[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4382 Enrolled Bill (ENR)]
H.R.4382
One Hundred Fifth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the twenty-seventh day of January, one thousand nine hundred and ninety-
eight
An Act
To amend the 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 Congress assembled,

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

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(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''.

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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''.

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(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.''.

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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''.

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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''.

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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''.

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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.''.

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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.

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(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)''.

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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))''.

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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.''.

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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.

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Mammography Quality Standards Reauthorization Act of 1998 — HR. 4382

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