[Congressional Bills 104th Congress]
[From the U.S. Government Printing Office]
[H.R. 4217 Introduced in House (IH)]
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 Opportunities,
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 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.
Be it enacted by the Senate and House of Representatives 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 ACTIVITIES REGARDING
PREGNANCY-RELATED COMPLICATIONS
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, including pregnancy-induced
hypertension, embolism, hemmorage, infection, and ectopic
pregnancy.
(2) Sufficient data on the incidence and prevalence 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 detrimental
effect on the state of medical knowledge on the prevention and
treatment of pregnancy-related complications.
(4) The state of medical knowledge can be improved 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 complications.
SEC. 102. CENTERS FOR DISEASE CONTROL AND PREVENTION; 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 section 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 activities:
``(1) Collecting data on the incidence and prevalence 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 pregnancy-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 pregnancy.
``(d) Authorization of Appropriations.--
``(1) Technical assistance for collection of data.--For the
purpose of carrying out subsection (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 prevalence of
each of ectopic pregnancy, preeclampsia, placenta
previa, abruptio placentae, all hypertensive disorders
of pregnancy, and such other pregnancy-related
complications as the Secretary determines to be
appropriate.
(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).
(C)(i) The national incidence and prevalence of
cases in which pregnancy-related complications were a
contributing factor in the death of the patients
involved, including a specification of the incidence
and prevalence of such cases according to the type of
complication involved.
(ii) The risk factors associated with the cases
specified in clause (i).
(D) The extent of the effectiveness of Federal and
State activities for the collection of epidemiological
data on pregnancy-related complications, including
consideration of the extent to which cases of such
complications are not being identified.
(E) The extent to which research on the prevention
and treatment of pregnancy-related complications is
being conducted in the United States, including a
specification of any areas that have received
insufficient study.
(2) Recommendations of secretary.--In addition to the
determinations required in paragraph (1), the study under such
paragraph shall include the recommendations of the Secretary
for the following:
(A) Improving the effectiveness of Federal and
State activities for the collection of the
epidemiological data described in paragraph (1),
including developing and implementing a uniform system
for collecting and exchanging the data.
(B) An agenda for the conduct and support by the
Federal Government of research on preventing and
treating pregnancy-related complications, 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 transmitted 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 modifications 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 DIETARY 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 defects 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, within 5 years, be increased to
50 percent if effective activities 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 Centers 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 PROTECTION ACT OF 1996
SEC. 301. SHORT TITLE OF TITLE.
This title may be cited as the ``Newborns' and Mothers' 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 consideration 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 follow-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 childbirth, shall ensure that coverage
is provided with respect to a mother who is a participant, beneficiary,
or policyholder under such plan and her newborn child for a minimum 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 authorization 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, beneficiary, 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 coverage 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 hospital, a
birthing center, an intermediate care facility, a
federally qualified health center, a federally
qualified rural health clinic, or a State health
department maternity clinic; or
(B) another setting determined appropriate under
regulations promulgated by the Secretary, 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 promulgating
regulations under paragraph (1)(B), the Secretary shall
consider telemedicine and other innovative means to provide
follow-up care and shall consider 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 conditions 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 subsection (a) concerning appropriate
post-delivery care settings, ensure that, to the extent practicable,
such regulations 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 coverage 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 reimbursement
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, participant, or beneficiary in a
manner inconsistent with this title.
SEC. 306. NOTICE.
(a) Employee Health Benefit Plan.--An employee 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 notice to each
policyholder regarding coverage required under this title. Such notice
shall be in writing, prominently 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 standards shall be enforced 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. 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 requirements 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 participant, 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 require 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 requirements of
this title.
(b) Employee Health Benefit Plans.--With respect to employee health
benefit plans, the standards established 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 failure 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 standards
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 appropriate to carry out this title.
SEC. 309. DEFINITIONS.
