
committee becomes law. Even then, you know, the Secretary could 
say okay, there is a small net benefit and so we do want to 
require this as a basic benefit, or, you know, you basically 
leave it up to the insurance companies to decide the way they 
do today. But, you know, the misinformation out there I think 
is that even under the bill that we passed, for once there is 
going to be a requirement that some of these screenings occur. 
If you rate it as an A, it has to be done. If you rate it as a 
B, it has to be done. If you rate it as a C, the Secretary can 
say it has to be done. Right now there is nothing, nothing at 
all, and the Republicans in their alternative would continue 
the status quo that says you don't have to cover anything, and 
I just appreciate it because I think you have helped me 
clarify.
    I yield now to the gentleman from Illinois, Mr. Shimkus.
    Mr. Shimkus. Thank you, Mr. Chairman, because what we need 
in this country is a continued debate on the failed health care 
bill that we passed on the Floor of the House. That is what we 
really need to do and that is what we are doing today, and we 
are using obviously what happened through your process to make 
the claim, the short-term concern of a public option, which 
many of my colleagues on the other side have said is the 
gateway to a one-payer system. So when the government controls 
all the health care decisions in this country, they will 
eventually default to control costs through rationed care.
    Now, the process, the scientific process that you have just 
admitted to said there is a small net benefit. When there is 
decreased revenue available, the default will be based upon 
3962 just what you say on your website. Your website recommends 
against routine screening mammography in women age 40 to 49. Do 
you think that this statement would be perceived by women 
younger than 50 that they should not get a mammogram on your 
website?
    Dr. Petitti. We have communicated very poorly about the C 
recommendation. It is clear that many women, many physicians 
and certainly the media interpreted that language as if we were 
recommending against women in their 40s ever having a 
mammogram. That was not our intention.
    Mr. Shimkus. I understand, but we are concerned of 
commissions. We are concerned of bureaucracy. We are concerned 
of rationed care. We are concerned about bureaucrats saying 
there is no real net benefit, and then--yeah, it is right. It 
is exactly what we are concerned about and that is why we are 
having this debate. In the bill, and Chairman Pallone pretty 
adequately talked about the differences--we know that services 
with a rating of A and B must be included in essential benefit 
package. In this case with the highest rating of C, women would 
not receive--currently if this was law, as is today, women in 
the C category would not receive this as a covered benefit 
under 3962, and that is part of our concern and this does segue 
into the full health care debate. The commissioner on part of 
the bill, and I don't have the whole 2,000 pages, I just pulled 
out excerpts. The commissioner shall specify the benefits to be 
made available under exchange participating health benefits 
plans during each year, and then you can go further on. Basic, 
enhanced and premium, and then the premium plus, A, approved by 
the commissioner, and then you can go to the C section, which 
is again highlighted, and we continue to have preventive 
services including those services recommended with a grade A or 
B by the task force on clinical preventive services.
    So this is again for a lot of us an important debate. Do 
any of you know an individual who has been diagnosed for cancer 
between the ages of 40 and 49 personally?
    Dr. Petitti. Oh, I know many individuals who have been 
diagnosed with cancer----
    Mr. Shimkus. Dr. Calonge?
    Dr. Petitti [continuing]. Between the ages of 40 and 49.
    Dr. Calonge. Yes.
    Mr. Shimkus. And then the other question, what about over 
the age of 74? Anyone who has been diagnosed with----
    Dr. Petitti. Yes.
    Mr. Shimkus. Because although we are focusing on 40 to 49, 
in your report over 74 has the I category, and we don't even 
know if it is. So what are we saying to those over the age of 
74?
    Dr. Petitti. I speak to the evidence and to the mapping of 
the evidence to the task force recommendations.
    Mr. Shimkus. And I appreciate that, and I only got 38 
seconds and I am going to be punctual on my time. Part of this 
concern with H.R. 3962 is as we said, the public option, the 
gateway to a one-payer system, eventually rationed care, and 
then a decision based upon the financial ability of the country 
to fund care across the spectrum but also our seniors in our 
country, and again, this incomplete aspect for 74, it speaks to 
the concern that if you are elderly in this country and we get 
to a one-payer system, there will be decisions made not based 
upon health care but on cost, and I yield back my time.
    Mr. Pallone. Thank you.
    Chairman Waxman.
    Mr. Waxman. Thank you, Mr. Chairman.
    The health care bill that the Republicans are complaining 
about is not law yet your agency, the Preventive Task Force, is 
an operation. Is it set up under law?
    Dr. Calonge. Yes.
    Mr. Waxman. And your job isn't to make recommendations to 
insurance companies, is it?
    Dr. Calonge. That is correct.
    Mr. Waxman. Your job is to make recommendations on 
preventive services so that the latest science and information 
about the science is communicated to clinical practitioners. 
Isn't that your job?
    Dr. Calonge. That is correct.
    Mr. Waxman. And this is very useful information. Now, we 
are focused on the breast cancer issue, but that is not the 
only area where you have made recommendations. Isn't that true?
    Dr. Calonge. That is correct.
    Mr. Waxman. How many other areas has the task force made 
recommendations in the last couple of years, let us say?
    Dr. Calonge. Well, our current portfolio is 105 total and 
we take up around 15 new or updated topics annually.
    Mr. Waxman. You have recommended that teenagers be screened 
for mental illness?
    Dr. Calonge. Yes, that was a new recommendation this year, 
Congressman, that we just came out with, so this is new 
services that have not been recommended prior.
    Mr. Waxman. And there was a breast feeding behavioral 
intervention recommendation?
    Dr. Calonge. That is correct.
    Mr. Waxman. And you have had a recommendation that aspirin 
for the prevention of cardiovascular disease be a way to 
prevent the disease. Is that right?
    Dr. Calonge. That is correct.
    Mr. Waxman. So you have had a whole range. You say how 
many, 103?
    Dr. Calonge. A hundred and five total.
    Mr. Waxman. A hundred and five total. I am assuming that 
none of the others have been as controversial as this 
particular one.
    Dr. Calonge. That is correct.
    Mr. Waxman. So we have a controversial issue because it 
challenges the accepted notion about the frequency of breast 
cancer screening and we are going to hear a lot more about that 
from the next panel. But I want to have us look at the 
challenges being raised by some of the Republicans, which I 
think is all political. They are acting as if your 
recommendations based on bringing the scientists who have the 
expertise which are directed at clinical people will be used to 
ration care. That is their argument: we are going to ration 
care. And then they say well, that is because there is going to 
be a health care bill that will provide a requirement for 
minimum benefits. Now, there will be minimum benefits in that 
it should have access to hospitals, it should have access to 
doctors, have access to pharmaceuticals. Your area is in the 
preventive area and nothing could be more important to me than 
having the latest science on how to prevent diseases, because 
if we can prevent illnesses, we won't have to treat them later. 
Your task force will continue in operation. You will convene 
the scientists who are experts in different areas of 
prevention.
    Now, I guess the question, I am not raising this to you but 
the question is, how will your recommendations affect the 
minimum benefits that will be required for health care 
insurers? Health care insurers could be a public insurance, if 
that survives in this legislation process. It certainly would 
be private insurance. Right now private insurance doesn't have 
to abide by your recommendations. Isn't that true?
    Dr. Calonge. That is correct.
    Mr. Waxman. And some of them cover these preventive 
services and some of them don't. Isn't that true?
    Dr. Calonge. That is correct as well.
    Mr. Waxman. It is their decision. But if we are going to 
provide subsidies for people to get insurance and we are going 
to try to get a market where insurance companies compete 
against each other based on price and quality, we ought to make 
sure that all of them provide at least a minimum set of 
benefits. One of the star issues for Republicans is to have a 
lot of insurance plans that don't provide any minimum benefit 
at all. They can be cheaper if they don't provide minimum 
benefits. Well, I find that troubling. But let us say we are 
going to have minimum benefits and you make a recommendation. 
Is your recommendation under the proposed bill automatically 
going to be in effect for all insurance? Do you know whether 
that to be the case?
    Dr. Calonge. Congressman, I am not well----
    Mr. Waxman. You are not an expert on the bill.
    Dr. Calonge. That is correct.
    Mr. Waxman. But let me explain what the bill will do. The 
new bill will take your recommendations. They will go to the 
Secretary. The Secretary will review them. The Secretary will 
have a notice of rule and comment and a public process and then 
decide whether that is a minimum benefit. Now, a minimum 
benefit is a minimum benefit. It is not a maximum benefit. So 
if there is a recommendation as you proposed on breast cancer 
screening, that will be not a requirement of insurance to do no 
more than that, it will be a recommendation that will require 
insurance companies to do that as a floor, not a ceiling. I 
just wanted to set this out because I think some people 
watching this hearing may get confused when they hear stories 
about bureaucrats or rationing care or the health care bill 
being a gateway to single payer. We expect a bill with 
competition and people to make choices between insurance plans 
but we don't want the choices between insurance plans to be 
those that cover breast cancer screening and those who don't, 
but those are at least a minimum of preventive services that we 
can hope will prevent diseases and need for paying for care for 
those diseases.
    Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, Chairman Waxman.
    Next is the gentleman from Texas, Mr. Burgess.
    Dr. Burgess. Thank you, Mr. Chairman.
    Let me ask you a question. I have got the clinical 
guidelines, and I guess this is a reprint from the Annals of 
Internal Medicine, the last page of which is an appendix which 
lists the members of the U.S. Preventive Services Task Force, 
and a number of individuals are listed there. Their specialties 
are not. Is anyone on the list there a board-certified OB/GYN?
    Dr. Petitti. Yes, there are two board-certified OB/GYNs on 
the task force, and that is a usual--we usually have two.
    Dr. Burgess. Which are those two that are on the list that 
I have in front of me?
    Dr. Petitti. Kimberly Gregory and Wanda Nicholson.
    Dr. Burgess. And they both participated in this decision?
    Dr. Petitti. Kimberly Gregory was on the task force when 
this decision was voted; Wanda was not. There was another OB/
GYN on the task force when this topic was voted. That was 
George Siwaya, who is a professor of OB/GYN at University of 
California-San Francisco.
    Dr. Burgess. Were these unanimous votes?
    Dr. Petitti. No, the votes were not unanimous.
    Dr. Burgess. Do we know how the individuals voted?
    Dr. Petitti. I can't recall. That is in the record, and we 
could make that information available to the committee if that 
is important.
    Dr. Burgess. I would like to see it. I don't know if the 
committee will deem it as important, but I would certainly 
appreciate the opportunity to see it.
    Now, is there a radiologist in this group?
    Dr. Petitti. No, there is no radiologist in this group.
    Dr. Burgess. Is that a problem?
    Dr. Petitti. The expertise of this panel has been called 
into question. The experts are individuals who have experience 
in screening science and prevention. Radiologists were 
consulted and reviewed the documents and the recommendations 
and provided input.
    Dr. Burgess. On this task force, the majority of these 
individuals were primary care doctors. Was there a general 
surgeon on the task force?
    Dr. Petitti. Well, again, the experts are experts in 
primary care and prevention, and yes, there were, and I would 
have to count them, four primary care physicians on the task 
force currently and four at the time that these were voted.
    Dr. Burgess. But was there a general surgeon who 
specializes in----
    Dr. Petitti. No, there was no----
    Dr. Burgess [continuing]. Needle localization and breast 
biopsy?
    Dr. Petitti. No, there wasn't. They were consulted.
    Dr. Burgess. They were consulted. All right. And I 
apologize for being in and out but we are doing nine 
simultaneous hearings today and the financial services makeover 
requires some attention and thought as well. On the issue, 
though of talking about--you said you factored in the 
psychological events surrounding a callback on a positive 
mammogram. You factored in the psychological cost, if you will, 
to the patient in that exchange. Do I understand that 
correctly?
    Dr. Petitti. Well, the issue was a qualitative assessment. 
Anxiety, psychological distress, inconvenience are all 
considered to be harms and potential harms, and again, it is a 
part of the net benefit equation.
