[Congressional Record Volume 144, Number 122 (Tuesday, September 15, 1998)]
[House]
[Pages H7745-H7750]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




       MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT OF 1998

  Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 4382) to amend the Public Health Service Act to revise and 
extend the program for mammography quality standards, as amended.
  The Clerk read as follows:

                               H.R. 4382

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Mammography Quality 
     Standards Reauthorization Act of 1998''.

     SEC. 2. AUTHORIZATION OF APPROPRIATIONS.

       (a) In General.--Section 354(r)(2) of the Public Health 
     Service Act (42 U.S.C. 263b(r)(2)) is amended in each of 
     subparagraphs (A) and (B) by striking ``1997'' and inserting 
     ``2002''.
       (b) Technical Amendments.--Section 354(r)(2) of the Public 
     Health Service Act (42 U.S.C. 263b(r)(2)) is amended in 
     subparagraph (A) by striking ``subsection (q)'' and inserting 
     ``subsection (p)'', and in subparagraph (B) by striking 
     ``fiscal year'' and inserting ``fiscal years''.

     SEC. 3. APPLICATION OF CURRENT VERSION OF APPEAL REGULATIONS.

       Section 354(d)(2)(B) of the Public Health Service Act (42 
     U.S.C. 263b(d)(2)(B)) is amended by striking ``42 C.F.R. 498 
     and in effect on the date of the enactment of this section'' 
     and inserting ``part 498 of title 42, Code of Federal 
     Regulations''.

     SEC. 4. ACCREDITATION STANDARDS.

       (a) In General.--Section 354(e)(1)(B) of the Public Health 
     Service Act (42 U.S.C. 263b(e)(1)(B)) is amended--
       (1) in clause (i), by striking ``practicing physicians'' 
     each place such term appears and inserting ``review 
     physicians''; and
       (2) in clause (ii), by striking ``financial relationship'' 
     and inserting ``relationship''.
       (b) Definition.--Section 354(a) of the Public Health 
     Service Act (42 U.S.C. 263b(a)) is amended by adding at the 
     end the following:
       ``(8) Review physician.--The term `review physician' means 
     a physician as prescribed by the Secretary under subsection 
     (f)(1)(D) who meets such additional requirements as may be 
     established by an accreditation body under subsection (e) and 
     approved by the Secretary to review clinical images under 
     subsection (e)(1)(B)(i) on behalf of the accreditation 
     body.''.

     SEC. 5. CLARIFICATION OF FACILITIES' RESPONSIBILITY TO RETAIN 
                   MAMMOGRAM RECORDS.

       Section 354(f)(1)(G) of the Public Health Service Act (42 
     U.S.C. 263b(f)(1)(G)) is amended by striking clause (i) and 
     inserting the following:
       ``(i) a facility that performs any mammogram--

       ``(I) except as provided in subclause (II), maintain the 
     mammogram in the permanent medical records of the patient for 
     a period of not less than 5 years, or not less than 10 years 
     if no subsequent mammograms of such patient are performed at 
     the facility, or longer if mandated by State law; and
       ``(II) upon the request of or on behalf of the patient, 
     transfer the mammogram to a medical institution, to a 
     physician of the patient, or to the patient directly; and''.

     SEC. 6. DIRECT REPORTS TO PATIENTS.

       Section 354(f)(1)(G)(ii) of the Public Health Service Act 
     (42 U.S.C. 263b(f)(1)(G)(ii)) is amended by striking 
     subclause (IV) and inserting the following:
       ``(IV) whether or not such a physician is available or 
     there is no such physician, a summary of the written report 
     shall be sent directly to the patient in terms easily 
     understood by a lay person; and''.

     SEC. 7. SCOPE OF INSPECTIONS.

       Section 354(g)(1)(A) of the Public Health Service Act (42 
     U.S.C. 263b(g)(1)(A)) is amended in the first sentence--
       (1) by striking ``certified''; and
       (2) by inserting ``the certification requirements under 
     subsection (b) and'' after ``compliance with''.

     SEC. 8. DEMONSTRATION PROGRAM REGARDING FREQUENCY OF 
                   INSPECTIONS.

