[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3010 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 3010

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 HOUSE OF REPRESENTATIVES

                            October 4, 1999

Mr. Shays (for himself, Ms. DeLauro, Mr. Gejdenson, Mr. Larson, and Mr. 
   Maloney of Connecticut) introduced the following bill; which was 
referred to the Committee on Commerce, and in addition to the Committee 
 on Ways and Means, 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 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Restraint Safety Act of 1999''.

SEC. 2. INDIVIDUALS' RIGHT TO FREEDOM FROM RESTRAINT AND REPORTING OF 
              SENTINEL EVENTS UNDER MEDICARE.

    (a) Amendment to Social Security Act.--
            (1) In general.--Part D of title XVIII of the Social 
        Security Act (42 U.S.C. 1395x et seq.) is amended by adding at 
        the end the following:

 ``individuals' freedom from restraint and reporting of sentinel events

    ``Sec. 1897. (a) Definitions.--In this section:
            ``(1) Chemical restraint.--The term `chemical restraint' 
        means the non-therapeutic use of a medication that--
                    ``(A) is unrelated to the patient's medical 
                condition; and
                    ``(B) is imposed for disciplinary purposes or the 
                convenience of staff.
            ``(2) Physical restraint.--The term `physical restraint' 
        means any mechanical or personal restriction that immobilizes 
        or reduces the ability of an individual to move his or her 
        arms, legs, or head freely. Such term does not include devices, 
        such as orthopedically prescribed devices, surgical dressings 
        or bandages, protective helmets, and other methods involving 
        the physical holding of a resident for the purpose of 
        conducting routine physical examinations or tests or to protect 
        the patient from falling out of bed or to permit a patient to 
        participate in activities without the risk of physical harm to 
        the patient.
            ``(3) Provider of services.--The term `provider of 
        services' has the meaning given that term in section 1861(u), 
        except that for purposes of this section the term includes a 
        psychiatric hospital but does not include a home health agency.
            ``(4) Seclusion.--The term `seclusion' means any separation 
        of the resident from the general population of the facility 
        that prevents the resident from returning to such population 
        when he or she desires.
            ``(5) Sentinel event.--The term `sentinel event' means an 
        unexpected occurrence involving an individual in the care of a 
        provider of services for treatment for a psychiatric or 
        psychological illness that results in death or serious physical 
        or psychological injury that is unrelated to the natural course 
        of the individual's illness or underlying condition.
    ``(b) Protection of Right To Be Free From Restraints.--A provider 
of services eligible to be paid under this title for providing services 
to an individual entitled to benefits under part A or enrolled under 
part B (including an individual provided with a Medicare+Choice plan 
offered by a Medicare+Choice organization under part C) shall--
            ``(1) protect and promote the right of each such individual 
        to be free from physical or mental abuse, corporal punishment, 
        and any physical or chemical restraints or involuntary 
        seclusion imposed for purposes of discipline or convenience;
            ``(2) impose restraints--
                    ``(A) only to ensure the physical safety of the 
                individual or other individuals in the care or custody 
                of the provider, a staff member, or others; and
                    ``(B) only upon the written order of a physician or 
                other licensed independent practitioner permitted by 
                the State and the facility to order such restaint or 
                seclusion that specifies the duration and circumstances 
                under which the restraints are to be used (except in 
                emergency circumstances specified by the Secretary 
                until such an order could reasonably be obtained); and
            ``(3) submit the reports required under subsection (d).
    ``(c) Construction.--Nothing in this section shall be construed as 
prohibiting the use of restraints for medical immobilization, adaptive 
support, or medical protection.
    ``(d) Reports.--
            ``(1) Reports to agencies or entities with oversight 
        authority.--
                    ``(A) In general.--A provider of services shall 
                report each sentinel event that occurs to an individual 
                while the individual is in the care or custody of the 
                provider to--
                            ``(i) in the case of a provider of services 
                        participating in the program established under 
                        this title or the medicaid program under title 
                        XIX as a result of accreditation by a national 
                        accrediting body, the national accrediting body 
                        for that provider; and
                            ``(ii) in the case of all other providers 
                        of services, the Secretary or, upon agreement 
                        between the Secretary and the relevant State, 
                        the State agency designated by the Secretary.
                    ``(B) Investigation and further reporting of 
                sentinel events.--Upon receipt of a report made 
                pursuant to subparagraph (A), the agency or entity with 
oversight authority shall--
                            ``(i) ensure that the provider--
                                    ``(I) conducts an investigation of 
                                the sentinel event reported;
                                    ``(II) determines the root cause or 
                                causes of the sentinel event; and
                                    ``(III) establishes a time-limited 
                                plan or strategy, that allows the 
                                agency or entity with oversight 
                                authority to review and approve the 
                                analyses and any corrective actions 
                                proposed or made by the provider of 
                                services, to correct the problem or 
                                problems that resulted in the sentinel 
                                event, and to lead to risk reduction; 
                                and
                            ``(ii) prepare and submit the reports 
                        required under paragraph (2).
            ``(2) Reports to the secretary.--
                    ``(A) In general.--Subject to subparagraph (D), the 
                agency or entity with oversight authority shall submit 
                a report containing the information described in 
                subparagraph (B) to the Secretary in such form and 
