[House Report 105-713]
[From the U.S. Government Publishing Office]



105th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES

 2d Session                                                     105-713
_______________________________________________________________________


 
       MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT OF 1998
                                _______
                                

 September 14, 1998.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

  Mr. Bliley, from the Committee on Commerce, submitted the following

                              R E P O R T

                        [To accompany H.R. 4382]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Commerce, to whom was referred the bill 
(H.R. 4382) to amend the Public Health Service Act to revise 
and extend the program for 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..............................................     4
Background and Need for Legislation..............................     4
Hearings.........................................................     7
Committee Consideration..........................................     7
Rollcall Votes...................................................     7
Committee Oversight Findings.....................................     8
Committee on Government Reform and Oversight.....................     8
New Budget Authority, Entitlement Authority, and Tax Expenditures     8
Committee Cost Estimate..........................................     8
Congressional Budget Office Estimate.............................     8
Federal Mandates Statement.......................................    13
Advisory Committee Statement.....................................    13
Constitutional Authority Statement...............................    13
Applicability to Legislative Branch..............................    13
Section-by-Section Analysis of the Legislation...................    14
Changes in Existing Law Made by the Bill, as Reported............    15
Appendix.........................................................    23

                               Amendment

  The amendment is as follows:
  Strike out all after the enacting clause and insert in lieu 
thereof the following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Mammography Quality Standards 
Reauthorization Act of 1998''.

SEC. 2. AUTHORIZATION OF APPROPRIATIONS.

  (a) In General.--Section 354(r)(2) of the Public Health Service Act 
(42 U.S.C. 263b(r)(2)) is amended in each of subparagraphs (A) and (B) 
by striking ``1997'' and inserting ``2002''.
  (b) Technical Amendments.--Section 354(r)(2) of the Public Health 
Service Act (42 U.S.C. 263b(r)(2)) is amended in subparagraph (A) by 
striking ``subsection (q)'' and inserting ``subsection (p)'', and in 
subparagraph (B) by striking ``fiscal year'' and inserting ``fiscal 
years''.

SEC. 3. APPLICATION OF CURRENT VERSION OF APPEAL REGULATIONS.

  Section 354(d)(2)(B) of the Public Health Service Act (42 U.S.C. 
263b(d)(2)(B)) is amended by striking ``42 C.F.R. 498 and in effect on 
the date of the enactment of this section'' and inserting ``part 498 of 
title 42, Code of Federal Regulations''.

SEC. 4. ACCREDITATION STANDARDS.

  (a) In General.--Section 354(e)(1)(B) of the Public Health Service 
Act (42 U.S.C. 263b(e)(1)(B)) is amended--
          (1) in clause (i), by striking ``practicing physicians'' each 
        place such term appears and inserting ``review physicians''; 
        and
          (2) in clause (ii), by striking ``financial relationship'' 
        and inserting ``relationship''.
  (b) Definition.--Section 354(a) of the Public Health Service Act (42 
U.S.C. 263b(a)) is amended by adding at the end the following:
          ``(8) Review physician.--The term `review physician' means a 
        physician as prescribed by the Secretary under subsection 
        (f)(1)(D) who meets such additional requirements as may be 
        established by an accreditation body under subsection (e) and 
        approved by the Secretary to review clinical images under 
        subsection (e)(1)(B)(i) on behalf of the accreditation body.''.

SEC. 5. CLARIFICATION OF FACILITIES' RESPONSIBILITY TO RETAIN MAMMOGRAM 
                    RECORDS.

  Section 354(f)(1)(G) of the Public Health Service Act (42 U.S.C. 
263b(f)(1)(G)) is amended by striking clause (i) and inserting the 
following:
                          ``(i) a facility that performs any 
                        mammogram--
                                  ``(I) except as provided in subclause 
                                (II), maintain the mammogram in the 
                                permanent medical records of the 
                                patient for a period of not less than 5 
                                years, or not less than 10 years if no 
                                subsequent mammograms of such patient 
                                are performed at the facility, or 
                                longer if mandated by State law; and
                                  ``(II) upon the request of or on 
                                behalf of the patient, transfer the 
                                mammogram to a medical institution, to 
                                a physician of the patient, or to the 
                                patient directly; and''.

SEC. 6. DIRECT REPORTS TO PATIENTS.

  Section 354(f)(1)(G)(ii) of the Public Health Service Act (42 U.S.C. 
263b(f)(1)(G)(ii)) is amended by striking subclause (IV) and inserting 
the following:
                          ``(IV) whether or not such a physician is 
                        available or there is no such physician, a 
                        summary of the written report shall be sent 
                        directly to the patient in terms easily 
                        understood by a lay person; and''.

SEC. 7. SCOPE OF INSPECTIONS.

  Section 354(g)(1)(A) of the Public Health Service Act (42 U.S.C. 
263b(g)(1)(A)) is amended in the first sentence--
          (1) by striking ``certified''; and
          (2) by inserting ``the certification requirements under 
        subsection (b) and'' after ``compliance with''.

SEC. 8. DEMONSTRATION PROGRAM REGARDING FREQUENCY OF INSPECTIONS.

  Section 354(g) of the Public Health Service Act (42 U.S.C. 263b(g)) 
is amended--
          (1) in paragraph (1)(E), by inserting ``, subject to 
        paragraph (6)'' before the period; and
          (2) by adding at the end the following paragraph:
          ``(6) Demonstration program.--
                  ``(A) In general.--The Secretary may establish a 
                demonstration program under which inspections under 
                paragraph (1) of selected facilities are conducted less 
                frequently by the Secretary (or as applicable, by State 
                or local agencies acting on behalf of the Secretary) 
                than the interval specified in subparagraph (E) of such 
                paragraph.
                  ``(B) Requirements.--Any demonstration program under 
                subparagraph (A) shall be carried out in accordance 
                with the following:
                          ``(i) The program may not be implemented 
                        before April 1, 2001. Preparations for the 
                        program may be carried out prior to such date.
                          ``(ii) In carrying out the program, the 
                        Secretary may not select a facility for 
                        inclusion in the program unless the facility is 
                        substantially free of incidents of 
                        noncompliance with the standards under 
                        subsection (f). The Secretary may at any time 
                        provide that a facility will no longer be 
                        included in the program.
                          ``(iii) The number of facilities selected for 
                        inclusion in the program shall be sufficient to 
                        provide a statistically significant sample, 
                        subject to compliance with clause (ii).
                          ``(iv) Facilities that are selected for 
                        inclusion in the program shall be inspected at 
                        such intervals as the Secretary determines will 
                        reasonably ensure that the facilities are 
                        maintaining compliance with such standards.''.