       Section 354(g) of the Public Health Service Act (42 U.S.C. 
     263b(g)) is amended--
       (1) in paragraph (1)(E), by inserting ``, subject to 
     paragraph (6)'' before the period; and
       (2) by adding at the end the following paragraph:
       ``(6) Demonstration program.--
       ``(A) In general.--The Secretary may establish a 
     demonstration program under which inspections under paragraph 
     (1) of selected facilities are conducted less frequently by 
     the Secretary (or as applicable, by State or local agencies 
     acting on behalf of the Secretary) than the interval 
     specified in subparagraph (E) of such paragraph.
       ``(B) Requirements.--Any demonstration program under 
     subparagraph (A) shall be carried out in accordance with the 
     following:
       ``(i) The program may not be implemented before April 1, 
     2001. Preparations for the program may be carried out prior 
     to such date.
       ``(ii) In carrying out the program, the Secretary may not 
     select a facility for inclusion in the program unless the 
     facility is substantially free of incidents of noncompliance 
     with the standards under subsection (f). The Secretary may at 
     any time provide that a facility will no longer be included 
     in the program.
       ``(iii) The number of facilities selected for inclusion in 
     the program shall be sufficient to provide a statistically 
     significant sample, subject to compliance with clause (ii).
       ``(iv) Facilities that are selected for inclusion in the 
     program shall be inspected at such intervals as the Secretary 
     determines will reasonably ensure that the facilities are 
     maintaining compliance with such standards.''.

[[Page H7746]]

     SEC. 9. CLARIFICATION OF AUTHORITY TO DELEGATE INSPECTION 
                   RESPONSIBILITY TO LOCAL GOVERNMENT AGENCIES.

       Section 354 of the Public Health Service Act (42 U.S.C. 
     263b) is amended--
       (1) in subsections (a)(4), (g)(1), (g)(3), and (g)(4), by 
     inserting ``or local'' after ``State'' each place such term 
     appears;
       (2) in the heading of subsection (g)(3), by inserting ``or 
     local'' after ``state''; and
       (3) in subsection (i)(1)(D)--
       (A) by inserting ``or local'' after ``State'' the first 
     place such term appears; and
       (B) by inserting ``or local agency'' after ``State'' the 
     second place such term appears.

     SEC. 10. PATIENT NOTIFICATION CONCERNING HEALTH RISKS.

       (a) Requirement.--Section 354(h) of the Public Health 
     Service Act (42 U.S.C. 263b(h)) is amended--
       (1) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively; and
       (2) by inserting after paragraph (1) the following:
       ``(2) Patient information.--If the Secretary determines 
     that the quality of mammography performed by a facility 
     (whether or not certified pursuant to subsection (c)) was so 
     inconsistent with the quality standards established pursuant 
     to subsection (f) as to present a significant risk to 
     individual or public health, the Secretary may require such 
     facility to notify patients who received mammograms at such 
     facility, and their referring physicians, of the deficiencies 
     presenting such risk, the potential harm resulting, 
     appropriate remedial measures, and such other relevant 
     information as the Secretary may require.''.
       (b) Civil Money Penalty.--Section 354(h)(3) of the Public 
     Health Service Act (42 U.S.C. 263b(h)(3)), as redesignated by 
     subsection (a)(1), is amended--
       (1) by striking ``and'' at the end of subparagraph (B);
       (2) by redesignating subparagraph (C) as subparagraph (D); 
     and
       (3) by inserting after subparagraph (B) the following:
       ``(C) each failure to notify a patient of risk as required 
     by the Secretary pursuant to paragraph (2), and''.
       (c) Conforming Amendment.--Section 354(h)(4) of the Public 
     Health Service Act (42 U.S.C. 263b(h)(4)), as redesignated by 
     subsection (a)(1), is amended by striking ``paragraphs (1) 
     and (2)'' and inserting ``paragraphs (1) through (3)''.

     SEC. 11. REQUIREMENT TO COMPLY WITH INFORMATION REQUESTS.

       Section 354(i)(1)(C) of the Public Health Service Act (42 
     U.S.C. 263b(i)(1)(C)) is amended--
       (1) by inserting after ``Secretary'' the first place such 
     term appears the following: ``(or of an accreditation body 
     approved pursuant to subsection (e))''; and
       (2) by inserting after ``Secretary'' the second place such 
     term appears the following: ``(or such accreditation body or 
     State carrying out certification program requirements 
     pursuant to subsection (q))''.

     SEC. 12. ADJUSTMENT TO SEVERITY OF SANCTIONS.

       Section 354(i)(2)(A) of the Public Health Service Act (42 
     U.S.C. 263b(i)(2)(A)) is amended by striking ``makes the 
     finding'' and all that follows and inserting the following: 
     ``has reason to believe that the circumstance of the case 
     will support one or more of the findings described in 
     paragraph (1) and that--
       ``(i) the failure or violation was intentional; or
       ``(ii) the failure or violation presents a serious risk to 
     human health.''.

     SEC. 13. TECHNICAL AMENDMENT.

       Section 354(q)(4)(B) of the Public Health Service Act (42 
     U.S.C. 263b(q)(4)(B)) is amended by striking ``accredited'' 
     and inserting ``certified''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Florida (Mr. Bilirakis) and the gentleman from Ohio (Mr. Brown) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Florida (Mr. Bilirakis).


