I

104TH CONGRESS

2D SESSION H. R. 4217

To promote safer motherhood through improved surveillance and research

on pregnancy outcomes through health professional and public education

regarding pregnancy-related morbidity and mortality, through increased

public education concerning folic acid supplements, through requiring

health plan coverage of minimum hospital stays for childbirth, and

through establishment of quality standards for facilities performing

ultrasound procedures.

IN THE HOUSE OF REPRESENTATIVES

SEPTEMBER 26, 1996

Mrs. SCHROEDER (for herself, Mr. DINGELL, Ms. MCKINNEY, Mrs. LOWEY,

Mrs. CLAYTON, Ms. NORTON, and Mrs. MEEK of Florida) introduced the

following bill; which was referred to the Committee on Commerce, and

in addition to the Committee on Economic and Educational 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.
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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Safe Motherhood Act of 1996’’.

6 (b) TABLE OF CONTENTS.—The table of contents of

7 this Act is as follows:

8 TITLE I—EPIDEMIOLOGICAL

9 AND EDUCATIONAL ACTIVI10 TIES REGARDING PREG11 NANCY-RELATED COMPLICA12 TIONS

13 SEC. 101. SHORT TITLE; FINDINGS.

14 (a) SHORT TITLE.—This title may be cited as the

15 ‘‘Pregnancy-Related Morbidity and Mortality Surveillance

16 and Research Act’’.

17 (b) FINDINGS.—The Congress finds as follows:

18 (1) Each year women in the United States die

19 as a result of pregnancy-related complications, in20 cluding pregnancy-induced hypertension, embolism,

21 hemmorage, infection, and ectopic pregnancy.

22 (2) Sufficient data on the incidence and preva23 lence of pregnancy-related complications, including

24 with respect to deaths, is not available because the
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1 systems in the United States for the collection of

2 such data is limited.

3 (3) The lack of sufficient data has had a det4 rimental effect on the state of medical knowledge on

5 the prevention and treatment of pregnancy-related

6 complications.

7 (4) The state of medical knowledge can be im8 proved by improving the systems for collecting data,

9 and by using the data as a basis for research on the

10 prevention and treatment of pregnancy-related com11 plications.

12 SEC. 102. CENTERS FOR DISEASE CONTROL AND PREVEN13 TION; EPIDEMIOLOGICAL DATA AND PUBLIC

14 EDUCATION.

15 Part C of title III of the Public Health Service Act

16 (42 U.S.C. 243 et seq.) is amended by inserting after sec17 tion 317F the following section:

18 ‘‘EPIDEMIOLOGICAL DATA AND PUBLIC EDUCATION

19 REGARDING PREGNANCY-RELATED COMPLICATIONS

20 ‘‘SEC. 317G. (a) TECHNICAL ASSISTANCE TO STATES

21 FOR COLLECTION OF DATA.—The Secretary, acting

22 through the Director of the Centers for Disease Control

23 and Prevention, shall provide technical assistance to the

24 States for the purpose of assisting with the following ac25 tivities:
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1 ‘‘(1) Collecting data on the incidence and preva2 lence of pregnancy-related complications.

3 ‘‘(2) Identifying and reporting the risk factors

4 associated with such complications.

5 ‘‘(3) Identifying and reporting cases in which

6 pregnancy-related complications were a contributing

7 factor in the death of the patients involved, and

8 identifying and reporting the risk-factors associated

9 with such cases.

10 ‘‘(b) PUBLIC EDUCATION.—The Secretary, acting

11 through the Director of the Centers for Disease Control

12 and Prevention, shall carry out activities to educate health

13 professionals and the public on the prevention of preg14 nancy-related complications and the treatments available

15 for such complications.

16 ‘‘(c) DEFINITION.—For purposes of this section, the

17 term ‘pregnancy-related complication’ means a disease,

18 disorder, or other medical condition that is related to preg19 nancy.

20 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—

21 ‘‘(1) TECHNICAL ASSISTANCE FOR COLLECTION

22 OF DATA.—For the purpose of carrying out sub23 section (a), there are authorized to be appropriated

24 $25,000,000.
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1 ‘‘(2) PUBLIC EDUCATION.—For the purpose of

2 carrying out subsection (b), there are authorized to

3 be appropriated $25,000,000.’’.

4 SEC. 103. COMPREHENSIVE EPIDEMIOLOGICAL REPORT TO

5 CONGRESS.

6 (a) STUDY.—

7 (1) IN GENERAL.—The Secretary of Health and

8 Human Services, acting through the Director of the

9 Centers for Disease Control and Prevention, shall

10 carry out a study for the purpose of determining the

11 following:

12 (A)(i) The national incidence and preva13 lence of each of ectopic pregnancy,

14 preeclampsia, placenta previa, abruptio

15 placentae, all hypertensive disorders of preg16 nancy, and such other pregnancy-related com17 plications as the Secretary determines to be ap18 propriate.

19 (ii) The risk factors associated with the

20 complications specified in clause (i).

21 (B) The overall national incidence and

22 prevalence of pregnancy-related complications

23 (considering all types of complications together,

24 except to the extent that data is not collected

25 under subparagraph (A) on a complication).
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1 (C)(i) The national incidence and preva2 lence of cases in which pregnancy-related com3 plications were a contributing factor in the

4 death of the patients involved, including a spec5 ification of the incidence and prevalence of such

6 cases according to the type of complication in7 volved.

8 (ii) The risk factors associated with the

9 cases specified in clause (i).

10 (D) The extent of the effectiveness of Fed11 eral and State activities for the collection of epi12 demiological data on pregnancy-related com13 plications, including consideration of the extent

14 to which cases of such complications are not

15 being identified.

16 (E) The extent to which research on the

17 prevention and treatment of pregnancy-related

18 complications is being conducted in the United

19 States, including a specification of any areas

20 that have received insufficient study.

21 (2) RECOMMENDATIONS OF SECRETARY.—In

22 addition to the determinations required in paragraph

23 (1), the study under such paragraph shall include

24 the recommendations of the Secretary for the follow25 ing:
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1 (A) Improving the effectiveness of Federal

2 and State activities for the collection of the epi3 demiological data described in paragraph (1),

4 including developing and implementing a uni5 form system for collecting and exchanging the

6 data.

7 (B) An agenda for the conduct and sup8 port by the Federal Government of research on

9 preventing and treating pregnancy-related com10 plications, including the following:

11 (i) Research to determine whether

12 there is a significant relationship between

13 the development of such complications and

14 multiple births, unintended pregnancy,

15 treatments for infertility, sexually trans16 mitted diseases, and the lack of access to

17 health care.

18 (ii) Other research to identify women

19 who may be at risk for such complications.

20 (C) Statutory or administrative modifica21 tions to the program of education established in

22 section 317G(b) of the Public Health Service

23 Act (as added by section 102 of this Act).

24 (b) REPORT.—Not later than 3 years after the date

25 of the enactment of this Act, the Secretary shall complete
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1 the study required in subsection (a) and submit to the

2 Congress the findings made in the study.

3 (c) DEFINITIONS.—For purposes of this section:

4 (1) The term ‘‘pregnancy-related complication’’

5 means a disease, disorder, or other medical condition

6 that is related to pregnancy.

7 (2) The term ‘‘Secretary’’ means the Secretary

8 of Health and Human Services.

9 (d) AUTHORIZATION OF APPROPRIATIONS.—For the

10 purpose of carrying out this section, there is authorized

11 to be appropriated $50,000,000 for each of the fiscal years

12 1997 through 1999.

13 TITLE II—PUBLIC EDUCATION

14 REGARDING FOLIC ACT AS DI15 ETARY SUPPLEMENT

16 SEC. 201. SHORT TITLE; FINDINGS.

17 (a) SHORT TITLE.—This title may be cited as the

18 ‘‘Folic Acid Public Education Act’’.

19 (b) FINDINGS.—The Congress finds as follows:

20 (1) Folic acid, a vitamin of the B complex, is

21 effective in preventing the serious, common birth de22 fects spina bifida and anencephaly, but only if the

23 woman involved consumes the vitamin daily before

24 she becomes pregnant and during the initial days

25 after she becomes pregnant.
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1 (2) Only 25 percent of women of reproductive

2 age in the United States consume a sufficient daily

3 quantity of folic acid, and this percentage can, with4 in 5 years, be increased to 50 percent if effective ac5 tivities are carried out to educate the public.

