[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):
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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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