                             General Leave

  Mr. BILIRAKIS. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days within which to revise and extend their 
remarks and include extraneous material on this legislation.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Florida?
  There was no objection.
  Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, without question the Mammography Quality Standards Act 
of 1992 has been an overwhelming success. In May my Subcommittee on 
Health and Environment heard extensive testimony regarding the Act from 
program experts and patient groups. Officials from the General 
Accounting Office reported that the Act has increased mammography 
facilities' adherence to acceptable quality assurance standards, thus 
improving mammography services. Before it took effect, 11 percent of 
facilities tested were unable to pass image quality tests, and now the 
nationwide figure is 2 percent.
  Screening mammography is currently the most effective technique for 
early detection of breast cancer. This procedure can identify small 
tumors and breast abnormalities up to two years before they can be 
detected by touch. More than 90 percent of these early stage cancers 
can be cured, according to the Food and Drug Administration.
  Today, the House is considering legislation to reauthorize this most 
important act. Last November, the Senate passed its own reauthorization 
bill by unanimous consent, without discussion or amendment. During the 
course of my subcommittee's hearing in May, however, we learned that 
some important issues were not addressed in the Senate bill.
  The measure before us, the Mammography Quality Standards 
Reauthorization Act of 1998, includes language approved by the full 
Committee on Commerce to address these concerns.
  H.R. 4382 differs in two major respects from the Senate-passed bill. 
First, it provides for direct patient notification of all mammography 
examinations, in language that is easy for patients to understand. 
Second, it permits the Food and Drug Administration to conduct a 
demonstration project to address the feasibility of inspecting high 
quality mammography facilities at less than annual intervals.
  The need, Mr. Speaker, for this legislation is clear. Breast cancer 
is the most commonly diagnosed nonskin cancer and the second leading 
cause of cancer deaths among women. Tragically, experts predict that 
during this decade alone, as many as 1.8 million women will be 
diagnosed with breast cancer, and 500,000 will die from it.
  There is a ray of hope, however, in the use of mammography for early 
detection of breast cancer. The probability of survival and the 
avoidance of mastectomy increases significantly when the disease is 
discovered in its early stages.
  Today, the House, Mr. Speaker, can continue to ensure safe and 
accurate mammography services for women by approving this important 
bipartisan legislation. I join the gentleman from Virginia (Mr. Bliley) 
full committee chairman, the gentleman from Michigan (Mr. Dingell) 
ranking member, and the gentleman from Ohio (Mr. Brown) ranking member 
of the subcommittee in urging Members' support for passage of the 
Mammography Quality Standards Reauthorization Act.
  Mr. Speaker, I reserve the balance of my time.

                              {time}  1500

  Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise today in support of H.R. 4382, the Mammography 
Quality Standards Reauthorization Act of 1998. Breast cancer is the 
second leading cause of cancer deaths in American women. According to 
the Department of Health and Human Services the incidence of breast 
cancer has increased by approximately 1 percent per year since the 
early 1970's. HHS estimates that 44,000 women died from breast cancer 
last year, more than 180,000 new cases of breast cancer were diagnosed. 
According to the same HHS report nearly half a million women will die 
from breast cancer in the 1990's, more than a million and a half new 
cases will be diagnosed during this same period of time. They are our 
mothers, our spouses, our sisters, our daughters and our friends.
  In 1994 I founded in response to breast cancer rates and incidence 
being much higher in northeast Ohio than in many other parts of the 
Nation, I founded the Northeast Ohio Breast Cancer Task Force to 
increase awareness of the value of early detection of breast cancer. 
Over and over the task force members have stressed the value of 
mammographies in this process.
  Mammography is considered to be the most effective method for early 
detection of breast cancer. In women over 50 the detection rate can 
exceed 90 percent resulting in a decrease in breast cancer deaths among 
women as much as 30 percent. The Mammography Quality Standards Act was 
first enacted 6 years ago to ensure that the mammographies performed at 
approximately 10,000 facilities throughout the United States are safe 
and reliable.
  The GAO stated that the MQSA increased the quality of mammography 
services while not decreasing access to them. The key to MQSA is its 
system of annual inspections of mammography

