[Congressional Record (Bound Edition), Volume 150 (2004), Part 15]
[House]
[Pages 20810-20812]
[From the U.S. Government Publishing Office, www.gpo.gov]




       MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT OF 2004

  Mr. BARTON of Texas. Mr. Speaker, I move to suspend the rules and 
pass the bill (H. R. 4555) to amend the Public Health Service Act to 
revise and extend provisions relating to mammography quality standards, 
as amended.
  The Clerk read as follows:

                               H.R. 4555

       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 2004''.

     SEC. 2. TEMPORARY RENEWAL AND LIMITED PROVISIONAL 
                   CERTIFICATE.

       Section 354 of the Public Health Service Act (42 U.S.C. 
     263b) is amended--
       (1) in subsection (b)(1)--
       (A) in subparagraph (A)--
       (i) in the matter preceding clause (i), by inserting ``or a 
     temporary renewal certificate'' after ``certificate''; and
       (ii) in clause (i), by striking ``subsection (c)(1)'' and 
     inserting ``paragraphs (1) or (2) of subsection (c)'';
       (B) in subparagraph (B)--
       (i) in the matter preceding clause (i), by inserting ``or a 
     limited provisional certificate'' after ``certificate''; and
       (ii) in clause (i), by striking ``subsection (c)(2)'' and 
     inserting ``paragraphs (3) and (4) of subsection (c)''; and
       (C) in the flush matter at the end, by striking 
     ``provisional certificate'' and inserting ``temporary renewal 
     certificate, provisional certificate, or a limited 
     provisional certificate''; and
       (2) in subsection (c)--
       (A) by redesignating paragraph (2) as paragraph (4); and
       (B) by inserting after paragraph (1) the following:
       ``(2) Temporary renewal certificate.--The Secretary may 
     issue a temporary renewal certificate, for a period of not to 
     exceed 45 days, to a facility seeking reaccreditation if the 
     accreditation body has issued an accreditation extension, for 
     a period of not to exceed 45 days, for any of the following:
       ``(A) The facility has submitted the required materials to 
     the accreditation body within the established time frames for 
     the submission of such materials but the accreditation body 
     is unable to complete the reaccreditation process before the 
     certification expires.
       ``(B) The facility has acquired additional or replacement 
     equipment, or has had significant personnel changes or other 
     unforeseen situations that have caused the facility to be 
     unable to meet reaccreditation timeframes, but in the opinion 
     of the accreditation body have not compromised the quality of 
     mammography.
       ``(3) Limited provisional certificate.--The Secretary may, 
     upon the request of an accreditation body, issue a limited 
     provisional certificate to an entity to enable the entity to 
     conduct examinations for educational purposes while an onsite 
     visit from an accreditation body is in progress. Such 
     certificate shall be valid only during the time the site 
     visit team from the accreditation body is physically in the 
     facility, and in no case shall be valid for longer than 72 
     hours. The issuance of a certificate under this paragraph, 
     shall not preclude the entity from qualifying for a 
     provisional certificate under paragraph (4).''.

     SEC. 3. NATIONAL ADVISORY COMMITTEE.

       Section 354(n) of the Public Health Service Act (42 U.S.C. 
     263b(n)) is amended--
       (1) in paragraph (2), by striking subparagraph (C) and all 
     that follows and inserting the following:
       ``(C) other health professionals,

     whose clinical practice, research specialization, or 
     professional expertise include a significant focus on 
     mammography. The Secretary shall appoint at least 4 
     individuals from among national breast cancer or consumer 
     health organizations with expertise in mammography, at least 
     2 industry representatives with expertise in mammography 
     equipment, and at least 2 practicing physicians who provide 
     mammography services.''; and
       (2) in paragraph (4), by striking ``biannually'' and 
     inserting ``annually''.

     SEC. 4. AUTHORIZATION OF APPROPRIATIONS.

       Subparagraphs (A) and (B) of section 354(r)(2) of the 
     Public Health Service Act (42 U.S.C. 263b(r)(2)(A) and (B)) 
     are amended by striking ``2002'' each place it appears and 
     inserting ``2007''.

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


                             General Leave

  Mr. BARTON of Texas. 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.

[[Page 20811]]