As used in this title:
(1) Attending provider.--The term ``attending provider''
shall include--
(A) the obstetrician-gynecologists, pediatricians,
family physicians, and other physicians primarily
responsible for the care of a mother and newborn; and
(B) the nurse midwives and nurse practitioners
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 welfare benefit plan,
governmental plan, or church plan (as defined under
paragraphs (1), (32), and (33) of section 3 of the
Employee Retirement 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 hospital
benefits) for participants and beneficiaries whether--
(i) directly;
(ii) through a health plan offered by a
health plan issuer as defined in paragraph (4);
or
(iii) otherwise.
(B) Rule of construction.--An employee health
benefit plan shall not be construed to be a health plan
or a health plan issuer.
(C) Arrangements not included.--Such term does not
include the following, or any combination thereof:
(i) Coverage only for accident, or
disability income insurance, or any combination
thereof.
(ii) Medicare supplemental health insurance
(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 general
liability insurance and automobile liability
insurance.
(v) Workers compensation or similar
insurance.
(vi) Automobile medical payment insurance.
(vii) Coverage for a specified disease or
illness.
(viii) Hospital or fixed indemnity
insurance.
(ix) Short-term limited duration insurance.
(x) Credit-only, dental-only, or vision-
only insurance.
(xi) A health insurance policy providing
benefits only for long-term care, nursing home
care, home health care, community-based care,
or any combination thereof.
(4) Group purchaser.--The term ``group purchaser'' means
any person (as defined under paragraph (9) of section 3 of the
Employee Retirement Income Security Act of 1974 (29 U.S.C.
1002(9)) or entity that purchases or pays for health benefits
(such as provider or hospital benefits) on behalf of
participants or beneficiaries in connection with an employee
health benefit plan.
(5) Health plan.--
(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 provides or pays for health benefits
(such as provider 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
disability income insurance, or any combination
thereof.
(ii) Medicare supplemental health insurance
(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 general
liability insurance and automobile liability
insurance.
(v) Workers compensation or similar
insurance.
(vi) Automobile medical payment insurance.
(vii) Coverage for a specified disease or
illness.
(viii) Hospital or fixed indemnity
insurance.
(ix) Short-term limited duration insurance.
(x) Credit-only, dental-only, or vision-
only insurance.
(xi) A health insurance policy providing
benefits only for long-term care, nursing home
care, home health care, community-based care,
or any combination thereof.
(E) Certain plans included.--Such term includes any
plan or arrangement not described in any clause of
subparagraph (D) which provides for benefit payments,
on a periodic 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 payments
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 coverage 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 caesarean section;
(3) that requires health plans to provide coverage 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 professional 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 provisions of State law or
regulation that provide greater protection 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 employee health benefit plans, as
defined in section 309(3).
SEC. 311. REPORTS TO CONGRESS CONCERNING CHILDBIRTH.
(a) Findings.--Congress finds that--
(1) childbirth is one part of a continuum of experience
that includes prepregnancy, pregnancy and prenatal care, labor
and delivery, the immediate postpartum period, and a longer
period of adjustment 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 research, and patient
preferences; and
(3) there is a need to--
(A) examine the issues and consequences associated
with the length of hospital stays following childbirth;
(B) examine the follow-up practices for mothers and
newborns used in conjunction with shorter hospital
stays;
(C) identify appropriate health care practices 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 advisory 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 intended to enhance the quality,
safety, and effectiveness of health care services
provided to mothers and newborns;
(B) develop a consensus among the members of the
advisory panel regarding the appropriateness of the
specific requirements of this title; and
(C) prepare and submit to the Secretary of Health
and Human Services, as part of the report of the
Secretary submitted under subsection (d), a report
summarizing the consensus developed under subparagraph
(B) if any, including the reasons for not reaching such
a consensus.
(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
appointed 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.
(ii) Requirement.--The panel shall include
representatives from each of the following
categories:
(I) Health care practitioners.
(II) Health plans.
(III) Hospitals.