[[Page H7747]]

facilities by FDA-approved accreditation bodies. These comprehensive 
examinations and mammography facility equipment and personnel assure 
the mammographies are of the highest quality. These inspections are 
funded by using a user fee, so our action is both timely and necessary 
to the smooth continuation of this important and successful program.
  The bill before us today makes some changes and, I believe, 
improvements in the existing statute.
  First, H.R. 4382 contains a provision requiring direct patient 
notification of the results of mammography test results. Under the 
current program patients who are self-referred, meaning they were not 
referred to the mammography facility by a physician, are already 
notified of the test results directly by the facility. Our hearing 
earlier this year in the subcommittee of the gentleman from Florida 
(Mr. Bilirakis) showed that some facilities voluntarily directly notify 
their patients in addition to notifying the referring physician to 
ensure the patient receives the test results in a timely manner.
  This bill is a common sense extension of direct patient notification 
to all mammography facility patients, self-referred and physician-
referred. Good practice guidelines published by the Agency for Health 
Care Policy and Research spell out in detail the manner for providing 
direct patient notification. This is a good addition to the MQSA and 
one which is supported by all breast cancer patient advocacy 
organizations.
  Second, H.R. 4382 authorizes a limit on demonstration project to 
determine whether inspections may be required less than annually for 
those facilities with excellent records. Currently violations of 
standards are ranked into three levels according to their severity with 
Level One being the most serious, Level Three being the least serious. 
It is intended that only facilities with minor violations or clean 
records may qualify for the demonstration program.
  Also the authorization is timed such that facilities must compile an 
excellent record under HHS final rules, not the less rigorous interim 
rules currently in place. This is an authorization, not a requirement. 
It is intended that HHS not approve any demonstration program unless it 
is satisfied that patient safety will not be compromised.
  Mr. Speaker, I congratulate my colleagues who have worked hard to 
make this day happen. I particularly want to thank the chairman of the 
Subcommittee on Health and the Environment, the gentleman from Florida 
(Mr. Bilirakis) thank the gentleman from Virginia (Mr. Bliley) and the 
gentleman from Michigan (Mr. Dingell), the full committee chair and 
ranking member, the gentlewoman from Colorado (Ms. DeGette) who is 
sitting here today for her good work in this, and I also want to thank 
the majority counsel, Mark Wheat, and the democratic staff, John Ford 
in particular, and Kevin Brennan from my office for their tireless 
work.
  I urge my colleagues' support of this legislation.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BILBRAY. Mr. Speaker, I yield 3 minutes to the gentleman from 
Virginia (Mr. Bliley) the chairman of the full Committee on Commerce.
  Mr. BLILEY. Mr. Speaker, I thank the gentleman for yielding this time 
to me.
  Mr. Speaker, I am pleased that the House will pass H.R. 4382, the 
Mammography Quality Standards Reauthorization Act of 1998 today. The 
bill will assure the safety, accuracy and overall quality in 
mammography services for the early detection of breast cancer. I want 
to thank the ever diligent chairman of the Subcommittee on Health and 
Environment, the gentleman from Florida (Mr. Bilirakis) the ranking 
minority member of the full committee, the gentleman from Michigan (Mr. 
Dingell), the ranking minority member of the subcommittee, the 
gentleman from Ohio (Mr. Brown) for their hard work and close 
cooperation to make this bill a reality today.
  Mr. Speaker, breast cancer is the most common cancer among women. 
Experts tell us each year that 46,000 women die of this disease. We 
must remember that these women are not mere numbers; they are mothers, 
daughters, friends and colleagues, and even my own wife. The fact that 
1 in 9 women will develop breast cancer at some point in their lives 
compels us to action. We must act now.
  Mr. Speaker, the front line against breast cancer is early detection 
through mammography, a procedure which can identify small tumors and 
breast abnormalities up to 2 years before they can be detected by 
touch. The FDA, the GAO, the College of Radiology and breast cancer 
patients themselves all agree that mammography provides the best source 
of detection for the diagnosis and treatment of this deadly disease.
  Women who seek mammograms, however, must be assured that their 
results will be accurate and not misleading. The bill will help to 
prevent mammograms of poor quality which instill false sense of 
security in the patient who may be in the early stages of breast 
cancer.
  H.R. 4382 improves current law in two key ways. First, H.R. 4382 
provides for direct patient notification, in layman's terms, of all 
mammography examinations so that women are fully informed of their 
results. As the August 4 joint letter of endorsement from the American 
Cancer Society the National Alliance of Breast Cancer Organizations and 
the Susan G. Coleman Breast Cancer Foundation states, quote:
  Studies have shown that women believe their mammography results are 
normal if they are not contacted after their examination. An 
increasing number of mammography facilities have begun to report both 
normal and abnormal findings directly to women as well as her referring 
physician without disrupting the relationships with her referring 
provider.

