[House Report 108-694]
[From the U.S. Government Publishing Office]
108th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 108-694
======================================================================
MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT OF 2004
_______
September 22, 2004.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Barton of Texas, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany H.R. 4555]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 4555) to amend the Public Health Service Act to
revise and extend provisions relating to mammography quality
standards, having considered the same, report favorably thereon
with an amendment and recommend that the bill as amended do
pass.
CONTENTS
Page
Amendment........................................................ 1
Purpose and Summary.............................................. 2
Background and Need for Legislation.............................. 3
Hearings......................................................... 3
Committee Consideration.......................................... 3
Committee Votes.................................................. 3
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.............................. 6
Section-by-Section Analysis of the Legislation................... 6
Changes in Existing Law Made by the Bill, as Reported............ 7
Amendment
The amendment is 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 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''.
Purpose and Summary
The purpose of H.R. 4555 is to reauthorize the Mammography
Quality Standards Act (MQSA).
Background and Need for Legislation
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. 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). When performing this function, the FDA
also considers the special circumstances required in ensuring
clear, accurate and reliable mammograms of patients with breast
implants. As of June 30, 2004, there were 9,039 MQSA-certified
facilities in the United States and its territories.
There are four FDA-approved accreditation bodies under
MQSA. The period of approval for each of the accreditation
bodies is seven years, after which time they need to apply for
renewal of their status. The approved bodies are the American
College of Radiology, and the States of Arkansas, 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-eight States
and jurisdictions have contracted with FDA to perform these
inspections.
Inspectors perform science-based inspections to (1)
determine the radiation dose for the standard mammography; (2)
assess image quality using a standard image quality phantom;
(3) empirically evaluate the quality of the facility's film
processing; (4) and, 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.
Hearings
The Committee on Energy and Commerce has not held hearings
on the legislation.
Committee Consideration
On June 15, 2004 the Subcommittee on Health met in open
markup session and approved H.R. 4555 for Full Committee
consideration by a voice vote. On June 24, 2004, the Committee
on Energy and Commerce met in open markup session and approved
H.R. 4555, as amended, by a voice vote.
Committee Votes
There were no record votes taken in connection with
ordering H.R. 4555 reported. A motion by Mr. Pickering to order
H.R. 4555 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.
4555, the Mammography Quality Standards Reauthorization Act,
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 7, 2004.
Hon. Joe Barton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 4555, the
Mammography Quality Standards Reauthorization Act of 2004.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Julia
Christensen.
Sincerely,
Elizabeth M. Robinson
(For Douglas Holtz-Eakin, Director).
Enclosure.
H.R. 4555--Mammography Quality Standards Reauthorization Act of 2004
Summary: H.R. 4555 would reauthorize funding for programs
carried out under the Mammography Quality Standards Act (MQSA)
of 1992. (The program was last reauthorized in 1998.)
Authorizations for the program expired at the end of fiscal
year 2002 for activities not supported by user fees. The bill
would authorize the appropriation of such sums as necessary
through fiscal year 2007. Assuming the appropriation of the
necessary amounts, CBO estimates that implementing H.R. 4555
would cost $10 million in 2005 and $51 million over the 2005-
2009 period. Enacting the bill would not affect direct spending
or receipts.
H.R. 4555 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. 4555 is shown in the following table.
The costs fall within budget function 550 (health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------
2004 2005 2006 2007 2008 2009
----------------------------------------------------------------------------------------------------------------
SPENDING SUBJECT TO APPROPRIATION
MQSA spending under current law:
Estimated budget authority \1\.............................. 16 0 0 0 0 0
Estimated outlays........................................... 16 7 2 0 0 0
Proposed changes:
Estimated authorization level............................... 0 17 17 18 0 0
Estimated outlays........................................... 0 10 15 17 7 2
MQSA spending under H.R. 4555:
Estimated authorization level \1\........................... 16 17 17 18 0 0
Estimated outlays........................................... 16 17 17 17 7 2
----------------------------------------------------------------------------------------------------------------
\1\ The 2004 level is the amount appropriated in that year for activities authorized under the Mammography
Quality Standards Act but not supported by user fees.