    Dr. Burgess. When I was I school back in the 1970s, I 
realize it was a long time ago, but mammographic screening was 
not, at least in the area that I went to school, that was not 
something that was done. You sent someone for a mammogram, it 
was kind of a big deal because you felt something, but it 
wasn't done as just part of a routine screening. In fact, I 
don't think, as I recall looking back, it was probably the mid-
1980s when that became a standardized screening test, and in 
fact in Texas, I don't know whether this is true nationwide but 
in Texas I know women can self-refer for mammography. When that 
all happened, that psychological cost was one of the arguments 
that was used by people who felt that routine screening would 
not be a good idea. So how is it that we have come to the point 
now where we rejected it back in the 1980s but now in 2009 this 
is a factor again that is worthy of our consideration?
    Dr. Petitti. Again, this is not determinative. It is 
information that we want women to know about. We want them to 
know how common it is. Again, the false positive rate is much 
lower as women get older and that is part of the net risk 
benefit equation. We would not want women to be afraid of 
having mammography. This is again one piece of information that 
women and their physicians should discuss when decided when to 
start screening.
    Dr. Burgess. And does that same rationale apply to self-
examination?
    Dr. Petitti. The task force recommended against clinicians 
teaching women breast self-examination. They did not recommend 
that women not pay attention to their bodies, that they ignore 
lumps or that they ignore problems that might come up when they 
find a lump. Again, the task force recommendation was against 
doctors teaching women breast self-examination.
    Dr. Burgess. Well, how are women supposed to get that 
knowledge? If they can't just get it by intuition, someone 
along the line has got to provide them some guidelines on 
proper time to do the exam and how to do it and what to be 
concerned about and what not to be concerned about. As I 
recall, and I may be wrong on this but I don't ever recall 
coding and being compensated for teaching breast self-exams so 
it is not a--I mean, I wasn't a cost center for you. I wasn't a 
cost driver. My only inference from that could be that you are 
worried that people will find things that then lead to 
procedures and we are better off if we don't ask, don't tell.
    Dr. Petitti. Again, the evidence--there have been two very 
well-conducted randomized clinical trials in which women were 
taught how to do breast self-examination and both of those 
trials found no overall benefit in terms of reducing mortality 
from breast cancer. Again, we go to the evidence.
    Dr. Burgess. Well, and I will say anecdotally----
    Mr. Pallone. The gentleman's time has expired.
    Dr. Burgess [continuing]. As I said in my opening 
statement, it does strike me----
    Mr. Pallone. Mr. Burgess, you are 2 minutes over.
    Dr. Burgess. It does strike me that the amount of disease--
--
    Mr. Pallone. Mr. Burgess.
    Dr. Burgess [continuing]. The amount of disease that was 
brought to my attention by the patient herself, and again----
    Mr. Pallone. Dr. Burgess, your time has expired.
    Dr. Burgess. I will just be interested in what some of the 
other clinicians tell us when they get their chance to testify. 
Thank you, Chairman.
    Mr. Pallone. Dr. Burgess, you are almost 3 minutes over and 
we are about to vote.
    I think we have time for one more set of questions and then 
we are going to vote. We have five votes. We will take one more 
set of questions and then we will adjourn and come back after 
the five votes. Next is--Chairman Dingell, did you want to 
proceed now?
    Mr. Dingell. I think I can proceed rather quickly, Mr. 
Chairman. Yes, please.
    I would like to welcome you both to the committee and tell 
you how helpful it is to have you here. From the things I have 
heard said on the other side of the aisle about you folks at 
the agency, I was afraid you would appear with horns, tail, 
fangs and in a red suit breathing fire demanding that we 
immediately terminate all health benefits for the unfortunate, 
sick, weak, poor and especially with regard to mammograms and 
Pap smears. So I am very much comforted and I want to welcome 
you to the committee this morning.
    I just have really one question that I think is important. 
I find it curious that the task force has repeatedly over the 
years voted to leave costs out of its deliberations on whether 
to provide or not approved preventive service. Why?
    Dr. Calonge. Thank you, Congressman. I think this is a key 
question. The task force believes its major charge from 
Congress and responsibility to primary care clinicians and 
patients is that we set the evidence-based stake in the ground 
immune from how much it costs to achieve the benefits 
associated with a given effective preventive service. So----
    Mr. Dingell. So your short answer is, that you are 
recommending the needed services, the needed tests, the needed 
treatments as opposed to looking at the cost. Is that it?
    Dr. Calonge. That is correct.
    Mr. Dingell. Okay. Now, to assist my colleagues on the 
other side of the aisle, and I do this out of great affection 
and respect and charity, you address this question in your 
statement and you say here, and I will read this for the 
benefit of my colleagues on the other side, you say, ``Task 
force recommendations are based on consideration of the health 
benefits and health harms of providing the preventive service 
and on the scientific certainty of whether the preventive 
service works. Cost effectiveness of specific prevention 
services are not addressed by the task force in its 
deliberation.'' Then you say this: ``The task force only--'' 
and that is underlined ``considers scientific evidence of 
health benefits and health harms. The task force has 
specifically discussed whether cost should influence a 
recommendation and has repeatedly voted to leave costs out of 
deliberations on whether or not to provide a preventive 
service.'' Is that right?
    Dr. Calonge. That is correct.
    Mr. Dingell. Now, when your recommendations are made, are 
they used to put a ceiling on benefits or are they used to 
describe a minimum level of benefits that people should get?
    Dr. Calonge. Congressman, I must admit that it is outside 
of the scope of our recommendations how they are used by other 
entities.
    Mr. Dingell. Okay. Now, your recommendations are not 
expected to be substituted for the need of the patient or the 
concerns and expertise of the doctor, and they are not intended 
to intrude into the doctor-patient relationship. Am I correct 
in that interpretation or am I wrong?
    Dr. Calonge. That is correct. In fact, if you read our 
statement that is published in the annals, it says, ``The task 
force recognizes the clinical or policy decisions involve more 
considerations than this body of evidence alone. Clinicians 
should understand the evidence and individualized decision-
making to the specific patient or situation.'' This actually 
precedes all recommendations. It is a recommendation statement 
that we expect clinicians to do what they are trained to do in 
order to address the needs of the individual patient for his or 
her best interest.
    Mr. Dingell. Now, you do permit as the task force goes 
about its business to have different agencies and persons of 
concern present in the deliberations. Is that not so?
    Dr. Calonge. That is correct.
    Mr. Dingell. And your deliberations are public?
    Dr. Calonge. At this point, the deliberations of a task 
force vote are by invitation only.
    Mr. Dingell. By invitation, but you don't gag the people 
who come in to listen. They can go out and say what is going on 
and they also are permitted to make comments to you on the task 
force. Is that not so?
    Dr. Calonge. We actually invite comments from our partners 
to help us do our job better and to take into consideration 
different viewpoints and different issues.
    Mr. Dingell. And you allow citizen input?
    Dr. Calonge. The task force is currently moving towards 
increased private-citizen input with the resource we have 
available to consider and identify those. We have prior to this 
time done more with input through specific groups that we 
invite to comment because we think they are important 
stakeholders. This is an issue that the task force believes 
that in the interests of enhanced transparency and 
responsibility to the American public and the patients whose 
physicians may consider our recommendation needs to be 
improved.
    Mr. Dingell. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, Chairman Dingell.
    We have five votes, I would say about an hour, but when 
they are done we will come back and reconvene. The committee 
stands in recess.
    [Recess.]
    Mr. Pallone. Thank you both for being here. We now go to a 
Republican member, Mr. Gingrey.
    Dr. Gingrey. Mr. Chairman, thank you, and I thank the 
witnesses.
    My first question kind of pertains to what Dr. Burgess, Dr. 
Petitti, was asking you a little bit earlier about how many OB/
GYNs there currently are on the task force. I wanted to 
specifically ask you though how many GYN oncologists serve as 
members of the task force when the recommendations were 
promulgated--GYN cancer specialists.
    Dr. Petitti. There are no GYN cancer specialists on the 
U.S. Preventive Services Task Force.
    Dr. Gingrey. Well, let me read to you from testimony that 
we are going to hear from the second panel, in fact, the 
president of the National Breast Cancer Coalition, Fran Visco, 
Attorney Fran Visco, where she states in her testimony, ``We 
want to note that the attacks against the makeup of the task 
force are misplaced. Screening is an issue of primary care. It 
is a health intervention for a healthy population. The experts 
in this area, those with the scientific training and 
objectivity to do the necessary analyses are primary care 
health professionals and methodologists such as epidemiologists 
and biostatisticians, not radiologists or medical 
oncologists.'' And I am quoting directly from her statement, 
which we will hear later. What is your opinion on that?
    Dr. Petitti. The task force expertise in this area was 
sufficient to weight the evidence that led to its 
recommendations. The recommendations are made by the task force 
with the input of a variety of other specialty groups. They are 
not made in a vacuum. In this case, they were submitted to, I 
can't remember the number of partner organizations but it was 
at least 10. Each of these partner organizations sent them out 
to experts. Those experts provided written opinions.
    Dr. Gingrey. And some of those experts then would be cancer 
specialists?
    Dr. Petitti. Yes.
    Dr. Gingrey. Female-cancer specialists?
    Dr. Petitti. There was----
    Dr. Gingrey. So by that response, I guess you would take 
exception to the comments by Ms. Visco, but we will hear from 
her later.
    Let me ask you another question. On your website--and 
either you or Dr. Calonge--on the USPSTF website, it clearly 
states that the United States Preventive Services Task Force 
recommends against routine screening mammography in women age 
40 to 49 years. Do you think that this statement could be 
perceived by women younger than 50 that they should not get a 
mammogram?
    Dr. Petitti. We need to immediately figure out how to get 
that statement off the website. I think it could be 
misconstrued. It has been misconstrued and we need to fix our 
website.
    Dr. Gingrey. Dr. Petitti, I thank you for that response, 
and I hope that you will do that. I think it is very important. 
I agree with you.
    I want to ask you, Dr. Calonge, are you aware that the 
Senate version of health care reform, specifically section 
4004, I think it is on page 1,150, that requires the Secretary 
of HHS to create a national prevention awareness campaign based 
on all of your task force recommendations, both those that you 
favor, the A's and B's, and those you recommend against, the 
C's and D's? Do you think that this national awareness campaign 
could be perceived by women younger than 50 that they should 
not get a mammogram or perform a breast self-examination?
    Dr. Calonge. I wonder, Congressman, if it would be okay if 
you restate your question, because the first part of it and the 
second part I didn't----
    Dr. Gingrey. Well, what I am saying is, in the Senate bill, 
if it becomes law, if that prevails, the Senate language in the 
conference report, it becomes law, and it specifically says, 
and I named the page and section, that the Secretary would 
require the creation of a national prevention awareness 
campaign, television ads, TV spots based on all the task force 
recommendations both those that you in favor of and those you 
recommend against. Don't you think or do you think this 
national awareness campaign could be perceived by women younger 
than 50 that they should not get a mammogram nor should they 
perform breast self-examination?
    Dr. Calonge. Thank you for the clarification, Congressman. 
So I can't speak specifically to the bill or to the policy. I 
will speak to the communication of the recommendation which we 
believe needs to focus on the decision to start regular 
biannual screening before the age of 50 should be an individual 
one and take patient context into account including the 
patient's values regarding specific benefits and harms, and so 
that message which I realize is preceded by the ``recommends 
against'' statement is one we feel communication needs to be 
improved and that clear message of what the task force intended 
needs to lead that, not follow.
    Dr. Gingrey. Thank you, Doctor.
    Mr. Chairman, if you will bear with me just for maybe 15 
seconds, I had one other point I wanted to make. The United 
States Preventive Services Task Force concludes that the 
current evidence is insufficient to assess the additional 
benefits and harms of clinical breast examination beyond 
screening mammography in women 40 years or older. That is 
saying that you don't recommend that the clinician, a 
physician, primary care physician, OB/GYN specialist, should 
routinely do a breast examination as part of a complete 
physical in her or her patients, that that has no value?
