[Senate Report 108-220]
[From the U.S. Government Publishing Office]
Calendar No. 424
108th Congress Report
SENATE
1st Session 108-220
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MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT OF 2003
_______
December 9, 2003.--Ordered to be printed
_______
Mr. Gregg, from the Committee on Health, Education, Labor, and
Pensions, submitted the following
R E P O R T
[To accompany S. 1879]
The Committee on Health, Education, Labor, and Pensions, to
which was referred the bill (S. 1879) to amend the Public
Health Service Act to revise and extend provisions relating to
mammography quality standards, having considered the same,
reports favorably thereon without amendment and recommends that
the bill do pass.
CONTENTS
Page
I. Purpose and need for legislation.................................1
II. Summary..........................................................2
III. History of legislation and votes in committee....................3
IV. Explanation of bill and committee views..........................3
V. Regulatory impact statement......................................4
VI. Application of law to the legislative branch.....................4
VII. Cost estimate....................................................4
VIII.Section-by-section analysis......................................4
IX. Changes in existing law..........................................5
I. Purpose and Need for Legislation
Breast cancer is the second leading cause of cancer deaths
among American women. In 2001, an estimated 192,200 new cases
of breast cancer were diagnosed and an estimated 40,200 women
died from the disease. The probability of survival increases
significantly, however, when breast cancer is discovered in its
early stages. Currently, the most effective technique for early
detection of breast cancer is screening mammography.
The Mammography Quality Standards Act was originally passed
in 1992 to ensure that all women have access to quality
mammography for the detection of breast cancer in its earliest,
most treatable stages. The MQSA has had a positive impact on
mammography quality. FDA inspection data continue to show
overall facility compliance with the national standards to
ensure the quality of the x-ray images. Currently, over 60
percent of facilities have no violations, and only 2 percent
have noncompliance with at the most serious level. Over 99
percent of all mammography facilities pass the phantom image
test during their facility inspection. Experts agree that
improving the quality of images should lead to more accurate
interpretation by physicians and, therefore the MQSA remains an
essential tool for early detection and for combating mortality
associated with breast cancer. Moreover, the death rate from
cancer in the U.S. has been decreasing about 2 percent annually
during the past decade, suggesting that public awareness, early
detection and improved therapies are having an impact on the
disease.
Congress reauthorized MQSA in 1998, extending the program
through 2002. Although MQSA was slated for reauthorization in
the 107th Congress, no such action was taken on the bill due to
controversy surrounding the best ways to enhance MQSA without
causing additional medical litigation or flight from the
mammography profession. Reducing the authorization period on a
one-time basis from 5 years to 2 years will give the committee
additional time to consider the best ways to enhance MQSA
without affecting access to quality mammography services.
The Mammography Quality Standards Reauthorization Act of
2003 (S. 1879) is also needed to permit the Secretary to issue
a temporary renewal certificate, under certain circumstances
that do not affect the quality of mammography services, to
allow for the completion of reaccreditation and recertification
without a disruption of service that could result in the delay
of the diagnosis and treatment of breast cancer. In addition,
this legislation will permit the Secretary to issue a limited
provisional certificate to allow a facility to perform the
screening exam necessary to demonstrate their ability to
provide quality mammography during a survey by the accrediting
body.
II. Summary
S. 1879 amends the Public Health Service Act to extend
funding for the mammography facilities certification program
through FY 2005.
The legislation also permits the Secretary of Health and
Human Services (the Secretary) to issue two additional types of
certificates--temporary renewal and limited provisional
certificates--for specific periods of time for circumstances
outlined in the legislation. The Secretary may issue a
temporary renewal certificate for up to 45 days to facilities
seeking reaccreditation that have been awarded an accreditation
extension for specified reasons, including inability of the
accrediting body to complete the process in time and unforeseen
situations which cause the facility to be unable to meet the
reaccreditation timeframes, but do not compromise the quality
of mammography.
A limited provisional certificate may be issued by the
Secretary upon the request of an accreditation body for a
limited provisional certificate--that is valid up to 72 hours--
to enable the facility to conduct examinations for educational
purposes during an onsite visit by the accreditation body.