  Second, 4382 authorizes the Food and Drug Administration to conduct a 
demonstration project to determine the merits of inspecting mammography 
centers of excellence less frequently than once a year so that 
inspection resources can be freed up to monitor other mammography 
facilities through it that need greater attention.
  Passage of this bipartisan legislation is a critical step in the war 
on breast cancer. We have already witnessed the success of the 
Mammography Quality Standards Act of 1992, and I am hopeful that today 
we will be able to reauthorize the act and continue to improve our 
efforts to save the lives of many women.
  Mr. BROWN of Ohio. Mr. Speaker, I yield 3 minutes to the gentlewoman 
from the District of Columbia (Ms. Norton).
  Ms. NORTON. Mr. Speaker, I thank the gentleman for yielding this time 
to me, and I want to thank him and the Chair of the subcommittee for 
their hard work on this very important bill, a bill that had the very 
special concern of the Congressional Women's Caucus as well.
  Mr. Speaker, there was a time when talk of mammograms was for the 
``cognizentti'' the most conscious of women. Today mammography has 
become the primary engine for a virtual revolution in the battle 
against breast cancer. Women of all backgrounds and income groups are 
coming forward in large numbers to take advantage of mammography.
  Why has mammography become so important and so widely used? Part of 
the reason is that women are now convinced that the machinery is safe 
and reliable and that the people who in fact implement that procedure 
know what they are doing. The Mammography Quality Standards Act is at 
the center of this confidence of women and their families.
  The bill before us would reauthorize the act to 2002. It is important 
to have it reauthorized every few years because of changes in science. 
We who are in the Women's Congressional Caucus, virtually all the women 
in Congress, are particularly grateful for this bill because we choose 
this bill among seven as our priority must-pass bills. Already this 
body has passed four of the seven must-pass bills, provisions of the 
Violence Against Women Act, the bill that allows Federal employees 
choices in contraception; a bill that will set up a commission on women 
and minorities in science and technology, and this most important 
mammography standards act.
  The act is critical because untrained and unqualified physicians and 
technicians may be people who misread mammograms, may cause more 
problems

[[Page H7748]]

than they solve. It is bad enough to suspect having this disease, but 
false positives are quite intolerable. The bill assures us that 
equipment and personnel will be FDA approved.
  Mr. Speaker, the Women's Caucus had its own hearings this year on 
tamoxifen, this great new discovery that looks as if it can prevent and 
cure cancer, but no miracle drugs can be effective without reliable 
detection. Today's legislation will save lives, it fulfills an 
important obligation of the 105th Congress. On behalf of the 
Congressional Women's Caucus, I want to extend my appreciation for 
those who have worked so hard to bring this bill forward.
  Mr. BILBRAY. Mr. Speaker, I yield 3 minutes to the gentlewoman from 
Maryland (Mrs. Morella).
  Mrs. MORELLA. Mr. Speaker, I rise in very strong support of H.R. 
4382, the Mammography Quality Standards Reauthorization Act. My special 
thanks to the gentleman from Florida (Mr. Bliley), to the subcommittee 
chairman, the gentleman from Florida (Mr. Bilirakis) and for the 
ranking members of the full committee, the gentleman from Michigan (Mr. 
Dingell) and the subcommittee, the gentleman from Ohio (Mr. Brown). I 
also want to commend the gentlewoman from Connecticut (Mrs. Johnson). 
She has worked so hard to ensure passage of this very important 
legislation, and I want to reiterate the fact that this bill has been 
one of the list of legislative priorities for the Congressional Caucus 
for Women's Issues co-chaired by the gentlewoman from Connecticut (Mrs. 
Johnson) and the gentlewoman from the District of Columbia (Ms. 
Norton). I am proud to be a co sponsor of this bill which enjoys strong 
bipartisan support in the Women's Caucus and, as I am certain in, the 
Congress as a whole.
  As my colleagues know, a recent GAO report indicates that facility 
compliance has expanded significantly under the current mammography 
facility inspection program. During the first year inspections in more 
than one quarter of the facilities had significant violations. However 
during the second year inspection, the number of such violations had 
dropped to about 10 percent. At the same time, however, GAO found 
inconsistencies in the way the inspections had been conducted and a 
lack of procedures to ensure that the expeditious reporting and 
correction of violations.
  Now H.R. 4382 expands the protections in the current law, and it will 
help us to address some of these concerns.
  We have come a long way over the past decade as mammography screening 
technologies have steadily improved. Indeed exciting progress is being 
made through the transfer have imaging technology from the defense, 
space, intelligence and computer graphics fields to improving the early 
detection of breast cancer. We in Congress must do everything possible 
to encourage the current partnership among HHS, the Department of 
Defense, the CIA, Department of Commerce, NASA and other Federal 
agencies. We must also ensure the collaborations between government and 
industry are encouraged for the development of new imaging 
technologies. As we make these strides in screening technologies, it is 
imperative that facilities and personnel performing these procedures 
provide high quality services.
  This reauthorization bill is also very timely as Medicare coverage of 
mammography screening has been expanded from every 2 years to annual 
coverage as a result of last year's Balanced Budget Act, and we all 
deserve a pat on the back for that. It is incumbent upon us to ensure 
that high quality screening is available to all women regardless of 
where they live, their age and their economic circumstances.