(IV) Employers.
(V) States.
(VI) Consumers.
(c) Studies.--
(1) In general.--The Secretary of Health and Human Services
shall conduct a study of--
(A) the factors affecting the continuum of care
with respect to maternal and child health care,
including outcomes following childbirth;
(B) the factors determining the length of hospital
stay following childbirth;
(C) the diversity of negative or positive outcomes
affecting mothers, infants, and families;
(D) the manner in which post natal care has changed
over time and the manner in which that care has adapted
or related to changes in the length of hospital stay,
taking into account--
(i) the types of post natal care available
and the extent to which such care is accessed;
and
(ii) the challenges associated with
providing post natal care to all populations,
including vulnerable populations, and solutions
for overcoming these challenges; and
(E) the financial incentives that may--
(i) impact the health of newborns and
mothers; and
(ii) influence the clinical decisionmaking
of health care providers.
(2) Resources.--The Secretary of Health and Human Services
shall provide to the advisory panel the resources necessary to
carry out the duties of the advisory panel.
(d) Reports.--
(1) In general.--The Secretary of Health and Human Services
shall prepare and submit to the Committee on Labor and Human
Resources of the Senate and the Committee on Commerce of the
House of Representatives a report that contains--
(A) a summary of the study conducted under
subsection (c);
(B) a summary of the best practices used in the
public and private sectors for the care of newborns and
mothers;
(C) recommendations for improvements in prenatal
care, post natal care, delivery and follow-up care, and
whether the implementation of such improvements should
be accomplished by the private health care sector,
Federal or State governments, or any combination
thereof; and
(D) limitations on the databases in existence on
the date of enactment of this Act.
(2) Submission of reports.--The Secretary of Health and
Human Services shall prepare and submit to the Committees
referred to in paragraph (1)--
(A) an initial report concerning the study
conducted under subsection (c) and the report required
under subsection (d), not later than 18 months after
the date of enactment of this Act;
(B) an interim report concerning such study and
report not later than 3 years after the date of
enactment of this Act; and
(C) a final report concerning such study and report
not later than 5 years after the date of enactment of
this Act.
(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 section.
SEC. 312. EFFECTIVE DATE.
Except as otherwise provided for in this title, the provisions of
this title shall apply as follows:
(1) With respect to health plans, such provisions 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 `accreditation body'
means a body that has been approved 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 interpretation
of the ultrasound, and any production of a permanent
record of such ultrasonography, including videotapes.
``(4) Inspection.--The term `inspection' means an onsite
evaluation of the facility by the Secretary 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
examination 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
examination 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 respect to the facility. The Secretary
may issue or renew a certificate under this paragraph for not
more than 3 years.
``(2) Provisional certificate.--The Secretary may issue a
provisional certificate for an entity 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
describe 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 facility or
an authorized agent of the person, submits 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 manufacturer,
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
performed and the number of such
procedures performed in the prior 12
months; and
``(II) the names and qualifications
(educational background, training, 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
information available, and submit such
reports, to the Secretary as the
Secretary may require; and
``(III) update the information
submitted under subparagraph (A) or
assurances submitted under this
subparagraph on a timely basis as
required 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 required by the Secretary.
``(2) Appeal.--If the Secretary denies an application 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 accordance
with the procedures set forth in regulations 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 facility may not
operate unless the denial of the application is overturned at
the conclusion of the administrative 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 established by the
Secretary as described in subparagraph (B) and provides
the assurances required by subparagraph (C).
``(B) Standards.--The Secretary shall establish
standards for accreditation bodies, including--
``(i) standards that prohibit individuals
conducting the reviews from maintaining any
financial relationship to the facility
undergoing review which would constitute a
conflict of interest;
``(ii) standards that limit the imposition
of fees for accreditation to reasonable
amounts;
``(iii) standards that are equal to
standards established under subsection (f)
which are relevant to accreditation as
determined by the Secretary; and
``(iv) such additional standards as the
Secretary may require.
