I
104TH CONGRESS
2D SESSION
H. R. 4217
To promote safer motherhood through improved surveillance and research
on pregnancy outcomes through health professional and public education
regarding pregnancy-related morbidity and mortality, through increased
public education concerning folic acid supplements, through requiring
health plan coverage of minimum hospital stays for childbirth, and
through establishment of quality standards for facilities performing
ultrasound procedures.
IN THE HOUSE OF REPRESENTATIVES
SEPTEMBER 26, 1996
Mrs. SCHROEDER (for herself, Mr. DINGELL, Ms. MCKINNEY, Mrs. LOWEY,
Mrs. CLAYTON, Ms. NORTON, and Mrs. MEEK of Florida) introduced the
following bill; which was referred to the Committee on Commerce, and
in addition to the Committee on Economic and Educational Opportuni-
ties, for a period to be subsequently determined by the Speaker, in each
case for consideration of such provisions as fall within the jurisdiction of
the committee concerned
A BILL
To promote safer motherhood through improved surveillance
and research on pregnancy outcomes through health pro-
fessional and public education regarding pregnancy-relat-
ed morbidity and mortality, through increased public
education concerning folic acid supplements, through re-
quiring health plan coverage of minimum hospital stays
for childbirth, and through establishment of quality
standards for facilities performing ultrasound procedures.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Safe Motherhood Act of 1996’’.
(b) TABLE OF CONTENTS.—The table of contents of
this Act is as follows:
TITLE 
I—EPIDEMIOLOGICAL
AND EDUCATIONAL ACTIVI-
TIES 
REGARDING 
PREG-
NANCY-RELATED 
COMPLICA-
TIONS
SEC. 101. SHORT TITLE; FINDINGS.
(a) SHORT TITLE.—This title may be cited as the
‘‘Pregnancy-Related Morbidity and Mortality Surveillance
and Research Act’’.
(b) FINDINGS.—The Congress finds as follows:
(1) Each year women in the United States die
as a result of pregnancy-related complications, in-
cluding pregnancy-induced hypertension, embolism,
hemmorage, infection, and ectopic pregnancy.
(2) Sufficient data on the incidence and preva-
lence of pregnancy-related complications, including
with respect to deaths, is not available because the
systems in the United States for the collection of
such data is limited.
(3) The lack of sufficient data has had a det-
rimental effect on the state of medical knowledge on
the prevention and treatment of pregnancy-related
complications.
(4) The state of medical knowledge can be im-
proved by improving the systems for collecting data,
and by using the data as a basis for research on the
prevention and treatment of pregnancy-related com-
plications.
SEC. 102. CENTERS FOR DISEASE CONTROL AND PREVEN-
TION; EPIDEMIOLOGICAL DATA AND PUBLIC
EDUCATION.
Part C of title III of the Public Health Service Act
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 317F the following section:
‘‘EPIDEMIOLOGICAL DATA AND PUBLIC EDUCATION
REGARDING PREGNANCY-RELATED COMPLICATIONS
‘‘SEC. 317G. (a) TECHNICAL ASSISTANCE TO STATES
FOR
COLLECTION
OF
DATA.—The Secretary, acting
through the Director of the Centers for Disease Control
and Prevention, shall provide technical assistance to the
States for the purpose of assisting with the following ac-
tivities:
‘‘(1) Collecting data on the incidence and preva-
lence of pregnancy-related complications.
‘‘(2) Identifying and reporting the risk factors
associated with such complications.
‘‘(3) Identifying and reporting cases in which
pregnancy-related complications were a contributing
factor in the death of the patients involved, and
identifying and reporting the risk-factors associated
with such cases.
‘‘(b) PUBLIC EDUCATION.—The Secretary, acting
through the Director of the Centers for Disease Control
and Prevention, shall carry out activities to educate health
professionals and the public on the prevention of preg-
nancy-related complications and the treatments available
for such complications.
‘‘(c) DEFINITION.—For purposes of this section, the
term ‘pregnancy-related complication’ means a disease,
disorder, or other medical condition that is related to preg-
nancy.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) TECHNICAL ASSISTANCE FOR COLLECTION
OF DATA.—For the purpose of carrying out sub-
section (a), there are authorized to be appropriated
$25,000,000.
