[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
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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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