[Senate Report 108-220]
[From the U.S. Government Publishing Office]



                                                       Calendar No. 424
108th Congress                                                   Report
                                 SENATE
 1st Session                                                    108-220
======================================================================
 
       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.

                                
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