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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.