IB
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 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 Public
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 phy-
sician’ means a physician as prescribed by the Sec-
retary under subsection (f)(1)(D) who meets such ad-
ditional requirements as may be established by an ac-
creditation body under subsection (e) and approved
by the Secretary to review clinical images under sub-
section (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 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 pa-
tient are performed at the facility, or
longer if mandated by State law; and
‘‘(II) upon the request of or on be-
half of the patient, transfer the mam-
mogram to a medical institution, to a
physician of the patient, or to the pa-
tient 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 demonstration
program under subparagraph (A) shall be car-
ried 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 noncompli-
ance 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 suffi-
cient to provide a statistically significant
sample, subject to compliance with clause
(ii).
‘‘(iv) Facilities that are selected for in-
clusion in the program shall be inspected at
such intervals as the Secretary determines
will reasonably ensure that the facilities are
maintaining compliance with such stand-
ards.’’.
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 insert-
ing ‘‘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-
ant 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 defi-
ciencies presenting such risk, the potential harm re-
sulting, appropriate remedial measures, and such
other relevant information as the Secretary may re-
quire.’’.
(b) CIVIL MONEY PENALTY.—Section 354(h)(3) of the
Public Health Service Act (42 U.S.C. 263b(h)(3)), as redes-
ignated by subsection (a)(1), is amended—
(1) by striking ‘‘and’’ at the end of subpara-
graph (B);
(2) by redesignating subparagraph (C) as sub-
paragraph (D); and
(3) by inserting after subparagraph (B) the fol-
lowing:
‘‘(C) each failure to notify a patient of risk
as required by the Secretary pursuant to para-
graph (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 accredita-
tion 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 para-
graph (1) and that—
‘‘(i) the failure or violation was inten-
tional; 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 ‘‘accred-
ited’’ and inserting ‘‘certified’’.