SEC. 9. CLARIFICATION OF AUTHORITY TO DELEGATE INSPECTION 
                    RESPONSIBILITY TO LOCAL GOVERNMENT AGENCIES.

  Section 354 of the Public Health Service Act (42 U.S.C. 263b) is 
amended--
          (1) in subsections (a)(4), (g)(1), (g)(3), and (g)(4), by 
        inserting ``or local'' after ``State'' each place such term 
        appears;
          (2) in the heading of subsection (g)(3), by inserting ``or 
        local'' after ``state''; and
          (3) in subsection (i)(1)(D)--
                  (A) by inserting ``or local'' after ``State'' the 
                first place such term appears; and
                  (B) by inserting ``or local agency'' after ``State'' 
                the second place such term appears.

SEC. 10. PATIENT NOTIFICATION CONCERNING HEALTH RISKS.

  (a) Requirement.--Section 354(h) of the Public Health Service Act (42 
U.S.C. 263b(h)) is amended--
          (1) by redesignating paragraphs (2) and (3) as paragraphs (3) 
        and (4), respectively; and
          (2) by inserting after paragraph (1) the following:
          ``(2) Patient information.--If the Secretary determines that 
        the quality of mammography performed by a facility (whether or 
        not certified pursuant to subsection (c)) was so inconsistent 
        with the quality standards established pursuant to subsection 
        (f) as to present a significant risk to individual or public 
        health, the Secretary may require such facility to notify 
        patients who received mammograms at such facility, and their 
        referring physicians, of the deficiencies presenting such risk, 
        the potential harm resulting, appropriate remedial measures, 
        and such other relevant information as the Secretary may 
        require.''.
  (b) Civil Money Penalty.--Section 354(h)(3) of the Public Health 
Service Act (42 U.S.C. 263b(h)(3)), as redesignated by subsection 
(a)(1), is amended--
          (1) by striking ``and'' at the end of subparagraph (B);
          (2) by redesignating subparagraph (C) as subparagraph (D); 
        and
          (3) by inserting after subparagraph (B) the following:
                  ``(C) each failure to notify a patient of risk as 
                required by the Secretary pursuant to paragraph (2), 
                and''.
  (c) Conforming Amendment.--Section 354(h)(4) of the Public Health 
Service Act (42 U.S.C. 263b(h)(4)), as redesignated by subsection 
(a)(1), is amended by striking ``paragraphs (1) and (2)'' and inserting 
``paragraphs (1) through (3)''.

SEC. 11. REQUIREMENT TO COMPLY WITH INFORMATION REQUESTS.

  Section 354(i)(1)(C) of the Public Health Service Act (42 U.S.C. 
263b(i)(1)(C)) is amended--
          (1) by inserting after ``Secretary'' the first place such 
        term appears the following: ``(or of an accreditation body 
        approved pursuant to subsection (e))''; and
          (2) by inserting after ``Secretary'' the second place such 
        term appears the following: ``(or such accreditation body or 
        State carrying out certification program requirements pursuant 
        to subsection (q))''.

SEC. 12. ADJUSTMENT TO SEVERITY OF SANCTIONS.

  Section 354(i)(2)(A) of the Public Health Service Act (42 U.S.C. 
263b(i)(2)(A)) is amended by striking ``makes the finding'' and all 
that follows and inserting the following: ``has reason to believe that 
the circumstance of the case will support one or more of the findings 
described in paragraph (1) and that--
                          ``(i) the failure or violation was 
                        intentional; or
                          ``(ii) the failure or violation presents a 
                        serious risk to human health.''.

SEC. 13. TECHNICAL AMENDMENT.

  Section 354(q)(4)(B) of the Public Health Service Act (42 U.S.C. 
263b(q)(4)(B)) is amended by striking ``accredited'' and inserting 
``certified''.

                          Purpose and Summary

    The Mammography Quality Standards Reauthorization Act of 
1998 reauthorizes programs for inspection and certification of 
mammography facilities. It also provides for direct patient 
notification of all mammography examinations, requiring that 
``a summary of the written report shall be provided to every 
patient in terms easily understood by a lay person;'' and 
permits the Food and Drug Administration (FDA) to conduct a 
limited demonstration project to determine the feasibility of 
inspecting high-performing mammography facilities on a less 
than annual basis.
    The Mammography Quality Standards Reauthorization Act of 
1998, H.R. 4382, contains a number of provisions which go 
beyond the requirements of the Mammography Quality Standards 
Act of 1992. H.R. 4382:
          Clarifies the responsibility of the mammography 
        facility to retain mammogram records so that women have 
        the ability to obtain the original of their mammograms;
          Clarifies that both State and local government 
        agencies have inspection authority;
          Ensures that patients and referring physicians will 
        be advised of any mammogram facility deficiencies;
          Mandates direct patient notification written in 
        layman's terms; and
          Permits the FDA to conduct a limited demonstration 
        project to determine the feasibility of inspecting 
        high-performing mammography facilities on a schedule 
        less frequent than the current annual cycle.

                  Background and Need for Legislation

    According to the May 8, 1998, testimony of the General 
Accounting Office (GAO) before the Subcommittee on Health and 
Environment (see GAO/T-HEHS-98-164), breast cancer is the most 
commonly diagnosed non-skin cancer and the second leading cause 
of cancer deaths among American women. Experts estimate that 
during the 1990s as many as 1.8 million women will be diagnosed 
with breast cancer, and 500,000 will die from it. An estimated 
44,000 women died from breast cancer in 1997 and an estimated 
180,200 new cases of the disease were diagnosed. The 
probability of survival, as well as use of breast-conserving 
therapy and the avoidance of mastectomy, increases 
significantly when the disease is discovered in its early 
stages. Presently, the most effective technique for early 
detection of breast cancer is screening mammography, an X-ray 
procedure that can detect small tumors and breast abnormalities 
up to 2 years before they can be detected by touch. Over 90 
percent of these early stage cancers can be cured, according to 
the FDA. The use of mammography as a tool for detecting early 
cancer continues to increase. When surveyed, the percentage of 
women aged 50 and older who had reported receiving mammograms 
in the previous year increased from 26 percent in 1987 to 57 
percent in 1995, according to the Centers for Disease Control 
and Prevention (CDC). The percentage of women aged 40 to 49 who 
received mammograms in the five years prior to 1995 increased 
from 59 percent to 66 percent.
    The authorization for the original legislation expired at 
the end of Fiscal Year 1997. Progress made in combating breast 
cancer is ascribed in part to the success of the Mammography 
Quality Standards Act of 1992 (Public Law 102-539) (MQSA). Many 
organizations, including the following, expressly support 
reauthorization of MQSA: the American Cancer Society, the 
National Coalition for Cancer Survivorship, the National Breast 
Cancer Coalition, the National Alliance of Breast Cancer 
Organizations, the Y-ME National Breast Cancer Organization, 
the Breast Cancer Resource Committee, the Susan G. Komen 
Foundation, the Women's Legal Defense Fund, the American 
College of Radiology, the American College of Obstetricians and 
Gynecologists, the American Registry of Diagnostic Medical 
Sonographers, the American Institute of Ultrasound in Medicine, 
and the Conference of Radiation Control Program Directors.