Basis of estimate: For this estimate, CBO assumes that the
bill will be enacted in fiscal year 2004, that the necessary
appropriations will be provided near the start of each fiscal
year, and that outlays will not follow historical spending
patterns for the MQSA program.
H.R. 4555 would authorize the appropriation of such sums as
necessary through 2007 for the Food and Drug Administration
(FDA) to carry out MQSA activities that are not supported by
user fees. Such 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 and
a limited provisional certificate to facilities seeking
reaccreditation under certain circumstances. CBO estimates that
these activities could be carried out with funding set at the
2004 appropriation level, adjusted for inflation. We estimate
that these activities would cost $8 million in 2005 and $33
million over the 2005-2009 period.
H.R. 4555 would modify composition of the National
Mammography Quality Assurance Advisory Committee to include two
industry representatives with expertise in mammography
equipment. CBO assumes that this requirement would effectively
add two new members to the committee. The bill also would cut
back the committee's meeting schedule by directing the
committee to convene only once each year instead of meeting
biannually as required under current law. We estimate that
implementing those changes, on balance, would have a negligible
effect on FDA's costs associated with the advisory committee.
In addition, H.R. 4555 would reauthorize the breast cancer
screening surveillance research grant program, administered by
the National Cancer Institute. The bill would authorize the
appropriation of such sums as necessary for that program, at an
estimated cost of $2 million in 2005 and $18 million over the
2005-2009 period. The program funds research to determine the
effectiveness of screening programs in reducing breast cancer
mortality.
Intergovernmental and private-sector impact: H.R. 4555
contains no intergovernmental or private-sector mandates as
defined in UMRA and would impose no costs on state, local, or
tribal governments.
Previous cost estimate: On March 9, 2004, CBO transmitted a
cost estimate for S. 1879, the Mammography Quality Standards
Act of 2003, as passed by the Senate on February 2, 2004. The
main difference between the bills is that H.R. 4555 would
reauthorize the MQSA program (including the breast cancer
screening surveillance research grants) through fiscal year
2007, while S. 1879 would reauthorize MQSA activities through
2005. H.R. 4555 also would make administrative changes to the
National Mammography Quality Assurance Advisory Committee; S.
1879 does not contain a similar provision. Our cost estimates
reflect those differences.
Estimate prepared by: Federal Costs: Julia Christenson.
Impact on State, Local, and Tribal Governments: Leo Lex. Impact
on Private Sector: Meena Fernandes.
Estimate approved by: Peter H. Fontaine, Deputy 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 designates the short title of the bill as ``The
Mammography Quality Standards Reauthorization Act of 2004.''
Section 2. Temporary Renewal and Limited Provisional Certificate
Section 2 amends section 354 of the Public Health Service
Act to authorize 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 prohibit the facility from meeting the accreditation time
frames; (3) or, if there are other unforeseen circumstances
that keep 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 2 also allows the Secretary to issue, upon the
request of an accreditation body, a limited provisional
certificate, for a period not to exceed 72 hours, to allow an
entity to conduct examination for educational purposes while an
onsite visit from an accreditation body is in progress.
Finally, section 2 permits the Secretary to appoint
individuals with expertise in mammography equipment to the
National Mammography Quality Assurance Advisory Committee and
grants the Advisory Committee greater flexibility in how many
times the Committee must meet annually.
Section 3. Authorization of Appropriations
Section 3 authorizes the appropriations of such sums as
necessary through fiscal year 2007.
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) * * *
(b) Certificate Requirement.--
(1) Certificate.--No facility may conduct an
examination or procedure described in paragraph (2)
involving mammography after October 1, 1994, unless the
facility obtains--
(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);
* * * * * * *
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) * * *
(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).
* * * * * * *
(n) National Advisory Committee.--
(1) * * *
(2) Composition.--The Advisory Committee shall be
composed of not fewer than 13, nor more than 19
individuals, who are not officers or employees of the
Federal Government. The Secretary shall make
appointments to the Advisory Committee from among--
(A) * * *
* * * * * * *
[(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 and at least 2 practicing physicians who
provide mammography services.]
(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.
* * * * * * *
(4) Meetings.--The Advisory Committee shall meet not
less than quarterly for the first 3 years of the
program and thereafter, at least [biannually] annually.
* * * * * * *
(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.
* * * * * * *