``(C) Assurances.--The accrediting body shall
provide the Secretary satisfactory assurances that the
body will--
``(i) comply with the standards as
described in subparagraph (B);
``(ii) comply with the requirements
described in paragraph (4);
``(iii) submit to the Secretary the name of
any facility for which the accreditation 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 manner; and
``(vi) provide such other additional
information 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 regulations 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 Secretary may withdraw the
approval of an accreditation body if the Secretary
determines that the accreditation body does not meet
the standards under subparagraph (B) of paragraph (1),
the requirements of clauses (i) through (vi) of
subparagraph (C) of paragraph (1), or the requirements
of paragraph (4).
``(B) Effect of withdrawal.--If the Secretary
withdraws the approval of an accreditation body under
subparagraph (A), the certificate of any facility
accredited by the body shall continue in effect until
the expiration of a reasonable period, as determined by
the Secretary, for such facility to obtain another
accreditation.
``(3) Accreditation.--To be accredited by an approved
accreditation body a facility shall meet--
``(A) the standards described in paragraph (1)(B)
which the Secretary determines are applicable to the
facility, and
``(B) such other standards which the accreditation
body may require.
``(4) Compliance.--To ensure that facilities accredited by
an accreditation body will continue to meet the standards of
the accreditation body, the accreditation body shall--
``(A) make onsite visits of the facilities
accredited by the body of a sufficient number and of
such frequency to allow a reasonable estimate of the
performance of the body; and
``(B) take such additional measures as the
Secretary determines to be appropriate.
Visits made under subparagraph (A) shall be made after
providing such notice as the Secretary may require.
``(5) Revocation of accreditation.--If an accreditation
body revokes the accreditation of a facility, the certificate
of the facility shall continue in effect until such time as may
be determined by the Secretary.
``(6) Evaluation and report.--
``(A) Evaluation.--The Secretary shall evaluate the
performance of each approved accreditation body by--
``(i) inspecting under subsection (g)(2) a
sufficient number of the facilities accredited
by the body to allow a reasonable estimate of
the performance of the body; and
``(ii) such additional means as the
Secretary determines to be appropriate.
``(f) Quality Standards.--
``(1) In general.--The standards referred to in subsection
(d)(1)(B)(i) are standards established by the Secretary which
include--
``(A) standards that require establishment and
maintenance of a quality assurance and quality control
program at each facility that is adequate and
appropriate to ensure the reliability and accuracy of
interpretation of fetal ultrasound;
``(B) a requirement that personnel who perform
ultrasound--
``(i)(I) be licensed by a State to perform
ultrasound procedures; or
``(II) be certified as qualified to perform
ultrasound procedures by an organization
described in paragraph (2)(A); and
``(ii) during the 2-year period beginning
October 1, 1997, meet training standards for
personnel who perform ultrasonography or meet
experience requirements which shall at a
minimum include 1 year of experience in the
performance of ultrasonography; and
``(iii) upon the expiration of such 2-year
period meet minimum training standards for
personnel who perform fetal ultrasound;
``(C) a requirement that ultrasound images be
interpreted by a physician who is certified as
qualified to interpret fetal ultrasound and who meets
training and continuing medical education requirements
as established by the Secretary;
``(D) a requirement that fetal ultrasonography be
performed only when medically necessary.
``(E) a requirement that--
``(i) a facility that performs any fetal
ultrasound maintain a record of such ultrasound
in the permanent medical records of the
patient--
``(I) for a period of not fewer
than 5 years, or longer if mandated by
State law; or
``(II) until such time as the
patient should request that the
patient's medical records be forwarded
to a medical institution or a physician
of the patient;
whichever is longer; and
``(ii)(I) a facility must assure the
preparation of a written report of the results
of any fetal ultrasound examination signed by
the interpreting physician;
``(II) such written report shall be
provided to the patient's physicians (if any);
``(III) if such a physician is not
available or if there is no such physician, the
written report shall be sent directly to the
patient; and
``(IV) if such report is sent to the
patient, the report shall include a summary
written in terms easily understood by a lay
person.