               Mammography Quality Standards Act of 1992

    In response to concerns about the safety, accuracy, and 
overall quality of mammography services, the 102nd Congress 
enacted the Mammography Quality Standards Act of 1992. The 
provisions of MQSA are found in Section 354 of the Public 
Health Service Act. Under this legislation, no mammography 
facility (as defined by the legislation) may operate in the 
UnitedStates after October 1, 1994, without certification by 
the Secretary of the Department of Health and Human Services (HHS) as 
having met HHS-established program requirements. To obtain 
certification, mammography facilities must be accredited by an HHS-
approved body (the four current accreditation bodies are the American 
College of Radiology and the States of Iowa, Arkansas, and California). 
This entails passing an evaluation of clinical images from a facility 
and compliance with national regulations for personnel, equipment, 
quality assurance, and notification of examination results to patients. 
To maintain certification status, facilities must show continued 
compliance with the regulations during annual inspections and through 
reaccreditation every three years. Various sanctions are authorized 
under the Act and may be imposed by either HHS or a State on a facility 
that is found not to be in compliance with MQSA's requirements.
    MQSA established national, uniform quality standards for 
mammography. These standards require that facilities:
          Use only radiological technologists and equipment 
        designed for mammography;
          Employ only qualified physicians to interpret the 
        results of the mammograms;
          Establish a quality assurance and control program to 
        ensure the reliability, clarity, and accurate 
        interpretation of mammograms;
          Undergo inspections by qualified inspectors on an 
        annual basis; and
          Be accredited by an HHS-approved accrediting 
        organization.
    Additionally, MQSA directed the Secretary of HHS to 
establish tough sanctions for any facility not following the 
standards. Finally, the Act provided adequate funding for 
accrediting organizations to ensure that all facilities can be 
certified and inspected.
    The FDA has the responsibility for implementing and 
enforcing MQSA. On December 21, 1993, the agency set forth 
standards for accreditation and certification that mammography 
professionals and facilities would have to meet by October 1, 
1994, or be banned from performing mammography. Final rules 
were developed with the advice of the National Mammography 
Quality Assurance Advisory Committee (composed of consumer and 
medical representatives) and were published on October 28, 
1997, 62 Fed. Reg. 55852. The rules become effective on April 
28, 1999. The Agency for Health Care Policy and Research 
(AHCPR) has also issued formal Mammography Clinical Practice 
Guidelines. See AHCPR Guideline Number 13, October 1994.
    Costs of the program related to annual inspections may be 
covered through the collection of fees from mammography 
facilities. As of 1997, FDA charged $1,178 for the first 
mammography unit and $152 for each additional unit. Funding for 
other activities required under MQSA is available through an 
authorization of appropriations for ``such sums as may be 
necessary'' for Fiscal Year 1993 through Fiscal Year 1997.
    The effectiveness of mammography as a cancer detection 
technique is directly related to the quality of mammography 
procedures. As of 1997, there were 10,025 certified mammography 
facilities in the United States, of which 9,687 were fully 
certified. The remainder were provisionally certified while 
they were in the process of becoming accredited or reinstated. 
The names and locations of certified facilities are available 
from the Cancer Information Service at the toll-free number of 
the National Cancer Institute, 1-800-4-CANCER. Additionally, 
all certified facilities are issued a certificate by the FDA 
which must be prominently displayed and which must be made 
available for examination upon request.

                  GAO's Assessment of the MQSA Program

    As required by MQSA, GAO published two interim reports 
(October 1995 and January 1997) and a final report (October 
1997) on the program established by the FDA to implement the 
requirements of the Act. The first interim report focused on 
the Act's initial impact on access to and quality of 
mammography services and the second focused on FDA's annual 
inspection program. In short, GAO found that MQSA has increased 
mammography facilities' adherence to accepted quality assurance 
standards, which has, in turn, had a favorable effect on 
mammography services. The GAO also concluded that MQSA's 
establishment of nationwide minimum standards and required 
facility accreditation, resulted in thousands of facilities 
having to improve their quality assurance processes. FDA's 
annual inspections of facilities, now in their third year, 
continue to show increasing compliance with these national 
quality standards. GAO found further evidence of improvement in 
the quality of the X-ray images. Before the Act took effect, 11 
percent of facilities tested were unable to pass image quality 
tests; now, due to the heightened scrutiny under MQSA, the 
nationwide failure rate for passing image quality tests is only 
two percent.
    When Congress enacted MQSA, concern was expressed that some 
women might have difficulty obtaining mammography services if 
facilities chose to close down rather than to upgrade their 
operations to meet the new quality standards. GAO found no 
indication that access problems had developed as a result of 
MQSA. Nationwide, the number of facilities that stopped 
offering mammograms was nearly offset by the number of new 
entrants into the field.

