Mammography Quality Standards Reauthorization Act of 1998
PL 105-248 (H.R.4382), enacted 10/09/1998

112 STAT. 1864 
PUBLIC LAW 105-248—OCT. 9, 1998 
Public Law 105-248 
105th Congress 
Oct. 9, 1998 
[H.R. 4382] 
Mammography 
Quality 
Standards 
Reauthorization 
Act of 1998. 
42 u s e 201 note. 
An Act 
To amend the PubHc 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 subpara-
graph (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 REGULA-
TIONS. 
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 i n j e c t 
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)(l)(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)(l)(B)(i) on behalf of the accreditation body.". 
PUBLIC LAW 105-248—OCT. 9, 1998 
112 STAT. 1865 
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)(l)(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), main-
tain 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)(l)(G)(ii) of the Public Health Service Act (42 
U.S.C. 263b(f)(l)(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)(l)(A)) is amended in the first sentence— 
(1) by striking "certified"; and 
(2) by inserting "the certification requirements under sub-
section (b) and" after "compliance with". 
SEC. 8. DEMONSTRATION 
PROGRAM REGARDING FREQUENCY OF 
INSPECTIONS. 
Section 354(g) of the Pubhc 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 fre-
quently 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.—^^y 
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 
112 STAT. 1866 
PUBLIC LAW 105-248—OCT. 9, 1998 
(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 statis-
tically 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 PubUc 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)(l)(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 Pubhc 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)". 
PUBLIC LAW 105-248—OCT. 9, 1998 
112 STAT. 1867 
SEC. 11. REQUIREMENT TO COMPLY WITH INFORMATION REQUESTS. 
Section 354(i)(l)(C) of the Public Health Service Act (42 U.S.C. 
263b(i)(l)(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): 
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. 
112 STAT. 1866 
PUBLIC LAW 105-248—OCT. 9, 1998 
(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 statis-
tically 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 PubUc 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)(l)(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 Pubhc 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)". 
PUBLIC LAW 105-248—OCT. 9, 1998 
112 STAT. 1867 
SEC. 11. REQUIREMENT TO COMPLY WITH INFORMATION REQUESTS. 
Section 354(i)(l)(C) of the Public Health Service Act (42 U.S.C. 
263b(i)(l)(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): 
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.