[Congressional Record Volume 150, Number 124 (Tuesday, October 5, 2004)]
[House]
[Pages H8079-H8080]
From the Congressional Record Online through the 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.
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
[[Page H8080]]
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]ammography 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) the rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
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