Subparagraph (E) shall not be construed to limit a patient's
access to the patient's medical records.
``(2) Certification of personnel.--The Secretary shall by
regulation--
``(A) specify organizations eligible to certify
individuals to perform fetal ultrasound as required by
paragraph (1)(B); and
``(B) establish standards for a program to certify
physicians described in paragraph (1)(C).
``(g) Inspections.--
``(1) Inspections.--
``(A) In general.--The Secretary may enter and
inspect certified facilities to determine compliance
with the standards established under subsection (f).
The Secretary shall, if feasible, delegate to a State
agency the authority to make such inspections.
``(B) Identification.--The Secretary, or State
agency acting on behalf of the Secretary, may conduct
inspections only on presenting identification to the
owner, operator, or agent in charge of the facility to
be inspected.
``(C) Scope of inspection.--In conducting
inspections, the Secretary or State agency acting on
behalf of the Secretary--
``(i) shall have access to all equipment,
materials, records, and information that the
Secretary or State agency considers necessary
to determine whether the facility is being
operated in accordance with this section; and
``(ii) may copy, or require the facility to
submit to the Secretary or the State agency,
any of the materials, records, or information.
``(D) Qualifications of inspectors.--Qualified
individuals, as determined by the Secretary, shall
conduct all inspections. The Secretary may request that
a State agency acting on behalf of the Secretary
designate a qualified officer or employee to conduct
the inspections, or designate a qualified Federal
officer or employee to conduct inspections. The
Secretary shall establish minimum qualifications and
appropriate training for inspectors and criteria for
certification of inspectors in order to inspect
facilities for compliance with subsection (f).
``(E) Frequency.--The Secretary or State agency
acting on behalf of the Secretary shall conduct
inspections under this paragraph of each facility as
frequently as needed to assure that facilities are in
compliance with this section, but no more frequently
than once every 2 years.
``(F) Records and annual reports.--The Secretary or
a State agency acting on behalf of the Secretary which
is responsible for inspecting ultrasound facilities
shall maintain records of inspections required under
this paragraph for a period as prescribed by the
Secretary. Such a State agency shall annually prepare
and submit to the Secretary a report concerning the
inspections carried out under this paragraph. Such
reports shall include a description of the facilities
inspected and the results of such inspections.
``(2) Inspection of accredited facilities.--The Secretary
shall inspect annually a sufficient number of the facilities
accredited by an accreditation body to provide the Secretary
with a reasonable estimate of the performance of such body.
``(3) Inspection of facilities inspected by state
agencies.--The Secretary shall inspect annually facilities
inspected by State agencies acting on behalf of the Secretary
to assure a reasonable performance by such State agencies.
``(4) Timing.--The Secretary, or State agency, may conduct
inspections under paragraphs (1), (2), and (3), during regular
business hours or at a mutually agreeable time and after
providing such notice as the Secretary may prescribe, except
that the Secretary may waive such requirements if the continued
performance of ultrasonography at such facility threatens the
public health.
``(5) Limited reinspection.--Nothing in this section limits
the authority of the Secretary to conduct limited reinspections
of facilities found not to be in compliance with this section.
``(h) Sanctions.--
``(1) In general.--In order to promote voluntary compliance
with this section, the Secretary may, in lieu of taking the
actions authorized by subsection (i), impose one or more of the
following sanctions:
``(A) Directed plans of correction which afford a
facility an opportunity to correct violations in a
timely manner.
``(B) Payment for the cost of onsite monitoring.
