II

106TH CONGRESS

1ST SESSION S. 736

To amend titles XVIII and XIX of the Social Security Act to ensure that

individuals enjoy the right to be free from restraint, and for other purposes.

IN THE SENATE OF THE UNITED STATES

MARCH 25, 1999

Mr. LIEBERMAN (for himself and Mr. DODD) introduced the following bill;

which was read twice and referred to the Committee on Finance

A BILL

To amend titles XVIII and XIX of the Social Security Act

to ensure that individuals enjoy the right to be free

from restraint, and for other purposes.

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.

4 This Act may be cited as the ‘‘Freedom From Re5 straint Act of 1999’’.
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1 SEC. 2. INDIVIDUALS’ RIGHT TO FREEDOM FROM RE2 STRAINT AND REPORTING OF SENTINEL

3 EVENTS UNDER MEDICARE.

4 (a) IN GENERAL.—Part D of title XVIII of the Social

5 Security Act (42 U.S.C. 1395x et seq.) is amended by add6 ing at the end the following:

7 ‘‘INDIVIDUALS’ FREEDOM FROM RESTRAINT AND

8 REPORTING OF SENTINEL EVENTS

9 ‘‘SEC. 1897. (a) DEFINITIONS.—In this section:

10 ‘‘(1) PROVIDER OF SERVICES.—The term ‘pro11 vider of services’ has the meaning given that term

12 in section 1861(u), except that for purposes of this

13 section the term includes a psychiatric hospital but

14 does not include a home health agency.

15 ‘‘(2) SENTINEL EVENT.—The term ‘sentinel

16 event’ means an unexpected occurrence involving an

17 individual in the care of a provider of services for

18 treatment for a psychiatric or psychological illness

19 that results in death or serious physical or psycho20 logical injury that is unrelated to the natural course

21 of the individual’s illness or underlying condition.

22 ‘‘(b) PROTECTION OF RIGHT TO BE FREE FROM RE23 STRAINTS.—A provider of services eligible to be paid

24 under this title for providing services to an individual enti25 tled to benefits under part A or enrolled under part B

26 (including an individual provided with a Medicare+Choice
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1 plan offered by a Medicare+Choice organization under

2 part C) shall—

3 ‘‘(1) protect and promote the right of each such

4 individual to be free from physical or mental abuse,

5 corporal punishment, involuntary seclusion, and any

6 physical or chemical restraints imposed for purposes

7 of discipline or convenience;

8 ‘‘(2) impose restraints—

9 ‘‘(A) only to ensure the physical safety of

10 the individual or other individuals in the care or

11 custody of the provider; and

12 ‘‘(B) only upon the written order of a phy13 sician that specifies the duration and cir14 cumstances under which the restraints are to be

15 used (except in emergency circumstances speci16 fied by the Secretary until such an order could

17 reasonably be obtained); and

18 ‘‘(2) submit the reports required under sub19 section (c).

20 ‘‘(c) REPORTS.—

21 ‘‘(1) REPORTS TO AGENCIES OR ENTITIES WITH

22 OVERSIGHT AUTHORITY.—

23 ‘‘(A) IN GENERAL.—A provider of services

24 shall report each sentinel event that occurs to
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1 an individual while the individual is in the care

2 or custody of the provider to—

3 ‘‘(i) in the case of a provider of serv4 ices participating in the program estab5 lished under this title or the medicaid pro6 gram under title XIX as a result of accred7 itation by a national accrediting body, the

8 national accrediting body for that provider;

9 and

10 ‘‘(ii) in the case of all other providers

11 of services, the Secretary or, upon agree12 ment between the Secretary and the rel13 evant State, the State agency designated

14 by the Secretary.

15 ‘‘(B) INVESTIGATION AND FURTHER RE16 PORTING OF SENTINEL EVENTS.—Upon receipt

17 of a report made pursuant to subparagraph

18 (A), the agency or entity with oversight author19 ity shall—

20 ‘‘(i) ensure that the provider—

21 ‘‘(I) conducts an investigation of

22 the sentinel event reported;

23 ‘‘(II) determines the root cause

24 or causes of the sentinel event; and
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1 ‘‘(III) establishes a time-limited

2 plan or strategy, that allows the agen3 cy or entity with oversight authority

4 to review and approve the analyses

5 and any corrective actions proposed or

6 made by the provider of services, to

7 correct the problem or problems that

8 resulted in the sentinel event, and to

9 lead to risk reduction; and

10 ‘‘(ii) prepare and submit the reports

11 required under paragraph (2).