                              {time}  1515

  This legislation will further this goal by providing additional 
protections beyond the current law.
  Mr. Speaker, I urge my colleagues to vote for this critical 
legislation.
  Mr. BROWN of Ohio. Mr. Speaker, I yield 5 minutes to the gentlewoman 
from Colorado (Ms. DeGette).
  Ms. DeGETTE. Mr. Speaker, I rise in strong support of H.R. 4382, the 
Mammography Quality Standards Reauthorization Act.
  I want to take a moment to thank the chairman and ranking member of 
the Subcommittee on Health and Environment for their steadfast 
commitment to reauthorizing and improving this act in such an 
expeditious and thoughtful manner. I am particularly grateful to the 
subcommittee chairman the gentleman from Florida (Mr. Bilirakis) for 
hearing a request from the gentleman from Ohio (Mr. Brown) and me in 
July to ensure that the MQSA included the provision we cared so much 
about on direct patient notification.
  Mr. Speaker, few public health initiatives that we have undertaken in 
this Congress are as vital to American women as the MQSA. Before this 
test, there were no Federal standards for labs, technicians, physicians 
and quality controls. Women were subject to inconsistent and nonuniform 
regulations, depending on what State they lived in. Women were 
literally putting their health and their lives at risk when they 
obtained mammograms from unregulated or poorly regulated facilities.
  Reauthorizing and strengthening the MQSA has added importance in 
1998. Breast cancer today remains the second leading cause of cancer 
deaths among women. Mr. Speaker, 44,000 women died from breast cancer 
in 1997, and 180,000 new cases of the disease were reported. In this 
decade alone, 1.8 million women will be diagnosed with breast cancer, 
and 500,000 of them will die from it. Congress must continue to help 
American women attack this devastating disease in its early stages.
  We know that surviving breast cancer and avoiding mastectomy depends 
on early discovery of the disease. But of course, mammography as a tool 
is only as good as the equipment used to detect the cancer. Therefore, 
it is absolutely critical that we improve our ability to detect breast 
cancer by improving the safety, accuracy and overall quality of 
mammography services.
  Strict and frequent certification of mammography facilities is 
essential to this program's success. I believe that the demonstration 
project in the bill which examines the feasibility of inspecting high-
performing mammography facilities on a less than annual basis is 
thoughtfully designed and sufficiently limited to protect the best 
interests of patients. Nevertheless, I want to urge my colleagues to be 
cautious about expanding this demonstration project until we have more 
information. MQSA itself has only been fully operational for 3 years, 
and we want to make sure whatever changes we make still protect the 
lives and health of women.
  As I said earlier, I am very pleased that the chairman and ranking 
member worked cooperatively to include a provision on direct patient 
notification. I personally have met too many women who have had 
mammograms and never received the results. Whether it be physician 
failure, whether it be clinic failure, they never got a copy of the 
results. Unfortunately and too often, tragically, women who do not hear 
anything assume no news is good news. We are making an extremely 
valuable and potentially life-threatening improvement to MQSA today by 
including written notification to patients.
  Mr. Speaker, I am proud of the Committee on Commerce's hard work on 
this bill and its commitment to reach a consensus on this vital piece 
of legislation. I believe while relatively simple, this bill is one of 
our most important achievements of this Congress, and it will save 
millions of lives and the health of millions of women.
  Mr. BILIRAKIS. Mr. Speaker, I yield 5 minutes to the gentlewoman from 
Connecticut (Mrs. Johnson), who has already been recognized as being 
one of the real motivators behind this legislation.
  Mrs. JOHNSON of Connecticut. Mr. Speaker, I rise today in support of 
this legislation to reauthorize the Mammogram Quality Standards Act. I 
want to thank the gentleman from Florida (Mr. Bilirakis) and his 
subcommittee for their thoughtful work on this legislation and for 
significant improvements in this bill over current law.
  This has been a priority of the Congresswomen's Caucus, and we 
appreciate the commitment of the gentleman from Florida (Mr. Bilirakis) 
for reauthorization and his commitment to improving current law.
  The Mammogram Quality Standards Act has given women and their health 
care providers the assurance that they

