Mammography Quality Standards Reauthorization Act of 1998

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''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.

Summary: Mammography Quality Standards Reauthorization Act of 1998 - Amends the Public Health Service Act to authorize appropriations to carry out provisions relating to the certification of mammography facilities. Requires that appeals from certification denials follow procedures in effect at that time . Requires that standards for accreditation bodies: (1) mandate review of clinical images by qualified review physicians. And (2) prohibit those conducting reviews from having any relationship with the facility being reviewed that would constitute a conflict of interest. Modifies mammogram record retention requirements. Requires that a summary of the written report regarding a mammography be sent directly to the patient in terms easily understood by a lay person. Allows inspection of facilities for compliance with certification requirements and mammography quality standards . Authorizes a demonstration program under which inspections are conducted less often than the current minimum of annually. Allows inspections to be conducted by a local agency on behalf of the Secretary of Health and Human Services. Empowers the Secretary to require a facility to notify patients who received mammograms if the Secretary determines the quality was so inconsistent with standards as to present a significant risk to the individual or public health. Authorizes civil money penalties for failure to comply. Allows certificate suspension or revocation for a failure to comply with an accreditation body's requests for records or materials. Modifies requirements for certification suspension before holding a hearing.