6 SEC. 202. ROLE OF FOLIC ACID IN PREVENTION OF BIRTH

7 DEFECTS; EDUCATION THROUGH HEALTH

8 PROFESSIONALS.

9 (a) IN GENERAL.—The Secretary of Health and

10 Human Services, acting through the Director of the Cen11 ters for Disease Control and Prevention, may carry out

12 a program to encourage physicians, nurses, nutritionists,

13 and other health professionals to educate patients that

14 consuming a daily supplement of folic acid is effective in

15 preventing birth defects.

16 (b) AUTHORIZATION OF APPROPRIATIONS.—For the

17 purpose of carrying out this section, there is authorized

18 to be appropriated $20,000,000 for each of the fiscal years

19 1997 through 1999.

20 TITLE III—NEWBORNS’ AND

21 MOTHERS’ HEALTH PROTEC22 TION ACT OF 1996

23 SEC. 301. SHORT TITLE OF TITLE.

24 This title may be cited as the ‘‘Newborns’ and Moth25 ers’ Health Protection Act of 1996’’.
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1 SEC. 302. FINDINGS.

2 Congress finds that—

3 (1) the length of post-delivery inpatient care

4 should be based on the unique characteristics of

5 each mother and her newborn child, taking into con6 sideration the health of the mother, the health and

7 stability of the newborn, the ability and confidence

8 of the mother and father to care for the newborn,

9 the adequacy of support systems at home, and the

10 access of the mother and newborn to appropriate fol11 low-up health care; and

12 (2) the timing of the discharge of a mother and

13 her newborn child from the hospital should be made

14 by the attending provider in consultation with the

15 mother.

16 SEC. 303. REQUIRED COVERAGE FOR MINIMUM HOSPITAL

17 STAY FOLLOWING BIRTH.

18 (a) IN GENERAL.—Except as provided in subsection

19 (b), a health plan or an employee health benefit plan that

20 provides maternity benefits, including benefits for child21 birth, shall ensure that coverage is provided with respect

22 to a mother who is a participant, beneficiary, or policy23 holder under such plan and her newborn child for a mini24 mum of 48 hours of inpatient length of stay following a

25 normal vaginal delivery, and a minimum of 96 hours of

26 inpatient length of stay following a caesarean section,
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1 without requiring the attending provider to obtain author2 ization from the health plan or employee health benefit

3 plan.

4 (b) EXCEPTION.—Notwithstanding subsection (a), a

5 health plan or an employee health benefit plan shall not

6 be required to provide coverage for post-delivery inpatient

7 length of stay for a mother who is a participant, bene8 ficiary, or policyholder under such plan and her newborn

9 child for the period referred to in subsection (a) if—

10 (1) a decision to discharge the mother and her

11 newborn child prior to the expiration of such period

12 is made by the attending provider in consultation

13 with the mother; and

14 (2) the health plan or employee health benefit

15 plan provides coverage for post-delivery follow-up

16 care as described in section 304.

17 SEC. 304. POST-DELIVERY FOLLOW-UP CARE.

18 (a) IN GENERAL.—

19 (1) GENERAL RULE.—In the case of a decision

20 to discharge a mother and her newborn child from

21 the inpatient setting prior to the expiration of 48

22 hours following a normal vaginal delivery or 96

23 hours following a caesarean section, the health plan

24 or employee health benefit plan shall provide cov25 erage for timely post-delivery care. Such health care
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1 shall be provided to a mother and her newborn child

2 by a registered nurse, physician, nurse practitioner,

3 nurse midwife or physician assistant experienced in

4 maternal and child health in—

5 (A) the home, a provider’s office, a hos6 pital, a birthing center, an intermediate care fa7 cility, a federally qualified health center, a fed8 erally qualified rural health clinic, or a State

9 health department maternity clinic; or

10 (B) another setting determined appropriate

11 under regulations promulgated by the Sec12 retary, in consultation with the Secretary of

13 Health and Human Services;

14 except that such coverage shall ensure that the

15 mother has the option to be provided with such care

16 in the home.

17 (2) CONSIDERATIONS BY SECRETARY.—In pro18 mulgating regulations under paragraph (1)(B), the

19 Secretary shall consider telemedicine and other inno20 vative means to provide follow-up care and shall con21 sider care in both urban and rural settings.

22 (b) TIMELY CARE.—As used in subsection (a), the

23 term ‘‘timely post-delivery care’’ means health care that

24 is provided—
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1 (1) following the discharge of a mother and her

2 newborn child from the inpatient setting; and

3 (2) in a manner that meets the health care

4 needs of the mother and her newborn child, that

5 provides for the appropriate monitoring of the condi6 tions of the mother and child, and that occurs not

7 later than the 72-hour period immediately following

8 discharge.

9 (c) CONSISTENCY WITH STATE LAW.—The Secretary

10 shall, with respect to regulations promulgated under sub11 section (a) concerning appropriate post-delivery care set12 tings, ensure that, to the extent practicable, such regula13 tions are consistent with State licensing and practice laws.

14 SEC. 305. PROHIBITIONS.

15 In implementing the requirements of this title, a

16 health plan or an employee health benefit plan may not—

17 (1) deny enrollment, renewal, or continued cov18 erage to a mother and her newborn child who are

19 participants, beneficiaries or policyholders based on

20 compliance with this title;

21 (2) provide monetary payments or rebates to

22 mothers to encourage such mothers to request less

23 than the minimum coverage required under this

24 title;
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1 (3) penalize or otherwise reduce or limit the re2 imbursement of an attending provider because such

3 provider provided treatment in accordance with this

4 title; or

5 (4) provide incentives (monetary or otherwise)

6 to an attending provider to induce such provider to

7 provide treatment to an individual policyholder, par8 ticipant, or beneficiary in a manner inconsistent with

9 this title.

10 SEC. 306. NOTICE.

11 (a) EMPLOYEE HEALTH BENEFIT PLAN.—An em12 ployee health benefit plan shall provide conspicuous notice

13 to each participant regarding coverage required under this

14 title not later than 120 days after the date of enactment

15 of this Act, and as part of its summary plan description.

16 (b) HEALTH PLAN.—A health plan shall provide no17 tice to each policyholder regarding coverage required

18 under this title. Such notice shall be in writing, promi19 nently positioned, and be transmitted—

20 (1) in a mailing made within 120 days of the

21 date of enactment of this Act by such plan to the

22 policyholder; and

23 (2) as part of the annual informational packet

24 sent to the policyholder.
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1 SEC. 307. APPLICABILITY.

2 (a) CONSTRUCTION.—

3 (1) IN GENERAL.—A requirement or standard

4 imposed under this title on a health plan shall be

5 deemed to be a requirement or standard imposed on

6 the health plan issuer. Such requirements or stand7 ards shall be enforced by the State insurance com8 missioner for the State involved or the official or of9 ficials designated by the State to enforce the re10 quirements of this title. In the case of a health plan

11 offered by a health plan issuer in connection with an

12 employee health benefit plan, the requirements or

13 standards imposed under this title shall be enforced

14 with respect to the health plan issuer by the State

15 insurance commissioner for the State involved or the

16 official or officials designated by the State to enforce

17 the requirements of this title.

18 (2) LIMITATION.—Except as provided in section

19 308(c), the Secretary shall not enforce the require20 ments or standards of this title as they relate to

21 health plan issuers or health plans. In no case shall

22 a State enforce the requirements or standards of

23 this title as they relate to employee health benefit

24 plans.

25 (b) RULE OF CONSTRUCTION.—Nothing in this title

26 shall be construed to affect or modify the provisions of
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1 section 514 of the Employee Retirement Income Security

2 Act of 1974 (29 U.S.C. 1144).

3 (c) RULE OF CONSTRUCTION.—Nothing in this title

4 shall be construed to require that a mother who is a par5 ticipant, beneficiary, or policyholder covered under this

6 title—

7 (1) give birth in a hospital; or

8 (2) stay in the hospital for a fixed period of

9 time following the birth of her child.