‘‘(2) PUBLIC EDUCATION.—For the purpose of
carrying out subsection (b), there are authorized to
be appropriated $25,000,000.’’.
SEC. 103. COMPREHENSIVE EPIDEMIOLOGICAL REPORT TO
CONGRESS.
(a) STUDY.—
(1) IN GENERAL.—The Secretary of Health and
Human Services, acting through the Director of the
Centers for Disease Control and Prevention, shall
carry out a study for the purpose of determining the
following:
(A)(i) The national incidence and preva-
lence 
of 
each 
of 
ectopic 
pregnancy,
preeclampsia, 
placenta 
previa, 
abruptio
placentae, all hypertensive disorders of preg-
nancy, and such other pregnancy-related com-
plications as the Secretary determines to be ap-
propriate.
(ii) The risk factors associated with the
complications specified in clause (i).
(B) The overall national incidence and
prevalence of pregnancy-related complications
(considering all types of complications together,
except to the extent that data is not collected
under subparagraph (A) on a complication).
(A) Improving the effectiveness of Federal
and State activities for the collection of the epi-
demiological data described in paragraph (1),
including developing and implementing a uni-
form system for collecting and exchanging the
data.
(B) An agenda for the conduct and sup-
port by the Federal Government of research on
preventing and treating pregnancy-related com-
plications, including the following:
(i) Research to determine whether
there is a significant relationship between
the development of such complications and
multiple births, unintended pregnancy,
treatments for infertility, sexually trans-
mitted diseases, and the lack of access to
health care.
(ii) Other research to identify women
who may be at risk for such complications.
(C) Statutory or administrative modifica-
tions to the program of education established in
section 317G(b) of the Public Health Service
Act (as added by section 102 of this Act).
(b) REPORT.—Not later than 3 years after the date
of the enactment of this Act, the Secretary shall complete
the study required in subsection (a) and submit to the
Congress the findings made in the study.
(c) DEFINITIONS.—For purposes of this section:
(1) The term ‘‘pregnancy-related complication’’
means a disease, disorder, or other medical condition
that is related to pregnancy.
(2) The term ‘‘Secretary’’ means the Secretary
of Health and Human Services.
(d) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there is authorized
to be appropriated $50,000,000 for each of the fiscal years
1997 through 1999.
TITLE 
II—PUBLIC 
EDUCATION
REGARDING FOLIC ACT AS DI-
ETARY SUPPLEMENT
SEC. 201. SHORT TITLE; FINDINGS.
(a) SHORT TITLE.—This title may be cited as the
‘‘Folic Acid Public Education Act’’.
(b) FINDINGS.—The Congress finds as follows:
(1) Folic acid, a vitamin of the B complex, is
effective in preventing the serious, common birth de-
fects spina bifida and anencephaly, but only if the
woman involved consumes the vitamin daily before
she becomes pregnant and during the initial days
after she becomes pregnant.
(2) Only 25 percent of women of reproductive
age in the United States consume a sufficient daily
quantity of folic acid, and this percentage can, with-
in 5 years, be increased to 50 percent if effective ac-
tivities are carried out to educate the public.
SEC. 202. ROLE OF FOLIC ACID IN PREVENTION OF BIRTH
DEFECTS; EDUCATION THROUGH HEALTH
PROFESSIONALS.
(a) IN GENERAL.—The Secretary of Health and
Human Services, acting through the Director of the Cen-
ters for Disease Control and Prevention, may carry out
a program to encourage physicians, nurses, nutritionists,
and other health professionals to educate patients that
consuming a daily supplement of folic acid is effective in
preventing birth defects.
(b) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there is authorized
to be appropriated $20,000,000 for each of the fiscal years
1997 through 1999.
TITLE 
III—NEWBORNS’ 
AND
MOTHERS’ HEALTH PROTEC-
TION ACT OF 1996
SEC. 301. SHORT TITLE OF TITLE.
This title may be cited as the ‘‘Newborns’ and Moth-
ers’ Health Protection Act of 1996’’.
SEC. 302. FINDINGS.