12 ‘‘(2) REPORTS TO THE SECRETARY.—

13 ‘‘(A) IN GENERAL.—Subject to subpara14 graph (D), the agency or entity with oversight

15 authority shall submit a report containing the

16 information described in subparagraph (B) to

17 the Secretary in such form and manner, and by

18 such date, as the Secretary prescribes.

19 ‘‘(B) INFORMATION TO BE REPORTED.—

20 ‘‘(i) IN GENERAL.—The report sub21 mitted under subparagraph (A) shall be

22 submitted to the Secretary at regular in23 tervals, but not less frequently than annu24 ally, and shall include—
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1 ‘‘(I) a description of the sentinel

2 events occurring during the period

3 covered by the report;

4 ‘‘(II) a description of any correc5 tive action taken by the providers of

6 services with respect to the sentinel

7 events or any other measures nec8 essary to prevent similar sentinel

9 events from occurring in the future;

10 ‘‘(III) proposed systems changes

11 identified as a result of analysis of

12 events from multiple providers; and

13 ‘‘(IV) such additional information

14 as the Secretary determines to be es15 sential to ensure compliance with the

16 requirements of this section.

17 ‘‘(ii) INFORMATION EXCLUDED.—The

18 report submitted under subparagraph (A)

19 shall not identify any individual provider of

20 services, practitioner, or individual.

21 ‘‘(C) ADDITIONAL REPORTING REQUIRE22 MENTS WHEN A PROVIDER HAS BEEN IDENTI23 FIED AS HAVING A PATTERN OF POOR PER24 FORMANCE.—
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1 ‘‘(i) IN GENERAL.—In addition to the

2 report required under subparagraph (A),

3 the agency or entity with oversight author4 ity shall report to the Secretary the name

5 and address of any provider of services

6 with a pattern of poor performance.

7 ‘‘(ii) DETERMINATION OF PATTERN.—

8 The agency or entity with oversight au9 thority shall determine if a pattern of poor

10 performance exists with respect to a pro11 vider of services in accordance with the

12 definition of pattern of poor performance

13 developed by the Secretary under clause

14 (iii).

15 ‘‘(iii) DEVELOPMENT OF DEFINI16 TION.—The Secretary, in consultation with

17 national accrediting organizations and oth18 ers, shall develop a definition to identify a

19 provider of services with a pattern of poor

20 performance.

21 ‘‘(D) AUTHORITY TO WAIVE REPORTING

22 REQUIREMENT.—The Secretary may waive the

23 requirement to submit a report required under

24 this paragraph (but not a report regarding a

25 sentinel event that resulted in death required
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1 under paragraph (3)) upon consideration of the

2 severity of the sentinel event.

3 ‘‘(3) ADDITIONAL REPORTING REQUIREMENTS

4 FOR SENTINEL EVENTS RESULTING IN DEATH.—In

5 addition to the report required under paragraph (1),

6 a provider of services shall report any sentinel event

7 resulting in death to—

8 ‘‘(A) the Secretary or the Secretary’s des9 ignee;

10 ‘‘(B) the State Attorney General or, upon

11 agreement with the State Attorney General, to

12 the appropriate law enforcement agency;

13 ‘‘(C) the State agency responsible for li14 censing the provider of services; and

15 ‘‘(D) the State protection and advocacy

16 system established pursuant to part C of title I

17 of the Developmental Disabilities Assistance

18 and Bill of Rights Act (42 U.S.C. 6041 et seq.)

19 for the State in which the event occurred.