10 SEC. 308. ENFORCEMENT.

11 (a) HEALTH PLAN ISSUERS.—Each State shall re12 quire that each health plan issued, sold, renewed, offered

13 for sale or operated in such State by a health plan issuer

14 meet the standards established under this title. A State

15 shall submit such information as required by the Secretary

16 demonstrating effective implementation of the require17 ments of this title.

18 (b) EMPLOYEE HEALTH BENEFIT PLANS.—With re19 spect to employee health benefit plans, the standards es20 tablished under this title shall be enforced in the same

21 manner as provided for under sections 502, 504, 506, and

22 510 of the Employee Retirement Income Security Act of

23 1974 (29 U.S.C. 1132, 1134, 1136, and 1140). The civil

24 penalties contained in paragraphs (1) and (2) of section

25 502(c) of such Act (29 U.S.C. 1132(c) (1) and (2)) shall
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1 apply to any information required by the Secretary to be

2 disclosed and reported under this section.

3 (c) FAILURE TO ENFORCE.—In the case of the fail4 ure of a State to substantially enforce the standards and

5 requirements set forth in this title with respect to health

6 plans, the Secretary, in consultation with the Secretary

7 of Health and Human Services, shall enforce the stand8 ards of this title in such State. In the case of a State

9 that fails to substantially enforce the standards set forth

10 in this title, each health plan issuer operating in such

11 State shall be subject to civil enforcement as provided for

12 under sections 502, 504, 506, and 510 of the Employee

13 Retirement Income Security Act of 1974 (29 U.S.C. 1132,

14 1134, 1136, and 1140). The civil penalties contained in

15 paragraphs (1) and (2) of section 502(c) of such Act (29

16 U.S.C. 1132(c) (1) and (2)) shall apply to any information

17 required by the Secretary to be disclosed and reported

18 under this section.

19 (d) REGULATIONS.—The Secretary, in consultation

20 with the Secretary of Health and Human Services, may

21 promulgate such regulations as may be necessary or ap22 propriate to carry out this title.

23 SEC. 309. DEFINITIONS.

24 As used in this title:
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1 (1) ATTENDING PROVIDER.—The term ‘‘attend2 ing provider’’ shall include—

3 (A) the obstetrician-gynecologists, pediatri4 cians, family physicians, and other physicians

5 primarily responsible for the care of a mother

6 and newborn; and

7 (B) the nurse midwives and nurse practi8 tioners primarily responsible for the care of a

9 mother and her newborn child in accordance

10 with State licensure and certification laws.

11 (2) BENEFICIARY.—The term ‘‘beneficiary’’ has

12 the meaning given such term under section 3(8) of

13 the Employee Retirement Income Security Act of

14 1974 (29 U.S.C. 1002(8)).

15 (3) EMPLOYEE HEALTH BENEFIT PLAN.—

16 (A) IN GENERAL.—The term ‘‘employee

17 health benefit plan’’ means any employee wel18 fare benefit plan, governmental plan, or church

19 plan (as defined under paragraphs (1), (32),

20 and (33) of section 3 of the Employee Retire21 ment Income Security Act of 1974 (29 U.S.C.

22 1002 (1), (32), and (33))) that provides or pays

23 for health benefits (such as provider and hos24 pital benefits) for participants and beneficiaries

25 whether—
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1 (i) directly;

2 (ii) through a health plan offered by

3 a health plan issuer as defined in para4 graph (4); or

5 (iii) otherwise.

6 (B) RULE OF CONSTRUCTION.—An em7 ployee health benefit plan shall not be con8 strued to be a health plan or a health plan is9 suer.

10 (C) ARRANGEMENTS NOT INCLUDED.—

11 Such term does not include the following, or

12 any combination thereof:

13 (i) Coverage only for accident, or dis14 ability income insurance, or any combina15 tion thereof.

16 (ii) Medicare supplemental health in17 surance (as defined under section

18 1882(g)(1) of the Social Security Act).

19 (iii) Coverage issued as a supplement

20 to liability insurance.

21 (iv) Liability insurance, including gen22 eral liability insurance and automobile li23 ability insurance.

24 (v) Workers compensation or similar

25 insurance.
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1 (vi) Automobile medical payment in2 surance.

3 (vii) Coverage for a specified disease

4 or illness.

5 (viii) Hospital or fixed indemnity in6 surance.

7 (ix) Short-term limited duration in8 surance.

9 (x) Credit-only, dental-only, or vision10 only insurance.

11 (xi) A health insurance policy provid12 ing benefits only for long-term care, nurs13 ing home care, home health care, commu14 nity-based care, or any combination there15 of.

16 (4) GROUP PURCHASER.—The term ‘‘group

17 purchaser’’ means any person (as defined under

18 paragraph (9) of section 3 of the Employee Retire19 ment Income Security Act of 1974 (29 U.S.C.

20 1002(9)) or entity that purchases or pays for health

21 benefits (such as provider or hospital benefits) on

22 behalf of participants or beneficiaries in connection

23 with an employee health benefit plan.

24 (5) HEALTH PLAN.—
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1 (A) IN GENERAL.—The term ‘‘health plan’’

2 means any group health plan or individual

3 health plan.

4 (B) GROUP HEALTH PLAN.—The term

5 ‘‘group health plan’’ means any contract, policy,

6 certificate or other arrangement offered by a

7 health plan issuer to a group purchaser that

8 provides or pays for health benefits (such as

9 provider and hospital benefits) in connection

10 with an employee health benefit plan.

11 (C) INDIVIDUAL HEALTH PLAN.—The term

12 ‘‘individual health plan’’ means any contract,

13 policy, certificate or other arrangement offered

14 to individuals by a health plan issuer that pro15 vides or pays for health benefits (such as pro16 vider and hospital benefits) and that is not a

17 group health plan.

18 (D) ARRANGEMENTS NOT INCLUDED.—

19 Such term does not include the following, or

20 any combination thereof:

21 (i) Coverage only for accident, or dis22 ability income insurance, or any combina23 tion thereof.
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1 (ii) Medicare supplemental health in2 surance (as defined under section

3 1882(g)(1) of the Social Security Act).

4 (iii) Coverage issued as a supplement

5 to liability insurance.

6 (iv) Liability insurance, including gen7 eral liability insurance and automobile li8 ability insurance.

9 (v) Workers compensation or similar

10 insurance.

11 (vi) Automobile medical payment in12 surance.

13 (vii) Coverage for a specified disease

14 or illness.

15 (viii) Hospital or fixed indemnity in16 surance.

17 (ix) Short-term limited duration in18 surance.

19 (x) Credit-only, dental-only, or vision20 only insurance.

21 (xi) A health insurance policy provid22 ing benefits only for long-term care, nurs23 ing home care, home health care, commu24 nity-based care, or any combination there25 of.
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1 (E) CERTAIN PLANS INCLUDED.—Such

2 term includes any plan or arrangement not de3 scribed in any clause of subparagraph (D)

4 which provides for benefit payments, on a peri5 odic basis, for—

6 (i) a specified disease or illness, or

7 (ii) a period of hospitalization,

8 without regard to the costs incurred or services

9 rendered during the period to which the pay10 ments relate.

11 (6) HEALTH PLAN ISSUER.—The term ‘‘health

12 plan issuer’’ means any entity that is licensed (prior

13 to or after the date of enactment of this Act) by a

14 State to offer a health plan.

15 (7) PARTICIPANT.—The term ‘‘participant’’ has

16 the meaning given such term under section 3(7) of

17 the Employee Retirement Income Security Act of

18 1974 (29 U.S.C. 1002(7)).

19 (8) SECRETARY.—The term ‘‘Secretary’’ unless

20 otherwise specified means the Secretary of Labor.

21 SEC. 310. PREEMPTION.

22 (a) IN GENERAL.—The provisions of sections 3, 5,

23 and 6 relating to inpatient care shall not preempt a State

24 law or regulation—
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1 (1) that provides greater protections to patients

2 or policyholders than those required in this title;

3 (2) that requires health plans to provide cov4 erage for at least 48 hours of inpatient length of

5 stay following a normal vaginal delivery, and at least

6 96 hours of inpatient length of stay following a cae7 sarean section;

8 (3) that requires health plans to provide cov9 erage for maternity and pediatric care in accordance

10 with guidelines established by the American College

11 of Obstetricians and Gynecologists, the American

12 Academy of Pediatrics, or other established profes13 sional medical associations; or

14 (4) that leaves decisions regarding appropriate

15 length of stay entirely to the attending provider, in

16 consultation with the mother.