                                Hearings

    The Subcommittee on Health and Environment held a hearing 
on May 8, 1998, on the ``Reauthorization of the Mammography 
Quality Standards Act.'' The Subcommittee received testimony 
from the following witnesses: Dr. D. Bruce Burlington, 
Director, Center for Devices and Radiological Health, Food and 
Drug Administration, accompanied by Ms. Florence Houn, 
Director, Division of Mammography Quality and Radiation 
Programs, Center for Devices and Radiological Health, Food and 
Drug Administration; Ms. Judy M. Destouet on behalf of the 
American College of Radiology; Ms. Amy S. Langer, Executive 
Director, National Alliance of Breast Cancer Organizations; Ms. 
Marsha Lillie-Blanton, Associate Director, Health Services, 
Quality, and Public Health Issues, General Account Office, 
accompanied by Mr. Frank Pasquier, Assistant Director, Health 
Services, Quality, and Public Health Issues, General Accounting 
Office; Mr. Robert A. Smith, Senior Director, Cancer Detection 
and Treatment, American Cancer Society; and Ms. Frances M. 
Visco, President, National Breast Cancer Coalition.

                        Committee Consideration

    On August 3, 1998, the Subcommittee on Health and 
Environment met in open markup session to consider a Committee 
Print entitled the ``Mammography Quality Standards 
Reauthorization Act of 1998.'' By a voice vote, the 
Subcommittee agreed to the Committee Print, amended, and 
approved the introduction of a clean bill for Full Committee 
consideration. The clean bill was introduced in the House on 
August 3, 1998, as H.R. 4382. On August 5, 1998, the Full 
Committee on Commerce met in open markup session and ordered 
H.R. 4382, the Mammography Quality Standards Reauthorization 
Act of 1998, reported to the House, amended, by a voice vote, a 
quorum being present.

                             Rollcall Votes

    Clause 2(l)(2)(B) of rule XI of the Rules of the House 
requires the Committee to list the recorded votes on the motion 
to report legislation and amendments thereto. There were no 
recorded votes taken in connection with ordering H.R. 4382 
reported. An en bloc amendment offered by Mr. Bilirakis making 
technical and clarifying corrections was adopted by a voice 
vote. A motion by Mr. Bliley to order H.R. 4382 reported to the 
House, amended, was agreed to by a voice vote, a quorum being 
present.

                      Committee Oversight Findings

    Pursuant to clause 2(l)(3)(A) of rule XI of the Rules of 
the House of Representatives, the Committee held a legislative 
hearing on May 8, 1998, and made findings that are reflected in 
this report.

              Committee on Government Reform and Oversight

    Pursuant to clause 2(l)(3)(D) of rule XI of the Rules of 
the House of Representatives, no oversight findings have been 
submitted to the Committee by the Committee on Government 
Reform and Oversight.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 2(l)(3)(B) of rule XI of the 
Rules of the House of Representatives, the Committee finds that 
H.R 4382, the Mammography Quality Standards Reauthorization Act 
of 1998, 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 2(l)(3)(C) of rule XI 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, September 14, 1998.
Hon. Tom Bliley,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 4382, the 
Mammography Quality Standards Reauthorization Act of 1998, as 
ordered reported by the Committee on Commerce on August 5, 
1998.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff is Julia Christensen.
            Sincerely,
                                         June E. O'Neill, Director.
    Enclosure.

H.R. 4382--Mammography Quality Standards Reauthorization Act of 1998

    Summary: H.R. 4382 would reauthorize Mammography Quality 
Standards Act (MQSA) programs through fiscal year 2002. CBO 
estimates that enacting H.R. 4382 would increase federal 
government spending by $15 million in fiscal year 1999 and by 
$79 million over the 1999-2003 period. The bill would also 
reduce federal revenues by about $1 million in 1999 and by $5 
million over the 1999-2003 period, assuming an enactment date 
of October 1, 1998.
    Almost all of the increase in spending would be for the 
reauthorized programs that are subject to appropriation. In 
addition, the bill would require facilities performing 
mammograms to send written summaries of test results to all 
patients, which would both increase costs for federal health 
facilities that perform mammograms and also result in higher 
costs for Medicaid and the Federal Employees Health Benefits 
Program (FEHBP). CBO estimates that the increase in direct 
spending for Medicaid and FEHBP would total less than $1 
million annually. This provision would also reduce federal 
revenues because it would raise the costs of employer-sponsored 
health insurance, and correspondingly reduce the amount of 
employee compensation subject to income and payroll taxes. 
Because the bill would affect direct spending and receipts, 
pay-as-you-go procedures would apply.
    The requirement that mammogram facilities provide patients 
with easily understandable written summaries of their test 
results would also constitute an intergovernmental and private-
sector mandate as defined in the Unfunded Mandates Reform Act 
of 1995 (UMRA). CBO estimates that the costs to state, local, 
and tribal governments of complying with this mandate would not 
exceed the threshold for intergovernmental mandates established 
in the law ($50 million in 1996, adjusted annually for 
inflation). Likewise, CBO estimates that the cost of this new 
requirement to the private sector would not exceed the 
applicable threshold ($100 million in 1996, adjusted annually 
for inflation).
    Estimated cost to the Federal Government: The estimated 
budgetary impact of the H.R. 4382 is shown in the following 
table. The costs of this legislation fall within budget 
function 550 (Health).

                                    [By fiscal year, in millions of dollars]
----------------------------------------------------------------------------------------------------------------
                                                              1998     1999     2000     2001     2002     2003
----------------------------------------------------------------------------------------------------------------
                                        SPENDING SUBJECT TO APPROPRIATION
Spending under current law
    Budget Authority \1\..................................       17        0        0        0        0        0
    Estimated Outlays.....................................       17        3        1        0        0        0
Proposed changes:
    Authorization Level...................................        0       18       19       20       20        0
    Estimated Outlays.....................................        0       15       18       19       20        4
Spending under H.R. 4382:
    Authorization level...................................       17       18       19       20       20        0
    Estimated outlays.....................................       17       18       19       19       20        4
                                           CHANGES IN DIRECT SPENDING
Estimated budget authority................................        0        1        1        1        1        1
Estimated outlays.........................................        0        1        1        1        1        1
                                               CHANGES IN REVENUES
Estimated revenues........................................        0       -1       -1       -1       -1       -1
----------------------------------------------------------------------------------------------------------------
\1\ The 1998 level is the amount appropriated for that year.
This estimate assumes that H.R. 4382 is enacted on October 1, 1998.

