[105th Congress Public Law 248]
[From the U.S. Government Printing Office]


<DOC>
[DOCID: f:publ248.105]

        MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT OF 1998
Public Law 105-248
105th Congress

                                 An Act


 
To amend the <<NOTE: Oct. 9, 1998 -  [H.R. 4382]>> Public Health Service 
 Act to revise and extend the program for mammography quality standards.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in <<NOTE: Mammography Quality Standards 
Reauthorization Act of 1998.>> Congress assembled,

SECTION 1. SHORT <<NOTE: 42 USC 201 note.>> 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''.

    Approved October 9, 1998.

LEGISLATIVE HISTORY--H.R. 4382 (S. 537):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 105-713 (Comm. on Commerce).
CONGRESSIONAL RECORD, Vol. 144 (1998):
            Sept. 15, considered and passed House.
            Sept. 25, considered and passed Senate.

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