17 (b) FOLLOW-UP CARE.—The provisions of section

18 304 relating to follow-up care shall not preempt those pro19 visions of State law or regulation that provide greater pro20 tection to patients or policyholders than those required

21 under this title or that provide mothers and newborns with

22 an option of timely post delivery follow-up care (as defined

23 in section 304(b)) in the home.
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1 (c) EMPLOYEE HEALTH BENEFIT PLANS.—Nothing

2 in this section affects the application of this title to em3 ployee health benefit plans, as defined in section 309(3).

4 SEC. 311. REPORTS TO CONGRESS CONCERNING CHILD5 BIRTH.

6 (a) FINDINGS.—Congress finds that—

7 (1) childbirth is one part of a continuum of ex8 perience that includes prepregnancy, pregnancy and

9 prenatal care, labor and delivery, the immediate

10 postpartum period, and a longer period of adjust11 ment for the newborn, the mother, and the family;

12 (2) health care practices across this continuum

13 are changing in response to health care financing

14 and delivery system changes, science and clinical re15 search, and patient preferences; and

16 (3) there is a need to—

17 (A) examine the issues and consequences

18 associated with the length of hospital stays fol19 lowing childbirth;

20 (B) examine the follow-up practices for

21 mothers and newborns used in conjunction with

22 shorter hospital stays;

23 (C) identify appropriate health care prac24 tices and procedures with regard to the hospital

25 discharge of newborns and mothers;
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1 (D) examine the extent to which such care

2 is affected by family and environmental factors;

3 and

4 (E) examine the content of care during

5 hospital stays following childbirth.

6 (b) ADVISORY PANEL.—

7 (1) IN GENERAL.—Not later than 90 days after

8 the date of enactment of this Act, the Secretary of

9 Health and Human Services shall establish an advi10 sory panel (hereafter referred to in this section as

11 the ‘‘advisory panel’’) to—

12 (A) guide and review methods, procedures,

13 and data collection necessary to conduct the

14 study described in subsection (c) that is in15 tended to enhance the quality, safety, and effec16 tiveness of health care services provided to

17 mothers and newborns;

18 (B) develop a consensus among the mem19 bers of the advisory panel regarding the appro20 priateness of the specific requirements of this

21 title; and

22 (C) prepare and submit to the Secretary of

23 Health and Human Services, as part of the re24 port of the Secretary submitted under sub25 section (d), a report summarizing the consensus
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1 developed under subparagraph (B) if any, in2 cluding the reasons for not reaching such a con3 sensus.

4 (2) PARTICIPATION.—

5 (A) DEPARTMENT REPRESENTATIVES.—

6 The Secretary of Health and Human Services

7 shall ensure that representatives from within

8 the Department of Health and Human Services

9 that have expertise in the area of maternal and

10 child health or in outcomes research are ap11 pointed to the advisory panel established under

12 paragraph (1).

13 (B) REPRESENTATIVES OF PUBLIC AND

14 PRIVATE SECTOR ENTITIES.—

15 (i) IN GENERAL.—The Secretary of

16 Health and Human Services shall ensure

17 that members of the advisory panel include

18 representatives of public and private sector

19 entities having knowledge or experience in

20 one or more of the following areas:

21 (I) Patient care.

22 (II) Patient education.

23 (III) Quality assurance.

24 (IV) Outcomes research.

25 (V) Consumer issues.
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1 (ii) REQUIREMENT.—The panel shall

2 include representatives from each of the

3 following categories:

4 (I) Health care practitioners.

5 (II) Health plans.

6 (III) Hospitals.

7 (IV) Employers.

8 (V) States.

9 (VI) Consumers.

10 (c) STUDIES.—

11 (1) IN GENERAL.—The Secretary of Health and

12 Human Services shall conduct a study of—

13 (A) the factors affecting the continuum of

14 care with respect to maternal and child health

15 care, including outcomes following childbirth;

16 (B) the factors determining the length of

17 hospital stay following childbirth;

18 (C) the diversity of negative or positive

19 outcomes affecting mothers, infants, and fami20 lies;

21 (D) the manner in which post natal care

22 has changed over time and the manner in which

23 that care has adapted or related to changes in

24 the length of hospital stay, taking into ac25 count—
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1 (i) the types of post natal care avail2 able and the extent to which such care is

3 accessed; and

4 (ii) the challenges associated with pro5 viding post natal care to all populations,

6 including vulnerable populations, and solu7 tions for overcoming these challenges; and

8 (E) the financial incentives that may—

9 (i) impact the health of newborns and

10 mothers; and

11 (ii) influence the clinical decisionmak12 ing of health care providers.

13 (2) RESOURCES.—The Secretary of Health and

14 Human Services shall provide to the advisory panel

15 the resources necessary to carry out the duties of

16 the advisory panel.

17 (d) REPORTS.—

18 (1) IN GENERAL.—The Secretary of Health and

19 Human Services shall prepare and submit to the

20 Committee on Labor and Human Resources of the

21 Senate and the Committee on Commerce of the

22 House of Representatives a report that contains—

23 (A) a summary of the study conducted

24 under subsection (c);
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1 (B) a summary of the best practices used

2 in the public and private sectors for the care of

3 newborns and mothers;

4 (C) recommendations for improvements in

5 prenatal care, post natal care, delivery and fol6 low-up care, and whether the implementation of

7 such improvements should be accomplished by

8 the private health care sector, Federal or State

9 governments, or any combination thereof; and

10 (D) limitations on the databases in exist11 ence on the date of enactment of this Act.

12 (2) SUBMISSION OF REPORTS.—The Secretary

13 of Health and Human Services shall prepare and

14 submit to the Committees referred to in paragraph

15 (1)—

16 (A) an initial report concerning the study

17 conducted under subsection (c) and the report

18 required under subsection (d), not later than 18

19 months after the date of enactment of this Act;

20 (B) an interim report concerning such

21 study and report not later than 3 years after

22 the date of enactment of this Act; and

23 (C) a final report concerning such study

24 and report not later than 5 years after the date

25 of enactment of this Act.
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1 (e) TERMINATION OF PANEL.—The advisory panel

2 shall terminate on the date that occurs 60 days after the

3 date on which the last report is submitted under this sec4 tion.

5 SEC. 312. EFFECTIVE DATE.

6 Except as otherwise provided for in this title, the pro7 visions of this title shall apply as follows:

8 (1) With respect to health plans, such provi9 sions shall apply to such plans on the first day of

10 the contract year beginning on or after January 1,

11 1997.

12 (2) With respect to employee health benefit

13 plans, such provisions shall apply to such plans on

14 the first day of the first plan year beginning on or

15 after January 1, 1997.

16 TITLE IV—ULTRASOUND

17 SEC. 401. SHORT TITLE.

18 This title may be cited as the ‘‘Ultrasound Quality

19 Standards Act of 1996’’.

20 SEC. 402. CERTIFICATION OF ULTRASOUND FACILITIES.

21 Part F of title III of the Public Health Service Act

22 (42 U.S.C. 262 et seq.) is amended by adding at the end

23 the following new subpart:
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•HR 4217 IH

1 ‘‘Subpart 4—Ultrasonography Facilities

2 ‘‘SEC. 355. CERTIFICATION OF ULTRASOUND FACILITIES.

3 ‘‘(a) DEFINITIONS.—As used in this section:

4 ‘‘(1) ACCREDITATION BODY.—The term ‘ac5 creditation body’ means a body that has been ap6 proved by the Secretary under subsection (e)(1)(A)

7 to accredit ultrasound facilities.

8 ‘‘(2) CERTIFICATE.—The term ‘certificate’

9 means the certificate described in subsection (b)(1).