    Basis of estimate: For the purposes of this estimate, CBO 
assumed that all amounts authorized in the bill would be 
appropriated by the start of each fiscal year and that outlays 
would follow historical spending patterns.
    Spending subject to appropriation: H.R. 4382 would 
reauthorize the Mammography Quality Standards Act through 2002, 
with some slight modifications to current law. Section 2 would 
authorize the breast cancer screening surveillance research 
grant program, administered by the National Cancer Institute, 
at a cost of almost $4 million in 1999 and $15 million over the 
1999-2003 period. This program, operated jointly with the 
Centers for Disease Control and Prevention and the Department 
of Defense, funds research to determine the cost and 
effectiveness of screening programs in reducing breast cancer 
mortality.
    Section 2 would also reauthorize funding for program 
activities that are not supported by the MQSA user fees. These 
activities include administering mammography facilities, 
providing consumer education, and establishing standards for 
accreditation bodies, equipment, personnel, and quality 
assurance. This provision would increase authorizations of 
appropriations for the MQSA program by $14 million in 1999 and 
by $59 million over the 1999-2003 period.
    Section 6 of the bill would require facilities providing 
mammograms to send each patient a written and easily 
understandable summary of the results of her mammogram. CBO's 
earlier estimate of draft MQSA reauthorization language for S. 
537--dated October 23, 1997--was prepared before the issuance 
of the final regulations implementing MQSA. This estimate 
assumes that additional facilities have implemented systems of 
written notification over the past year to comply with the 
final rule requiring a notification system of some form, 
thereby lowering CBO's estimate of the aggregate cost of the 
provision.
    The Food and Drug Administration (FDA) estimates that about 
40 million mammograms were performed in 1997, and the number is 
expected to increase over time. In cases where patients are not 
already provided with written summaries of the results of their 
mammograms, CBO estimates that enactment of this provision 
would cost health plans and providers an additional $1 per 
mammogram, on average. As a result, the cost to federal 
programs operating facilities that perform mammograms, such as 
the Indian Health Service, would increase by less than $1 
million a year.
    Section 7 would permit FDA inspectors to enter any 
mammography facility to determine compliance with MQSA 
certification requirements. Under current law, the agency is 
authorized to enter only certified facilities. According to the 
FDA, only a small number of unlicensed mammography facilities 
are operational; therefore, the agency would have to conduct 
few additional inspections under the proposal. Based on data 
provided by the FDA, CBO estimates that this provision would 
increase federal costs by less than $1 million annually.Section 
8 would allow the Secretary of Health and Human Services (HHS) to set 
up an open-ended demonstration program that allows certain well-run 
facilities to undergo less frequent inspections than currently required 
by law. CBO assumed the selected facilities would be subject to 
biannual inspections. (Current law requires each facility be inspected 
annually.) CBO assumed that 150 facilities would participate in the 
first year of the demonstration program. This estimate assumes 
implementation of the demonstration program would begin on October 1, 
2001, with preparations starting in fiscal year 1999.
    Current law directs the Secretary of HHS to assess an 
inspection fee on facilities--other than governmental entities 
as defined by statute--to cover the aggregate costs of the 
inspection program in each fiscal year. (The cost of inspecting 
governmental entities is paid through federal funds 
appropriated to the FDA.) Current law requires that the fee be 
reasonably based on the proportion of inspection costs related 
to each facility. However, section 8 would allow the estimated 
150 facilities participating in the demonstration program to 
forgo a cycle of inspections during fiscal year 2002. During 
that year, CBO assumed that these facilities would not be 
required to pay any fee in lieu of the inspection fee to the 
MQSA program.
    Current law effectively caps inspection fees for facilities 
at their reasonable prorated share of running the MQSA 
inspection program and disallows cross subsidization of the 
costs of the program among facilities. As a result, section 8 
would have the effect of either decreasing the collections of 
fees available to operate their inspection program or requiring 
an increase in authorizations of appropriations to continue the 
MQSA inspection program as it is currently operated.
    This estimate assumes that resources associated with the 
MQSA inspection program, such as the inspector workforce, would 
be maintained at current levels over the 1999-2003 period. The 
demonstration program described in section 8 would increase 
authorizations of appropriations for the MQSA program by less 
than $1 million over the 1999-2003 period. This amount would 
cover the portion of the costs of maintaining the inspection 
program attributable to the demonstration program participants 
during the off-inspection year (excepting the expenses related 
to forgone field inspections) plus the cost of running the 
demonstration program through fiscal year 2003.
    Because of the open-ended nature of the demonstration 
program, its cost to the federal government would climb under 
the bill as the number of facilities participating rose over 
time. Increased participation would create a wedge in the 
shares of inspection program costs borne by facilities exempted 
from inspection fees in the years they are not inspected and by 
facilities that continue to be inspected annually. Such an 
arrangement would transfer a growing share of the cost of the 
inspection program to the federal government through increases 
in authorizations of appropriations if current program 
resources were maintained and fees were not collected from the 
demonstration program participants to cover their reasonable 
share of program expenses in non-inspection years.
    Direct spending and revenues: As noted earlier, requiring 
facilities to send written summaries of mammogram results 
directly to patients would cost health plans and providers an 
additional $1 per mammogram, on average. This requirement would 
increase costs for Medicaid and FEHBP by less than $1 million 
annually. (CBO assumes these costs to the federal government 
would extend beyond the expiration of the MQSA program because 
health plans and providers would continue to provide these 
reports to patients and would incur costs.) Medicare spending 
would not be significantly affected, because almost all 
payments for mammograms are based on a fee schedule.
    Higher costs for health plans and providers would also 
increase premiums for employer-sponsored health insurance, with 
a corresponding reduction in the amount of employee 
compensation subject to income and payroll taxes. The Joint 
Committee on Taxation estimates that income and payroll tax 
revenues would fall by about $1 million a year.
    Pay-as-you-go considerations: The Balanced Budget and 
Emergency Deficit Control Act of 1985 sets up pay-as-you-go 
procedures for legislation affecting direct spending or 
receipts. Because section 6 of the bill would affect direct 
spending and receipts, pay-as-you-go procedures would apply. 
The impact of this provision on Medicaid and FEHBP outlays and 
on federal revenues is shown in the table below. For purposes 
of enforcing pay-as-you-go procedures, only the effects in the 
budget year and the succeeding four years are counted.