    Dr. Petitti. The evidence does not provide support for a 
clinical doing a clinical breast examination.
    Dr. Gingrey. Well, I thank you for that response and your 
honesty.
    Mr. Chairman, I know I have gone beyond my time. I 
appreciate your patience. I think that is terrible and 
something needs to be done about that.
    Mr. Pallone. Next is our vice chair, the gentlewoman from 
California, Ms. Capps.
    Mrs. Capps. Thank you, Mr. Chairman.
    I just want to say thank you to both of you for being here, 
for your excellent testimony and being among the few on Capitol 
Hill who apologize occasionally, and it is not a habit that we 
do very well so the fact that you--I wouldn't call it an 
apology as much as acknowledging the communication glitches 
that occurred perhaps, and for me, I think it was a lot of was 
timing, but I don't take it as a negative thing. I think we are 
seen as a very positive overall experience happening in our 
country, not to minimize the confusion that many women 
experience, but I think we can use it as a teachable moment. 
Let us put it that way. The timing of the release of the report 
and the debate on health care reform has been seized by many 
who want to detract really from the health care legislation to 
use your testimony in widely misconstrued ways, and I want to 
take a minute of my time to mention one very important 
distinction but it is also an important point of what the 
health care reform bill is, which actually will be augmenting a 
lot of the preventive work that you are doing because women 
will be able to have occasion to understand more about cancer 
prevention in its wider forms and their behaviors and their 
body changes, which are all essential. But the essential 
benefits package in the exchange consists of 11 benefit 
categories including inpatient hospital services as examples, 
outpatient services, maternity care, prescription drugs as well 
as preventive services. But with regard to preventive services, 
the bill says that the recommended items and services with a 
grade of A or B from U.S. Preventive Services Task Force shall 
be covered as part of the essential benefits package, a 
rightful designation of the importance of your studies and your 
recommendations, but not a conclusive piece of it, and they 
said this be something which we highly recommend that there be 
no cost sharing for this grade A and B of your recommendations. 
The benefits advisory committee, part of the health reform, 
will be able to recommend through its public standard-setting 
process that additional preventive services such as mammograms 
for women under 40 or between 40 and 49 be covered without cost 
sharing. I mean, there is an additional recommendation that can 
come as part of the bcc bill. The Secretary may also approve 
such coverage. The essential thing here is that the benefits 
package, the essential benefits package is a floor, not a 
ceiling, and that really is important. I want the record to 
state that very clearly. Once the exchange goes into effect and 
there is real competition between private insurance plans, they 
may wish to offer more-attractive packages to win more, you 
know, coverage so it may be understood more fully as we go 
along this. I just wanted to make sure that is in the record.
    But I wanted to give you even more opportunity, both of you 
or one of you, to talk about what the future could hold. You 
see, I think this is an opportunity, a ``wow'' moment, as one 
of the advocate groups put it, and I want to commend all of the 
breast cancer advocacy groups who have brought us to a level in 
this country where when a set of recommendations like yours 
comes out, that there is a more intelligent audience receiving 
it, able to understand it and able to use it and to advocate 
even more in a wide range of ways which I think is very healthy 
for our country to be a part of. I am only giving you about a 
minute but I would like you to elaborate further on ways that 
your task force can communicate in the future in ways that 
maybe we can access and use more efficiently.
    Dr. Petitti. Well, what I thought would happen with these 
recommendations is that it would move the discussion more 
towards the notion of individualized decision making and risk 
stratification. What I thought is, it might initiate a dialog 
where we decided to work harder at finding out who really is at 
higher risk so we could make more tailored recommendations for 
screening, and among those groups that we really have ignored 
are African American women who----
    Mrs. Capps. Absolutely.
    Dr. Petitti [continuing]. Are younger and women of 
Ashkenazi Jewish background, some of whom have a very high risk 
based strictly on their membership in this group. Again, what I 
thought would happen would be a move towards individualized, 
tailored, risk-stratified decision making and not this sort of 
rehashing of a bunch of old data.
    Mrs. Capps. Dr. Calonge, would you like to add anything to 
that? And I know I am squeezing a few more seconds. I think 
this is really important.
    Dr. Calonge. I want to echo the issue about individualized 
decision making. We hear a lot about personalized medicine and 
I think the basis of personalized medicine can be and should be 
individual based decision making, and it is really what we were 
hoping the language for the younger age group would start 
engendering, this issue about, you know, we as consumers of 
health care should kind of understand that every test we have 
and every treatment we have has both inherent risks and 
benefits and we should make our decisions based on 
understanding those and then what is important to us.
    Mrs. Capps. And that underscores the value of the work that 
you do in this topic and in every other topic and the 
importance of having educated in the area of health a 
population that can seize the material as well as primary care 
providers and others doctors, you know, use your information 
every single day to make the kind of informed decisions that 
they and their patients need to have before them. So I hope 
this can be the beginning.
    I again want to thank our chairman. This is the kind of 
setting, this hearing setting that is so important for us to 
take advantage of and use your expertise and your research and 
have this kind of debate, if you will, but discussion. So I 
thank you again for being here.
    Mr. Pallone. Thank you.
    Mr. Rogers.
    Mr. Rogers. Thank you for being here, and I have some quick 
yes or no questions if I may just to get through it. Were you 
familiar with the references to your task force in the bill as 
it was introduced in July?
    Dr. Petitti. No.
    Mr. Rogers. So you knew nothing about the over a dozen 
references to your task force in this bill?
    Dr. Petitti. You know, I hate to say, but I was busy 
preparing a course in biostatistics, and the answer is honestly 
no.
    Mr. Rogers. And is that consistent through the whole task 
force or any of its representatives or administration thereof?
    Dr. Calonge. I hesitate to have the two of us represent the 
opinions of all the task force.
    Mr. Rogers. But it wasn't part of your discussions?
    Dr. Calonge. In July? Absolutely not.
    Mr. Rogers. Are you aware that in this particular bill, and 
I think maybe our Health Committee chairman was mistaken and I 
think the chairman emeritus was mistaken. This is not 
necessarily a new committee. They may create a new name but in 
the bill--and I will just read right from the bill. ``The 
preventive services task force convened under section 915A of 
the Public Health Service Act and the Task Force on Community 
Preventive Services, and then in quotation marks ''as such 
section task forces were in existence the day before the day of 
the enactment of this Act shall be transferred to the Task 
Force on Clinical Preventive Services and the Task Force on 
Community Preventive Services, respectively, established under 
these sections,'' And then it goes on to say that whatever your 
recommendations were prior to that enactment are in effect. Are 
you aware of that, sir or ma'am?
    Dr. Petitti. Well, certainly----
    Mr. Rogers. Yes or no. I am sorry.
    Dr. Petitti. Yes, I am now aware of it.
    Mr. Rogers. But were you aware of that during your 
deliberations?
    Dr. Petitti. No.
    Mr. Rogers. Would that have changed your deliberations at 
all?
    Dr. Petitti. I can't speculate on what might have happened.
    Mr. Rogers. Interesting. So what you are saying is that 
according to the law of which this committee wants to enact you 
have now taken ages 40 to 49 and made them a category C which 
means they will not be paid for under this committee. That is 
interesting.
    Now, let me ask you this. You say you didn't consider cost. 
Is every appendix that is attached to your task force 
recommendation, is that something that would have been reviewed 
by the individuals who made the determination? Is that 
something of value? That is why you attached it as an appendix, 
I imagine?
    Dr. Petitti. Yes, all the material and evidence is germane 
to the----
    Mr. Rogers. Thank you very much. Are you familiar with 
appendix C1 where the question is, what is the cost 
effectiveness of screening, that assigns a dollar value by 
quality of years of life? Are you familiar with this? This 
clearly is a cost-effectiveness portion of your study. Clearly 
you cannot in good conscience tell this committee you didn't 
consider cost. You just told me that every piece of information 
according to your study is considered. This is a dollar value 
per quality of life and it is done on mammography screenings.
    Dr. Petitti. The committee----
    Mr. Rogers. Will you remove this from your task force study 
as well as your recommendation that said----
    Dr. Petitti. I am sorry but I am trying to see what you are 
pointing at, and I----
    Mr. Rogers. It is appendix C1 of your own task force 
recommendation that clearly, clearly considers cost just by 
your own testimony, and again, you can see why women of America 
and those of us who are very concerned about bureaucracies 
interacting between health care. On your website again you say 
that you recommend against routine screening. You say that you 
are going to take that off. That is great. You say that gee, we 
didn't consider cost but on your own report it says you 
considered costs. You can see why after we are creating 118 
brand-new commissions just like yours all of your authority 
will now be enacted into law according to their own bill by the 
reference I have just read. I mean, it is pretty serious.
    And let me ask you another question. As a part of this, it 
says, and I am going to read this again from the bill because I 
think some of my members on the other side maybe either haven't 
read the bill or maybe misunderstand their own language, but 
even under the--this is the Indian health care section, section 
206, I would encourage you to read it, under mammography and 
other cancer screening, ``The Secretary shall ensure that 
screening provided for under this paragraph complies,'' meaning 
you have got to do it ``with the recommendations of the task 
force with respect to, A, frequency, B, the population to be 
served, and C, the procedure or technology to be used,'' all of 
which is referenced in your report. Imagine that when this 
passes your report now becomes a matter of law according to 
their own language in this bill right here. Would that change 
your consideration as a scientist knowing by your own testimony 
it did not pass unanimously? You say science and evidence but 
clearly people equally learned as both of you believe that that 
was the wrong answer? Is this something you should reconsider?
    Mr. Pallone. Mr. Rogers----
    Mr. Rogers. I would like an answer to my question.
    Mr. Pallone. No, I know, but I am going to ask you to go 
beyond that. I mean, you used your 5 minutes. Take what time is 
necessary to respond because I am not sure you even know what 
the questions are, but please take your time.
    Dr. Petitti. I was going to say that.
    Mr. Roger. I got my yes and no's.
    Dr. Petitti. There were a number of different questions and 
I am not sure which one to respond to. What I would like to 
say, and I want to say it again on the record, that when we 
voted for the recommendations for mammography screening A, B 
and C, we voted them without regard to cost or cost-
effectiveness analysis. I can say honestly, absolutely, the 
word ``cost'' was not in the room. It was not mentioned. It was 
not uttered and it did not in any way determine----
    Mr. Rogers. But it was part of your study, was it not? Was 
it not part of your study? You just told me that everything 
that was in your study was considered. Appendix C1 considers 
cost. How could you----
    Mr. Pallone. Mr. Rogers' time is up, but you can respond 
and say what you want but we have got to move on.
    Mr. Rogers. I have more questions, Mr. Chairman, if you 
would like.
    Dr. Petitti. I have nothing more to say.
    Mr. Pallone. Mr. Rogers, I am just trying to make sure she 
is able to respond, but I think we should move on because we 
are a minute over now and she doesn't want to say anything 
else.
    Mr. Rogers. Well, Mr. Chairman, my only caution here is 
that--and I----
    Mr. Pallone. I understand what you are----
    Mr. Rogers. No, I do believe the intention of the other 
side is real. I do believe that. But the language of the bill 
of which I believe that most Members of Congress have not 
read----
    Mr. Pallone. But she has repeatedly said that the bill--she 
didn't even know what was in the bill and their deliberations 
were done under the previous Administration before President 
Obama was even President of the United States, so----
    Mr. Rogers. But, Mr. Chairman, the point here is that she 
did say that cost wasn't part of their voting but it certainly 
was part of their report. That is very important knowledge for 
all of us to know when we raise questions about adding--when 
you----
    Mr. Pallone. You made your statement. She responded to it. 
Let us move on. I can't help but repeat that their 
deliberations, as I said, even preceded the current 
Administration. But whatever, let us move on.
    Next on the Democratic side is the gentlewoman from the 
Virgin Islands, Ms. Christensen.