20 ‘‘(4) RESPONSIBILITIES OF THE AGENCY OR

21 ENTITY WITH OVERSIGHT AUTHORITY.—Upon re22 ceipt of a report of a sentinel event that resulted in

23 death, the agency or entity with oversight authority

24 shall, in addition to the requirements of paragraph

25 (2)—
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1 ‘‘(A) determine whether the death was re2 lated to the use of restraints or seclusion; and

3 ‘‘(B) notify the Secretary of the determina4 tion.

5 ‘‘(5) SANCTIONS FOR FAILURE TO REPORT.—

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

7 establish sanctions, including intermediate sanc8 tions, as appropriate, for failure of a provider

9 of services or an agency or entity with oversight

10 authority to submit the reports and information

11 required under this subsection.

12 ‘‘(B) REMOVAL OF AGENCY OR ENTITY

13 WITH OVERSIGHT AUTHORITY.—The Secretary,

14 after notice to an agency or entity with over15 sight authority of a provider of services, as de16 termined in paragraph (1), and opportunity to

17 comply, may remove the agency or entity of

18 such authority if the agency or entity refuses to

19 submit the reports and information required

20 under this subsection.

21 ‘‘(6) LIABILITY FOR REPORTING.—An indi22 vidual, provider of services, agency, or entity shall be

23 liable with respect to any information contained in

24 a report required under this subsection if the indi25 vidual, provider of services, agency, or entity had
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1 knowledge of the falsity of the information contained

2 in the report at the time the report was submitted

3 under this subsection. Nothing in the preceding sen4 tence shall be construed as limiting the liability of

5 an individual, provider of services, agency, or entity

6 for damages relating to the occurrence of a sentinel

7 event, including a sentinel event that results in

8 death.

9 ‘‘(7) NONDISCLOSURE OF ANALYSIS.—Notwith10 standing any other provision of law or regulation,

11 the root cause analysis developed under this sub12 section shall be kept confidential and shall not be

13 subject to disclosure or discovery in a civil action.

14 ‘‘(d) ESTABLISHMENT OR DESIGNATION OF SEN15 TINEL EVENTS DATABASE.—

16 ‘‘(1) IN GENERAL.—Not later than 1 year after

17 the date of enactment of this section, the Secretary

18 shall establish or designate a database of informa19 tion using the reports submitted under paragraphs

20 (2) and (3) of subsection (c) (in this subsection re21 ferred to as the ‘Sentinel Events Database’).

22 ‘‘(2) CONTENTS.—

23 ‘‘(A) IN GENERAL.—Subject to subpara24 graph (B), the Sentinel Events Database shall

25 include the following:
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1 ‘‘(i) The name and address of any

2 provider of services that is the subject of

3 a report submitted under subsection (c)(3),

4 if the agency or entity with oversight au5 thority has determined that the death was

6 related to the use of restraints or seclu7 sion.

8 ‘‘(ii) The information reported by the

9 agency or entity under subparagraphs (B)

10 and (C) of subsection (c)(2).

11 ‘‘(B) CONFIDENTIALITY.—The Secretary

12 shall establish procedures to ensure that the

13 privacy of individuals whose treatment is the

14 subject of a report submitted under paragraph

15 (2) or (3) of subsection (c) is protected.

16 ‘‘(3) PROCEDURES FOR ENTRY OF INFORMA17 TION.—

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

19 ‘‘(i) prior to entry of information in

20 the Sentinel Events Database, disclose the

21 information to the provider of services that

22 is the subject of the information; and

23 ‘‘(ii) establish procedures to—

24 ‘‘(I) resolve disputes regarding

25 the accuracy of the information; and
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1 ‘‘(II) ensure the accuracy of the

2 information.

3 ‘‘(B) NO DELAY OF SANCTIONS.—Any

4 sanction to be imposed by the Secretary against

5 a provider of services or an agency or entity

6 with oversight authority in relation to a sentinel

7 event shall not be delayed as a result of a dis8 pute regarding the accuracy of information to

9 be entered into the database.

10 ‘‘(4) ACCESS TO THE DATABASE.—

11 ‘‘(A) AVAILABILITY.—The Secretary shall

12 establish procedures for making the information

13 maintained in the Sentinel Events Database re14 lated to a sentinel event resulting in death, and

15 any reports of sentinel injuries arising from

16 those providers of services with a pattern of

17 poor performance identified in accordance with

18 subsection (c)(2)(C), available to Federal and

19 State agencies, national accrediting bodies,

20 health care researchers, and the public.