                                    [By fiscal year, in millions of dollars]
----------------------------------------------------------------------------------------------------------------
                                      1998   1999   2000   2001   2002   2003   2004   2005   2006   2007   2008
----------------------------------------------------------------------------------------------------------------
Changes in outlays.................      0      1      1      1      1      1      1      1      1      1      1
Changes in receipts................      0     -1     -1     -1     -1     -1     -1     -1     -1     -1     -1
----------------------------------------------------------------------------------------------------------------

    Estimated impact on State, local, and tribal governments: 
The requirement that mammogram facilities provide patients with 
easily understandable written summaries of their test results 
would constitute a mandate as defined by the Unfunded Mandates 
Reform Act. Based on survey and statistical data provided by 
the Food and Drug Administration and professional health care 
associations, CBO estimates that state, local and tribal 
medical facilities that perform mammograms would face 
additional costs of approximately $3 million annually during 
the first five years of implementation. The costs would include 
the initial development or purchase of a classification and 
reporting system, its implementation, and other operational 
costs. As noted earlier in the explanation of federal costs, 
these costs are lower than CBO's earlier estimate of draft MQSA 
reauthorization language (dated October 23, 1997). Since then, 
CBO has received updated information about the proportion of 
facilities that are governmentally operated and about the 
number of facilities that currently provide written reports.
    States would face additional Medicaid costs of less than $1 
million annually as a result of the notification requirements. 
However, because states have sufficient flexibility to alter 
their financial or programmatic responsibilities to offset 
these costs, the requirement would not be a mandate as defined 
by UMRA. The bill would also allow the Secretary of Health and 
Human Services to require certain mammogram facilities to 
notify patients if the quality of care in those facilities is 
found to fall short of existing statutory standards. Facilities 
would be free from the responsibility to make such 
notifications, however, if they are in compliance with the 
underlying standards. Consequently, this provision would not be 
considered a mandate under UMRA.
    Finally, the bill would allow local governments to be 
approved to inspect mammogram facilities. Local governments, 
like states, would receive federal reimbursements for the costs 
associated with the inspections.
    Estimated impact on the private sector: The requirement to 
directly send patients written summaries of their test results 
would also constitute a mandate on the over 9,000 private 
sector facilities in the U.S. that perform mammograms. These 
facilities include hospitals, outpatient departments, clinics, 
radiology practices, mobile units, and physicians' offices. CBO 
estimates that the direct cost of this requirement on these 
private sector entities would not exceed the threshold for 
private-sector mandates specified in UMRA ($100 million in 
1996, adjusted annually for inflation) in any of the first five 
years the mandate would be effective.
    Estimate prepared by: Federal cost estimate: Julia 
Christensen; Impact on State, local, and tribal governments: 
Leo Lex; Impact on the private sector: Julia Christensen.
    Estimate approved by: Paul N. Van de Water, Assistant 
Director for Budget Analysis Division.

                       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 2(l)(4) of rule XI 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 as the ``Mammography 
Quality Standards Reauthorization Act of 1998.''

Section 2. Authorization of appropriations

    Section 2 authorizes the Mammography Quality Standards Act 
through Fiscal Year 2002, and makes a technical amendment.

Section. 3. Application of current version of appeal regulations

    Section 3 makes a technical amendment to the present 
statute.

Section 4. Accreditation standards

    Section 4 clarifies that physicians employed in reviewing 
mammography facilities (``review physicians'') may not have any 
conflicting relationships that may interfere with an even-
handed review. This section permits the Secretary of HHS to 
impose additional requirements on review physicians through an 
accreditation body.

Section 5. Clarification of facilities responsibility to retain 
        mammogram records

    Section 5 clarifies that mammography facilities shall 
maintain permanent medical records of their patients for not 
less than five years, or not less than ten years if no 
subsequent mammograms are performed at the same facility. This 
section permits State law to require longer periods of time, 
and also permits the patient to transfer the mammogram record 
to another medical institution, a physician, or the patient 
herself.

Section 6. Direct reports to patients

    Section 6 provides that all mammography patients receive a 
written summary of the mammography report in language easily 
understood by a lay person. A similar provision in the 
Mammography Quality Standards Act of 1992 provided for direct 
patient notification for self-referred women. H.R. 4382 
broadens the scope to require direct patient notification to 
all mammography patients.
    In October 1994, the U.S. Department of Health and Human 
Services Agency for Health Care Policy and Research published 
``Quality Determinants of Mammography,'' Clinical Practice 
Guideline Number 13. According to this guideline, ``Any written 
communication must have language that is carefully constructed 
to impart results without causing undue anxiety, to promote a 
relationship between the woman and a health care provider, and 
to encourage the woman to take the next step.'' The Committee 
envisions that this written notification need not be any more 
detailed than the examples that appear in the ``Quality 
Determinants of Mammography.'' Chapter Four of this 
publication, which contains sample letters, is reprinted as an 
appendix to this report. In the interests of timely compliance 
of mammography facilities, the Committee anticipates that this 
new requirement will not be obligatory until April 28, 1999, 
the day the final regulations for Quality Mammography Standards 
go into effect pursuant to the final rule published by HHS in 
the Federal Register on October 28, 1997, 62 Fed. Reg. 55852.

Section 7. Scope of inspections

    Section 7 clarifies that the Secretary of HHS may inspect 
both certified and uncertified facilities to monitor compliance 
with certification requirements.

Section 8. Demonstration program regarding frequency of inspections

    Section 8 authorizes the Secretary of HHS to undertake a 
demonstration project that may reduce the inspection burden by 
reducing the inspection frequency on those mammography 
facilities of the highest quality. The Committee anticipates 
that such a demonstration project would be large enough to 
produce sufficient, reliable data, but should not cover more 
than three to five States.
     Although the demonstration project may not be implemented 
before April 1, 2001, the Committee encourages the Secretary to 
begin preparations well before this date so the program can 
begin on or immediately after the statutory date. The Committee 
believes that a focus of the limited resources available for 
this program on those facilities having the greatest difficulty 
meeting the quality standards will provide the greatest benefit 
to the public health of women receiving the benefits of 
mammography.

Section 9. Clarification of authority to delegate inspection 
        responsibility to local government agencies

    Section 9 clarifies that local governments may be delegated 
inspection authority.

Section 10. Patient notification concerning health risks

    Section 10 requires that substandard mammography facilities 
notify their patients of the deficiencies presenting 
significant health risks.

Section 11. Requirement to comply with information requests

Section 11 clarifies that the requirements to comply with information 
        requests apply to those requests originating from accrediting 
        bodies as well as the Secretary of HHS.

Section 12. Adjustment to severity of sanctions

    Section 12 adjusts the severity of sanctions so that the 
necessary findings include intentional failures or failures 
that would place human health at serious risk.