    Mrs. Christensen. Thank you for your presentations and your 
answers thus far. I want to go back to the issue of African 
American women. Some years ago, many of us worked to ensure 
that mammograms be recommended and covered for women of African 
descent under age 40, and given that even though we may have a 
lower breast cancer incidence, we are more than likely to be 
diagnosed at later stages and have a higher mortality rate, and 
even in younger women, we find that younger African American 
women are more likely to be diagnosed with breast cancer. So in 
the recommendations, why wouldn't the task force single out 
this particular group and maybe give them a different 
recommendation rather than lumping all women between 40 and 49 
or younger under C or I?
    Dr. Petitti. You make an excellent point, and I think again 
what I expected to happen with these recommendations is that we 
would begin to focus on how to make more stratified and nuanced 
recommendations that would identify those groups who are 
unrecognized as being at higher risk of consequences of breast 
cancer when diagnosed at a young age.
    Mrs. Christensen. So even though the bill says in the 
Indian Health Service that your recommendations would be 
applied, you might look at the Native American population as a 
group and decide maybe a different grade for different age 
groups in that particular age group and make that 
recommendation. Might that not happen?
    Dr. Petitti. Yes. I think that the accompanying editorial 
to our recommendations pointed the direction that we thought we 
would be going, you know, not in Congress trying to defend them 
but moving to the point where we have more individualized risk, 
and I would say that based on my understanding of the science, 
which I follow very closely, that breast cancer in young 
African American women is a topic which is not widely 
appreciated as being one which perhaps needs a different kind 
of recommendation. Again, we need to do better at the risk 
stratification and individualized risk. I can't say the task 
force will immediately be able to go back and--
    Mrs. Christensen. I understand, but you recognize it, and 
this is not the final answer?
    Dr. Petitti. This is definitely not the final answer. I 
think people would have wished that we would have not even ever 
opened this topic again after 2002.
    Mrs. Christensen. Especially not right now.
    Dr. Petitti. That was an accident.
    Mrs. Christensen. But given what occurred in response to 
the article and the press taking it up and how it has been 
interpreted, have you looked at other ways of presenting 
recommendations that might be controversial? I have never 
really liked the fact that the press really gets these advance 
notices and they start to tell us what is coming up in the 
medical journal because they don't really understand it.
    Dr. Petitti. Well, we communicated very poorly. We should 
have spent more time talking with our stakeholder groups. We 
should have had a formal communication plan both to consumers 
and physicians.
    Mrs. Christensen. I agree. Can you explain how the 
overdiagnosis--it is a bit confusing but can you explain how 
overdiagnosis occurs when DCIS or early-stage lesions, 
especially in younger individuals is diagnosed and treated? 
Because my understanding on the DCIS is that it is likely a 
precursor to invasive cancer, so is the task force that it 
might be better to not diagnose it or if you think it is there 
to leave it alone and not do further investigation or remove 
it? Because I would think--anxiety is one of the issues that 
you raised. I would think it would be more anxiety provoking to 
think that I had a CA in situ or early-stage cancer and sit and 
wait on it rather than to have it biopsied and removed.
    Dr. Petitti. Well, here we are definitely getting way out 
of my range of expertise. This is a topic which I would want to 
have addressed by a medical oncologist and those who are now 
working so hard to try to understand better how we separate and 
differentiate those tumors that are going to progress rapidly 
and those tumors that aren't going to progress, but this is 
outside my area of expertise.
    Mrs. Christensen. Well, speaking to surgical oncologists 
actually yesterday, they feel that DCIS is many times a 
precursor to invasive cancer and I am surprised that it is 
listed as one of those things that maybe we are overdiagnosing 
or overtreating, but I think my time is up, so thank you for 
your answers.
    Mr. Pallone. The gentleman from Arizona, Mr. Shadegg.
    Mr. Shadegg. I thank you, Mr. Chairman.
    First, I have to express some sympathy for you. You have 
stepped into a controversy which has been made much larger as a 
result of the overall health care reform that is going forward, 
and I think that to a certain degree you have been sucked into 
a much larger battle than your own efforts to try to make 
recommendations would have otherwise merited.
    As I understand your recommendation, you base it on science 
and you say look, here is what we have concluded based on that 
science, it shouldn't be automatic, it ought to be something 
you think through and here is our recommendations. That makes a 
lot of sense to me. I presume from that you believe that it 
should be a decision between the patient and her doctor and 
that, for example, if a particular patient had a history of 
cancer or breast cancer, then you might get screening at a 
younger age, or in some of the categories where you didn't feel 
it should be automatic but under those circumstances it should 
occur. Is that correct?
    Dr. Petitti. Yes, that is correct.
    Mr. Shadegg. Okay. You would then agree with me that if the 
government were to prohibit an insurance plan from providing 
coverage for someone who after consulting with their doctor or 
looking at their family history thought she needed it, that 
would make that at least not an insurable event, correct?
    Dr. Petitti. I am not here to get involved in the coverage 
and health care reform coverage issue.
    Mr. Shadegg. Fair enough. I will just then state for the 
record that in my view, the government should never prohibit 
someone and the government should never able to prohibit 
someone from offering mammogram coverage or as an insurance 
company or a public plan nor should it be able to prohibit an 
individual women or her family from deciding they want to 
purchase mammogram coverage, and I am deeply troubled that this 
bill, which seems to be the larger context into which your work 
has been reported, does precisely that.
    I do want to say that it is important, Mr. Chairman, that 
facts be abided by and unfortunately, in a piece of legislation 
this size, it is subject to interpretation and it is subject to 
quick review without people being very precise in their 
language. I want to make it very clear, I mean no personal 
offense by this by there have been things stated in this room 
today that are flat untrue. For example, the chairman said that 
if a C option--you have your A and your B and now a C--is 
determined by the Secretary to be covered, it is to be covered. 
That is in fact flat not true. The only way a C option can be 
covered under the language of this bill is for two things to 
happen. First, the Health Benefits Advisory Committee has to 
say contrary to what the bill says we think it should be 
covered, and then the Secretary has to say it. So it not a 
single decision by the Secretary.
    Second, and I am sorry he is not here but the chairman of 
the full committee came and made an adamant argument, which has 
been repeated several times here today, that the bill 
prescribes minimum benefits and therefore to say that coverage 
of mammograms is not prohibited is untrue, that all the bill 
does is prescribe minimums. That also is flat not true. If you 
go to page 169 of the bill passed by the Congress, you will 
discover, as I mentioned earlier, that there are four levels of 
plans. There is a basic plan, an enhanced plan, a premium plan 
and a premium plus plan. The basic plan can only cover A's and 
B's, the things you recommend be an A or a B. It could cover a 
C if the two exceptions I just pointed out were to occur. But 
the basic plan absent those things happening does not cover 
anything but A's and B's, but more important than that, the 
definition of enhanced plan and the definition of premium plan 
both prohibit any additional benefits. They say you can have an 
enhanced plan and you can have lower cost sharing. You can have 
a premium plan and it can have lower cost sharing but it can 
only cover the basic services. So all three of the first levels 
of plans are prohibited from covering any service other than an 
A or a B. Only until you get the definition of a premium plus 
plan, and I would point the chairman of the full committee to 
page 169, lines 20 through 25, does it say a premium plus plan 
is a premium plan that also provides additional benefits. That 
is the only plan that can provide a benefit beyond the basic 
plan, and therefore the first three levels of plans are 
prohibited from covering mammograms by law whether they are 
offered by the government or offered by a private insurance 
company. Whether they are in the public plan or in a private 
plan, they are prohibited, and that may not be the intent. As 
the ranking member, Mr. Barton, made very clear, we need to 
deal not with what the--we need to deal with what the bill says 
and if it does not reflect our intent, and I would hope in this 
case it doesn't, because I don't think the government ought to 
be in the business of telling people you cannot buy coverage 
for mammograms. Then we need to fix the language of the bill or 
at least talk truthfully about it, and the chairman of the full 
committee was wrong when he said that this sets only minimums. 
There are words at the beginning of the bill which refer to 
minimums but the words of the bill specifically say it can only 
cover those items with the exception of when both the Secretary 
and the Health Benefits Advisory Committee decide to cover a C, 
and I appreciate the opportunity to put that into the record. 
Thank you, Mr. Chairman.
    Mr. Pallone. Thank you. I don't want to keep belaboring the 
point but the reason I responded to your statement and said 
that there were situations where the Secretary, and now you are 
saying advisory commission could add it to a basic benefit 
package was because when you made your opening statement you 
suggested that it couldn't be done that way, that they couldn't 
include it. So I don't want to belabor the point. I don't 
disagree with you but you are disagreeing with yourself because 
you initially said that they couldn't add it as a basic 
benefit, and now you are saying they can.
    Mr. Shadegg. If the gentleman would yield?
    Mr. Pallone. Sure.
    Mr. Shadegg. I actually didn't say they couldn't add it. I 
didn't discuss whether they could add it. I said that the basic 
plan cannot offer it, and it cannot offer it absent 
extraordinary circumstances, which are two other things.
    Mr. Pallone. See, I think----
    Mr. Shadegg. And I think what we are----
    Mr. Pallone. I think the problem is, we are saying the same 
thing but I am not going to get into it. I don't think there is 
any difference between what you said and what I said.
    Mr. Shadegg. Let us agree on that, but let us agree to fix 
it so that the bill doesn't say that someone cannot choose to 
buy a plan--for that matter, let us allow people who get a 
public plan to get mammogram coverage.
    Mr. Pallone. I am not going to continue to belabor it 
because I think that we are not necessarily disagreeing on 
whether it could or could not be included.
    The next person is the gentlewoman from Florida, Ms. 
Castor.
    Ms. Castor. Thank you, Mr. Chairman, and thank you very 
much for your testimony today. I believe the larger issue is 
the lack of access to any screening or health service for 
millions of American women of all ages, and I would like you to 
comment upon the implications of your latest recommendations on 
the millions of women who are not being screened at all. What 
do you say to them no matter their age?
    Dr. Petitti. You know, again, the task force can't fix 
these problems. I am here as a member of the task force 
speaking to mammography guidelines and speaking to the evidence 
we used to make them. There are clearly huge issues facing this 
country about health care and health insurance and health 
policy but I am not an expert in that area.
    Dr. Calonge. If I could just add to the point that it is 
clear that the provision of mammography and screening for 
breast cancer extends life, and so that is the service that we 
recommend, and I think everyone in the room knows that and 
needs to keep in mind that if the idea is to maximize health 
and extend life, then the services that are recommended should 
be considered for provision.
    Ms. Castor. I mean, your recommendations talk about how, 
for example, the age 40 to 49, how it is important for women 
and their doctors to have a personalized plan with their 
trusted physician but there are many, many women out there who 
don't have a trusted physician, they don't have--they are not 
receiving their checkups. Certainly you all have something to 
say to women all across America no matter their age on being as 
proactive as they can in taking personal responsibility, 
finding--you must have something to say on higher risk groups 
to help us communicate in a better way. You have already 
acknowledged that you did not do the job in communication but 
here is your chance today to bring all of your expertise and to 
provide a message to women on the importance of taking personal 
responsibility and getting their screenings. They may not have 
access to care but there are wonderful nonprofit groups where 
they provide some services in communities. Can you at least go 
that far and provide a proactive message to women in this 
country on the importance of taking care of themselves and 
seeking out these screenings?
    Dr. Petitti. Well, again, I feel uncomfortable in being 
asked to put on a personal hat rather than my task force hat. I 
would be remiss if I didn't encourage women to be interested in 
their health, to take care of themselves, but I am here as a 
member of task force to speak to the mammography guideline 
recommendations and not to go beyond my expertise. I have 
friends who have no insurance. My daughter is uninsured. I know 
women who are uninsured who can't get surgeries they need. But 
that is not my role here. My role here is to speak to the 
mammography guidelines.