Congress finds that—
(1) the length of post-delivery inpatient care
should be based on the unique characteristics of
each mother and her newborn child, taking into con-
sideration the health of the mother, the health and
stability of the newborn, the ability and confidence
of the mother and father to care for the newborn,
the adequacy of support systems at home, and the
access of the mother and newborn to appropriate fol-
low-up health care; and
(2) the timing of the discharge of a mother and
her newborn child from the hospital should be made
by the attending provider in consultation with the
mother.
SEC. 303. REQUIRED COVERAGE FOR MINIMUM HOSPITAL
STAY FOLLOWING BIRTH.
(a) IN GENERAL.—Except as provided in subsection
(b), a health plan or an employee health benefit plan that
provides maternity benefits, including benefits for child-
birth, shall ensure that coverage is provided with respect
to a mother who is a participant, beneficiary, or policy-
holder under such plan and her newborn child for a mini-
mum of 48 hours of inpatient length of stay following a
normal vaginal delivery, and a minimum of 96 hours of
inpatient length of stay following a caesarean section,
without requiring the attending provider to obtain author-
ization from the health plan or employee health benefit
plan.
(b) EXCEPTION.—Notwithstanding subsection (a), a
health plan or an employee health benefit plan shall not
be required to provide coverage for post-delivery inpatient
length of stay for a mother who is a participant, bene-
ficiary, or policyholder under such plan and her newborn
child for the period referred to in subsection (a) if—
(1) a decision to discharge the mother and her
newborn child prior to the expiration of such period
is made by the attending provider in consultation
with the mother; and
(2) the health plan or employee health benefit
plan provides coverage for post-delivery follow-up
care as described in section 304.
SEC. 304. POST-DELIVERY FOLLOW-UP CARE.
(a) IN GENERAL.—
(1) GENERAL RULE.—In the case of a decision
to discharge a mother and her newborn child from
the inpatient setting prior to the expiration of 48
hours following a normal vaginal delivery or 96
hours following a caesarean section, the health plan
or employee health benefit plan shall provide cov-
erage for timely post-delivery care. Such health care
shall be provided to a mother and her newborn child
by a registered nurse, physician, nurse practitioner,
nurse midwife or physician assistant experienced in
maternal and child health in—
(A) the home, a provider’s office, a hos-
pital, a birthing center, an intermediate care fa-
cility, a federally qualified health center, a fed-
erally qualified rural health clinic, or a State
health department maternity clinic; or
(B) another setting determined appropriate
under regulations promulgated by the Sec-
retary, in consultation with the Secretary of
Health and Human Services;
except that such coverage shall ensure that the
mother has the option to be provided with such care
in the home.
(2) CONSIDERATIONS BY SECRETARY.—In pro-
mulgating regulations under paragraph (1)(B), the
Secretary shall consider telemedicine and other inno-
vative means to provide follow-up care and shall con-
sider care in both urban and rural settings.
(b) TIMELY CARE.—As used in subsection (a), the
term ‘‘timely post-delivery care’’ means health care that
is provided—
(1) following the discharge of a mother and her
newborn child from the inpatient setting; and
(2) in a manner that meets the health care
needs of the mother and her newborn child, that
provides for the appropriate monitoring of the condi-
tions of the mother and child, and that occurs not
later than the 72-hour period immediately following
discharge.
(c) CONSISTENCY WITH STATE LAW.—The Secretary
shall, with respect to regulations promulgated under sub-
section (a) concerning appropriate post-delivery care set-
tings, ensure that, to the extent practicable, such regula-
tions are consistent with State licensing and practice laws.
SEC. 305. PROHIBITIONS.
In implementing the requirements of this title, a
health plan or an employee health benefit plan may not—
(1) deny enrollment, renewal, or continued cov-
erage to a mother and her newborn child who are
participants, beneficiaries or policyholders based on
compliance with this title;
(2) provide monetary payments or rebates to
mothers to encourage such mothers to request less
than the minimum coverage required under this
title;
(3) penalize or otherwise reduce or limit the re-
imbursement of an attending provider because such
provider provided treatment in accordance with this
title; or
(4) provide incentives (monetary or otherwise)
to an attending provider to induce such provider to
provide treatment to an individual policyholder, par-
ticipant, or beneficiary in a manner inconsistent with
this title.
SEC. 306. NOTICE.