                manner, and by such date, as the Secretary prescribes.
                    ``(B) Information to be reported.--
                            ``(i) In general.--The report submitted 
                        under subparagraph (A) shall be submitted to 
                        the Secretary at regular intervals, but not 
                        less frequently than annually, and shall 
                        include--
                                    ``(I) a description of the sentinel 
                                events occurring during the period 
                                covered by the report;
                                    ``(II) a description of any 
                                corrective action taken by the 
                                providers of services with respect to 
                                the sentinel events or any other 
                                measures necessary to prevent similar 
                                sentinel events from occurring in the 
                                future;
                                    ``(III) proposed systems changes 
                                identified as a result of analysis of 
                                events from multiple providers; and
                                    ``(IV) such additional information 
                                as the Secretary determines to be 
                                essential to ensure compliance with the 
                                requirements of this section.
                            ``(ii) Information excluded.--The report 
                        submitted under subparagraph (A) shall not 
                        identify any individual provider of services, 
                        practitioner, or individual.
                    ``(C) Additional reporting requirements when a 
                provider has been identified as having a pattern of 
                poor performance.--
                            ``(i) In general.--In addition to the 
                        report required under subparagraph (A), the 
                        agency or entity with oversight authority shall 
                        report to the Secretary the name and address of 
                        any provider of services with a pattern of poor 
                        performance.
                            ``(ii) Determination of pattern.--The 
                        agency or entity with oversight authority shall 
                        determine if a pattern of poor performance 
                        exists with respect to a provider of services 
                        in accordance with the definition of pattern of 
                        poor performance developed by the Secretary 
                        under clause (iii).
                            ``(iii) Development of definition.--The 
                        Secretary, in consultation with national 
                        accrediting organizations and others, shall 
                        develop a definition to identify a provider of 
                        services with a pattern of poor performance.
                    ``(D) Authority to waive reporting requirement.--
                The Secretary may waive the requirement to submit a 
                report required under this paragraph (but not a report 
                regarding a sentinel event that resulted in death 
                required under paragraph (3)) upon consideration of the 
                severity of the sentinel event.
            ``(3) Additional reporting requirements for sentinel events 
        resulting in death.--In addition to the report required under 
        paragraph (1), a provider of services shall report any sentinel 
        event resulting in death to--
                    ``(A) the Secretary or the Secretary's designee;
                    ``(B) the State Attorney General or, upon agreement 
                with the State Attorney General, to the appropriate law 
                enforcement agency;
                    ``(C) the State agency responsible for licensing 
                the provider of services; and
                    ``(D) the State protection and advocacy system 
                established pursuant to part C of title I of the 
                Developmental Disabilities Assistance and Bill of 
                Rights Act (42 U.S.C. 6041 et seq.) for the State in 
                which the event occurred.
            ``(4) Responsibilities of the agency or entity with 
        oversight authority.--Upon receipt of a report of a sentinel 
        event that resulted in death, the agency or entity with 
        oversight authority shall, in addition to the requirements of 
        paragraph (2)--
                    ``(A) determine whether the death was related to 
                the use of restraints or seclusion; and
                    ``(B) notify the Secretary of the determination.
            ``(5) Sanctions for failure to report.--
                    ``(A) In general.--The Secretary shall establish 
                sanctions, including intermediate sanctions, as 
                appropriate, for failure of a provider of services or 
                an agency or entity with oversight authority to submit 
                the reports and information required under this 
                subsection.
                    ``(B) Removal of agency or entity with oversight 
                authority.--The Secretary, after notice to an agency or 
                entity with oversight authority of a provider of 
                services, as determined in paragraph (1), and 
                opportunity to comply, may remove the agency or entity 
                of such authority if the agency or entity refuses to 
submit the reports and information required under this subsection.
            ``(6) Liability for reporting.--An individual, provider of 
        services, agency, or entity shall be liable with respect to any 
        information contained in a report required under this 
        subsection if the individual, provider of services, agency, or 
        entity had knowledge of the falsity of the information 
        contained in the report at the time the report was submitted 
        under this subsection. Nothing in the preceding sentence shall 
        be construed as limiting the liability of an individual, 
        provider of services, agency, or entity for damages relating to 
        the occurrence of a sentinel event, including a sentinel event 
        that results in death.
            ``(7) Nondisclosure of analysis.--Notwithstanding any other 
        provision of law or regulation, the root cause analysis 
        developed under this subsection shall be kept confidential and 
        shall not be subject to disclosure or discovery in a civil 
        action.
    ``(d) Establishment or Designation of Sentinel Events Database.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Secretary shall establish or 
        designate a database of information using the reports submitted 
        under paragraphs (2) and (3) of subsection (d) (in this 
        subsection referred to as the `Sentinel Events Database').
            ``(2) Contents.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                Sentinel Events Database shall include the following:
                            ``(i) The name and address of any provider 
                        of services that is the subject of a report 
                        submitted under subsection (d)(3), if the 
                        agency or entity with oversight authority has 
                        determined that the death was related to the 
                        use of restraints or seclusion.
                            ``(ii) The information reported by the 
                        agency or entity under subparagraphs (B) and 
                        (C) of subsection (d)(2).
                    ``(B) Confidentiality.--The Secretary shall 
                establish procedures to ensure that the privacy of 
                individuals whose treatment is the subject of a report 
                submitted under paragraph (2) or (3) of subsection (d) 
                is protected.
            ``(3) Procedures for entry of information.--
                    ``(A) In general.--The Secretary shall--
                            ``(i) prior to entry of information in the 
                        Sentinel Events Database, disclose the 
                        information to the provider of services that is 
                        the subject of the information; and
                            ``(ii) establish procedures to--
                                    ``(I) resolve disputes regarding 
                                the accuracy of the information; and
                                    ``(II) ensure the accuracy of the 
                                information.
                    ``(B) No delay of sanctions.--Any sanction to be 
                imposed by the Secretary against a provider of services 
                or an agency or entity with oversight authority in 
                relation to a sentinel event shall not be delayed as a 
                result of a dispute regarding the accuracy of 
                information to be entered into the database.
            ``(4) Access to the database.--
                    ``(A) Availability.--The Secretary shall establish 
                procedures for making the information maintained in the 
                Sentinel Events Database related to a sentinel event 
                resulting in death, and any reports of sentinel 
                injuries arising from those providers of services with 
                a pattern of poor performance identified in accordance 
                with subsection (d)(2)(C), available to Federal and 
State agencies, national accrediting bodies, health care researchers, 
and the public.
                    ``(B) Internet access.--In addition to any other 
                procedures that the Secretary develops under 
                subparagraph (A), the information in the Sentinel 
                Events Database shall be accessible through the 
                Internet.
                    ``(C) Fees for disclosure.--
                            ``(i) In general.--Subject to clause (ii), 
                        the Secretary may establish or approve 
                        reasonable fees for disclosing information 
                        maintained in the Sentinel Events Database.
                            ``(ii) No fee for federal agencies.--No fee 
                        shall be charged to a Federal agency for access 
                        to the Sentinel Events Database.
                            ``(iii) Application of fees.--Fees 
                        collected under this clause shall be applied by 
                        the Secretary toward the cost of maintaining 
                        the Sentinel Events Database.''.
            (2) Effective date.--
                    (A) In general.--Subject to subparagraph (B), the 
                amendments made by this subsection take effect on the 
                date of enactment of this Act.
                    (B) Reporting requirements.--The reporting 
                requirements under section 1897(d) of the Social 
                Security Act, as added by paragraph (1), shall apply to 
                sentinel events occurring on and after the date of 
                enactment of this Act.
    (b) Individuals' Right to Freedom From Restraint and Reporting of 
Sentinel Events Under Medicaid.--
            (1) State plans for medical assistance.--Section 1902(a) of 
        the Social Security Act (42 U.S.C. 1396a(a)) is amended--
                    (A) in paragraph (65), by striking the period and 
                inserting ``; and''; and
                    (B) by adding at the end the following:
            ``(66) provide that the State will ensure that any 
        congregate care provider (as defined in section 1905(v)) that 
        provides services to an individual for which medical assistance 
        is available shall--
                    ``(A) protect and promote the right of each 
                individual to be free from physical or mental abuse, 
                corporal punishment, involuntary seclusion, and any 
                physical or chemical restraints imposed for purposes of 
                discipline or convenience;
                    ``(B) impose restraints only--
                            ``(i) to ensure the physical safety of the 
                        individual or other individuals; and
                            ``(ii) upon the written order of a 
                        physician that specifies the duration and 
                        circumstances under which the restraints are to 
                        be used (except in emergency circumstances 
                        specified by the Secretary until such an order 
                        could reasonably be obtained); and
                    ``(C) submit the reports required under subsection 
                (d) of section 1897 (relating to sentinel events) in 
                the same manner as a provider of services under that 
                section is required to submit such reports.''.
            (2) Definition of congregate care provider.--Section 1905 
        of the Social Security Act (42 U.S.C. 1396d) is amended by 
        adding at the end the following:
    ``(v) The term `congregate care provider' means an entity that 
provides hospital services, nursing facility services, services of 
intermediate care facilities for the mentally retarded, hospice care, 
residential treatment centers for children, services in an institution 
for mental diseases, inpatient psychiatric hospital services for 
individuals under age 21, or congregate care services under a waiver 
authorized under section 1915(c).''.
            (3) Effective date.--
                    (A) In general.--Subject to subparagraph (B), the 
                amendments made by this subsection take effect on the 
                date of enactment of this Act.
                    (B) Reporting requirements.--The reporting 
                requirements under section 1902(a)(66)(C) of the Social 
                Security Act (42 U.S.C. 1396a(a)(66)(C)), as added by 
                paragraph (1), shall apply to sentinel events occurring 
                on and after the date of enactment of this Act.
                                 <all>