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Union Calendar No. 409
105th CONGRESS
2d Session
H. R. 4382
[Report No. 105-713]
To amend the Public Health Service Act to revise and extend the program
for mammography quality standards.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 3, 1998
Mr. Bliley (for himself, Mr. Bilirakis, Mr. Dingell, Mr. Brown of Ohio,
Mr. Hastert, Mr. Waxman, Mr. Barton of Texas, Mr. Towns, Mr. Upton, Mr.
Pallone, Mr. Greenwood, Mr. Deutsch, Mr. Deal of Georgia, Ms. Eshoo,
Mr. Burr of North Carolina, Mr. Stupak, Mr. Bilbray, Mr. Green, Mr.
Lazio of New York, Mr. Strickland, Mrs. Cubin, Ms. DeGette, Mr. Hall of
Texas, and Ms. Furse) introduced the following bill; which was referred
to the Committee on Commerce
September 14, 1998
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed
in italic]
[For text of introduced bill, see copy of bill as introduced on August
3, 1998]
_______________________________________________________________________
A BILL
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,
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''.
Union Calendar No. 409
105th CONGRESS
2d Session
H. R. 4382
[Report No. 105-713]
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to revise and extend the program
for mammography quality standards.
_______________________________________________________________________
September 14, 1998
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
Pages: 1 Other Popular 105th Congressional Bills Documents:
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