``(2) Civil money penalties.--The Secretary may assess
civil money penalties in an amount not to exceed $10,000 for--
``(A) failure to obtain a certificate as required
by subsection (b),
``(B) each failure by a facility to substantially
comply with, or each day on which a facility fails to
substantially comply with, the standards established
under subsection (f) or the requirements described in
subclauses (I) through (III) of subsection
(d)(1)(B)(ii), and
``(C) each violation, or for each aiding and
abetting in a violation of, any provision of, or
regulation promulgated under, this section by an owner,
operator, or any employee of a facility required to
have a certificate.
``(3) Procedures.--The Secretary shall develop and
implement procedures with respect to when and how each of the
sanctions is to be imposed under paragraphs (1) and (2). Such
procedures shall provide for notice to the owner or operator of
the facility and a reasonable opportunity for the owner or
operator to respond to the proposed sanctions and appropriate
procedures for appealing determinations relating to the
imposition of sanctions.
``(i) Suspension and Revocation.--
``(1) In general.--The certificate of a facility issued
under subsection (c) may be suspended or revoked if the
Secretary finds, after providing, except as provided in
paragraph (2), reasonable notice and an opportunity for a
hearing to the owner or operator of the facility, that the
owner, operator, or any employee of the facility--
``(A) has been guilty of misrepresentation in
obtaining the certificate;
``(B) has failed to comply with the requirements of
subsection (d)(1)(B)(ii)(III) or the standards
established by the Secretary under subsection (f);
``(C) has failed to comply with reasonable requests
of the Secretary for any record, information, report,
or material that the Secretary concludes is necessary
to determine the continued eligibility of the facility
for a certificate or continued compliance with the
standards established under subsection (f);
``(D) has refused a reasonable request of the
Secretary, any Federal officer or employee duly
designated by the Secretary, or any State officer or
employee duly designated by the State, for permission
to inspect the facility or the operations and pertinent
records of the facility in accordance with subsection
(g);
``(E) has violated or aided and abetted in the
violation of any provision of, or regulation
promulgated under, this section; or
``(F) has failed to comply with a sanction imposed
under subsection (h).
``(2) Action before a hearing.--
``(A) In general.--The Secretary may suspend the
certificate of the facility before holding a hearing
required by paragraph (1) if the Secretary makes the
finding described in paragraph (1) and determines
that--
``(i) the failure of a facility to comply
with the standards established by the Secretary
under subsection (f) presents a serious risk to
human health; or
``(ii) a facility has engaged in an action
described in subparagraph (D) or (E) of
paragraph (1).
``(B) Hearing.--If the Secretary suspends a
certificate under subparagraph (A), the Secretary shall
provide an opportunity for a hearing to the owner or
operator of the facility not later than 60 days from
the effective date of the suspension. The suspension
shall remain in effect until the decision of the
Secretary made after the hearing.
``(3) Ineligibility to own or operate facilities after
revocation.--If the Secretary revokes the certificate of a
facility on the basis of an act described in paragraph (1), no
person who owned or operated the facility at the time of the
act may, within 2 years of the revocation of the certificate,
own or operate a facility that requires a certificate under
this section.
``(j) Injunctions.--If the Secretary determines that--
``(1) continuation of any activity related to the provision
of fetal ultrasonography by a facility would constitute a
serious risk to human health, the Secretary may bring suit in the
district court of the United States for the district in which the
facility is situated to enjoin continuation of the activity; and
``(2) a facility is operating without a certificate as
required by subsection (b), the Secretary may bring suit in the
district court of the United States for the district in which
the facility is situated to enjoin the operation of the
facility.
Upon a proper showing, the district court shall grant a temporary
injunction or restraining order against continuation of the activity or
against operation of a facility, as the case may be, without requiring
the Secretary to post a bond, pending issuance of a final order under
this subsection.
``(k) Judicial Review.--
``(1) Petition.--If the Secretary imposes a sanction on a
facility under subsection (h) or suspends or revokes the
certificate of a facility under subsection (i), the owner or
operator of the facility may, not later than 60 days after the
date the action of the Secretary becomes final, file a petition
with the United States court of appeals for the circuit in
which the facility is situated for judicial review of the
action. As soon as practicable after receipt of the petition,
the clerk of the court shall transmit a copy of the petition to
the Secretary or other officer designated by the Secretary. As
soon as practicable after receipt of the copy, the Secretary
shall file in the court the record on which the action of the
Secretary is based, as provided in section 2112 of title 28,
United States Code.