Section 13. Technical amendment

    Section 13 makes a technical amendment.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3 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) Definitions.--As used in this section:
          (1) * * *

           *       *       *       *       *       *       *

          (4) Inspection.--The term ``inspection'' means an 
        onsite evaluation of the facility by the Secretary, or 
        State or local agency on behalf of the Secretary.

           *       *       *       *       *       *       *

          (8) Review physician.--The term ``review physician'' 
        means a physician as prescribed by the Secretary under 
        subsection (f)(1)(D) who meets such additional 
        requirements as may be established by an accreditation 
        body under subsection (e) and approved by the Secretary 
        to review clinical images under subsection (e)(1)(B)(i) 
        on behalf of the accreditation body.

           *       *       *       *       *       *       *

  (d) Application for Certificate.--
          (1) * * *
          (2) Appeal.--If the Secretary denies an application 
        for the certification of a facility submitted under 
        paragraph (1)(A), the Secretary shall provide the owner 
        or lessor of the facility or the agent of the owner or 
        lessor who submitted such application--
                  (A) a statement of the grounds on which the 
                denial is based, and
                  (B) an opportunity for an appeal in 
                accordance with the procedures set forth in 
                regulations of the Secretary published at [42 
                C.F.R. 498 and in effect on the date of the 
                enactment of this section] part 498 of title 
                42, Code of Federal Regulations.

           *       *       *       *       *       *       *

  (e) Accreditation.--
          (1) Approval of accreditation bodies.--
                  (A) * * *
                  (B) Standards.--The Secretary shall establish 
                standards for accreditation bodies, including--
                          (i) standards that require an 
                        accreditation body to perform--
                                  (I) a review of clinical 
                                images from each facility 
                                accredited by such body not 
                                less often than every 3 years 
                                which review will be made by 
                                qualified [practicing] review 
                                physicians; and
                                  (II) a review of a random 
                                sample of clinical images from 
                                such facilities in each 3-year 
                                period beginning October 1, 
                                1994, which review will be made 
                                by qualified [practicing] 
                                review physicians;
                          (ii) standards that prohibit 
                        individuals conducting the reviews 
                        described in clause (i) from 
                        maintaining any [financial] 
                        relationship to the facility undergoing 
                        review which would constitute a 
                        conflict of interest;

           *       *       *       *       *       *       *

  (f) Quality Standards.--
          (1) In general.--The standards referred to in 
        subsection (d)(1)(B)(i) are standards established by 
        the Secretary which include--
                  (A) * * *

           *       *       *       *       *       *       *

                  (G) a requirement that--
                          [(i) a facility that performs any 
                        mammogram maintain the mammogram in the 
                        permanent medical records of the 
                        patient--
                                  [(I) for a period of not less 
                                than 5 years, or not less than 
                                10 years if no additional 
                                mammograms of such patient are 
                                performed at the facility, or 
                                longer if mandated by State 
                                law; or
                                  [(II) until such time as the 
                                patient should request that the 
                                patient's medical records be 
                                forwarded to a medical 
                                institution or a physician of 
                                the patient;
                        whichever is longer; and]
                          (i) a facility that performs any 
                        mammogram--
                                  (I) except as provided in 
                                subclause (II), maintain the 
                                mammogram in the permanent 
                                medical records of the patient 
                                for a period of not less than 5 
                                years, or not less than 10 
                                years if no subsequent 
                                mammograms of such patient are 
                                performed at the facility, or 
                                longer if mandated by State 
                                law; and
                                  (II) upon the request of or 
                                on behalf of the patient, 
                                transfer the mammogram to a 
                                medical institution, to a 
                                physician of the patient, or to 
                                the patient directly; and
                          (ii)(I) a facility must assure the 
                        preparation of a written report of the 
                        results of any mammography examination 
                        signed by the interpreting physician;

           *       *       *       *       *       *       *

                          [(IV) if such report is sent to the 
                        patient, the report shall include a 
                        summary written in terms easily 
                        understood by a lay person; and]
                          (IV) whether or not such a physician 
                        is available or there is no such 
                        physician, a summary of the written 
                        report shall be sent directly to the 
                        patient in terms easily understood by a 
                        lay person; and

           *       *       *       *       *       *       *

  (g) Inspections.--
          (1) Annual inspections.--
                  (A) In general.--The Secretary may enter and 
                inspect [certified] facilities to determine 
                compliance with the certification requirements 
                under subsection (b) and the standards 
                established under subsection (f). The Secretary 
                shall, if feasible, delegate to a State or 
                local agency the authority to make such 
                inspections.
                  (B) Identification.--The Secretary, or State 
                or local agency acting on behalf of the 
                Secretary, may conduct inspections only on 
                presenting identification to the owner, 
                operator, or agent in charge of the facility to 
                be inspected.
                  (C) Scope of inspection.--In conducting 
                inspections, the Secretary or State or local 
                agency acting on behalf of the Secretary--
                          (i) shall have access to all 
                        equipment, materials, records, and 
                        information that the Secretary or State 
                        or local agency considers necessary to 
                        determine whether the facility is being 
                        operated in accordance with this 
                        section; and
                          (ii) may copy, or require the 
                        facility to submit to the Secretary or 
                        the State or local agency, any of the 
                        materials, records, or information.
                  (D) Qualifications of inspectors.--Qualified 
                individuals, as determined by the Secretary, 
                shall conduct all inspections. The Secretary 
                may request that a State or local agency acting 
                on behalf of the Secretary designate a 
                qualified officer or employee to conduct the 
                inspections, or designate a qualified Federal 
                officer or employee to conduct inspections. The 
                Secretary shall establish minimum 
                qualifications and appropriate training for 
                inspectors and criteria for certification of 
                inspectors in order to inspect facilities for 
                compliance with subsection (f).
                  (E) Frequency.--The Secretary or State or 
                local agency acting on behalf of the Secretary 
                shall conduct inspections under this paragraph 
                of each facility not less often than annually, 
                subject to paragraph (6).
                  (F) Records and annual reports.--The 
                Secretary or a State or local agency acting on 
                behalf of the Secretary which is responsible 
                for inspecting mammography facilities shall 
                maintain records of annual inspections required 
                under this paragraph for a period as prescribed 
                by the Secretary. Such a State or local agency 
                shall annually prepare and submit to the 
                Secretary a report concerning the inspections 
                carried out under this paragraph. Such reports 
                shall include a description of the facilities 
                inspected and the results of such inspections.