    Ms. Castor. You are familiar with the huge disparities in 
screening, diagnosis and treatment among various income levels 
and if you are African American, you are a Latina, correct?
    Dr. Petitti. There are disparities in health care 
throughout all services.
    Ms. Castor. If you could go back or will you go back and 
review your recommendations along the lines of higher risk 
groups, what we know in disparities of screening, diagnosis and 
treatment? Don't you think you could have done a better job in 
fleshing out some of those recommendations?
    Dr. Petitti. I think on many levels we know we could do a 
better job and among them is communication. We need to--we have 
tried for a number of years to make our recommendations more 
risk stratified. For breast cancer, this has been perhaps a 
little more difficult than for some other topics like 
osteoporosis, but again, what I thought would happen with these 
recommendations is we would start having exactly this kind of 
discussion: how do we find women who are extremely high risk, 
how do we communicate with them effectively, how do we make 
screening mammography something that is more individualized and 
tailored.
    Ms. Castor. Thank you.
    Dr. Calonge. I would only add to that a plea for 
consideration of research of preventive services in the 
specific populations who are underrepresented in screening and 
other prevention studies. We often fail in this area, and I 
will inform the committee that we had a discussion about health 
disparities associated with nearly every recommendation vote, 
and the frustration on our part is the lack of evidence of 
efficacy in a specific trial aimed at high-risk populations. So 
I think this is a consideration of the task force, and as we 
are evidence based, this is a real plea on our part for 
researchers and funders of research to consider adequate 
studies that include disparate groups for where we are 
concerned there may be differences and require different 
recommendations.
    Ms. Castor. Thank you.
    Mr. Pallone. Is the gentlewoman complete? All right. 
Thanks.
    The gentlewoman from Tennessee, Ms. Blackburn.
    Mrs. Blackburn. Thank you, Mr. Chairman. I guess you are 
not used to women speaking a little more quickly and being a 
bit more succinct and so maybe that is why we have time left 
many times.
    I want to thank you all for your patience and your 
endurance today and I really want to thank you for being here. 
This is an issue that is of tremendous concern to us, and as we 
look at what your findings were and as we look at the language 
of the bills that are before us, I think what we want to make 
certain we do is, if there is offending language in the bill, 
we want to get it out, and of course we want to make certain 
that we have a clear understanding of what you brought forward 
and of your intent, and I am going to try to be succinct on 
this because I do know you are ready to move on and we have 
another panel. Dr. Burgess asked that you submit the vote from 
your committee as you arrived at your finding and your guidance 
that you made public, and as you submit that vote, who voted 
and how, one thing I would like for you to do for the record is 
also submit to us your science or evidence upon which you based 
these recommendations, what was reviewed, what studies, what 
findings, what groups. If we can have that as a part of the 
record so that we can look at it, I think that would be very 
instructive to us as we decide how to best move forward. So I 
would like to ask you all to do that.
    I would also like to know what period of time, how long did 
you spend on this? How long was this up for discussion and 
under review? What was the thought process and the matrix that 
you worked from to come to this decision? Let us see a little 
bit about what you went through and how you went through it and 
how you worked, what your process is, how you arrived at those 
decisions. I do honestly believe that will be helpful to us 
with an understanding. I will have to say I agree with some of 
my colleagues, you have probably stepped into a bit of a 
quagmire that you did not expect as you released these 
findings, and I would like to ask you, were you all aware of 
how the H.R. 3962, how it would affect you, how your task force 
would be drawn into that bill, that the language of 3962 
actually pulls you in, renames you and then gives credence to 
these findings through statute?
    Dr. Petitti. Well, as unbelievable as it may seem to those 
who are so caught up in Washington, I was writing my 
biostatistics lecture and have been actually woefully and 
naively oblivious of what has been going on in the health care 
reform arena. Certainly from the point of view of specific 
statutory language in now what I know is a 2,000-page bill, you 
know, I knew nothing, and quite honestly when I found out that 
these recommendations were being released the week of the vote, 
the big vote, I was sort of stunned and then also terrified, 
and I think my being terrified was actually exactly the right 
reaction.
    Mrs. Blackburn. Dr. Calonge.
    Dr. Calonge. I would like to add again speaking 
specifically to the timeline for the consideration of this 
recommendation that it was completed prior to any sense that 
the role of the task force might change under upcoming health 
care reform. I will say that earlier this year we became aware 
of language in the House bill regarding the recommendations of 
the task force. However, this recommendation was considered and 
voted on with our explicit scientific methods well before that.
    Mrs. Blackburn. I appreciate that, and I do thank you all 
for your sensitivity to this. I think the linkage that exists 
with the language of changing your title and then giving 
credence in the force of law basically to the priority 
assignments that you would make is of concern to us and to our 
constituents. I thank you all. And I am only going to yield 
back 18 seconds but I yield it back, Mr. Chairman.
    Mr. Pallone. Thank you.
    Oh, I am sorry. The gentleman from Ohio, Mr. Space.
    Mr. Space. Thank you, Mr. Chairman.
    Just so I understand this correctly, the task force has 
been charged with developing a scientifically determined floor 
for preventive services in this bill. Is that your 
understanding of your role?
    Dr. Petitti. You know, I am realizing that I really don't 
understand the bill. I shouldn't speak to the bill. I have 
learned a lot about the bill here.
    Mr. Space. Well, the bill itself does in fact vest that 
kind of power with the task force to develop a scientifically 
determined floor, in other words, a minimum threshold under the 
basic coverage. Those recommendations then follow to the 
benefits advisory committee. Your recommendations will 
establish a floor under which the benefits advisory committee 
cannot go. They can go higher, however. Once the benefits 
advisory committee--and by the way, the benefits advisory 
committee consists of private medical doctors, patients, 
employers, insurance experts, a dentist and representatives of 
relevant government agencies. It is chaired by the surgeon 
general. Once it issues its recommendations, the Secretary--
those recommendations then are the floor. The Secretary then 
has the discretion to increase or enhance the coverage 
available in the basic essential benefits package. Once that 
has been established, private insurers have the additional 
option of offering more coverage. So the suggestion that 
because your task force has issued the recommendations that it 
has, no insurance policies will cover mammograms for women in 
these categories, even the suggestion that the essential 
benefits package as established by this bill will not cover 
them is preposterous. There is no truth in it.
    I do have a specific question I would like to ask you 
regarding some confusion that your findings have created back 
home in my district. There was a recent letter to the editor 
that was very widely distributed regarding your findings that 
have created some confusion, and I'd ask that you try to clear 
this up for us. The author of this letter writes, this is a 
quote, ``What is most troubling about the federal panel's 
recommendations is that they are based mainly on cost saving.'' 
She also expresses concern that the recommendations are ``cost-
saving measures.'' Can you tell us today in no uncertain terms 
what the role of cost of mammograms played in your 
investigation and findings?
    Dr. Petitti. This is an easy question. Cost played no role 
in our recommendations. Again, and I said it publicly in other 
settings and I will say it again here, I think I have said it 
three times here, cost was not a consideration in the voting of 
our recommendations.
    Mr. Space. Thank you. And finally, the author of that same 
letter pointed out that the task force contains ``no cancer 
specialists.'' This is obviously a point that would be 
disconcerting to many. Is it true that no member of the 
preventive task force have any experience in working with 
cancer?
    Dr. Petitti. That is incorrect. Members of the task force 
consist of myself. I was the vice chair of the National Cancer 
Policy Board. One member is a member of the National Cancer 
Institute Board of Scientific Counselors. Another member, 
current member is a professor of--he is the associate director 
of population sciences for the Dartmouth Hitchcock 
Comprehensive Cancer Center and an endowed chair of oncology. 
Again, the members of the task force have the expertise that 
permits them to make the kinds of recommendations they make 
within the arena of screening and preventive services.
    Mr. Space. Thank you, Doctor.
    I yield back my time.
    Mr. Pallone. Thank you.
    The gentleman from Texas, Mr. Green.
    Mr. Green. Thank you, Mr. Chairman, and I will be as quick 
as I can.
    I want to welcome our doctors. I guess having served on 
this subcommittee for 12 years now and the release from the 
USPSTF probably got more coverage than anything our 
subcommittee has done except the health care bill, and there 
was a lot of misinformation about it. But in your testimony you 
say that the individuals representing the views of the American 
College of Obstetricians and Gynecologists and the American 
Academy of Family Physicians weighed in on your recommendations 
and the obstetricians and gynecologists expressed concerns with 
the wording of the recommendations. Do you believe in the 
future it would be a good idea for the task force to actually 
have individual organizations such as these as actual reviewers 
instead of commenters?
    Dr. Petitti. Well, I want to clarify that they were 
official reviewers. First of all, as I pointed out, there were 
two members of the American College of Obstetrics and 
Gynecology on the panel. The ACOG reviewers were official 
reviewers. They made a number of comments. One of their 
comments which was the most substantive comment in retrospect 
was about their anticipation of misperception of our C 
recommendation, and they were right. And we should have 
listened more carefully to them and I am sure we will listen 
more carefully in the future.
    Mr. Green. And I think there was information I guess on the 
self-exam, and from your testimony earlier was that, you know, 
physicians need to be able to provide the expertise so women 
can do the self-exam, that it is not perfect. If there a 
question, then they ought to talk to their physician and that 
is where it goes from there. So that is why I don't understand 
the fear of the self-exam.
    My last question is, a major concern I have is the lack of 
transparency of the process within the USPSTF for deciding 
whether or not to change or create new screening 
recommendations, and depending on what happens with the health 
care bill, your initial decision could make a big difference. 
How could the task force be more open to outside input and 
feedback and what changes would you make in the future after 
what you have learned from this experience?
    Dr. Calonge. Thank you for this question. The task force 
understands the criticisms regarding transparency. As our 
profile has been increased during the discussion of health care 
reform, we believe it is incumbent upon us to increase our 
transparency in such a way that people understand as the 
previous Congresswoman asked how we get to the decisions that 
we get to. The task force is already working on new 
transparency approaches including allowing Internet-based 
public comment on different work products. We think that is a 
good step. We are cautiously trying to expand into areas of 
transparency to include potentially public commentary during 
meetings and other approaches that we believe meet the intent 
and the requirement for transparency so that the decisions are 
made in such a way that we are not spending time in front of 
the public trying to help people understand the processes. So 
we understand this criticism. We actually started working on 
enhancing transparency about a year and a half ago and I will 
only tell the Congressman that our slow working has to do with 
understanding the resource impact of becoming more transparent 
but we absolutely believe we need to do it and we are working 
towards that end.
    Mr. Green. Thank you.
    Thank you. Mr. Chairman.
    Mr. Pallone. Thank you, and I think that concludes our 
questions, but let me just thank both of you really. I think 
that you did a tremendous job today of clearing up a lot of 
misunderstandings, and as someone who has been in politics I 
guess I could say my entire life, I think it is kind of 
refreshing to find out that, you know, you really were very 
independent and not at all aware of what we were doing. I think 
we gives ourselves too much importance. We all think we are all 
so important, that everybody is paying so much attention to 
everything we do. It is kind of refreshing to know that you 
were not. Thank you.
    I will ask the next panel to come forward. Let me welcome 
our second panel and introduce the panel beginning on my left 
is Dr. Otis Webb Brawley, who is chief medical officer for the 
American Cancer Society, and next is Jennifer Luray, who is 
president of the Susan G. Komen for the Cure Advocacy Alliance, 
and then we have Dr. Donna Sweet, who is a member of the 
American College of Physicians' Clinical Assessment Efficacy 
Subcommittee, and finally, Fran Visco, who is president of the 
National Breast Cancer Coalition. I know some of you have been 
here before and thank you for being here. I won't repeat that 
we ask you each to keep your comments if you can to 5 minutes. 
They become part of the record. And if you want to, you can 
submit additional written comments later.
    Let us start with Dr. Brawley. Thank you.

