[House Report 107-601]
[From the U.S. Government Publishing Office]
107th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 107-601
======================================================================
MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT OF 2002
_______
July 22, 2002.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Tauzin, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 4888]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 4888) to reauthorize the Mammography Quality
Standards Act, and for other purposes, having considered the
same, report favorably thereon with amendments and recommend
that the bill as amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 3
Hearings......................................................... 4
Committee Consideration.......................................... 4
Committee Votes.................................................. 4
Committee Oversight Findings..................................... 4
Statement of General Performance Goals and Objectives............ 4
New Budget Authority, Entitlement Authority, and Tax Expenditures 4
Committee Cost Estimate.......................................... 4
Congressional Budget Office Estimate............................. 4
Federal Mandates Statement....................................... 6
Advisory Committee Statement..................................... 6
Constitutional Authority Statement............................... 6
Applicability to Legislative Branch.............................. 7
Section-by-Section Analysis of the Legislation................... 7
Changes in Existing Law Made by the Bill, as Reported............ 8
Amendment
The amendments are as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Mammography Quality Standards
Reauthorization Act of 2002''.
SEC. 2. 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)) are each amended by striking
``2002'' and inserting ``2007''.
SEC. 3. TEMPORARY CERTIFICATE.
Section 354(c) of the Public Health Service Act (42 U.S.C. 263b) is
amended by redesignating paragraph (2) as paragraph (3) and inserting
after paragraph (1) the following:
``(2) Temporary issuance of a certificate.--The Secretary may
issue a temporary renewal certificate for a period not to
exceed 45 days to a facility seeking reaccreditation if the
accreditation body for the facility has issued an accreditation
extension for a period not to exceed 45 days for any of the
following reasons:
``(A) The facility has met the established time
frames for submitting materials to the accreditation
body, but the accreditation body is unable to complete
the reaccreditation process before the certificate
expires.
``(B) Circumstances such as the facility acquiring
additional or replacement equipment, having low volume
of mammography, or having significant personnel changes
have caused the facility to be unable to meet
reaccreditation time frames.
``(C) Other unforeseen situations have caused the
facility to be unable to meet reaccreditation time
frames, but in the opinion of the accreditation body,
have not compromised the quality of mammography.''.
SEC. 4. GAO STUDY.
(a) Study.--The Comptroller General of the United States shall
conduct a study of the program established by the Mammography Quality
Standards Act of 1992 (the program under section 354 of the Public
Health Service Act, referred to in this Act as the ``MQSA'') to--
(1) evaluate the demonstration program regarding frequency of
inspections authorized under section 354(g) of the Public
Health Service Act, including the effect of the program on
compliance with the MQSA;
(2) evaluate the accessibility of mammography services;
(3) evaluate the role of States in acting as both
accreditation bodies and certification bodies under the MQSA;
and
(4) identify areas, if any, where the MQSA could be improved
to increase access to and quality of mammography services for
women.
(b) Report.--Not earlier than 3 years, but not later than 4 years
after the date of enactment of this section, the Comptroller General
shall submit to the Committee on Health, Education, Labor, and Pensions
of the Senate and the Committee on Energy and Commerce of the House of
Representatives a report on the study described in subsection (a).
SEC. 5. INSTITUTE OF MEDICINE STUDY.
(a) Study.--Not later than one year after the date of enactment of
this section, the Secretary of Health and Human Services (referred to
in this section as the ``Secretary'') shall request the Institute of
Medicine to enter into an agreement under which such Institute conducts
a study for the purpose of making recommendations regarding the
following:
(1) Ways to encourage more radiologists to be adequately
trained in mammography interpretation.
(2) Ways to ensure enough adequately trained personnel at all
levels to ensure the quality and availability of mammography
services to women.
(3) Whether interventional mammography procedures should be
subject to the requirements of the MQSA.
(4) Ways to improve continuing medical education
requirements, such as including an assessment of interpretive
skills, for physicians interpreting mammograms.