  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Texas?
  There was no objection.
  Mr. BARTON of Texas. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise in strong support of H.R. 4555, the Mammography 
Quality Standards Act. I want to commend my good friend and ranking 
minority member, the gentleman from Michigan (Mr. Dingell) for bringing 
the bill forward.
  It is particularly fitting that the House is considering this bill 
today, as the month of October is formally recognized as National 
Breast Cancer Awareness Month. It is estimated that this year over 
200,000 women will be diagnosed with breast cancer. Like many other 
diseases, early detection of breast cancer is critical to saving lives. 
Right now, mammograms are the best screening tool available to women to 
help detect breast cancer at an early age.
  In 1992, Congress enacted the Mammography Quality Standards Act to 
ensure that all women have access to quality mammography for the 
detection of breast cancer in its earliest, most treatable stages. The 
MQSA provides that screening and diagnostic services must be accredited 
and certified by the Food and Drug Administration. H.R. 4555 
reauthorizes the Act through fiscal year 2007.
  The bill includes a new provision to permit the Secretary of Health 
and Human Services to issue a temporary renewal certificate or a 
limited provisional certificate to any facility seeking reaccreditation 
under MQSA. The legislation also permits the Secretary to appoint 
individuals with expertise in mammography equipment to the National 
Mammography Quality Assurance Advisory Committee and grants the 
advisory committee greater flexibility in how many times the committee 
must meet annually.
  Mr. Speaker, this is a good piece of legislation and I would 
encourage my colleagues to support it.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself 3 minutes.
  Mr. Speaker, I would like to thank the gentleman from Texas (Chairman 
Barton) for his good work on this legislation, the gentleman from 
Michigan (Mr. Dingell) and the gentleman from Florida (Chairman 
Bilirakis) for offering this legislation reauthorizing the Mammography 
Quality Standards Act of 1992.
  The gentleman from Michigan (Mr. Dingell) pioneered this important 
legislation a dozen years or so ago. By increasing the breast cancer 
early detection rate, this legislation has undoubtedly contributed to 
the battle against this deadly disease.
  Breast cancer is the top cancer threat for American women. This year 
alone, in our country, almost 216,000 women will be diagnosed with 
breast cancer, and more than 40,000 will lose their lives from it.
  Accurate reading of mammograms is essential to early detection of 
breast cancer. Mammography has increased the survival rate for women in 
their 40s by 16 percent.
  Over a decade ago, Congress recognized the importance of high-quality 
mammography screening by passing the Mammography Quality Standards Act. 
This act was designed to ensure that mammography is safe and reliable 
and that breast cancer is detected during its most treatable stages. 
This act established national standards for mammography facilities, for 
personnel, including doctors who interpret mammograms, for equipment, 
and for operating procedures.
  This legislation today, H.R. 4555, ensures that American mammography 
providers continue to be held to high standards and that mammography 
continues to become a safer, more accurate tool for detecting breast 
cancer. It makes sense to update and extend this program to make 
certain we are fighting breast cancer as early as possible and as 
accurately as possible.
  I am pleased to support this important legislation.
  Mr. DINGELL. Mr. Speaker, I rise in support of H.R. 4555, the 
Mammography Quality Standards Reauthorization Act of 2004. I am proud 
to have introduced this bill, and proud to have helped author the 
original Mammography Quality Standards Act which has made a major 
contribution to improving the quality of mammograms.
  Just a few months ago, the Institute of Medicine (IOM) published a 
detailed reported entitled: ``Saving Women's Lives, Strategies for 
Improving Breast Cancer Detection and Diagnosis.'' According to the 
IOM, ``[m]ammo-
graphy is a safety net that saves lives each year, . . . and although 
mammography saves lives, it is not perfect.'' The IOM report noted that 
many women who would benefit from mammography do not undergo regular 
screening and others who do undergo regular screening develop breast 
cancers that were not detected by their mammography exam. While the 
report notes that progress has been made in reducing mortality from 
breast cancer, it is still the second leading cause of death for women.
  While research will hopefully lead us to improved techniques for 
detecting and treating breast cancer, another IOM study entitled: 
``Mammography and Beyond: Developing Technologies for Early Detection 
of Breast Cancer,'' concluded that mammography, while not perfect, is 
still the best choice for screening the general population to detect 
breast cancer at early and treatable stages. To be sure, there are 
important issues regarding quality and access with respect to screening 
and treatment services, and work on those will continue.
  This legislation is almost identical to S. 1879, a bill introduced by 
Senator Mikulski that has already been passed by the Senate. The only 
substantive difference is the authorization period. Our bill extends 
the authorization period through FY 2007, two years longer than the 
Senate bill. But I support a timely completion of various mammography 
issue studies requested by Senator Mikulski, and I look forward to 
working with her, Chairman Barton, my other colleagues, and 
stakeholders, including the Susan G. Komen Foundation, to bring an MQSA 
reauthorization bill to the President's desk as quickly as possible.
  Mr. GREEN of Texas. Mr. Speaker, I rise today in support of the 
Mammography Quality Standards Act. It is truly fitting for the House to 
pass a reauthorization of MQSA during October, which is Breast Cancer 
Awareness Month. This year, more than 215,000 individuals will learn 
that they have breast cancer. Hopefully, many of these will be early 
diagnoses, detected by mammograms that have proven time and again to be 
the most important tool for early detection.
  Thanks to the efforts of HHS, the FDA and private advocacy groups, 
such as the Susan G. Komen Foundation, an estimated 40 million 
mammograms are performed annually. And thanks to the Mammography 
Quality Standards Act initially enacted over a decade ago, women all 
across America have benefited from uniform quality standards for 
mammography facilities.
  For several years, I've been working with the FDA on issues related 
to silicone breast implants. I am concerned about recent studies on the 
effect of breast implants on mammography readings.
  Specifically, an April 2003 NIH report highlighted clinical studies 
suggesting that women with breast implants have more advanced cancer at 
diagnosis than women without breast implants. And more recently, a 
January 2004 article published in the Journal of the American Medical 
Association concluded that breast implants decrease the sensitivity of 
mammography screenings to detect breast cancer.
  The FDA has been extremely responsive on this issue and has 
acknowledged that breast implants can hide tumors or make it more 
difficult to include them in the image. As such, the FDA has suggested 
that medical professionals take special implant displacement views in 
addition to those taken during routine mammograms. These extra views 
are crucial to ensuring that women with breast implants have effective 
mammograms.
  The folks at FDA have worked wonders on mammography standards thus 
far. I have every confidence that they will keep up the good work and 
take into consideration the unique circumstances of women with breast 
implants. With that, Mr. Speaker, I would encourage all of my 
colleagues to support this important legislation.
  Mr. BROWN of Ohio. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Texas (Mr. Barton) that the House suspend the rules and 
pass the bill, H.R. 4555, as amended.
  The question was taken; and (two-thirds having voted in favor 
thereof)

[[Page 20812]]

the rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

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