``(2) Additional evidence.--If the petitioner applies to
the court for leave to adduce additional evidence, and shows to
the satisfaction of the court that the additional evidence is
material and that there were reasonable grounds for the failure
to adduce such evidence in the proceeding before the Secretary,
the court may order the additional evidence (and evidence in
rebuttal of the additional evidence) to be taken before the
Secretary, and to be adduced upon the hearing in such manner
and upon such terms and conditions as the court may determine
to be proper. The Secretary may modify the findings of the
Secretary as to the facts, or make new findings, by reason of
the additional evidence so taken, and the Secretary shall file
the modified or new findings, and the recommendations of the
Secretary, if any, for the modification or setting aside of the
original action of the Secretary with the return of the
additional evidence.
``(3) Judgment of court.--Upon the filing of the petition
referred to in paragraph (1), the court shall have jurisdiction
to affirm the action, or to set the action aside in whole or in
part, temporarily or permanently. The findings of the Secretary
as to the facts, if supported by substantial evidence, shall be
conclusive.
``(4) Finality of judgment.--The judgment of the court
affirming or setting aside, in whole or in part, any action of
the Secretary shall be final, subject to review by the Supreme
Court of the United States upon certiorari or certification, as
provided in section 1254 of title 28, United States Code.
``(l) Information.--
``(1) In general.--Not later than October 1, 1999, and
annually thereafter, the Secretary shall compile and make
available to physicians and the general public information that
the Secretary determines is useful in evaluating the
performance of facilities, including a list of facilities--
``(A) that have been convicted under Federal or
State laws relating to fraud and abuse, false billings,
or kickbacks;
``(B) that have been subject to sanctions under
subsection (h), together with a statement of the
reasons for the sanctions;
``(C) that have had certificates revoked or
suspended under subsection (i), together with a
statement of the reasons for the revocation or
suspension;
``(D) against which the Secretary has taken action
under subsection (j), together with a statement of the
reasons for the action;
``(E) whose accreditation has been revoked,
together with a statement of the reasons of the
revocation;
``(F) against which a State has taken adverse
action; and
``(G) that meet such other measures of performance
as the Secretary may develop.
``(2) Date.--The information to be compiled under paragraph
(1) shall be information for the calendar year preceding the
date the information is to be made available to the public.
``(3) Explanatory information.--The information to be
compiled under paragraph (1) shall be accompanied by such
explanatory information as may be appropriate to assist in the
interpretation of the information compiled under such
paragraph.
``(m) State Laws.--Nothing in this section shall be construed to
limit the authority of any State to enact and enforce laws relating to
the matters covered by this section that are at least as stringent as
this section or the regulations issued under this section.
``(n) Consultations.--In carrying out this section, the Secretary
shall consult with appropriate Federal agencies within the Department
of Health and Human Services for the purposes of developing standards,
regulations, evaluations, and procedures for compliance and oversight.
``(o) State Program.--
``(1) In general.--The Secretary may, upon application,
authorize a State--
``(A) to carry out, subject to paragraph (2), the
certification program requirements under subsections
(b), (c), (d), (g)(1), (h), (i), and (j) (including the
requirements under regulations promulgated pursuant to
such subsections), and
``(B) to implement the standards established by the
Secretary under subsection (f),
with respect to ultrasound facilities operating within the
State.