(5) Other areas, if any, where the MQSA could be improved to
increase the quality of mammography services for women.
(b) Report.--The Secretary shall ensure that, not later than 18
months after the date on which the Secretary enters into the agreement
under subsection (a), the study under such subsection is completed and
a report on the study is submitted to the Secretary, the Committee on
Health, Education, Labor, and Pensions of the Senate, and the Committee
on Energy and Commerce of the House of Representatives.
Amend the title so as to read:
A bill to amend the Public Health Service Act to extend the program
established by the Mammography Quality Standards Act of 1992, and for
other purposes.
Purpose and Summary
The purpose of H.R. 4888 is to reauthorize the Mammography
Quality Standards Act (``MQSA'').
Background and Need for Legislation
In 1992, Congress enacted the Mammography Quality Standards
Act (``MQSA'') to ensure that all women have access to quality
mammography for the detection of breast cancer in its earliest,
most treatable stages. In 1998, Congress reauthorized MQSA
through 2002 in the Mammography Quality Standards
Reauthorization Act of 1998.
The MQSA provides that screening and diagnostic services
must be accredited and certified by the Food and Drug
Administration (FDA). As of 2001, there were 9,646 MQSA-
certified mammography facilities in the United States and its
territories. Of these, 9,331 facilities are fully certified.
The remaining facilities are in the process of becoming
accredited.
FDA has approved five accreditation bodies under MQSA, each
of which can last no longer than three years. The approved
bodies are the American College of Radiology, and the States of
Arkansas, California, Iowa, and Texas. FDA reports annually to
the Congress about the performance of these accreditation
bodies.
There is also an annual facility inspection component under
the program. Under MQSA, trained FDA inspectors, with State
agencies under contract to the FDA, and with states that are
certifying agencies, perform annual MQSA inspections. Only FDA
performs annual inspections of Federal facilities. Forty-five
States and jurisdictions have contracted with FDA to perform
these inspections.
Inspectors perform science-based inspections to determine
the radiation dose for the standard Mammography; to assess
image quality using a standard image quality phantom; to
empirically evaluate the quality of the facility's film
processing; and to evaluate the facility's equipment. In
addition to the science-based inspections, the inspectors
review the facility's medical reports, lay summaries, and
medical audits to ensure the facility's procedures meet MQSA
requirements. MQSA requires FDA to collect fees from facilities
to cover the cost of their annual facility inspections.
The Committee expects the FDA to promulgate final
regulations establishing quality standards and accreditation
criteria specific to full field digital mammography and permit
mammography facilities to be certified to offer and maintain
full field digital mammography systems exclusively if they so
desire. It is the Committee's understanding that an entity has
submitted an application to become the accrediting body for
full field digital mammography, and that this application
contains proposed quality standards relating to full field
digital mammography. The Committee expects the FDA to continue
its review of these proposed standards and, if these standards
are appropriate, issue final regulations allowing facilities to
offer this technology exclusively and meet MQSA requirements.
Hearings
The Committee on Energy and Commerce did not hold hearings
on the legislation.
Committee Consideration
On Thursday, June 13, 2002, the Full Committee met in open
markup session and favorably ordered reported H.R. 4888, as
amended, by voice vote, a quorum being present.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 4888 reported. A motion by Mr. Tauzin to order H.R. 4888
reported to the House, as amended, was agreed to by a voice
vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held oversight
or legislative hearings on this legislation.
Statement of General Performance Goals and Objectives
The goal of this legislation is to continue the improvement
in the quality of mammograms nationwide.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
4888, the Mammography Quality Standards Reauthorization Act of
2002, would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, July 22, 2002.
Hon. W.J. ``Billy'' Tauzin,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed estimate of H.R. 4888, the Mammography
Quality Standards Reauthorization Act of 2002.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Julia M.
Christensen.
Sincerely,
Steven M. Lieberman
(For Dan L. Crippen, Director).
Enclosure.
