article: SECTION 1. SHORT TITLE. This Act may be cited as the ``Freedom From Restraint Act of 1999''. SEC. 2. INDIVIDUALS' RIGHT TO FREEDOM FROM RESTRAINT AND REPORTING OF SENTINEL EVENTS UNDER MEDICARE. (a) 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) 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. ``(2) 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, involuntary seclusion, and any physical or chemical restraints 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; and ``(B) only 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 ``(2) submit the reports required under subsection (c). ``(c) 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 (c) (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 (c)(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 (c)(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 (c) 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 (c)(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.''. (b) Effective Date.-- (1) In general.--Subject to paragraph (2), the amendments made by this section take effect on the date of enactment of this Act. (2) Reporting requirements.--The reporting requirements under section 1897(c) of the Social Security Act, as added by subsection (a), shall apply to sentinel events occurring on and after the date of enactment of this Act. SEC. 3. INDIVIDUALS' RIGHT TO FREEDOM FROM RESTRAINT AND REPORTING OF SENTINEL EVENTS UNDER MEDICAID. (a) State Plans for Medical Assistance.--Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)) is amended-- (1) in paragraph (65), by striking the period and inserting ``; and''; and (2) 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 (c) 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.''. (b) 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).''. (c) Effective Date.-- (1) In general.--Subject to paragraph (2), the amendments made by this section take effect on the date of enactment of this Act. (2) 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 subsection (a), shall apply to sentinel events occurring on and after the date of enactment of this Act.
summary: Allows the imposition of restraints: (1) only to ensure physical safety of the individual or others in the provider's care; and (2) only upon the written order of a physician specifying the duration and circumstances under which restraints are to be used (except in emergency circumstances specified by the Secretary of Health and Human Services until such an order could reasonably be obtained). Requires the service provider to investigate the sentinel event reported and the appropriate agencies or entities to review and approve the provider's root cause analysis before reporting on the matter to the Secretary for use in the Sentinel Events Database. Directs the Secretary to establish such Database for use on the Internet, with appropriate privacy safeguards for individuals whose treatment is the subject of a report under this Act. Requires additional reporting in certain cases, including: (1) to the Secretary about a provider identified as having a pattern of poor performance; and (2) to the State Attorney General or the appropriate State law enforcement agency in sentinel events involving death. Mandates sanctions for failure to report. Bars disclosure or discovery of a root cause analysis in a civil action.