``(2) Approval.-- The Secretary may approve an application
under paragraph (1) if the Secretary determines that--
``(A) the State has enacted laws and issued
regulations relating to ultrasound facilities which are
the requirements of this section (including the
requirements under regulations promulgated pursuant to
such subsections), and
``(B) the State has provided satisfactory
assurances that the State--
``(i) has the legal authority and qualified
personnel necessary to enforce the requirements
of and the regulations promulgated pursuant to
this section (including the requirements under
regulations promulgated pursuant to such
subsections),
``(ii) will devote adequate funds to the
administration and enforcement of such
requirements, and
``(iii) will provide the Secretary with
such information and reports as the Secretary
may require.
``(3) Authority of state.--In a State with an approved
application--
``(A) the State shall carry out the Secretary's
functions under subsections (e) and (f);
``(B) the State may take action under subsections
(h), (i), and (j); and
``(C) the State shall conduct oversight functions
under subsections (g)(2) and (g)(3).
``(4) Withdrawal of approval.--
``(A) In general.--The Secretary may, after
providing notice and opportunity for corrective action,
withdraw the approval of a State's authority under
paragraph (1) if the Secretary determines that the
State does not meet the requirements of such paragraph.
The Secretary shall promulgate regulations for the
implementation of this subparagraph.
``(B) Effect of withdrawal.--If the Secretary
withdraws the approval of a State under subparagraph
(A), the certificate of any facility accredited by the
State shall continue in effect until the expiration of
a reasonable period, as determined by the Secretary,
for such facility to obtain certification by the
Secretary.
``(p) Funding.--
``(1) Fees.--
``(A) In general.--The Secretary shall, in
accordance with this paragraph assess and collect fees
from persons described in subsection (d)(1)(A) (other
than persons who are governmental entities, as
determined by the Secretary) to cover the costs of
inspections conducted under subsection (g)(1) by the
Secretary or a State acting under a delegation under
subparagraph (A) of such subsection. Fees may be
assessed and collected under this paragraph only in
such manner as would result in an aggregate amount of
fees collected during any fiscal year which equals the
aggregate amount of costs for such fiscal year for
inspections of facilities of such persons under
subsection (g)(1). A person's liability for fees shall
be reasonably based on the proportion of the inspection
costs which relate to such person.
``(B) Deposit and appropriations.--
``(i) Deposit and availability.--Fees
collected under subparagraph (A) shall be
deposited as an offsetting collection to the
appropriations for the Department of Health and
Human Services as provided in appropriation
Acts and shall remain available without fiscal
year limitation.
``(ii) Appropriations.--Fees collected
under subparagraph (A) shall be collected and
available only to the extent provided in
advance in appropriation Acts.
``(2) Authorization of appropriations.--There are
authorized to be appropriated for the Secretary to carry out
activities which are not supported by fees authorized and
collected under paragraph (1), such sums as may be necessary
for fiscal years 1997 through 2001.''.
SEC. 403. DATA SURVEY.
The Institute of Medicine, by itself or with the National
Institutes of Health, shall survey the data collected on the prevalence
of the use of fetal ultrasound and the interaction between physicians
and consumers that may be driving the use of fetal ultrasound. The
survey should begin with data collected after the report in 1984 by the
National Institutes of Health on a consensus development conference on
diagnostic ultrasound imaging in pregnancy.
SEC. 404. OUTREACH.
The Secretary of Health and Human Services shall establish a
program to provide educational outreach to medical practitioners and
the public regarding the appropriateness of fetal ultrasound for the
health of mothers and fetuses.
SEC. 405. REPORT.
No later than January 1, 1999, the Secretary shall report to the
Committee on Labor and Human Resources of the Senate and the Committee
on Commerce of the House of Representatives on whether this program has
resulted in improvement of the quality of fetal ultrasound, and a
reduction in nonmedically indicated fetal ultrasonography, without
affecting access to medically necessary services or unnecessarily
burdening health care providers.
SEC. 406. TECHNICAL AMENDMENT.
Section 354(q)(3) of the Public Health Service Act (42 U.S.C.
263b(q)(3)) is amended by striking ``Secretary'' each place it occurs
and inserting ``State''.
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