 STATEMENTS OF OTIS WEBB BRAWLEY, M.D., CHIEF MEDICAL OFFICER, 
 AMERICAN CANCER SOCIETY; JENNIFER LURAY, PRESIDENT, SUSAN G. 
   KOMEN FOR THE CURE ADVOCACY ALLIANCE; DONNA SWEET, M.D., 
  M.A.C.P., MEMBER, AMERICAN COLLEGE OF PHYSICIANS' CLINICAL 
 ASSESSMENT EFFICACY SUBCOMMITTEE; AND FRAN VISCO, PRESIDENT, 
                NATIONAL BREAST CANCER COALITION

                 STATEMENT OF OTIS WEBB BRAWLEY

    Dr. Brawley. Good afternoon, Mr. Chairman and distinguished 
members of the committee. I am Otis Brawley, the chief medical 
officer of the American Cancer Society. On behalf of the 11 
million patients and survivors in America today, the Society 
thanks you for your continued leadership in the fight against 
your cancer and your commitment to enacting comprehensive 
health care reform legislation this year. I appreciate the 
opportunity to testify today about the important role 
mammograms play in combating breast cancer deaths.
    As a medical oncologist who actually treats breast cancer 
patients, I have treated hundreds of breast cancer patients in 
my career. Indeed, I have observed firsthand the heartbreak 
this disease has on women and their families. Over the years I 
have also witnessed the advances we have made in breast cancer 
early detection and treatment, advances that led to fewer women 
suffering and ultimately dying from this dreaded disease. I 
can't help but note that in our current system our society 
prohibits a large number of women, 30 to 40 percent of those 
who should be getting mammograms, from actually getting 
mammograms. I also have to note that in my own research 
published and cited before this committee before has shown that 
uninsured women of the same stage have poorer survival compared 
to insured women of the same stage. That is to say that even 
when early detected, insurance is a prognostic factor in breast 
cancer.
    Mr. Chairman, as you know, the Society in recent weeks has 
publicly disagreed with the recommendations of the U.S. 
Preventive Services Task Force with respect to mammography. Let 
me say right now that I have tremendous respect for the task 
force. As an academic physician, I look forward to virtually 
everything that the task force has published over the last 20 
years regarding cancer. I also want to say that reasonable 
experts can look at the science and disagree. There is useful 
screening that should be done and useless screening that 
actually can be harmful, and that is something that the task 
force I think should be looking at in an objective fashion and 
actually has generally done a very good job of doing.
    With respect to mammography, the scientific evidence 
supporting its value in reducing deaths from breast cancer is 
quite strong. In looking at the evidence, the Society along 
with other medical groups believes that screening mammography 
offers an identifiable and important survival benefit to women 
in the age group 40 to 49 and indeed women age 40 and above. 
More specifically, the Society believes that the reduction in 
mortality and less-invasive treatments associated with early 
detection of breast cancer using mammography continues to 
warrant a recommendation of annual screening for all women 
beginning at the age of 40. We do agree with the task force 
that women should be informed of the potential risks as well as 
the potential benefits of the procedure.
    The data and literature examined by the task force in the 
lead-up to its November announcement on mammography is 
essentially the same data reviewed by an expert panel of breast 
cancer researchers, clinicians and epidemiologists convened by 
the American Cancer Society in 2003. However, in that earlier 
review the Society's panel considered the additional findings 
of a population-based study of modern mammography which showed 
much stronger benefits from screening compared with the more 
limited data examined by the task force. Translated, we 
actually think there is a greater benefit to the mammography 
screening that does the task force.
    In addition, since that time, a number of advancements have 
emerged that have shown to increase the effectiveness of 
mammography for women age 40 to 49. There have been 
improvements in the quality of mammograms resulting from the 
Mammography Quality Standards Act, or MQSA. There has been a 
shift to using digital mammograms over film mammograms, which 
research indicates may be more effective in screening younger 
women with denser breasts. The introduction of new technologies 
such as magnetic resonance imaging has also proven to be a 
particularly effective tool in high-risk women.
    Let me very clear on the next point. We understand 
acknowledge that mammography screening is not a perfect test. 
Indeed, it is an imperfect test but we also believe that this 
imperfect test is the only good test other than awareness of 
one's breasts to help save lives at this time. We can and we 
must invest in research to find better tools for detecting and 
treating breast cancer. Women deserve a better test than 
mammography. Indeed, one of the great problems right now is, 
there is a certain complacency or satisfaction with the use of 
mammography in women of all ages. We need a better test. The 
essential fact right now is, mammography is one of the two ways 
that we can use to save lives.
    I have to note that there has been a lot of talk about 
breast self-exam, and as a medical oncologist and 
epidemiologist who is involved in screening and reads the 
screening literature and a doctor who treats, let me say that 
we have been talking past ourselves when we talk about breast 
self-exam today. Breast self-exam has shown in the medical 
literature and as spoken against by the task force is a woman 
doing a specific regimen and exam once a month. It actually 
would take about 20 to 30 minutes for a women to do. What most 
of us including the American Cancer Society have done is moved 
away from that regimented breast self-exam, which was advocated 
20 to 30 years ago, toward something which is a little bit 
different, which is women being aware of their breasts and 
essentially being aware of their breasts and looking for 
differences in their breasts on an almost daily basis. This is 
called breast awareness. Most women indeed find their breast 
cancer through breast awareness, not breast self-exam. There 
are two randomized clinical trials that show that breast 
awareness and breast self-exam are equivalent in terms of 
mortality reduction but breast self-exam actually increases the 
number of unnecessary biopsies done versus breast awareness, so 
I prefer to advocate breast awareness.
    I will note also that approximately 30 to 40 percent of 
American women age 40 and up are currently not getting regular 
mammograms. In the United States, about half of all women 
diagnosed with breast cancer actually are diagnosed through 
this breast awareness and not through mammography. For many of 
the women who cannot get mammography, this is the only way that 
they can actually have any type of early detection.
    In summing up, we know we can do better and with your help, 
Mr. Chairman, we are heading in the right direction. The 
Affordable Health Care for America Act, recently passed by the 
House, will improve health care and it provides a significant 
investment in cancer prevention and early detection by 
requiring first dollar coverage for prevention in both public 
and private plans with little or no cost to patients. The 
Society and its affiliate, the American Cancer Society----
    Mr. Pallone. Doctor, I think you are concluding but I know 
you are 2\1/2\ minutes over.
    Dr. Brawley. I am sorry. We strong support the changes you 
have made in the legislation that will help the task force 
improve the transparency and inclusiveness of its operations.
    Let me just stop at that point and say thank you for asking 
me to appear here.
    [The prepared statement of Dr. Brawley follows:]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



    
    Mr. Pallone. Thank you.
    Ms. Luray.

                  STATEMENT OF JENNIFER LURAY

    Ms. Luray. Thank you, Mr. Chairman, Mr. Ranking Member and 
members of the committee. Thank you for the opportunity to 
testify about the recommendations of the U.S. Preventive 
Services Task Force. My name is Jennifer Luray and I am 
president of the Susan G. Komen for the Cure Advocacy Alliance, 
and on behalf of the patients, survivors, scientists, 
clinicians and advocates of the Komen family, we thank you for 
holding this hearing, and I also want to thank the previous 
task force witnesses for their honesty in discussing how this 
was communicated to the public.
    Let me begin by stating that breast cancer experts agree 
far more than they disagree. This is a point that we have 
stressed since the task force recommendations were first 
released. There is no debate that mammography reduces the risk 
of dying from breast cancer, only debate over the timing and 
frequency of mammography. We don't want women to react to this 
latest controversy as a reason not to get screened.
    Komen in consultation with our scientific advisory board is 
not changing our screening recommendations at this time. We 
continue to recommend that women be aware of their breast 
health, understand their risks and continue to follow existing 
screening recommendations including mammography beginning at 
age 40 for women of average risk and earlier for women with 
known risks of breast cancer. As you can imagine, Komen 
affiliates have been inundated with concerns that the task 
force recommendations could lead to impediments to mammography. 
Many comments have come from breast cancer survivors who are 
diagnosed before the age of 50. This is a very typical one: ``I 
was 46 years old when I went in for my annual mammogram. Like 
so many other women, there is no history of breast cancer in my 
family. I was stage II, and if not for the mammogram, I would 
have had much more advanced cancer.''
    We know that mammography is an imperfect tool, but instead 
of stepping away from it, we must close the technology gap and 
come up with better methods. That is why Komen is funding 
promising screening research. We must work together, 
government, private industry, doctors and patient advocates to 
deliver screening technology that is more predictive and 
personalized but less expensive. Next year, Komen will host a 
national technology summit and we asked NIH to help us prepare 
by reporting on investments that they have made in screening 
technology. But let us also redouble our efforts on behalf of 
the one-third of women, some 23 million American women, who are 
not being screened due to lack of access, education or 
awareness.
    We partner closely with the CDC's National Breast and 
Cervical Cancer Early Detection Program to fund free clinics 
and mobile vans yet the GAO found that over half of eligible 
women for this program do not receive screening. That is a 
disturbing finding that underscores the need for access to 
affordable insurance to eliminate health disparities. And that 
is why Komen supports the valuable patient protections in H.R. 
3962 that would increase access to affordable health insurance, 
prevent insurance companies from denying coverage due to 
preexisting conditions, protect patients from high out-of-
pocket costs and increase access to mammography screening.
    In light of the new task force recommendations, however, we 
must ensure that women ages 40 to 49 will have access to the 
same coverage and cost-sharing benefits as women age 50 and 
older. Even a relatively small copayment reduces mammography 
rates. We do understand that H.R. 3962 will create a new entity 
which would not be bound by the task force's guidelines and 
that the bill does not exclude from the minimum benefits 
package services that are not rated A and B, i.e., we 
understand that the task force recommendations are a floor, not 
a ceiling. But out bottom line is that women in the 40 to 49 
age group may after consulting with their doctor choose to 
forego a mammogram but those who do choose to have one must 
have access to it on the same terms as women age 50 and older. 
The Komen Advocacy Alliance is pleased that H.R. 3962 includes 
patient representatives as advisors to the task force on 
clinical preventive services. We believe that patient advocates 
can help to develop and deliver effective messages about 
prevention and screening.
    We hope that these past few weeks of confusion will 
ultimately result in women taking more interest in their breast 
health, that many more underserved women will be screened and 
that an intensive effort to make breakthroughs in screening 
technology will begin anew. Thank you, Mr. Chairman.
    [The prepared statement of Ms. Luray follows:]


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    Mr. Pallone. Thank you.
    Dr. Sweet.

                    STATEMENT OF DONNA SWEET

    Dr. Sweet. Good afternoon, and thank you, Chairman, for 
this opportunity. I am Donna Sweet, a general internist, and I 
am pleased to present the testimony of the American College of 
Physicians. I am a member of the ACP's clinical efficacy 
assessment subcommittee, which oversees the development of 
ACP's evidence-based guidelines, and I provide also 
comprehensive medical care to hundreds of patients in the State 
of Kansas.
    Because ACP does not comment on the guidelines issued by 
other organizations, I am unable to express an ACP opinion of 
the task force recommendations but I can speak to the College's 
own guideline on screening mammography in women between ages 40 
to 49 years which was published actually in 2007. We recommend 
that clinicians should perform individualized assessment of 
risk for breast cancer to help guide decisions about screening 
mammography, inform women about the potential benefits and 
harms of mammography, and base screening mammography decisions 
on benefits and harms of screening as well as a women's 
preferences and her own breast cancer risk profile. The purpose 
of ACP's clinical guidelines is to facilitate an informed and 
educated discussion between the patient and her trusted 
clinician so that together they can decide on a personalized 
plan of screening, diagnosis and treatment.