(a) EMPLOYEE HEALTH BENEFIT PLAN.—An em-
ployee health benefit plan shall provide conspicuous notice
to each participant regarding coverage required under this
title not later than 120 days after the date of enactment
of this Act, and as part of its summary plan description.
(b) HEALTH PLAN.—A health plan shall provide no-
tice to each policyholder regarding coverage required
under this title. Such notice shall be in writing, promi-
nently positioned, and be transmitted—
(1) in a mailing made within 120 days of the
date of enactment of this Act by such plan to the
policyholder; and
(2) as part of the annual informational packet
sent to the policyholder.
SEC. 307. APPLICABILITY.
(a) CONSTRUCTION.—
(1) IN GENERAL.—A requirement or standard
imposed under this title on a health plan shall be
deemed to be a requirement or standard imposed on
the health plan issuer. Such requirements or stand-
ards shall be enforced by the State insurance com-
missioner for the State involved or the official or of-
ficials designated by the State to enforce the re-
quirements of this title. In the case of a health plan
offered by a health plan issuer in connection with an
employee health benefit plan, the requirements or
standards imposed under this title shall be enforced
with respect to the health plan issuer by the State
insurance commissioner for the State involved or the
official or officials designated by the State to enforce
the requirements of this title.
(2) LIMITATION.—Except as provided in section
308(c), the Secretary shall not enforce the require-
ments or standards of this title as they relate to
health plan issuers or health plans. In no case shall
a State enforce the requirements or standards of
this title as they relate to employee health benefit
plans.
(b) RULE OF CONSTRUCTION.—Nothing in this title
shall be construed to affect or modify the provisions of
section 514 of the Employee Retirement Income Security
Act of 1974 (29 U.S.C. 1144).
(c) RULE OF CONSTRUCTION.—Nothing in this title
shall be construed to require that a mother who is a par-
ticipant, beneficiary, or policyholder covered under this
title—
(1) give birth in a hospital; or
(2) stay in the hospital for a fixed period of
time following the birth of her child.
SEC. 308. ENFORCEMENT.
(a) HEALTH PLAN ISSUERS.—Each State shall re-
quire that each health plan issued, sold, renewed, offered
for sale or operated in such State by a health plan issuer
meet the standards established under this title. A State
shall submit such information as required by the Secretary
demonstrating effective implementation of the require-
ments of this title.
(b) EMPLOYEE HEALTH BENEFIT PLANS.—With re-
spect to employee health benefit plans, the standards es-
tablished under this title shall be enforced in the same
manner as provided for under sections 502, 504, 506, and
510 of the Employee Retirement Income Security Act of
1974 (29 U.S.C. 1132, 1134, 1136, and 1140). The civil
penalties contained in paragraphs (1) and (2) of section
502(c) of such Act (29 U.S.C. 1132(c) (1) and (2)) shall
apply to any information required by the Secretary to be
disclosed and reported under this section.
(c) FAILURE TO ENFORCE.—In the case of the fail-
ure of a State to substantially enforce the standards and
requirements set forth in this title with respect to health
plans, the Secretary, in consultation with the Secretary
of Health and Human Services, shall enforce the stand-
ards of this title in such State. In the case of a State
that fails to substantially enforce the standards set forth
in this title, each health plan issuer operating in such
State shall be subject to civil enforcement as provided for
under sections 502, 504, 506, and 510 of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1132,
1134, 1136, and 1140). The civil penalties contained in
paragraphs (1) and (2) of section 502(c) of such Act (29
U.S.C. 1132(c) (1) and (2)) shall apply to any information
required by the Secretary to be disclosed and reported
under this section.
(d) REGULATIONS.—The Secretary, in consultation
with the Secretary of Health and Human Services, may
promulgate such regulations as may be necessary or ap-
propriate to carry out this title.
SEC. 309. DEFINITIONS.
As used in this title:
(1) ATTENDING PROVIDER.—The term ‘‘attend-
ing provider’’ shall include—
(A) the obstetrician-gynecologists, pediatri-
cians, family physicians, and other physicians
primarily responsible for the care of a mother
and newborn; and
(B) the nurse midwives and nurse practi-
tioners primarily responsible for the care of a
mother and her newborn child in accordance
with State licensure and certification laws.
(2) BENEFICIARY.—The term ‘‘beneficiary’’ has
the meaning given such term under section 3(8) of
the Employee Retirement Income Security Act of
1974 (29 U.S.C. 1002(8)).
