[Congressional Bills 104th Congress]
[From the U.S. Government Publishing 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''.
                                 <all>