10 ‘‘(3) FACILITY.—

11 ‘‘(A) IN GENERAL.—The term ‘facility’

12 means a hospital, outpatient department, clinic,

13 radiology practice, or mobile unit, an office of

14 a physician, or other facility as determined by

15 the Secretary, that conducts fetal ultrasound

16 activities screening.

17 ‘‘(B) ACTIVITIES.—For the purposes of

18 this section, the activities of a facility include

19 the operation of ultrasound equipment, the in20 terpretation of the ultrasound, and any produc21 tion of a permanent record of such

22 ultrasonography, including videotapes.

23 ‘‘(4) INSPECTION.—The term ‘inspection’

24 means an onsite evaluation of the facility by the Sec25 retary or State agency on behalf of the Secretary.
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1 ‘‘(5) FETAL ULTRASOUND.—The term ‘fetal

2 ultrasound’ means ultrasonography performed on a

3 pregnant woman for purposes of viewing the fetus.

4 ‘‘(b) CERTIFICATE REQUIREMENT.—

5 ‘‘(1) CERTIFICATE.—No facility may conduct

6 an examination or procedure described in paragraph

7 (2) involving ultrasonography after October 1, 1997,

8 unless the facility obtains—

9 ‘‘(A) a certificate—

10 ‘‘(i) that is issued, and, if applicable,

11 renewed, by the Secretary in accordance

12 with subsection (c)(1);

13 ‘‘(ii) that is applicable to the examina14 tion or procedure to be conducted; and

15 ‘‘(iii) that is displayed prominently in

16 such facility; or

17 ‘‘(B) a provisional certificate—

18 ‘‘(i) that is issued by the Secretary in

19 accordance with subsection (c)(2);

20 ‘‘(ii) that is applicable to the examina21 tion or procedure to be conducted; and

22 ‘‘(iii) that is displayed prominently in

23 such facility.

24 The reference to a certificate in this section includes

25 a provisional certificate.
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1 ‘‘(2) EXAMINATION OR PROCEDURE.—A facility

2 shall obtain a certificate in order to—

3 ‘‘(A) operate ultrasound equipment that is

4 used to image the fetus;

5 ‘‘(B) provide for the interpretation of a

6 fetal ultrasound examination produced by such

7 equipment at the facility; and

8 ‘‘(C) provide for the processing of film or

9 videotape of the ultrasound images produced.

10 ‘‘(c) ISSUANCE AND RENEWAL OF CERTIFICATES.—

11 ‘‘(1) IN GENERAL.—The Secretary may issue or

12 renew a certificate for a facility if the person or

13 agent described in subsection (d)(1)(A) meets the

14 applicable requirements of subsection (d)(1) with re15 spect to the facility. The Secretary may issue or

16 renew a certificate under this paragraph for not

17 more than 3 years.

18 ‘‘(2) PROVISIONAL CERTIFICATE.—The Sec19 retary may issue a provisional certificate for an en20 tity to enable the entity to qualify as a facility. The

21 applicant for a provisional certificate shall meet the

22 requirements of subsection (d)(1), except providing

23 information required by clause (iii) of subsection

24 (d)(1)(A). A provisional certificate may be in effect

25 no longer than 6 months from the date it is issued,
35

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1 except that it may be extended once for a period of

2 not more than 90 days if the owner, lessor, or agent

3 of the facility demonstrates to the Secretary that

4 without such extension access to medically necessary

5 fetal ultrasonography in the geographic area served

6 by the facility would be significantly reduced and if

7 the owner, lessor, or agent of the facility will de8 scribe in a report to the Secretary steps that will be

9 taken to qualify the facility for certification under

10 subsection (b)(1).

11 ‘‘(d) APPLICATION FOR CERTIFICATE.—

12 ‘‘(1) SUBMISSION.—The Secretary may issue or

13 renew a certificate for a facility if—

14 ‘‘(A) the person who owns or leases the fa15 cility or an authorized agent of the person, sub16 mits to the Secretary, in such form and manner

17 as the Secretary shall prescribe, an application

18 that contains at a minimum—

19 ‘‘(i) a description of the manufac20 turer, model, and type of each instrument

21 used in the performance of fetal

22 ultrasonography by the facility;

23 ‘‘(ii) a description of the procedures

24 currently used to provide fetal

25 ultrasonography at the facility, including—
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•HR 4217 IH

1 ‘‘(I) the types of procedures per2 formed and the number of such proce3 dures performed in the prior 12

4 months; and

5 ‘‘(II) the names and qualifica6 tions (educational background, train7 ing, and experience) of the personnel

8 performing fetal ultrasonography and

9 interpreting the ultrasound images;

10 ‘‘(iii) proof of accreditation in such

11 manner as the Secretary shall prescribe;

12 and

13 ‘‘(B) the person or agent submits to the

14 Secretary—

15 ‘‘(i) a satisfactory assurance that the

16 facility will be operated in accordance with

17 standards established by the Secretary

18 under subsection (f) to assure the safety,

19 accuracy, and medical necessity of the fetal

20 ultrasonography;

21 ‘‘(ii) a satisfactory assurance that the

22 facility will—

23 ‘‘(I) permit inspections under

24 subsection (g);
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1 ‘‘(II) make such records and in2 formation available, and submit such

3 reports, to the Secretary as the Sec4 retary may require; and

5 ‘‘(III) update the information

6 submitted under subparagraph (A) or

7 assurances submitted under this sub8 paragraph on a timely basis as re9 quired by the Secretary; and

10 ‘‘(iii) such other information as the

11 Secretary may require.

12 An applicant shall not be required to provide in an

13 application under subparagraph (A) any information

14 which the applicant has supplied to the accreditation

15 body which accredited the applicant, except as re16 quired by the Secretary.

17 ‘‘(2) APPEAL.—If the Secretary denies an ap18 plication for the certification of a facility submitted

19 under paragraph (1)(A), the Secretary shall provide

20 the owner or lessor of the facility or the agent of the

21 owner or lessor who submitted such application—

22 ‘‘(A) a statement of the grounds on which

23 the denial is based, and

24 ‘‘(B) an opportunity for an appeal in ac25 cordance with the procedures set forth in regu-
38

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1 lations of the Secretary published at 42 C.F.R.

2 498 and in effect on the date of the enactment

3 of this section.

4 ‘‘(3) EFFECT OF DENIAL.—If the application

5 for the certification of a facility is denied, the facil6 ity may not operate unless the denial of the applica7 tion is overturned at the conclusion of the adminis8 trative appeals process provided in the regulations

9 referred to in paragraph (2)(B).

10 ‘‘(e) ACCREDITATION.—

11 ‘‘(1) APPROVAL OF ACCREDITATION BODIES.—

12 ‘‘(A) IN GENERAL.—The Secretary may

13 approve a private nonprofit organization or

14 State agency to accredit facilities for purposes

15 of subsection (d)(1)(A)(iii) if the accreditation

16 body meets the standards for accreditation es17 tablished by the Secretary as described in sub18 paragraph (B) and provides the assurances re19 quired by subparagraph (C).

20 ‘‘(B) STANDARDS.—The Secretary shall

21 establish standards for accreditation bodies, in22 cluding—

23 ‘‘(i) standards that prohibit individ24 uals conducting the reviews from maintain25 ing any financial relationship to the facility
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1 undergoing review which would constitute

2 a conflict of interest;

3 ‘‘(ii) standards that limit the imposi4 tion of fees for accreditation to reasonable

5 amounts;

6 ‘‘(iii) standards that are equal to

7 standards established under subsection (f)

8 which are relevant to accreditation as de9 termined by the Secretary; and

10 ‘‘(iv) such additional standards as the

11 Secretary may require.

12 ‘‘(C) ASSURANCES.—The accrediting body

13 shall provide the Secretary satisfactory assur14 ances that the body will—

15 ‘‘(i) comply with the standards as de16 scribed in subparagraph (B);

17 ‘‘(ii) comply with the requirements de18 scribed in paragraph (4);

19 ‘‘(iii) submit to the Secretary the

20 name of any facility for which the accredi21 tation body denies, suspends, or revokes

22 accreditation;

23 ‘‘(iv) notify the Secretary in a timely

24 manner before the accreditation body

25 changes the standards of the body;
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1 ‘‘(v) notify each facility accredited by

2 the accreditation body if the Secretary

3 withdraws approval of the accreditation

4 body under paragraph (2) in a timely man5 ner; and

6 ‘‘(vi) provide such other additional in7 formation as the Secretary may require.