(3) EMPLOYEE HEALTH BENEFIT PLAN.—
(A) IN
GENERAL.—The term ‘‘employee
health benefit plan’’ means any employee wel-
fare benefit plan, governmental plan, or church
plan (as defined under paragraphs (1), (32),
and (33) of section 3 of the Employee Retire-
ment Income Security Act of 1974 (29 U.S.C.
1002 (1), (32), and (33))) that provides or pays
for health benefits (such as provider and hos-
pital benefits) for participants and beneficiaries
whether—
(A) IN GENERAL.—The term ‘‘health plan’’
means any group health plan or individual
health plan.
(B) GROUP
HEALTH
PLAN.—The term
‘‘group health plan’’ means any contract, policy,
certificate or other arrangement offered by a
health plan issuer to a group purchaser that
provides or pays for health benefits (such as
provider and hospital benefits) in connection
with an employee health benefit plan.
(C) INDIVIDUAL HEALTH PLAN.—The term
‘‘individual health plan’’ means any contract,
policy, certificate or other arrangement offered
to individuals by a health plan issuer that pro-
vides or pays for health benefits (such as pro-
vider and hospital benefits) and that is not a
group health plan.
(D) ARRANGEMENTS
NOT
INCLUDED.—
Such term does not include the following, or
any combination thereof:
(i) Coverage only for accident, or dis-
ability income insurance, or any combina-
tion thereof.
(ii) Medicare supplemental health in-
surance 
(as 
defined 
under 
section
1882(g)(1) of the Social Security Act).
(iii) Coverage issued as a supplement
to liability insurance.
(iv) Liability insurance, including gen-
eral liability insurance and automobile li-
ability insurance.
(v) Workers compensation or similar
insurance.
(vi) Automobile medical payment in-
surance.
(vii) Coverage for a specified disease
or illness.
(viii) Hospital or fixed indemnity in-
surance.
(ix) Short-term limited duration in-
surance.
(x) Credit-only, dental-only, or vision-
only insurance.
(xi) A health insurance policy provid-
ing benefits only for long-term care, nurs-
ing home care, home health care, commu-
nity-based care, or any combination there-
of.
(E) CERTAIN
PLANS
INCLUDED.—Such
term includes any plan or arrangement not de-
scribed in any clause of subparagraph (D)
which provides for benefit payments, on a peri-
odic basis, for—
(i) a specified disease or illness, or
(ii) a period of hospitalization,
without regard to the costs incurred or services
rendered during the period to which the pay-
ments relate.
(6) HEALTH PLAN ISSUER.—The term ‘‘health
plan issuer’’ means any entity that is licensed (prior
to or after the date of enactment of this Act) by a
State to offer a health plan.
(7) PARTICIPANT.—The term ‘‘participant’’ has
the meaning given such term under section 3(7) of
the Employee Retirement Income Security Act of
1974 (29 U.S.C. 1002(7)).
(8) SECRETARY.—The term ‘‘Secretary’’ unless
otherwise specified means the Secretary of Labor.
SEC. 310. PREEMPTION.
(a) IN GENERAL.—The provisions of sections 3, 5,
and 6 relating to inpatient care shall not preempt a State
law or regulation—
(1) that provides greater protections to patients
or policyholders than those required in this title;
(2) that requires health plans to provide cov-
erage for at least 48 hours of inpatient length of
stay following a normal vaginal delivery, and at least
96 hours of inpatient length of stay following a cae-
sarean section;
(3) that requires health plans to provide cov-
erage for maternity and pediatric care in accordance
with guidelines established by the American College
of Obstetricians and Gynecologists, the American
Academy of Pediatrics, or other established profes-
sional medical associations; or
(4) that leaves decisions regarding appropriate
length of stay entirely to the attending provider, in
consultation with the mother.
(b) FOLLOW-UP CARE.—The provisions of section
304 relating to follow-up care shall not preempt those pro-
visions of State law or regulation that provide greater pro-
tection to patients or policyholders than those required
under this title or that provide mothers and newborns with
an option of timely post delivery follow-up care (as defined
in section 304(b)) in the home.