H.R. 4888--Mammography Quality Standards Reauthorization Act of 2002
Summary: H.R. 4888 would reauthorize funding for programs
carried out under the Mammography Quality Standards Act (MQSA)
of 1992. (The program was last reauthorized in 1998.) Current
authorizations expire after fiscal year 2002 for activities not
supported by user fees. The bill would authorize the
appropriation of such sums as necessary for fiscal years 2003
through 2007. Assuming the appropriation of the necessary
amounts, CBO estimates that implementing H.R. 4888 would cost
$12 million in 2003 and $77 million over the 2003-2007 period.
(That estimate assumes annual appropriations are adjusted for
inflation. Without such adjustment, the five-year total would
be $72 million.) The legislation would not affect direct
spending or receipts; therefore, pay-as-you-go procedures would
not apply.
H.R. 4888 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
and would impose no costs on State, local, or tribal
governments.
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 4888 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By Fiscal Year, in Million of Dollars--
-----------------------------------------------------------------
2002 2003 2004 2005 2006 2007
----------------------------------------------------------------------------------------------------------------
SPENDING SUBJECT TO APPROPRIATION
Spending under current law:
Estimated authorization level \1\......... 15 0 0 0 0 0
Estimated outlays......................... 15 4 1 0 0 0
Proposed changes: \2\
Estimated authorization level............. 0 16 16 16 17 17
Estimated outlays......................... 0 12 15 16 17 17
Spending under H.R. 4888:
Estimated authorization level \1\......... 15 16 16 16 17 17
Estimated outlays......................... 15 16 16 16 17 17
----------------------------------------------------------------------------------------------------------------
\1\ The 2000 level is the amount appropriated for that year for activities authorized under the Mammography
Quality Standards Act but not supported by user fees.
\2\ The amounts shown reflect annual adjustments for anticipated inflation for those activities for which the
bill would authorize such sums as necessary. Without such inflation adjustments, the five-year changes in
authorization levels would total $77 million (Instead of $82 million) and the changes in outlays would total
$72 million (instead of $77 million).
Basis of estimate: H.R. 4888 would authorize the
appropriation of such sums as necessary for 2003 through 2007
for the Food and Drug Administration to carry out MQSA
activities that are not supported by user fees. Those
activities include: establishing and enforcing standards for
mammography facilities, accreditation bodies, equipment,
personnel, and quality assurance; inspecting facilities run by
governmental entities; and providing consumer education. The
bill also would allow the Secretary of Health and Human
Services to issue a temporary renewal certificate to facilities
seeking reaccreditation under certain circumstances. CBO
estimates that these activities could be carried out with the
2002 appropriation levels adjusted for inflation. We estimate
that these activities would cost $7 million in 2003 and $45
million over the 2003-2007 period.
In addition, H.R. 4888 would reauthorize the breast cancer
screening surveillance research grant program, administered by
the National Cancer Institute. The bill would authorize such
sums as necessary for that program, at an estimated cost of $5
million in 2003 and $30 million over the 2003-2007 period. The
program funds research to determine the effectiveness of
screening programs in reducing breast cancer mortality. CBO's
estimate assumes continued funding at the 2002 level adjusted
for inflation.
H.R. 4888 would require the General Accounting Office and
the Institute of Medicine to conduct studies on the MQSA
program and the related issues surrounding the quality of
mammography services. CBO estimates that the cost of those
studies would be less than $500,000 in 2003 and would total
less than $1 million over the 2003-2007 period.
For this estimate, CBO assumes that the bill would have an
effective date of October 1, 2002. We also assume that the
necessary appropriations would be provided at the start of each
fiscal year and that outlays would follow historical spending
patterns for this program.
Pay-as-you-go considerations: None.
Intergovernmental and private-sector impact: H.R. 4888
contains no intergovernmental or private-sector impact as
defined in UMRA and would impose no costs on state, local, or
tribal governments.
Estimate prepared by: Federal costs: Julia Christenson:
Impact on state, local, and tribal governments: Leo Lex; impact
on the private sector; Jennifer Bowman.