21 ‘‘(B) INTERNET ACCESS.—In addition to

22 any other procedures that the Secretary devel23 ops under subparagraph (A), the information in

24 the Sentinel Events Database shall be accessible

25 through the Internet.
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1 ‘‘(C) FEES FOR DISCLOSURE.—

2 ‘‘(i) IN GENERAL.—Subject to clause

3 (ii), the Secretary may establish or approve

4 reasonable fees for disclosing information

5 maintained in the Sentinel Events Data6 base.

7 ‘‘(ii) NO FEE FOR FEDERAL AGEN8 CIES.—No fee shall be charged to a Fed9 eral agency for access to the Sentinel

10 Events Database.

11 ‘‘(iii) APPLICATION OF FEES.—Fees

12 collected under this clause shall be applied

13 by the Secretary toward the cost of main14 taining the Sentinel Events Database.’’.

15 (b) EFFECTIVE DATE.—

16 (1) IN GENERAL.—Subject to paragraph (2),

17 the amendments made by this section take effect on

18 the date of enactment of this Act.

19 (2) REPORTING REQUIREMENTS.—The report20 ing requirements under section 1897(c) of the Social

21 Security Act, as added by subsection (a), shall apply

22 to sentinel events occurring on and after the date of

23 enactment of this Act.
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1 SEC. 3. INDIVIDUALS’ RIGHT TO FREEDOM FROM RE2 STRAINT AND REPORTING OF SENTINEL

3 EVENTS UNDER MEDICAID.

4 (a) STATE PLANS FOR MEDICAL ASSISTANCE.—Sec5 tion 1902(a) of the Social Security Act (42 U.S.C.

6 1396a(a)) is amended—

7 (1) in paragraph (65), by striking the period

8 and inserting ‘‘; and’’; and

9 (2) by adding at the end the following:

10 ‘‘(66) provide that the State will ensure that

11 any congregate care provider (as defined in section

12 1905(v)) that provides services to an individual for

13 which medical assistance is available shall—

14 ‘‘(A) protect and promote the right of each

15 individual to be free from physical or mental

16 abuse, corporal punishment, involuntary seclu17 sion, and any physical or chemical restraints

18 imposed for purposes of discipline or conven19 ience;

20 ‘‘(B) impose restraints only—

21 ‘‘(i) to ensure the physical safety of

22 the individual or other individuals; and

23 ‘‘(ii) upon the written order of a phy24 sician that specifies the duration and cir25 cumstances under which the restraints are

26 to be used (except in emergency cir-
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1 cumstances specified by the Secretary until

2 such an order could reasonably be ob3 tained); and

4 ‘‘(C) submit the reports required under

5 subsection (c) of section 1897 (relating to sen6 tinel events) in the same manner as a provider

7 of services under that section is required to

8 submit such reports.’’.

9 (b) DEFINITION OF CONGREGATE CARE PRO10 VIDER.—Section 1905 of the Social Security Act (42

11 U.S.C. 1396d) is amended by adding at the end the fol12 lowing:

13 ‘‘(v) The term ‘congregate care provider’ means an

14 entity that provides hospital services, nursing facility serv15 ices, services of intermediate care facilities for the men16 tally retarded, hospice care, residential treatment centers

17 for children, services in an institution for mental diseases,

18 inpatient psychiatric hospital services for individuals

19 under age 21, or congregate care services under a waiver

20 authorized under section 1915(c).’’.

21 (c) EFFECTIVE DATE.—

22 (1) IN GENERAL.—Subject to paragraph (2),

23 the amendments made by this section take effect on

24 the date of enactment of this Act.
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1 (2) REPORTING REQUIREMENTS.—The report2 ing requirements under section 1902(a)(66)(C) of

3 the Social Security Act (42 U.S.C.

4 1396a(a)(66)(C)), as added by subsection (a), shall

5 apply to sentinel events occurring on and after the

6 date of enactment of this Act.

Æ