8 ‘‘(D) REGULATIONS.—Not later than 9

9 months after the date of the enactment of this

10 section, the Secretary shall promulgate regula11 tions under which the Secretary may approve

12 one or more accreditation bodies.

13 ‘‘(2) WITHDRAWAL OF APPROVAL.—

14 ‘‘(A) IN GENERAL.—The Secretary shall

15 promulgate regulations under which the Sec16 retary may withdraw the approval of an accred17 itation body if the Secretary determines that

18 the accreditation body does not meet the stand19 ards under subparagraph (B) of paragraph (1),

20 the requirements of clauses (i) through (vi) of

21 subparagraph (C) of paragraph (1), or the re22 quirements of paragraph (4).

23 ‘‘(B) EFFECT OF WITHDRAWAL.—If the

24 Secretary withdraws the approval of an accredi25 tation body under subparagraph (A), the certifi-
41

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1 cate of any facility accredited by the body shall

2 continue in effect until the expiration of a rea3 sonable period, as determined by the Secretary,

4 for such facility to obtain another accreditation.

5 ‘‘(3) ACCREDITATION.—To be accredited by an

6 approved accreditation body a facility shall meet—

7 ‘‘(A) the standards described in paragraph

8 (1)(B) which the Secretary determines are ap9 plicable to the facility, and

10 ‘‘(B) such other standards which the ac11 creditation body may require.

12 ‘‘(4) COMPLIANCE.—To ensure that facilities

13 accredited by an accreditation body will continue to

14 meet the standards of the accreditation body, the ac15 creditation body shall—

16 ‘‘(A) make onsite visits of the facilities ac17 credited by the body of a sufficient number and

18 of such frequency to allow a reasonable esti19 mate of the performance of the body; and

20 ‘‘(B) take such additional measures as the

21 Secretary determines to be appropriate.

22 Visits made under subparagraph (A) shall be made

23 after providing such notice as the Secretary may re24 quire.
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1 ‘‘(5) REVOCATION OF ACCREDITATION.—If an

2 accreditation body revokes the accreditation of a fa3 cility, the certificate of the facility shall continue in

4 effect until such time as may be determined by the

5 Secretary.

6 ‘‘(6) EVALUATION AND REPORT.—

7 ‘‘(A) EVALUATION.—The Secretary shall

8 evaluate the performance of each approved ac9 creditation body by—

10 ‘‘(i) inspecting under subsection (g)(2)

11 a sufficient number of the facilities accred12 ited by the body to allow a reasonable esti13 mate of the performance of the body; and

14 ‘‘(ii) such additional means as the

15 Secretary determines to be appropriate.

16 ‘‘(f) QUALITY STANDARDS.—

17 ‘‘(1) IN GENERAL.—The standards referred to

18 in subsection (d)(1)(B)(i) are standards established

19 by the Secretary which include—

20 ‘‘(A) standards that require establishment

21 and maintenance of a quality assurance and

22 quality control program at each facility that is

23 adequate and appropriate to ensure the reliabil24 ity and accuracy of interpretation of fetal

25 ultrasound;
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•HR 4217 IH

1 ‘‘(B) a requirement that personnel who

2 perform ultrasound—

3 ‘‘(i)(I) be licensed by a State to per4 form ultrasound procedures; or

5 ‘‘(II) be certified as qualified to per6 form ultrasound procedures by an organi7 zation described in paragraph (2)(A); and

8 ‘‘(ii) during the 2-year period begin9 ning October 1, 1997, meet training stand10 ards for personnel who perform

11 ultrasonography or meet experience re12 quirements which shall at a minimum in13 clude 1 year of experience in the perform14 ance of ultrasonography; and

15 ‘‘(iii) upon the expiration of such 2-

16 year period meet minimum training stand17 ards for personnel who perform fetal

18 ultrasound;

19 ‘‘(C) a requirement that ultrasound images

20 be interpreted by a physician who is certified as

21 qualified to interpret fetal ultrasound and who

22 meets training and continuing medical edu23 cation requirements as established by the Sec24 retary;
44

•HR 4217 IH

1 ‘‘(D) a requirement that fetal

2 ultrasonography be performed only when medi3 cally necessary.

4 ‘‘(E) a requirement that—

5 ‘‘(i) a facility that performs any fetal

6 ultrasound maintain a record of such

7 ultrasound in the permanent medical

8 records of the patient—

9 ‘‘(I) for a period of not fewer

10 than 5 years, or longer if mandated

11 by State law; or

12 ‘‘(II) until such time as the pa13 tient should request that the patient’s

14 medical records be forwarded to a

15 medical institution or a physician of

16 the patient;

17 whichever is longer; and

18 ‘‘(ii)(I) a facility must assure the

19 preparation of a written report of the re20 sults of any fetal ultrasound examination

21 signed by the interpreting physician;

22 ‘‘(II) such written report shall be pro23 vided to the patient’s physicians (if any);

24 ‘‘(III) if such a physician is not avail25 able or if there is no such physician, the
45

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1 written report shall be sent directly to the

2 patient; and

3 ‘‘(IV) if such report is sent to the pa4 tient, the report shall include a summary

5 written in terms easily understood by a lay

6 person.

7 Subparagraph (E) shall not be construed to limit a

8 patient’s access to the patient’s medical records.

9 ‘‘(2) CERTIFICATION OF PERSONNEL.—The

10 Secretary shall by regulation—

11 ‘‘(A) specify organizations eligible to cer12 tify individuals to perform fetal ultrasound as

13 required by paragraph (1)(B); and

14 ‘‘(B) establish standards for a program to

15 certify physicians described in paragraph

16 (1)(C).

17 ‘‘(g) INSPECTIONS.—

18 ‘‘(1) INSPECTIONS.—

19 ‘‘(A) IN GENERAL.—The Secretary may

20 enter and inspect certified facilities to deter21 mine compliance with the standards established

22 under subsection (f). The Secretary shall, if fea23 sible, delegate to a State agency the authority

24 to make such inspections.
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1 ‘‘(B) IDENTIFICATION.—The Secretary, or

2 State agency acting on behalf of the Secretary,

3 may conduct inspections only on presenting

4 identification to the owner, operator, or agent

5 in charge of the facility to be inspected.

6 ‘‘(C) SCOPE OF INSPECTION.—In conduct7 ing inspections, the Secretary or State agency

8 acting on behalf of the Secretary—

9 ‘‘(i) shall have access to all equip10 ment, materials, records, and information

11 that the Secretary or State agency consid12 ers necessary to determine whether the fa13 cility is being operated in accordance with

14 this section; and

15 ‘‘(ii) may copy, or require the facility

16 to submit to the Secretary or the State

17 agency, any of the materials, records, or

18 information.

19 ‘‘(D) QUALIFICATIONS OF INSPECTORS.—

20 Qualified individuals, as determined by the Sec21 retary, shall conduct all inspections. The Sec22 retary may request that a State agency acting

23 on behalf of the Secretary designate a qualified

24 officer or employee to conduct the inspections,

25 or designate a qualified Federal officer or em-
47

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1 ployee to conduct inspections. The Secretary

2 shall establish minimum qualifications and ap3 propriate training for inspectors and criteria

4 for certification of inspectors in order to inspect

5 facilities for compliance with subsection (f).

6 ‘‘(E) FREQUENCY.—The Secretary or

7 State agency acting on behalf of the Secretary

8 shall conduct inspections under this paragraph

9 of each facility as frequently as needed to as10 sure that facilities are in compliance with this

11 section, but no more frequently than once every

12 2 years.

13 ‘‘(F) RECORDS AND ANNUAL REPORTS.—

14 The Secretary or a State agency acting on be15 half of the Secretary which is responsible for in16 specting ultrasound facilities shall maintain

17 records of inspections required under this para18 graph for a period as prescribed by the Sec19 retary. Such a State agency shall annually pre20 pare and submit to the Secretary a report con21 cerning the inspections carried out under this

22 paragraph. Such reports shall include a descrip23 tion of the facilities inspected and the results of

24 such inspections.
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1 ‘‘(2) INSPECTION OF ACCREDITED FACILI2 TIES.—The Secretary shall inspect annually a suffi3 cient number of the facilities accredited by an ac4 creditation body to provide the Secretary with a rea5 sonable estimate of the performance of such body.