Estimate approved by: Robert A. Sunshine, Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short Title
Section 1 establishes the short title as the ``Mammography
Quality Standards Reauthorization Act of 2002.''
Section 2. Authorization of Appropriations
Section 2 extends the authorization of appropriations for
section 354(r)(2) of the Public Health Service Act until 2007.
Section 3. Temporary Certificate
Section 3 allows the Secretary of Health and Human Services
(HHS) to issue a temporary renewal certificate, for a period
not to exceed 45 days, to any facility seeking reaccreditation
under MQSA. In order for a facility to receive a temporary
renewal certificate from the Secretary, the facility must have
been issued an accreditation certificate not to exceed 45 days.
In order to be issued a temporary renewal certificate by the
Secretary, a facility needs to meet any of the following
criteria; (1) if the facility has met the established time
frames for submitting materials to the accreditation body for
reaccreditation, but the accreditation body is unable to
complete the process before the certificate expires; (2) if the
facility acquires additional or replacement equipment, has a
low volume of mammography, or has significant personnel changes
which prohibits the facility from meeting the accreditation
time frames; (3) or if there are other unforeseen circumstances
that cause the facility from meeting the reaccreditation time
frames, but at the same time have not compromised the quality
of mammography in the opinion of the accreditation body.
Section 4. GAO Study
Section 4 requires the General Accounting Office (GAO) to
conduct a study of the demonstration program established by
MQSA. In the study, GAO will (1) evaluate the program regarding
the frequency of inspections authorized under the Public Health
Service Act, including the effect of the program on compliance
with MQSA; (2) evaluate the accessibility of mammography
services; (3) evaluate the role of states in acting as both
accreditation bodies and certification bodies under the MQSA;
and, (4) identify areas where the MQSA could be improved to
increase access to and the quality of mammography services for
women.
Section 5. Institute of Medicine Study
Section 5 directs the Secretary of HHS to enter into an
agreement with the Institute of Medicine for the purpose of
conducting a study and making recommendations to the Secretary.
In the study, the Institute of Medicine will examine (1) ways
to encourage more radiologist to be adequately trained in
mammography interpretation; (2) ways to ensure enough
adequately trained personnel at all levels to ensure the
quality and availability of mammography services to women; (3)
whether interventional mammography procedures should be subject
to the requirements of the MQSA; (4) ways to improve continuing
medical education requirements, such as including an assessment
of interpretive skills, for physicians interpreting mammograms;
and, (5) other areas where the MQSA could be improved to
increase the quality of mammography services for women.
The Secretary will submit to the Committee on Health,
Education, Labor, and Pensions of the Senate, and the Committee
on Energy and Commerce of the House, a report on the study
conducted in this section within 18 months after the date on
which the Secretary enters into an agreement with the Institute
of Medicine.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (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):
SECTION 354 OF THE PUBLIC HEALTH SERVICE ACT
SEC. 354. CERTIFICATION OF MAMMOGRAPHY FACILITIES.
(a) * * *
* * * * * * *
(c) Issuance and Renewal of Certificates.--
(1) * * *
(2) Temporary issuance of a certificate.--The
Secretary may issue a temporary renewal certificate for
a period not to exceed 45 days to a facility seeking
reaccreditation if the accreditation body for the
facility has issued an accreditation extension for a
period not to exceed 45 days for any of the following
reasons:
(A) The facility has met the established time
frames for submitting materials to the
accreditation body, but the accreditation body
is unable to complete the reaccreditation
process before the certificate expires.
(B) Circumstances such as the facility
acquiring additional or replacement equipment,
having low volume of mammography, or having
significant personnel changes have caused the
facility to be unable to meet reaccreditation
time frames.
(C) Other unforeseen situations have caused
the facility to be unable to meet
reaccreditation time frames, but in the opinion
of the accreditation body, have not compromised
the quality of mammography.
[(2)] (3) 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) * * *
(2) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
section--
(A) to award research grants under subsection
(p), such sums as may be necessary for each of
the fiscal years 1993 through [2002] 2007; 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] 2007.