    Not all women between 40 and 49 have the same risk for 
breast cancer. Factors that increase the risk include older 
age, family history of breast cancer, older age at the time of 
first birth, younger age at menarche, and history of breast 
biopsy. In my own practice I use ACP's guidelines to engage my 
female patients in a discussion. I explain that mammography, 
although a potentially valuable tool to screen for breast 
cancer, is an imperfect one. For some patients, I will detect 
cancer at a more treatable stage. It can also lead to false 
positives, which can lead to biopsies, scarring and potential 
infection. It can lead to false negatives, that is, mammography 
does miss cancers. It may result in aggressive treatment of 
cancers that may never have become life threatening.
    Just in the past 3 days, I have had three different 
patients coming to see me who have been extremely confused over 
this whole issue. I was able to speak to each woman's risk 
profile and discuss with them the benefits and possible harms 
of getting a mammogram. One was a 66-year-old patient enrolled 
in Medicare who had come in for her routine visit for 
hypertension and clearly misunderstood most of the debate. She 
has a history of a sister with breast cancer. We have been 
doing yearly mammograms, and she was worried that I was not 
going to let her get a yearly mammogram because of these new 
recommendations. Another 71-year-old came in and she wanted to 
get her mammogram, which was scheduled in February, before 
January 1st--why she picked that date, I don't know--because 
she believed that the government would soon stop her from being 
able to get a mammogram and she didn't want that to happen. I 
was able to reassure her that I did not think mammograms would 
be rationed. The third, however, was a very good discussion, a 
46-year-old women whose mother had breast cancer. She wanted to 
discuss her own risk and actually was wondering if she had to 
have yearly mammograms. I was able to communicate to each of 
them that in them they did need yearly mammograms, that we did 
not do things from a cookie cutter. Women should not be treated 
all alike. And in all three cases, as I said, they did and will 
get their yearly mammograms but based on their individual risk 
factors and a discussion of why.
    The controversy over the breast cancer screening guidelines 
gives physicians the opportunity to educate their patients on 
the importance of evidence-based guidelines to help them make 
the best choice for them. It also has important lessons for 
policymakers. One is that the public is ill served when 
assessments of clinical effectiveness are politicized. The U.S. 
Preventive Services Task Force is a highly regarded, credible 
and independent group of experts. Differences of opinion on the 
task force recommendations should be openly discussed but it is 
not constructive to undermine public confidence by making ill-
founded attacks on the integrity, credibility, motivations and 
expertise of the clinicians and scientists on the task force. 
Such politicization if left unchallenged could result in future 
assessments being influenced by political or stakeholder 
interest instead of by science.
    Second, the ACP is concerned that the public is misled by 
some into believing that cost was behind the task force 
recommendations. According to ARC, the task force does not 
consider economic costs in making recommendations.
    Third, the public needs to understand that when health 
plans make decisions on covered benefits, they consider many 
different issues of which the evidence-based guidelines are 
just one. Under the bill passed by the House, health plans 
generally will be required to cover preventive measures for 
which a new constituted task force on clinical preventive 
services have given an A or a B. No limits are placed, though, 
on health plans' ability to provide benefits for other 
preventive services and to consult with other sources in making 
such determinations. Rather than limiting access to prevention, 
my patients will benefit from having a floor, not a limit on 
preventive services all health insurers will be required to 
cover usually with no out-of-pocket cost to them. And perhaps 
even more importantly as has been said here today many times, 
millions of women who have no access to health insurance will 
now have coverage and the ability to actually get screening 
mammograms.
    Fourth, we need to communicate information to the public in 
a way that facilitates an understanding of how evidence-based 
effectiveness reviews support, not supplant, individual 
decision making by patients and their clinicians. They should 
be informed that they have the right to know about the current 
best evidence on the benefits and risks of different treatments 
and interventions. My patients have the right to know that 
physicians will offer intervention shown to positively impact 
health and patient outcomes and they have a right to know that 
we will not recommend intervention shown not to provide any 
benefit and possibly cause harm. Patients have the right to be 
treated as individuals with their own unique values and 
personal risk characteristics instead of being asked to follow 
one-size-fits-all treatment protocols. And they have to know 
that the evidence comes from respected, independent and 
credible clinicians and other scientists protected from 
political and other stakeholder pressure.
    I thank you for this opportunity.
    [The prepared statement of Dr. Sweet follows:]


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    Mr. Pallone. Thank you, Doctor.
    Ms. Visco.

                    STATEMENT OF FRAN VISCO

    Ms. Visco. Thank you. I am Fran Visco, president of the 
National Breast Cancer Coalition and a 22-year breast cancer 
survivor.
    As you know, NBCC is a coalition of hundreds of groups from 
around the country dedicated to our mission to end breast 
cancer. One of our roles is to train advocates to understand 
the process, concepts and language of scientific research. We 
analyze scientific information for our members and the public 
from the perspective of lay advocates.
    Our number one priority for many years has been 
guaranteeing access to quality health care to everyone. We 
believe we cannot achieve our mission without it. We have been 
working with Congress and the Administration on this goal based 
on our framework for access to quality health care developed 
over a number of years of hard work by our grass roots 
leadership and a key component of that framework is making 
certain that trained consumers have a seat at every table where 
decisions are made on health care policy.
    We believe in evidence-based approaches to health care as a 
key to quality care. So what is the evidence behind mammography 
screening? As we are all well aware and as many people have 
said, mammography has significant limitations and there has 
been much controversy over the years about screening programs: 
at what age are they effective, how do we balance risk and 
benefits, how can we communicate the very real limitations of 
screening and the harms associated with it. In 1997, an NIH 
consensus conference recommended against routine screening of 
women under the age of 50, but political and outside 
organizational pushback, not evidence, torpedoed that 
recommendation. So in fact, we have known the issues with 
screening for decades.
    We also know that 40,000 women will die of breast cancer 
this year. Tens of millions of people in this country are 
uninsured. Many, many millions lack access to quality care. We 
know we have a great deal of work to do to fix this situation. 
We know that breast cancer is a complex disease, that while we 
have learned more about the biology of the disease, in the 4 
decades since mammography screening programs have been 
instituted, we have not yet learned how to detect life-
threatening breast cancer at a point where we can make a 
difference how to cure it for every woman, how to prevent it.
    Given all of this, we were frankly stunned at the reaction 
of the media and many in the cancer community and in government 
to the task force recommendations. The task force is a body of 
the right experts who looked carefully at updated evidence and 
objectively made recommendations not that different from their 
prior recommendations. Given all of this, the amount of time 
and attention given to these revised recommendations seems just 
a bit unseemly.
    The public has increasingly put their faith in screening 
and early detection, even though we have never had good 
evidence that this would have a significant impact, but too 
many did not want to highlight the known limitations of 
mammography. They wanted simple messages: once a year for a 
lifetime, early detection saves lives. The overemphasis on the 
importance of screening caused some people to state over and 
over again that mammograms prevent breast cancer, and please, 
let us be very clear, mammograms do not prevent breast cancer.
    We had hoped that the task force recommendations would 
cause all of us to stop and think about screening, take the 
time to look carefully at the evidence and put screening and 
its limitations into proper perspective, and that can still 
happen. It is important also to put this in the context of a 
population where screening programs are for a healthy 
population for the millions and millions of women, the vast 
majority of whom will never get breast cancer. The question 
then is how we devise a screening program that appropriately 
balances risks and benefits for these healthy women.
    So what did the task force actually say? To women in their 
40s, they said there are benefits and harms from mammography 
screening that you should know about and you should make an 
individual decision at what age you will begin a screening 
program. So the task force actually recommends giving women 
control over their own health care decisions. On self-
examination, Dr. Brawley pointed out that the self-examination 
touched on by the task force was that routine, regimented 
monthly search for cancer. It has been represented as saying 
that women shouldn't know their bodies. Of course they should. 
This isn't about that.
    Some are concerned that the new guidelines will prevent 
underserved women from entering the medical system at all, and 
we would counter that the solution to that is to enact 
universal access to health care for all, not to depend on a 
faulty test that exposes women to radiation and the risks of 
false positives in order to get them to a doctor. Disadvantaged 
women deserve the same access as all other women to quality 
evidence-based care and the right information. We do need to 
move forward because none of this is good enough for women.
    We can use this and we should have used this as an 
opportunity to educate the public about science, about 
evidence-based care to help alleviate the unwarranted fear, not 
to feed it. Some argue that public health messages need to be 
simple and changing guidelines will confuse women. We would 
argue that while messages need to be simple, they need to be 
truthful. Women deserve the facts.
    We have all heard from women over the past month who are 
outraged and who believe that a mammogram saved their life. 
These anecdotes are not evidence. They may be compelling sound 
bites, great media stories but they are not evidence on which 
we should base this Nation's public health agenda. That should 
be based on the type of scientific work done by the task force. 
We can't believe in science only when we like the answers it 
produces.
    I want to end with an anecdote. Carolina Hinestrosa was the 
executive vice president of the National Breast Cancer 
Coalition, and her breast cancer was detected early in her late 
30s, probably was not life threatening and she had treatment. 
She died this past June as a result of her treatment. Her story 
and all of the anecdotes just tell us how little we know about 
breast cancer, how we need to be so very careful about evidence 
and push for the right answers no matter how unhappy we are 
with what those answers are. Let us save our outrage for the 
reality that we know too little and women deserve so much more. 
Thank you.
    [The prepared statement of Ms. Visco follows:]


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    Mr. Pallone. Thank you, and we will try to get this done 
before the votes. I don't know if that is possible. I will 
start with myself.
    You know, I really want to apologize to you maybe on behalf 
of Congress, if I could that, because I was listening to what 
Dr. Sweet said, and you are absolutely right, that this has 
been totally politicized and I guess, you know, the problem is 
that Congress is political and maybe this isn't the vehicle for 
it. I mean, it is sort of interesting to see that in the first 
panel most of the members were here and most of the media were 
here and now we are on the second panel, which is not the 
political panel, and the situation is reversed, you know. And 
Ms. Visco talked about how essentially--and I don't want to put 
words in your mouth but, you know, after listening today, I 
can't help but say I am not sure there really was that much of 
a difference between what the task force said now versus what 
the recommendation was a few years ago or even between what you 
are saying and the previous panel said. It is just amazing how 
these differences, if there are any, have been exaggerated and 
politicized. I guess that is just the nature of the process 
around here so I don't know what we can do about it or make it 
any different, and I say that out of sadness, really.
    Let me ask you just a couple questions because I know the 
time is running out here. I will start with Dr. Brawley and 
also Ms. Luray. A few days after the task force 
recommendations, the Cancer Society issued a statement urging 
that health care reform create a transparent and evidence-based 
process for making task force recommendations, and I guess 
Komen echoed those concerns. But your statement, Dr. Brawley, 
listed a number of changes you would like to see in health 
reform and you discussed the importance of transparency and the 
task force's process of arriving at its recommendations. Now, I 
believe that the bill H.R. 3962 actually addresses those 
concerns, so I wanted you to really, you know, answer that. I 
mean, the importance of stakeholder input and those 
recommendations you made about that, does the bill H.R. 3962 
address those concerns?
    Dr. Brawley. Well, sir, I believe that it does. I think the 
most important thing is that the task force continue to provide 
objective evidence but also provide the objective evidence in 
an open arena where people can actually see the process.
    Mr. Pallone. And then Ms. Luray, from Komen's perspective, 
do you agree that the provisions in H.R. 3962 would improve the 
task force recommendations process? I mean, you don't have to 
just say yes or no, but go ahead.
    Ms. Luray. Sir, actually yes. I mean, H.R. 3962 has a 
stakeholder panel that would advise the new clinical services 
task force and we think that makes a lot of sense. Such a panel 
I think could have helped to really communicate the findings of 
this task force, and even though people might not--there still 
may have been disagreement within the scientific community, I 
think the message could have been delivered in a way that was 
much more helpful to women and their providers.
    Mr. Pallone. I was just trying to make the point really 
that the issues that the American Cancer Society and Komen 
raised months ago well before these task force recommendations 
emerged, you know, that we felt on the House side we were 
listening to, and I am trying to point out that as a result of 
your efforts and this collaboration that the bill contains the 
changes to the task force necessary to improve the process. 