6 ‘‘(3) INSPECTION OF FACILITIES INSPECTED BY

7 STATE AGENCIES.—The Secretary shall inspect an8 nually facilities inspected by State agencies acting

9 on behalf of the Secretary to assure a reasonable

10 performance by such State agencies.

11 ‘‘(4) TIMING.—The Secretary, or State agency,

12 may conduct inspections under paragraphs (1), (2),

13 and (3), during regular business hours or at a mutu14 ally agreeable time and after providing such notice

15 as the Secretary may prescribe, except that the Sec16 retary may waive such requirements if the continued

17 performance of ultrasonography at such facility

18 threatens the public health.

19 ‘‘(5) LIMITED REINSPECTION.—Nothing in this

20 section limits the authority of the Secretary to con21 duct limited reinspections of facilities found not to

22 be in compliance with this section.

23 ‘‘(h) SANCTIONS.—

24 ‘‘(1) IN GENERAL.—In order to promote vol25 untary compliance with this section, the Secretary
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1 may, in lieu of taking the actions authorized by sub2 section (i), impose one or more of the following sanc3 tions:

4 ‘‘(A) Directed plans of correction which af5 ford a facility an opportunity to correct viola6 tions in a timely manner.

7 ‘‘(B) Payment for the cost of onsite mon8 itoring.

9 ‘‘(2) CIVIL MONEY PENALTIES.—The Secretary

10 may assess civil money penalties in an amount not

11 to exceed $10,000 for—

12 ‘‘(A) failure to obtain a certificate as re13 quired by subsection (b),

14 ‘‘(B) each failure by a facility to substan15 tially comply with, or each day on which a facil16 ity fails to substantially comply with, the stand17 ards established under subsection (f) or the re18 quirements described in subclauses (I) through

19 (III) of subsection (d)(1)(B)(ii), and

20 ‘‘(C) each violation, or for each aiding and

21 abetting in a violation of, any provision of, or

22 regulation promulgated under, this section by

23 an owner, operator, or any employee of a facil24 ity required to have a certificate.
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1 ‘‘(3) PROCEDURES.—The Secretary shall de2 velop and implement procedures with respect to

3 when and how each of the sanctions is to be imposed

4 under paragraphs (1) and (2). Such procedures shall

5 provide for notice to the owner or operator of the fa6 cility and a reasonable opportunity for the owner or

7 operator to respond to the proposed sanctions and

8 appropriate procedures for appealing determinations

9 relating to the imposition of sanctions.

10 ‘‘(i) SUSPENSION AND REVOCATION.—

11 ‘‘(1) IN GENERAL.—The certificate of a facility

12 issued under subsection (c) may be suspended or re13 voked if the Secretary finds, after providing, except

14 as provided in paragraph (2), reasonable notice and

15 an opportunity for a hearing to the owner or opera16 tor of the facility, that the owner, operator, or any

17 employee of the facility—

18 ‘‘(A) has been guilty of misrepresentation

19 in obtaining the certificate;

20 ‘‘(B) has failed to comply with the require21 ments of subsection (d)(1)(B)(ii)(III) or the

22 standards established by the Secretary under

23 subsection (f);

24 ‘‘(C) has failed to comply with reasonable

25 requests of the Secretary for any record, infor-
51

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1 mation, report, or material that the Secretary

2 concludes is necessary to determine the contin3 ued eligibility of the facility for a certificate or

4 continued compliance with the standards estab5 lished under subsection (f);

6 ‘‘(D) has refused a reasonable request of

7 the Secretary, any Federal officer or employee

8 duly designated by the Secretary, or any State

9 officer or employee duly designated by the

10 State, for permission to inspect the facility or

11 the operations and pertinent records of the fa12 cility in accordance with subsection (g);

13 ‘‘(E) has violated or aided and abetted in

14 the violation of any provision of, or regulation

15 promulgated under, this section; or

16 ‘‘(F) has failed to comply with a sanction

17 imposed under subsection (h).

18 ‘‘(2) ACTION BEFORE A HEARING.—

19 ‘‘(A) IN GENERAL.—The Secretary may

20 suspend the certificate of the facility before

21 holding a hearing required by paragraph (1) if

22 the Secretary makes the finding described in

23 paragraph (1) and determines that—

24 ‘‘(i) the failure of a facility to comply

25 with the standards established by the Sec-
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1 retary under subsection (f) presents a seri2 ous risk to human health; or

3 ‘‘(ii) a facility has engaged in an ac4 tion described in subparagraph (D) or (E)

5 of paragraph (1).

6 ‘‘(B) HEARING.—If the Secretary suspends

7 a certificate under subparagraph (A), the Sec8 retary shall provide an opportunity for a hear9 ing to the owner or operator of the facility not

10 later than 60 days from the effective date of the

11 suspension. The suspension shall remain in ef12 fect until the decision of the Secretary made

13 after the hearing.

14 ‘‘(3) INELIGIBILITY TO OWN OR OPERATE FA15 CILITIES AFTER REVOCATION.—If the Secretary re16 vokes the certificate of a facility on the basis of an

17 act described in paragraph (1), no person who

18 owned or operated the facility at the time of the act

19 may, within 2 years of the revocation of the certifi20 cate, own or operate a facility that requires a cer21 tificate under this section.

22 ‘‘(j) INJUNCTIONS.—If the Secretary determines

23 that—

24 ‘‘(1) continuation of any activity related to the

25 provision of fetal ultrasonography by a facility would
53

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1 constitute a serious risk to human health, the Sec2 retary may bring suit in the district court of the

3 United States for the district in which the facility

4 is situated to enjoin continuation of the activity; and

5 ‘‘(2) a facility is operating without a certificate

6 as required by subsection (b), the Secretary may

7 bring suit in the district court of the United States

8 for the district in which the facility is situated to en9 join the operation of the facility.

10 Upon a proper showing, the district court shall grant a

11 temporary injunction or restraining order against continu12 ation of the activity or against operation of a facility, as

13 the case may be, without requiring the Secretary to post

14 a bond, pending issuance of a final order under this sub15 section.

16 ‘‘(k) JUDICIAL REVIEW.—

17 ‘‘(1) PETITION.—If the Secretary imposes a

18 sanction on a facility under subsection (h) or sus19 pends or revokes the certificate of a facility under

20 subsection (i), the owner or operator of the facility

21 may, not later than 60 days after the date the action

22 of the Secretary becomes final, file a petition with

23 the United States court of appeals for the circuit in

24 which the facility is situated for judicial review of

25 the action. As soon as practicable after receipt of the
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1 petition, the clerk of the court shall transmit a copy

2 of the petition to the Secretary or other officer des3 ignated by the Secretary. As soon as practicable

4 after receipt of the copy, the Secretary shall file in

5 the court the record on which the action of the Sec6 retary is based, as provided in section 2112 of title

7 28, United States Code.

8 ‘‘(2) ADDITIONAL EVIDENCE.—If the petitioner

9 applies to the court for leave to adduce additional

10 evidence, and shows to the satisfaction of the court

11 that the additional evidence is material and that

12 there were reasonable grounds for the failure to ad13 duce such evidence in the proceeding before the Sec14 retary, the court may order the additional evidence

15 (and evidence in rebuttal of the additional evidence)

16 to be taken before the Secretary, and to be adduced

17 upon the hearing in such manner and upon such

18 terms and conditions as the court may determine to

19 be proper. The Secretary may modify the findings of

20 the Secretary as to the facts, or make new findings,

21 by reason of the additional evidence so taken, and

22 the Secretary shall file the modified or new findings,

23 and the recommendations of the Secretary, if any,

24 for the modification or setting aside of the original
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1 action of the Secretary with the return of the addi2 tional evidence.