III. History of Legislation and Votes in Committee
On April 8, 2003, the HELP Committee held a hearing chaired
by Senator Ensign entitled ``Mammography Quality Standards Act
(MQSA): Patient Access to Quality Health Care.'' The hearing
focused on ways that the legislation could encourage self-
assessment of interpretive skills by radiologists with the goal
of reducing the number of missed breast cancers without
affecting medical litigation, and without causing flight by
radiologistsfrom the profession by contributing to the unique
regulatory requirements mandated under the MQSA.
On November 18, 2003, Senator Mikulski, for herself and
Senators Ensign, Kennedy, Snowe, Dodd, Murray, Jeffords and
Cantwell introduced S. 1879, the Mammography Quality Standards
Act of 2003. The bill was referred to the Health, Education,
Labor, and Pensions Committee. On November 21, 2003, the
committee was polled and unanimously approved S. 1879.
IV. Explanation of Bill and Committee Views
1. PERIOD OF REAUTHORIZATION
The committee intends for this limited reauthorization to
provide additional time to consider the MQSA program. At the
expiration of this 2-year reauthorization, the committee
intends to return to a 5-year authorization cycle. The
committee believes that the shortened reauthorization period is
necessary to evaluate different approaches to enhance MQSA
without driving dedicated people from the profession. The
committee also intends for this reauthorization to signal to
mammography professionals our support for the MQSA; FDA runs a
strong program that provides quality care to consumers. The
committee does not intend to repeat this 2-year reauthorization
period but will reauthorize the program in 2005 for a period of
5 years; that will be until 2010 and continue on a 5-year
reauthorization cycle.
The committee recognizes that at the present time,
mammography is not a perfect science and approximately one of
every 10 breast cancers cannot be detected on a mammogram. The
committee heard testimony that because the public misperceives
that mammography is 100 percent accurate, women frequently
resort to medical litigation if breast cancer is diagnosed
subsequent to having a mammogram that was interpreted as
normal. As a result of this, as well as other factors such as
reimbursement, the number of radiologists willing to practice
mammography is decreasing. The developing crisis in the
availability of mammography service is the greatest threat to
quality mammography at the present time, according to testimony
before the committee. Therefore, the committee recognizes the
difficulty in reaching a balance between enhancing MQSA and the
potential consequences of additional regulatory burdens or
increasing medical litigation.
2. TEMPORARY RENEWAL CERTIFICATE
Occasionally, circumstances not relating to mammography
quality preclude completion of the reaccreditation process
prior to expiration of the facility's certificate. The
situation can arise, for example, when a facility is
unavoidably delayed in the submission of information due to
installation of new equipment or unexpected transport delays in
transmitting images from place to place. This legislation
permits the Secretary to recognize these exceptional
circumstances to allow orderly completion of reaccreditation
and recertification without a disruption of service and thereby
avoiding the possibility of delaying the diagnosis and
treatment of women with breast cancer.
3. LIMITED PROVISIONAL CERTIFICATE
This legislation will authorize the Secretary to issue a
limited provisional certificate to permit the facility to
perform the screening exam necessary to demonstrate their
ability to provide quality mammography during a survey by the
accrediting body. Under the current statute, mammography
facilities that have lost their MQSA accreditation must be able
to perform an exam on a woman as part of a supervised,
educational on-site survey before it can be reaccredited. As a
result, this legislation will avoid the unnecessary closing of
facilities and thus avoid possible delays in the diagnosis and
treatment of breast cancer.
V. Regulatory Impact Statement
The committee has determined that there will be no increase
in the regulatory burden imposed by this bill. The
reauthorization of the funding for the program will not impact
the regulatory burden under the program. Both the temporary
renewal and limited provisional certificates are issued by the
Secretary under the appropriate circumstance, thus adding no
regulatory burdens to the facility.