That was my only point.
    And then the second one, and I am going to ask all of you 
this quickly, and that is, as you know, my colleagues on the 
Republican side have repeatedly raised concerns about the 
House-passed health reform bill in light of the task force 
recommendations, and they have repeatedly asserted that H.R. 
3962 somehow--well, I don't want to put words in their mouth 
but I think there is a suggestion that somehow the bill, you 
know, is a step backward on the issue of breast cancer or 
breast cancer screening, so I just want to ask each of you on 
the whole, do you think the House-passed health reform bill, 
H.R. 3962, is actually more helpful, is a step forward or a 
step backward with regard to women with breast cancer and these 
screening issues? And I will just ask each of you to comment on 
that briefly.
    Dr. Brawley. Mr. Chairman, if I can just say there are 
thousands of American women who die today because of lack of 
access. There are thousands of women who die today because they 
are detected early but they don't have insurance to get access 
to reasonable and good care. Any effort that gets those people 
reasonable and good care is a good effort that is going to save 
lives. We have been talking about the number of lives that 
would be lost due to this recommendation of, maybe it was a 
recommendation not to get screened for women in their 40s, 
maybe it wasn't, but the number of lives that we could just 
fix, that we could just save through a logistical fix is 
tremendous. Just get them access to care.
    Mr. Pallone. Ms. Luray.
    Ms. Luray. I would add in addition to the universal access 
that Dr. Brawley mentioned, also the limitations on preexisting 
conditions and out-of-pocket costs are currently a huge burden 
for breast cancer patients and one of the main items that our 
advocacy community throughout the country asks that we followed 
very closely in health care reform, and those protections are 
included in H.R. 3962.
    Mr. Pallone. Thank you.
    Dr. Sweet.
    Dr. Sweet. Absolutely. This bill will help the health of 
American women with and without breast cancer. There are a 
number who do manage to get diagnosed and then have no access 
to reasonable care, as Dr. Brawley said. The number of women 
even in my own practice that are locked into jobs that they 
would rather not stay in, they can't move because of lack of 
health insurability. They know if they leave their job and 
leave that health insurance, when they try to get the next one 
they are going to be uninsurable, and I think the fact that 
this bill addresses getting rid of preexisting conditions and 
guaranteeing health insurance to all at a reasonable cost is 
extremely important.
    And then the third thing is, the bill does address some of 
the health care workforce issues. Access means having a trusted 
clinician, as the woman from Florida said, and there are not 
enough of the primary care people out there anymore to be 
trusted clinicians for all the people we are going to give 
access to, and your bill does put in provisions to have an 
improved, I think, primary care workforce by improving payment 
and other things. So I think this bill is an absolute 
improvement. The millions of lives that we lose because of true 
lack of health insurance is much, much greater than what we are 
going to lose by a few women who decide not to have screening 
once they think about it.
    Mr. Pallone. Thank you.
    Ms. Visco.
    Ms. Visco. Well, as you know, Mr. Chairman, the National 
Breast Cancer Coalition has endorsed the House bill and we 
completely support it. We believe it is an incredibly important 
tool in eradicating breast cancer. We think it will move us 
forward tremendously in getting everyone access to health care 
and helping save lives from breast cancer, and I hope that this 
controversy does not cause the Congress to interfere in any way 
with the independence and objectivity of the task force. We 
cannot allow that to happen. We need evidence-based quality 
care. And I also truly wanted to ask the question that if the 
bill was changed to mandate C-level recommendations in a basic 
benefit package if everyone who spoke to that issue today would 
then support the bill. I tend to doubt that. So I really think 
that if we want to save lives, if we want to move forward, if 
we want to end breast cancer, we need guaranteed access to 
health care reform and the House bill is very important to 
achieving that end.
    Mr. Pallone. Thank you.
    Let me mention, I was under the impression we had votes. In 
fact, we are in recess on the Floor so there is actually not 
any real time constraints here.
    Chairman Dingell.
    Mr. Dingell. I want to thank the panel and congratulate 
them for their very fine presentation. I am going to begin by 
reading something which appeared, and you will recognize this, 
in the statement of Dr. Sweet. ``Under Affordable Health Care 
for America Act, H.R. 3962, passed by the House of 
Representatives, a new task force on clinical preventive 
services would be created which would take on many of the 
responsibilities of the current U.S. Preventive Services Task 
Force. This new entity will have an important role in making 
evidence-based recognitions on preventive services that 
insurers would be required to cover but the only binding effect 
the recommendations of the task force will have on health plans 
is a requirement that preventive measures for which the task 
force has been given an A or B rating must be covered. The bill 
does not give the task force and the federal government itself 
any authority to put limits on coverage, ration care or require 
that insurers deny coverage. Health plans could offer 
additional preventive and other benefits of their choosing and 
no restrictions would be placed on their ability to consider 
recommendations from sources other than the task force in 
making such coverage recommendations. And now, if you please, 
starting with you, Dr. Brawley, do you agree with that 
statement?
    Dr. Brawley. Well, sir, I am not a policy person, I am just 
a simple doctor.
    Mr. Dingell. Well, just yes or no.
    Dr. Brawley. But I do agree with your statement.
    Mr. Dingell. Thank you. I am not trying to lay traps here. 
I want that clear.
    Ms. Luray.
    Ms. Luray. Yes, Congressman. As I said in my testimony, we 
also see the role of the task force as creating more of a floor 
than a ceiling, so in that sense, I would agree with you.
    Mr. Dingell. Obviously, Dr. Sweet, you agree.
    Mr. Sweet. Yes, I do, and I have some very good policy 
people behind me that agree. That is important too.
    Mr. Dingell. I am just trying to lay to rest some of the 
nasty untruths that are being circulated about this 
legislation.
    Ms. Visco.
    Ms. Visco. Yes, I agree.
    Mr. Dingell. Now, each of your organizations has supported 
the legislation, H.R. 3962. Do you have any apprehension that 
the provisions that we are discussing today or any other part 
of this legislation will trigger a nasty program of rationing 
health care?
    Dr. Brawley. No, sir.
    Mr. Dingell. Ma'am?
    Ms. Luray. No, sir.
    Dr. Sweet. No.
    Mr. Dingell. Ms. Visco?
    Ms. Visco. No.
    Mr. Dingell. Mr. Chair, I guess that is all the questions I 
have got. I think we have laid to rest some of the unfortunate 
misapprehensions of our colleagues and I can only express my 
great regret that they are not here to participate and to learn 
from the wisdom of our witnesses. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, Chairman Dingell.
    Mr. Green.
    Mr. Green. Thank you, Mr. Chairman. I apologize for being 
in and out but we have both Secretary Gates, Secretary Clinton 
and the Joint Chiefs of Staff and the Foreign Affairs Committee 
talking about Afghanistan, although this is such an important 
issue for the district I represent.
    I represent a majority Hispanic district that is also a 
federally medically underserved area, and we face many, many 
issues to encourage women to see primary and preventive care 
services. We rely on our Harris County Hospital District and 
our community-based health clinics to provide the services and 
screening for our constituents. I worry that the revised 
recommendations will discourage the safety-net providers from 
aggressively educating and screening for breast cancer in these 
underserved populations. I often say we have one of the premier 
medical centers in the world including M.D. Anderson Cancer 
Center located in our backyard but my constituents can see the 
medical center, it is just hard for them to get there because 
they are substantially uninsured. And unfortunately, most do 
not have the access to the medical services. Could you briefly 
speak about the current access barriers for breast cancer 
screening minority in those residing in medically underserved 
districts face and what impact these recommendations may have 
on these populations? Dr. Brawley?
    Dr. Brawley. Well, Congressman, I hope the recommendations 
of the task force will have very little effect on your 
constituents with the exception that perhaps the discussions 
that we have in the news over the last few weeks will bring 
breast cancer much more to the forefront. I have some hope. I 
said in my testimony about half of all women in their 40s and 
50s who are diagnosed with breast cancer are actually diagnosed 
not through a traditional breast self-exam but through what we 
prefer to call breast awareness; they notice when they're 
getting dressed or when they in the shower, that sort of thing. 
Perhaps people will hear this national conversation we have had 
and actually be a little bit freer to come forth and get 
evaluated by a doctor should they find an abnormality. I also 
hope that people will continue listening to the other 
organizations like the American Cancer Society that have said 
that women age 40 and above should continue getting mammography 
on an annual basis but also I think it is important to realize 
that there is controversy about how good mammography is. And I 
will just leave you with one last statement. Mammography is 
imperfect but right now it is the best technical tool that we 
have other than awareness for early detection.
    Mr. Green. Mammography is much more valid than the PSA test 
is for males.
    Dr. Brawley. Oh, yes, absolutely. You are absolutely 
correct. There are nine studies in the literature that show 
that mammography saves lives. There are two randomized trials 
on PSA, one that shows it saves lives and another that fails to 
confirm that first finding.
    Mr. Green. Ms. Luray.
    Ms. Luray. Congressman, I would like to comment on that as 
well. As you know, we partner closely with the CDC and other 
providers to support free clinics and mobile vans in districts 
such as yours, and so we are very familiar with the kinds of 
constituents you have and really a very fragile relationship 
they have with the health care system, many of whom are 
uninsured, and so we have been working very hard in these last 
few weeks to make sure that the hullabaloo around the release 
of these recommendations doesn't cause women who really already 
have that fragile relationship who may just be coming into 
mammography clinics for the first time in their lives to say 
well, gee, maybe I don't need to come at all. So we are working 
very hard to ensure that that message doesn't get twisted 
around and be taken as a sign that mammography can't provide 
help to them.
    Dr. Sweet. And I would hope as a clinician doing this, just 
as in my practice, women will come in talking about it. There 
is nothing more likely to get a patient to bring something up 
than to see it on CNN or in the controversial position and 
maybe it will sort of nudge many of our clinicians who perhaps 
haven't taken the time to have that discussion to actually make 
it an individualized, personalized discussion with that woman 
about what she needs along with the fact, as we said earlier, 
that many, many of those women if health care reform can occur 
and we do have access to health insurance for the poor and the 
people who need it the most, we will be able to offer screening 
to some of these women in a clinical situation that have never 
had that available. So I truly see this as a critical time, and 
the hullabaloo, it is a political sort of system and there is a 
lot of things out there that just aren't true, I think, but it 
does bring women to discuss it, and once they bring it up, then 
the doctor, the clinician has to follow through.
    Mr. Green. Thank you.
    Ms. Visco.
    Ms. Visco. Yes, we are working very, very hard on making 
certain that everyone in this country has guaranteed access to 
quality health care, and that will certainly solve the problem. 
We are spending the majority of our resources on that issue. 
There are also a number of studies out there looking at what 
are the barriers to access for underserved population, why do 
they not access the health care system, and of course, one of 
the reasons is, because they don't have coverage for treatment. 
That is why the National Breast Cancer Coalition a number of 
years ago worked very hard to get enacted into law the CDC 
Breast and Cervical Cancer Treatment Act we knew that screening 
even if you do get a mammogram, you have to have access to 
treatment if you want to save a life. And so that is our number 
one concern and that is where we focus most of our work.
    Mr. Green. Thank you, Mr. Chairman. I know I am out of 
time. My concern about the furor over this is that women will 
make that decision not to, and again, early detection is still 
the answer, and particularly in underserved communities. Thank 
you, Mr. Chairman.
    Mr. Pallone. Thank you, and I think that concludes our 
questions. I just want to thank all of you again. Once again, I 
said to the previous panel, you certainly cleared up a lot of 
the misconceptions. I just hope we can get that message out to 
the media, which is often difficult.
    Some of the members may submit written questions, and we 
try to get those to you within the next 10 days, so you might 
get some additional questions. Of course, the clerk would 
notify you of that and the time period to get back to us. But I 
do want to thank you again.
    Without objection, this meeting of the subcommittee is 
adjourned. Thanks.
    [Whereupon, at 3:05 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]


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