           *       *       *       *       *       *       *

          (3) Inspection of facilities inspected by state or 
        local agencies.--The Secretary shall inspect annually 
        facilities inspected by State or local agencies acting 
        on behalf of the Secretary to assure a reasonable 
        performance by such State or local agencies.
          (4) Timing.--The Secretary, or State or local agency, 
        may conduct inspections under paragraphs (1), (2), and 
        (3), during regular business hours or at a mutually 
        agreeable time and after providing such notice as the 
        Secretary may prescribe, except that the Secretary may 
        waive such requirements if the continued performance of 
        mammography at such facility threatens the public 
        health.

           *       *       *       *       *       *       *

          (6) Demonstration program.--
                  (A) In general.--The Secretary may establish 
                a demonstration program under which inspections 
                under paragraph (1) of selected facilities are 
                conducted less frequently by the Secretary (or 
                as applicable, by State or local agencies 
                acting on behalf of the Secretary) than the 
                interval specified in subparagraph (E) of such 
                paragraph.
                  (B) Requirements.--Any demonstration program 
                under subparagraph (A) shall be carried out in 
                accordance with the following:
                          (i) The program may not be 
                        implemented before April 1, 2001. 
                        Preparations for the program may be 
                        carried out prior to such date.
                          (ii) In carrying out the program, the 
                        Secretary may not select a facility for 
                        inclusion in the program unless the 
                        facility is substantially free of 
                        incidents of noncompliance with the 
                        standards under subsection (f). The 
                        Secretary may at any time provide that 
                        a facility will no longer be included 
                        in the program.
                          (iii) The number of facilities 
                        selected for inclusion in the program 
                        shall be sufficient to provide a 
                        statistically significant sample, 
                        subject to compliance with clause (ii).
                          (iv) Facilities that are selected for 
                        inclusion in the program shall be 
                        inspected at such intervals as the 
                        Secretary determines will reasonably 
                        ensure that the facilities are 
                        maintaining compliance with such 
                        standards.
  (h) Sanctions.--
          (1) * * *
          (2) Patient information.--If the Secretary determines 
        that the quality of mammography performed by a facility 
        (whether or not certified pursuant to subsection (c)) 
        was so inconsistent with the quality standards 
        established pursuant to subsection (f) as to present a 
        significant risk to individual or public health, the 
        Secretary may require such facility to notify patients 
        who received mammograms at such facility, and their 
        referring physicians, of the deficiencies presenting 
        such risk, the potential harm resulting, appropriate 
        remedial measures, and such other relevant information 
        as the Secretary may require.
          [(2)] (3) Civil money penalties.--The Secretary may 
        assess civil money penalties in an amount not to exceed 
        $10,000 for--
                  (A) failure to obtain a certificate as 
                required by subsection (b),
                  (B) each failure by a facility to 
                substantially comply with, or each day on which 
                a facility fails to substantially comply with, 
                the standards established under subsection(f) 
or the requirements described in subclauses (I) through (III) of 
subsection (d)(1)(B)(ii), [and]
                  (C) each failure to notify a patient of risk 
                as required by the Secretary pursuant to 
                paragraph (2), and
                  [(C)] (D) each violation, or for each aiding 
                and abetting in a violation of, any provision 
                of, or regulation promulgated under, this 
                section by an owner, operator, or any employee 
                of a facility required to have a certificate.
          [(3)] (4) Procedures.--The Secretary shall develop 
        and implement procedures with respect to when and how 
        each of the sanctions is to be imposed under paragraphs 
        (1) [and (2)] through (3). Such procedures shall 
        provide for notice to the owner or operator of the 
        facility and a reasonable opportunity for the owner or 
        operator to respond to the proposed sanctions and 
        appropriate procedures for appealing determinations 
        relating to the imposition of sanctions.
  (i) Suspension and Revocation.--
          (1) In general.--The certificate of a facility issued 
        under subsection (c) may be suspended or revoked if the 
        Secretary finds, after providing, except as provided in 
        paragraph (2), reasonable notice and an opportunity for 
        a hearing to the owner or operator of the facility, 
        that the owner, operator, or any employee of the 
        facility--
                  (A) * * *

           *       *       *       *       *       *       *

                  (C) has failed to comply with reasonable 
                requests of the Secretary (or of an 
                accreditation body approved pursuant to 
                subsection (e)) for any record, information, 
                report, or material that the Secretary (or such 
                accreditation body or State carrying out 
                certification program requirements pursuant to 
                subsection (q)) concludes is necessary to 
                determine the continued eligibility of the 
                facility for a certificate or continued 
                compliance with the standards established under 
                subsection (f);
                  (D) has refused a reasonable request of the 
                Secretary, any Federal officer or employee duly 
                designated by the Secretary, or any State or 
                local officer or employee duly designated by 
                the State or local agency, for permission to 
                inspect the facility or the operations and 
                pertinent records of the facility in accordance 
                with subsection (g);

           *       *       *       *       *       *       *

          (2) Action before a hearing.--
                  (A) In general.--The Secretary may suspend 
                the certificate of the facility before holding 
                a hearing required by paragraph (1) if the 
                Secretary [makes the finding described in 
                paragraph (1) and determines that--
                          [(i) the failure of a facility to 
                        comply with the standards established 
                        by the Secretary under subsection (f) 
                        presents a serious risk to human 
                        health; or
                          [(ii) a facility has engaged in an 
                        action described in subparagraph (D) or 
                        (E) of paragraph (1).]
                has reason to believe that the circumstance of 
                the case will support one or more of the 
                findings described in paragraph (1) and that--
                          (i) the failure or violation was 
                        intentional; or
                          (ii) the failure or violation 
                        presents a serious risk to human 
                        health.

           *       *       *       *       *       *       *

  (q) State Program.--
          (1) * * *

           *       *       *       *       *       *       *

          (4) Withdrawal of approval.--
                  (A) * * *
                  (B) Effect of withdrawal.--If the Secretary 
                withdraws the approval of a State under 
                subparagraph (A), the certificate of any 
                facility [accredited] certified by the State 
                shall continue in effect until the expiration 
                of a reasonable period, as determined by the 
                Secretary, for such facility to obtain 
                certification by the Secretary.
  (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 
                [(q)] (p), such sums as may be necessary for 
                each of the fiscal years 1993 through [1997] 
                2002; 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 [year] 
                years 1993 through [1997] 2002.



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