[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 537 Referred in House (RFH)]

  1st Session
                                 S. 537


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 12, 1997

                 Referred to the Committee on Commerce

_______________________________________________________________________

                                 AN ACT


 
   To amend title III of the Public Health Service Act to revise and 
           extend the mammography quality standards program.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

SEC. 2. AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--Subparagraphs (A) and (B) of section 354(r)(2) of 
the Public Health Service Act (42 U.S.C. 263b(r)(2) (A) and (B)) are 
each amended by striking ``1997'' and inserting ``2002''.
    (b) Technical Amendment.--Section 354(r)(2)(A) of the Public Health 
Service Act (42 U.S.C. 263b(r)(2)(A)) is amended by striking 
``subsection (q)'' and inserting ``subsection (p)''.

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 ``and in effect on the date of 
enactment of this section''.

SEC. 4. 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 
                                additional 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, forward the 
                                mammogram to a medical institution or a 
                                physician of the patient; and''.

SEC. 5. 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. 6. 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 it 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 it appears; and
                    (B) by inserting ``or local agency'' after 
                ``State'' the second place it appears.

SEC. 7. 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 so redesignated, 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''.

SEC. 8. 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 it 
        appears ``(or of an accreditation body approved pursuant to 
        subsection (e))''; and
            (2) by inserting after ``Secretary'', the second place it 
        appears ``(or such accreditation body or certifying entity)''.

SEC. 9. 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. 10. 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''.

            Passed the Senate November 9, 1997.

            Attest:

                                                    GARY SISCO,

                                                             Secretary.