[[Page H7749]]

will receive high quality mammogram services, services meeting the 
standards set by the National Cancer Institute mammography screening 
guidelines. Early detection is still our best hope in the war against 
cancer, and high quality mammograms are still our best tool for early 
detection of breast cancer.
  Prior to the implementation of the Mammogram Quality Standards Act, 
there was a long history of public and professional concern over the 
safety and quality of mammogram services. The American Cancer Society 
and the General Accounting Office found a wide range of image, quality 
and patient radiation doses from dedicated mammography equipment. In 
addition, FDA surveys found wide variations in image quality and 
radiation dosages from site-to-site, and even day-to-day. These studies 
and surveys confirm the need for national compliance standards.
  The MQSA established the first comprehensive quality standards for 
mammography. Before these standards, the burden was on a woman and the 
health care providers to determine what health and safety standards 
applied in their State or geographic area. Only 11 States had 
comprehensive quality standards, so most women could not be assured 
that their mammograms were administered safely or interpreted 
correctly. Facing those facts, it is no wonder that mammograms were not 
effectively promoted to women who could benefit from early detection.
  The Mammogram Quality Safety Act has changed this rather sobering 
picture. Over the past 3 years, the quality of mammography has improved 
dramatically. According to a GAO report issued last October, the 
Mammogram Quality Standards Act has increased mammography facilities' 
adherence to accepted quality standards which has, in turn, had a 
positive effect on mammography services. Because of the Mammogram 
Quality Standards Act, almost all of the Nation's 10,000 facilities 
have been inspected and accredited. This process has a direct impact on 
the quality of mammography, as evidenced by the fact that nearly all of 
the facilities are now passing image quality tests as part of the 
inspection process.
  The Committee on Commerce's bill, under the leadership of the 
gentleman from Florida (Mr. Bilirakis), represents an advance over 
current law. It gives women an additional protection: the assurance 
that they will receive direct notification of their mammogram results. 
This protection is critical to ensure that women do not miss the 
opportunity for an early diagnosis by assuming that no news is good 
news, when no news could be bad news.
  Mr. Speaker, this addition builds on the guarantee in H.R. 4832 based 
on a provision in my legislation that women can access an original copy 
of their mammogram and are notified if a facility has failed its 
Mammogram Quality Standards Act inspection. I now hope that the Senate 
acts quickly on the amended House legislation, so that we can 
reauthorize this legislation before Congress adjourns. We must send the 
message to women that Congress is taking action to protect the quality 
of their health care, and that, in fact, we are modernizing current law 
to keep abreast of our improved knowledge of how to prevent cancer, how 
to identify it early, and how to assure that women have access to high 
quality health care services in our Nation.
  Mr. BROWN of Ohio. Mr. Speaker, I would inquire of the gentleman from 
Florida if he has any more speakers.
  Mr. BILIRAKIS. Mr. Speaker, I too do not have any further requests 
for time.
  At this point I yield myself such time as I may consume to again 
express what can be accomplished when people are willing to sit down 
around a table and give and take, if you will, and to work together. I 
want to add to the gentleman's previous comments regarding gratitudes 
to the chairman of the full committee and the ranking member of the 
full committee, as well as the members of the staff, and the 
gentlewoman from Connecticut (Mrs. Johnson) and the gentlewoman from 
Colorado (Ms. DeGette), who was really quite a significant player in 
the workup of this legislation.
  Mr. Speaker, I yield back the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may 
consume to echo the words of the gentleman from Florida, and I ask for 
support of the bill.
  Mr. DINGELL. Mr. Speaker, I rise in strong support of H.R. 4382, the 
Mammography Quality Standards Reauthorization Act of 1998. I am proud 
to have been one of the authors of the Mammography Quality Standards 
Act (MQSA). Breast cancer remains one of the leading causes of death in 
women, and its victims are our mothers, sisters, spouses, daughters, or 
friends. I hope that we will quickly reauthorize the MQSA so that it 
will continue to provide the incalculable benefit of early detection, 
with the hope of successful treatment.
  Those who administer the MQSA, the Food and Drug Administration's 
Center of Devices and Radiological Health, and those who benefit from 
it, patients represented by organizations such as the National Breast 
Cancer Coalition, the National Alliance of Breast Cancer Organizations, 
and the American Cancer Society, have judged the MQSA a success and 
support its reauthorization.
  GAO recently reported that the MQSA ``has had a positive impact on 
the quality of mammography services and no effect on access to them.'' 
There has been a dramatic decline in facilities that failed to meet the 
interim regulations. FDA has estimated that the MQSA's benefits have 
greatly exceeded its costs. Of course, the benefits of early diagnosis 
and treatment are priceless to patients and their family and friends.
  The bill before us contains two important new provisions: First, 
there is direct patient notification for all mammography patients. 
Second, it authorizes a demonstration program for less than annual 
inspections for facilities with excellent compliance records.
  Direct patient notification is already provided for self-referred 
patients, as well as voluntarily by a growing number of facilities in 
response to widespread patient support. Direct patient notification is 
in addition to, and not in lieu of, the notification a mammography 
facility provides to the referring physician. This is an important 
safeguard. It ensures that patients have the information they need in a 
timely fashion so that they can take any additional steps warranted by 
the test. Guidelines promulgated by the Agency for Health Care Policy 
and Research contain sample communications to patients and other 
safeguards to assure that direct patient notification is done in a 
timely, accurate, and sensitive manner. As I noted, direct patient 
notification is provided today for self-referred patients and for many, 
many others. The provision in the bill simply extends this to all 
patients of mammography services facilities.
  The bill's authorization of a carefully limited demonstration program 
for less than annual inspections of facilities with excellent 
compliance records is intended to be carried out at the discretion of 
the Secretary of HHS under criteria that assure no compromise in 
patient safety. The demonstration must occur after facilities have 
compiled a compliance record under the final regulations which have yet 
to go into effect, not the interim standards in force today.
  Mr. Speaker, the Senate has already passed a MQSA reauthorization 
bill that is somewhat different than the bill before us today. I would 
like to think that we took that body's product and improved upon it. 
The bill before us today is endorsed by the major breast cancer patient 
groups. I fervently hope that we will reauthorize this law this year so 
that the excellent progress of the MQSA can continue.
  Finally, Mr. Speaker, I wish to congratulate my colleagues whose work 
made this day possible. I especially want to note the efforts of the 
distinguished Chairman of the Subcommittee on Health and Environment, 
Mr. Bilirakis, as well as the Ranking Member of that Subcommittee, Mr. 
Brown. Many other members with passionate and longstanding interests in 
the MQSA and related issues have also worked hard and I note 
particularly the bipartisan efforts of my colleagues Representatives 
Norton and Nancy Johnson.
  Ms. DeLAURO. Mr. Speaker, as a cancer survivor, I am proud to join my 
colleagues in expressing my support for the Mammography Quality 
Standards Reauthorization Act.
  This bill improves the high national standards for mammography. It 
requires breast cancer screening centers to use only radiology 
technologists and equipment designed for mammography, and to hire only 
qualified physicians to analyze mammograms. It also requires facility 
inspections by qualified inspectors to ensure that Health and Human 
Service mammography standards are adhered to.
  The women who will benefit from this legislation are our neighbors, 
our colleagues, our kids' teachers, the women we stand in line with at 
the store. Early detection truly gives women a fighting chance against 
cancer. That's why enforcing the quality standards for a mammograms is 
essential to winning the battle.
  I would also like to take this opportunity to honor the women who are 
bravely fighting this deadly disease right now, to remember those

