105TH CONGRESS
2D SESSION
H. R. 4382
AN ACT
To amend the Public Health Service Act to revise
and extend the program for mammography qual-
ity standards.
105TH CONGRESS
2D SESSION
H. R. 4382
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 Representa-
tives 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 Pub-
lic Health Service Act (42 U.S.C. 263b(e)(1)(B)) is
amended—
(1) in clause (i), by striking ‘‘practicing physi-
cians’’ each place such term appears and inserting
‘‘review physicians’’; and
(2) in clause (ii), by striking ‘‘financial relation-
ship’’ 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 ac-
creditation 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 mam-
mogram—
‘‘(I) except as provided in sub-
clause (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 sen-
tence—
(1) by striking ‘‘certified’’; and
(2) by inserting ‘‘the certification requirements
under subsection (b) and’’ after ‘‘compliance with’’.
SEC. 8. DEMONSTRATION PROGRAM REGARDING FRE-
QUENCY 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 para-
graph:
‘‘(6) DEMONSTRATION PROGRAM.—
‘‘(A) IN GENERAL.—The Secretary may es-
tablish a demonstration program under which
inspections under paragraph (1) of selected fa-
cilities are conducted less frequently by the Sec-
retary (or as applicable, by State or local agen-
cies acting on behalf of the Secretary) than the
interval specified in subparagraph (E) of such
paragraph.
‘‘(B) REQUIREMENTS.—Any demonstra-
tion program under subparagraph (A) shall be
carried out in accordance with the following:
‘‘(i) The program may not be imple-
mented 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 in-
clusion in the program unless the facility is
substantially free of incidents of non-
compliance with the standards under sub-
section (f). The Secretary may at any time
provide that a facility will no longer be in-
cluded in the program.
‘‘(iii) The number of facilities selected
for inclusion in the program shall be suffi-
cient 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 deter-
mines will reasonably ensure that the fa-
cilities are maintaining compliance with
such standards.’’.
SEC. 9. CLARIFICATION OF AUTHORITY TO DELEGATE IN-
SPECTION RESPONSIBILITY TO LOCAL GOV-
ERNMENT 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 in-
serting ‘‘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 follow-
ing:
‘‘(2) PATIENT INFORMATION.—If the Secretary
determines that the quality of mammography per-
formed by a facility (whether or not certified pursu-
ing ‘‘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 ac-
creditation body approved pursuant to subsection
(e))’’; and
(2) by inserting after ‘‘Secretary’’ the second
place such term appears the following: ‘‘(or such ac-
creditation 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 follow-
ing: ‘‘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 inten-
tional; or
‘‘(ii) the failure or violation presents a
serious risk to human health.’’.