(c) EMPLOYEE HEALTH BENEFIT PLANS.—Nothing
in this section affects the application of this title to em-
ployee health benefit plans, as defined in section 309(3).
SEC. 311. REPORTS TO CONGRESS CONCERNING CHILD-
BIRTH.
(a) FINDINGS.—Congress finds that—
(1) childbirth is one part of a continuum of ex-
perience that includes prepregnancy, pregnancy and
prenatal care, labor and delivery, the immediate
postpartum period, and a longer period of adjust-
ment for the newborn, the mother, and the family;
(2) health care practices across this continuum
are changing in response to health care financing
and delivery system changes, science and clinical re-
search, and patient preferences; and
(3) there is a need to—
(A) examine the issues and consequences
associated with the length of hospital stays fol-
lowing childbirth;
(B) examine the follow-up practices for
mothers and newborns used in conjunction with
shorter hospital stays;
(C) identify appropriate health care prac-
tices and procedures with regard to the hospital
discharge of newborns and mothers;
(D) examine the extent to which such care
is affected by family and environmental factors;
and
(E) examine the content of care during
hospital stays following childbirth.
(b) ADVISORY PANEL.—
(1) IN GENERAL.—Not later than 90 days after
the date of enactment of this Act, the Secretary of
Health and Human Services shall establish an advi-
sory panel (hereafter referred to in this section as
the ‘‘advisory panel’’) to—
(A) guide and review methods, procedures,
and data collection necessary to conduct the
study described in subsection (c) that is in-
tended to enhance the quality, safety, and effec-
tiveness of health care services provided to
mothers and newborns;
(B) develop a consensus among the mem-
bers of the advisory panel regarding the appro-
priateness of the specific requirements of this
title; and
(C) prepare and submit to the Secretary of
Health and Human Services, as part of the re-
port of the Secretary submitted under sub-
section (d), a report summarizing the consensus
developed under subparagraph (B) if any, in-
cluding the reasons for not reaching such a con-
sensus.
(2) PARTICIPATION.—
(A) DEPARTMENT
REPRESENTATIVES.—
The Secretary of Health and Human Services
shall ensure that representatives from within
the Department of Health and Human Services
that have expertise in the area of maternal and
child health or in outcomes research are ap-
pointed to the advisory panel established under
paragraph (1).
(B) REPRESENTATIVES
OF
PUBLIC
AND
PRIVATE SECTOR ENTITIES.—
(i) IN
GENERAL.—The Secretary of
Health and Human Services shall ensure
that members of the advisory panel include
representatives of public and private sector
entities having knowledge or experience in
one or more of the following areas:
(I) Patient care.
(II) Patient education.
(III) Quality assurance.
(IV) Outcomes research.
(V) Consumer issues.
(e) TERMINATION OF PANEL.—The advisory panel
shall terminate on the date that occurs 60 days after the
date on which the last report is submitted under this sec-
tion.
SEC. 312. EFFECTIVE DATE.
Except as otherwise provided for in this title, the pro-
visions of this title shall apply as follows:
(1) With respect to health plans, such provi-
sions shall apply to such plans on the first day of
the contract year beginning on or after January 1,
1997.
(2) With respect to employee health benefit
plans, such provisions shall apply to such plans on
the first day of the first plan year beginning on or
after January 1, 1997.
TITLE IV—ULTRASOUND
SEC. 401. SHORT TITLE.
This title may be cited as the ‘‘Ultrasound Quality
Standards Act of 1996’’.
SEC. 402. CERTIFICATION OF ULTRASOUND FACILITIES.
Part F of title III of the Public Health Service Act
(42 U.S.C. 262 et seq.) is amended by adding at the end
the following new subpart:
‘‘Subpart 4—Ultrasonography Facilities
‘‘SEC. 355. CERTIFICATION OF ULTRASOUND FACILITIES.
‘‘(a) DEFINITIONS.—As used in this section:
‘‘(1) ACCREDITATION
BODY.—The term ‘ac-
creditation body’ means a body that has been ap-
proved by the Secretary under subsection (e)(1)(A)
to accredit ultrasound facilities.
‘‘(2) 
CERTIFICATE.—The 
term 
‘certificate’
means the certificate described in subsection (b)(1).