[[Page H7750]]

we loved who have lost that fight, and to renew our commitment to 
funding a cure. Many of us have already won the fight of our lives. 
With the help of early detection we beat a cancer diagnosis. Now we 
have an obligation to help breast cancer patients win their fights.
  Thank you again for the opportunity to speak on this important issue 
that touches the lives of so many American women and their families.
  Mr. RILEY. Mr. Speaker, I rise today in support of H.R. 4382, the 
Mammography Quality Standards Reauthorization Act, which establishes 
national, uniform standards for mammography. Mammograms are universally 
recognized as the best chance of discovering the presence of breast 
cancer at its earliest, most treatable stages. In fact, mammograms can 
detect breast cancer up to two years before it can be found through 
self-examination. When breast cancer is found and treated early, a 
woman has more treatment options and a good chance of complete 
recovery. Thus, it is important to detect breast cancer as early as 
possible.
  According to the American Cancer Society, it is estimated this year, 
that 178,700 women will be diagnosed with breast cancer, and 43,500 
women will die because of this terrible disease. These women are 
mothers, wives, daughters, sisters, friends, and neighbors.
  We do not know what causes breast cancer, nor can we cure the disease 
at this time. We do know, however, that early detection and prompt 
treatment, including mammography screening, represent a woman's best 
chance of discovering the presence at its earliest, most treatable 
stages. I urge my colleagues to support H.R. 4382.
  Mr. Brown of Ohio. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore (Mr. Shimkus). The question is on the motion 
offered by the gentleman from Florida (Mr. Bilirakis) that the House 
suspend the rules and pass the bill, H.R. 4382, as amended.
  The question was taken.
  Mr. BILIRAKIS. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 5 of rule I and the 
Chair's prior announcement, further proceedings on this motion will be 
postponed.

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