VI. Application of Law to the Legislative Branch
Section 102(b)(3) of Public Law 104-1, the Congressional
Accountability Act (CAA), requires a description of the
application of this bill to the legislative branch. S. 1879
extends funding for the mammography facilities certification
program through FY 2005 and permits the Secretary to issue two
additional types of certificates in certain circumstances to
permit the continued operation of facilities providing
mammography services. As such, it has no application to the
legislative branch.
VII. Cost Estimate
Due to time constraints the Congressional Budget Office
estimate was not included in the report. When received by the
committee, it will appear in the Congressional Record at a
later time.
VIII. Section-by-Section Analysis
S. 1879 amends the Public Health Service Act to revise and
extend provisions relating to mammography quality standards.
Sec. 1. Short title
Section 1 entitles the Act the ``Mammography Quality
Standards Reauthorization Act of 2003''.
Sec. 2. Temporary renewal and limited provisional certificate
Permits the Secretary of Health and Human Services (the
Secretary) to issue a temporary certificate to facilities
seeking reaccreditation and awarded an accreditation extension
for specified reasons, including the inability of the
accrediting body to complete the process in time and unforeseen
situations which cause the facility to be unable to meet the
reaccreditation timeframes, but do not compromise the quality
of mammography. The certificate is valid for up to 45 days.
Permits the Secretary to issue upon the request of an
accreditation body a limited provisional certificate--that is
valid up to 72 hours--to enable the entity to conduct
examinations for educational purposes during an onsite visit by
the accreditation body.
Sec. 3. Authorization of appropriations
Extends funding for the mammography facilities
certification program through FY 2005.
IX. Changes in Existing Law
In compliance with rule XXVI paragraph 12 of the Standing
Rules of the Senate, the following provides a print of the
statute or the part or section thereof to be amended or
replaced (existing law proposed to be omitted is enclosed in
black brackets, new matter is printed in italic, existing law
in which no change is proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
Mammography Quality Standards Reauthorization Act of 2003
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
Subpart 3--Mammography Facilities
SEC. 354. CERTIFICATION OF MAMMOGRAPHY FACILITIES.
(a) Definitions.--As used in this section:
* * * * * * *
(b) * * *
* * * * * * *
(A) a certificate or a temporary renewal
certificate--
(i) that is issued, and, if
applicable, renewed, by the Secretary
in accordance with [subsection (c)(1)]
paragraphs (1) or (2) of subsection
(c);
* * * * * * *
(B) a provisional certificate or a limited
provisional certificate--
(i) that is issued by the Secretary
in accordance with [subsection (c)(2)]
paragraphs (3) and (4) of subsection
(c);
(ii) * * *
* * * * * * *
The reference to a certificate in this section includes a
[provisional certificate] temporary renewal certificate,
provisional certificate, or a limited provisional certificate;
* * * * * * *
(c) Issuance and Renewal of Certificates.--
(1) In general.--* * *
(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).
[(2)](4) Provisional certificate.--The Secretary may
issue a provisional certificate for an entity to enable
the entity to qualify as a facility. The applicant for
a provisional certificate shall meet the requirements
of subsection (d)(1), except providing information
required by clauses (iii) and (iv) of subsection
(d)(1)(A). A provisional certificate may be in effect
no longer than 6 months from the date it is issued,
except that it may be extended once for a period of not
more than 90 days if the owner, lessor, or agent of the
facility demonstrates to the Secretary that without
such extension access to mammography in the geographic
area served by the facility would be significantly
reduced and if the owner, lessor, or agent of the
facility will describe in a report to the Secretary
steps that will be taken to qualify the facility for
certification under subsection (b)(1).
* * * * * * *
(r) Funding.--
(1) Fees.--
(A) In general.--* * *
(B) * * *
(i) * * *
* * * * * * *
(2) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
section--
(A) to award reseach grants under subsection
(p), such sums as may be necessary for each of
the fiscal years 1993 through [2002]2005; and
(B) for the Secretary to carry out other
activities which are not supported by fees
authorized and collected under paragraph (1),
such sums as may be necessary for fiscal years
1993 through [2002]2005.