‘‘(3) FACILITY.—
‘‘(A) IN
GENERAL.—The term ‘facility’
means a hospital, outpatient department, clinic,
radiology practice, or mobile unit, an office of
a physician, or other facility as determined by
the Secretary, that conducts fetal ultrasound
activities screening.
‘‘(B) ACTIVITIES.—For the purposes of
this section, the activities of a facility include
the operation of ultrasound equipment, the in-
terpretation of the ultrasound, and any produc-
tion 
of 
a 
permanent 
record 
of 
such
ultrasonography, including videotapes.
‘‘(4) 
INSPECTION.—The 
term 
‘inspection’
means an onsite evaluation of the facility by the Sec-
retary or State agency on behalf of the Secretary.
‘‘(5) FETAL
ULTRASOUND.—The term ‘fetal
ultrasound’ means ultrasonography performed on a
pregnant woman for purposes of viewing the fetus.
‘‘(b) CERTIFICATE REQUIREMENT.—
‘‘(1) CERTIFICATE.—No facility may conduct
an examination or procedure described in paragraph
(2) involving ultrasonography after October 1, 1997,
unless the facility obtains—
‘‘(A) a certificate—
‘‘(i) that is issued, and, if applicable,
renewed, by the Secretary in accordance
with subsection (c)(1);
‘‘(ii) that is applicable to the examina-
tion or procedure to be conducted; and
‘‘(iii) that is displayed prominently in
such facility; or
‘‘(B) a provisional certificate—
‘‘(i) that is issued by the Secretary in
accordance with subsection (c)(2);
‘‘(ii) that is applicable to the examina-
tion or procedure to be conducted; and
‘‘(iii) that is displayed prominently in
such facility.
The reference to a certificate in this section includes
a provisional certificate.
‘‘(2) EXAMINATION OR PROCEDURE.—A facility
shall obtain a certificate in order to—
‘‘(A) operate ultrasound equipment that is
used to image the fetus;
‘‘(B) provide for the interpretation of a
fetal ultrasound examination produced by such
equipment at the facility; and
‘‘(C) provide for the processing of film or
videotape of the ultrasound images produced.
‘‘(c) ISSUANCE AND RENEWAL OF CERTIFICATES.—
‘‘(1) IN GENERAL.—The Secretary may issue or
renew a certificate for a facility if the person or
agent described in subsection (d)(1)(A) meets the
applicable requirements of subsection (d)(1) with re-
spect to the facility. The Secretary may issue or
renew a certificate under this paragraph for not
more than 3 years.
‘‘(2) PROVISIONAL
CERTIFICATE.—The Sec-
retary may issue a provisional certificate for an en-
tity to enable the entity to qualify as a facility. The
applicant for a provisional certificate shall meet the
requirements of subsection (d)(1), except providing
information required by clause (iii) of subsection
(d)(1)(A). A provisional certificate may be in effect
no longer than 6 months from the date it is issued,
except that it may be extended once for a period of
not more than 90 days if the owner, lessor, or agent
of the facility demonstrates to the Secretary that
without such extension access to medically necessary
fetal ultrasonography in the geographic area served
by the facility would be significantly reduced and if
the owner, lessor, or agent of the facility will de-
scribe in a report to the Secretary steps that will be
taken to qualify the facility for certification under
subsection (b)(1).
‘‘(d) APPLICATION FOR CERTIFICATE.—
‘‘(1) SUBMISSION.—The Secretary may issue or
renew a certificate for a facility if—
‘‘(A) the person who owns or leases the fa-
cility or an authorized agent of the person, sub-
mits to the Secretary, in such form and manner
as the Secretary shall prescribe, an application
that contains at a minimum—
‘‘(i) a description of the manufac-
turer, model, and type of each instrument
used 
in 
the 
performance 
of 
fetal
ultrasonography by the facility;
‘‘(ii) a description of the procedures
currently 
used 
to 
provide 
fetal
ultrasonography at the facility, including—
‘‘(I) the types of procedures per-
formed and the number of such proce-
dures performed in the prior 12
months; and
‘‘(II) the names and qualifica-
tions (educational background, train-
ing, and experience) of the personnel
performing fetal ultrasonography and
interpreting the ultrasound images;
‘‘(iii) proof of accreditation in such
manner as the Secretary shall prescribe;
and
‘‘(B) the person or agent submits to the
Secretary—
‘‘(i) a satisfactory assurance that the
facility will be operated in accordance with
standards established by the Secretary
under subsection (f) to assure the safety,
accuracy, and medical necessity of the fetal
ultrasonography;
‘‘(ii) a satisfactory assurance that the
facility will—
‘‘(I) permit inspections under
subsection (g);
‘‘(II) make such records and in-
formation available, and submit such
reports, to the Secretary as the Sec-
retary may require; and
‘‘(III) update the information
submitted under subparagraph (A) or
assurances submitted under this sub-
paragraph on a timely basis as re-
quired by the Secretary; and
‘‘(iii) such other information as the
Secretary may require.