3 ‘‘(3) JUDGMENT OF COURT.—Upon the filing of

4 the petition referred to in paragraph (1), the court

5 shall have jurisdiction to affirm the action, or to set

6 the action aside in whole or in part, temporarily or

7 permanently. The findings of the Secretary as to the

8 facts, if supported by substantial evidence, shall be

9 conclusive.

10 ‘‘(4) FINALITY OF JUDGMENT.—The judgment

11 of the court affirming or setting aside, in whole or

12 in part, any action of the Secretary shall be final,

13 subject to review by the Supreme Court of the Unit14 ed States upon certiorari or certification, as provided

15 in section 1254 of title 28, United States Code.

16 ‘‘(l) INFORMATION.—

17 ‘‘(1) IN GENERAL.—Not later than October 1,

18 1999, and annually thereafter, the Secretary shall

19 compile and make available to physicians and the

20 general public information that the Secretary deter21 mines is useful in evaluating the performance of fa22 cilities, including a list of facilities—

23 ‘‘(A) that have been convicted under Fed24 eral or State laws relating to fraud and

25 abuse, false billings, or kickbacks;
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1 ‘‘(B) that have been subject to sanctions

2 under subsection (h), together with a statement

3 of the reasons for the sanctions;

4 ‘‘(C) that have had certificates revoked or

5 suspended under subsection (i), together with a

6 statement of the reasons for the revocation or

7 suspension;

8 ‘‘(D) against which the Secretary has

9 taken action under subsection (j), together with

10 a statement of the reasons for the action;

11 ‘‘(E) whose accreditation has been revoked,

12 together with a statement of the reasons of the

13 revocation;

14 ‘‘(F) against which a State has taken ad15 verse action; and

16 ‘‘(G) that meet such other measures of

17 performance as the Secretary may develop.

18 ‘‘(2) DATE.—The information to be compiled

19 under paragraph (1) shall be information for the cal20 endar year preceding the date the information is to

21 be made available to the public.

22 ‘‘(3) EXPLANATORY INFORMATION.—The infor23 mation to be compiled under paragraph (1) shall be

24 accompanied by such explanatory information as
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1 may be appropriate to assist in the interpretation of

2 the information compiled under such paragraph.

3 ‘‘(m) STATE LAWS.—Nothing in this section shall be

4 construed to limit the authority of any State to enact and

5 enforce laws relating to the matters covered by this section

6 that are at least as stringent as this section or the regula7 tions issued under this section.

8 ‘‘(n) CONSULTATIONS.—In carrying out this section,

9 the Secretary shall consult with appropriate Federal agen10 cies within the Department of Health and Human Services

11 for the purposes of developing standards, regulations,

12 evaluations, and procedures for compliance and oversight.

13 ‘‘(o) STATE PROGRAM.—

14 ‘‘(1) IN GENERAL.—The Secretary may, upon

15 application, authorize a State—

16 ‘‘(A) to carry out, subject to paragraph

17 (2), the certification program requirements

18 under subsections (b), (c), (d), (g)(1), (h), (i),

19 and (j) (including the requirements under regu20 lations promulgated pursuant to such sub21 sections), and

22 ‘‘(B) to implement the standards estab23 lished by the Secretary under subsection (f),

24 with respect to ultrasound facilities operating within

25 the State.
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1 ‘‘(2) APPROVAL.— The Secretary may approve

2 an application under paragraph (1) if the Secretary

3 determines that—

4 ‘‘(A) the State has enacted laws and issued

5 regulations relating to ultrasound facilities

6 which are the requirements of this section (in7 cluding the requirements under regulations pro8 mulgated pursuant to such subsections), and

9 ‘‘(B) the State has provided satisfactory

10 assurances that the State—

11 ‘‘(i) has the legal authority and quali12 fied personnel necessary to enforce the re13 quirements of and the regulations promul14 gated pursuant to this section (including

15 the requirements under regulations pro16 mulgated pursuant to such subsections),

17 ‘‘(ii) will devote adequate funds to the

18 administration and enforcement of such re19 quirements, and

20 ‘‘(iii) will provide the Secretary with

21 such information and reports as the Sec22 retary may require.

23 ‘‘(3) AUTHORITY OF STATE.—In a State with

24 an approved application—
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1 ‘‘(A) the State shall carry out the Sec2 retary’s functions under subsections (e) and (f);

3 ‘‘(B) the State may take action under sub4 sections (h), (i), and (j); and

5 ‘‘(C) the State shall conduct oversight

6 functions under subsections (g)(2) and (g)(3).

7 ‘‘(4) WITHDRAWAL OF APPROVAL.—

8 ‘‘(A) IN GENERAL.—The Secretary may,

9 after providing notice and opportunity for cor10 rective action, withdraw the approval of a

11 State’s authority under paragraph (1) if the

12 Secretary determines that the State does not

13 meet the requirements of such paragraph. The

14 Secretary shall promulgate regulations for the

15 implementation of this subparagraph.

16 ‘‘(B) EFFECT OF WITHDRAWAL.—If the

17 Secretary withdraws the approval of a State

18 under subparagraph (A), the certificate of any

19 facility accredited by the State shall continue in

20 effect until the expiration of a reasonable pe21 riod, as determined by the Secretary, for such

22 facility to obtain certification by the Secretary.

23 ‘‘(p) FUNDING.—

24 ‘‘(1) FEES.—
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1 ‘‘(A) IN GENERAL.—The Secretary shall,

2 in accordance with this paragraph assess and

3 collect fees from persons described in subsection

4 (d)(1)(A) (other than persons who are govern5 mental entities, as determined by the Secretary)

6 to cover the costs of inspections conducted

7 under subsection (g)(1) by the Secretary or a

8 State acting under a delegation under subpara9 graph (A) of such subsection. Fees may be as10 sessed and collected under this paragraph only

11 in such manner as would result in an aggregate

12 amount of fees collected during any fiscal year

13 which equals the aggregate amount of costs for

14 such fiscal year for inspections of facilities of

15 such persons under subsection (g)(1). A per16 son’s liability for fees shall be reasonably based

17 on the proportion of the inspection costs which

18 relate to such person.

19 ‘‘(B) DEPOSIT AND APPROPRIATIONS.—

20 ‘‘(i) DEPOSIT AND AVAILABILITY.—

21 Fees collected under subparagraph (A)

22 shall be deposited as an offsetting collec23 tion to the appropriations for the Depart24 ment of Health and Human Services as

25 provided in appropriation Acts and shall
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1 remain available without fiscal year limita2 tion.

3 ‘‘(ii) APPROPRIATIONS.—Fees col4 lected under subparagraph (A) shall be col5 lected and available only to the extent pro6 vided in advance in appropriation Acts.

7 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.—

8 There are authorized to be appropriated for the Sec9 retary to carry out activities which are not sup10 ported by fees authorized and collected under para11 graph (1), such sums as may be necessary for fiscal

12 years 1997 through 2001.’’.

13 SEC. 403. DATA SURVEY.

14 The Institute of Medicine, by itself or with the Na15 tional Institutes of Health, shall survey the data collected

16 on the prevalence of the use of fetal ultrasound and the

17 interaction between physicians and consumers that may

18 be driving the use of fetal ultrasound. The survey should

19 begin with data collected after the report in 1984 by the

20 National Institutes of Health on a consensus development

21 conference on diagnostic ultrasound imaging in pregnancy.

22 SEC. 404. OUTREACH.

23 The Secretary of Health and Human Services shall

24 establish a program to provide educational outreach to

25 medical practitioners and the public regarding the appro-
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1 priateness of fetal ultrasound for the health of mothers

2 and fetuses.

3 SEC. 405. REPORT.

4 No later than January 1, 1999, the Secretary shall

5 report to the Committee on Labor and Human Resources

6 of the Senate and the Committee on Commerce of the

7 House of Representatives on whether this program has re8 sulted in improvement of the quality of fetal ultrasound,

9 and a reduction in nonmedically indicated fetal

10 ultrasonography, without affecting access to medically

11 necessary services or unnecessarily burdening health care

12 providers.

13 SEC. 406. TECHNICAL AMENDMENT.

14 Section 354(q)(3) of the Public Health Service Act

15 (42 U.S.C. 263b(q)(3)) is amended by striking ‘‘Sec16 retary’’ each place it occurs and inserting ‘‘State’’.

Æ