An applicant shall not be required to provide in an
application under subparagraph (A) any information
which the applicant has supplied to the accreditation
body which accredited the applicant, except as re-
quired by the Secretary.
‘‘(2) APPEAL.—If the Secretary denies an ap-
plication for the certification of a facility submitted
under paragraph (1)(A), the Secretary shall provide
the owner or lessor of the facility or the agent of the
owner or lessor who submitted such application—
‘‘(A) a statement of the grounds on which
the denial is based, and
‘‘(B) an opportunity for an appeal in ac-
cordance with the procedures set forth in regu-
lations of the Secretary published at 42 C.F.R.
498 and in effect on the date of the enactment
of this section.
‘‘(3) EFFECT OF DENIAL.—If the application
for the certification of a facility is denied, the facil-
ity may not operate unless the denial of the applica-
tion is overturned at the conclusion of the adminis-
trative appeals process provided in the regulations
referred to in paragraph (2)(B).
‘‘(e) ACCREDITATION.—
‘‘(1) APPROVAL OF ACCREDITATION BODIES.—
‘‘(A) IN
GENERAL.—The Secretary may
approve a private nonprofit organization or
State agency to accredit facilities for purposes
of subsection (d)(1)(A)(iii) if the accreditation
body meets the standards for accreditation es-
tablished by the Secretary as described in sub-
paragraph (B) and provides the assurances re-
quired by subparagraph (C).
‘‘(B) STANDARDS.—The Secretary shall
establish standards for accreditation bodies, in-
cluding—
‘‘(i) standards that prohibit individ-
uals conducting the reviews from maintain-
ing any financial relationship to the facility
undergoing review which would constitute
a conflict of interest;
‘‘(ii) standards that limit the imposi-
tion of fees for accreditation to reasonable
amounts;
‘‘(iii) standards that are equal to
standards established under subsection (f)
which are relevant to accreditation as de-
termined by the Secretary; and
‘‘(iv) such additional standards as the
Secretary may require.
‘‘(C) ASSURANCES.—The accrediting body
shall provide the Secretary satisfactory assur-
ances that the body will—
‘‘(i) comply with the standards as de-
scribed in subparagraph (B);
‘‘(ii) comply with the requirements de-
scribed in paragraph (4);
‘‘(iii) submit to the Secretary the
name of any facility for which the accredi-
tation body denies, suspends, or revokes
accreditation;
‘‘(iv) notify the Secretary in a timely
manner before the accreditation body
changes the standards of the body;
‘‘(v) notify each facility accredited by
the accreditation body if the Secretary
withdraws approval of the accreditation
body under paragraph (2) in a timely man-
ner; and
‘‘(vi) provide such other additional in-
formation as the Secretary may require.
‘‘(D) REGULATIONS.—Not later than 9
months after the date of the enactment of this
section, the Secretary shall promulgate regula-
tions under which the Secretary may approve
one or more accreditation bodies.
‘‘(2) WITHDRAWAL OF APPROVAL.—
‘‘(A) IN
GENERAL.—The Secretary shall
promulgate regulations under which the Sec-
retary may withdraw the approval of an accred-
itation body if the Secretary determines that
the accreditation body does not meet the stand-
ards under subparagraph (B) of paragraph (1),
the requirements of clauses (i) through (vi) of
subparagraph (C) of paragraph (1), or the re-
quirements of paragraph (4).
‘‘(B) EFFECT
OF
WITHDRAWAL.—If the
Secretary withdraws the approval of an accredi-
tation body under subparagraph (A), the certifi-