102D CONGRESS 2D Session S.2949 To Amend the Public Health Service Act to provide for the conduct of expanded research and the establishment of innovative programs and policies with respect to traumatic brain injury, and for other purposes. IN THE SENATE OF THE UNITED STATES Mr.Kennedy(for himself and Mr.Inouye) introduced the following bill, which was read twice and referred to the Committee on Labor and Human Resources. ************* A BILL 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 "Traumatic Brain Injury Act of 1992". SECTION 2.FINDINGS AND PURPOSE. (a)FINDINGS--Congress finds that -- (1)the incidence of head injury in the United States is increasing with over 2,000,000 head injuries per year result- ing from automobile crashes,sports,recreational activities, assualts,violence and other falls and incidents; (2) a majority of all head injuries are caused by motor vehicle accidents; (3)individual between the ages of 15 and 24 are at greatest risk for suffering head injuries; (4)of the individuals who sustain head injuries each year, approximately 500,000 require hospitalization,and 75,000 to 100,000 of such individuals die within hours of the injury; (5)of the individuals who survive head injuries each year approximately 70,000 to 90,000 will suffer irreversible debilitating loss of function, 5,000 will contract epilepsy as a result of the injury,and 2,000 will exist in a coma; (6)a significant number of individuals with traumatic brain injury are not eaisly restored to society and require years of rehabilitation, medical follow-up and integrated community services,which are costly because they are not readily available; (7)individuals suffering with traumatic brain injury require coordinated and speciliazed services,including post-injury supervised programs facilitating community reentry; (8) many health and social service agencies,both public and private, overlook,exclude or inadequately serve individuals surviving traumatic brain injury; (9)society bears an economic cost of approximately $25,000,000,000 per year from the direct and indirect costs of traumatic brain injury, which include medical treatment,rehabilitative and support services and lost income; (10) a program to develop national standards for helmets used by bicyclists and others is needed; and (11) a national plan to provide services for individuals surviving traumatic brain injuries and their families is needed; (b)PURPOSE--It is the purpose of this Act to-- (1) facilitate the conduct of research and the collection and compiling of accurate statistical data on traumatic brain injury; (2) raise public awareness concerning the risks and impact of such injuries and the distinct needs of individuals surviving traumatic brain injury and their families; (3)promote the creation of innovative programs and policies to prevent traumatic brain injury and to rehabilitate those individuals who have survived such injuries; (4)designate a Federal agency to oversee and promote projects relating to the prevention of,and rehabilitation from, traumatic brain injury; (5)create State advisory boards to coordinate citizen participation in community programs dealing with traumatic brain injury; (6)create a traumatic brain injury registy to collect data on the number of persons who sustain traumatic brain injury; (7)establish standards for the marketing of brain injury services; (8)require the Secretary to publish an annual report concerning the activities of the Department of Health and Human Services in this Area; and (9) provide for the establishment of a program to establish national standards for helmets used by bicyclists and others. SEC.3.AMMENDMENT TO THE PUBLIC HEALTH SERVICES ACT. Title XII of the Public Health Service Act (42 U.S.C. 300d et seq.)is ammended-- (1) by redesignating part C as part D; (2)in section 1232(a)(42U.S.C.300d-32(a), by inserting "other than part C," and "carrying out this title." and (3)by inserting after part B, the following new part "Part C--TRAUMATIC BRAIN INJURY "SEC.1225.DEFINITIONS. "As used in this part: "(1) Director--The term "Director" means the Director of the Centers for Disease Control. "(2)TRAUMATIC BRAIN INJURY--The term "traumatic brain injury" means an acquired injury to the brain caused by an external physical force resulting in total or partial disability or impairments. Such term includes open and closed head injuries that may result in mild,moderate,or severe impairments in one or more areas including cognition,language,memory,attention, reasoning,abstract thinking,judgement,problem-solving,sensory perceptual and motor abilities,psychosocial behavior,physical functons,information processing,and speech. Such term does not include brain injuries that are congenital or degenerative or brain injuries induced by birth trauma, but may include brain injuries caued by anoxia and other related causes. "SEC.1225A.STUDY OF EFFECTIVENESS OF TRAUMATIC BRAIN INJURY INTERVENTIONS. "(a) CONDUCT.-The Secretary, acting through the Director of the Centers for Disease Control, shall conduct a study concerning traumatic brain injury. "(b)MAJOR FINDINGS-The study conducted under subsection (a) shall seek to-- "(1)determine the major causes of traumatic brain injury; "(2)identify common therapeutic interventions which are used for the rehabilitation of individuals with traumatic brain injuries,and shall include an analysis of-- "(A) the effectiveness of each such intervention in improving the functioning of individuals with brain injuries; and "(B)the comparative effectiveness of interventions employed in the course of rehabilitation of individuals with brain injuries to achieve the same or similar clinical outcome. "(3)determine the preventive efforts that are being used by States and non-profit agencies to reduce the occurance of such injuries; "(4)identify effective treatment and long-term rehabilitation services needed to meet the needs of individuals with traumatic brain injuries; "(5) develop practice guidelines for the treatment of traumatic brain injury; and "(6) determine whether there is a need for national standards for helmets used by bicyclists and others. "(c) REPORTING REQUIREMENTS.--Not later than 3 years after the date of enactment of this part, the Secretary shall prepare and submit to the appropriate committees of Congress, a report containing the results of the study conducted under subsection (a). "(d)BIENNIAL REPORT.--The Secretary shall biennially prepare a report containing recommendations for the prevention of traumatic brain injuries. Such reports shall be disseminmated to State health officers. "(c)AUTHORIZATION OF APPROPRIATION.--There are authorized to be appropriated to carry out this section, $2,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 1995. "SEC.1225B.AGENCY DATA GATHERING SYSTEMS. "(a)DATA GATHERING.--The Director shall be responsible for gathering data concerning the number of individuals surviving traumatic brain injury and regarding the cost of traumatic brain injuries. "(b)REPORTING SYSTEM.--To assist in data and information gathering as required under subsection(a), the Director shall establish a uniform reporting system under which hospitals, State and local health related agancies will report to the Director on matters including- "(1)the occurrence of traumatic brain injuries; "(2)the amount of traumatic brain injury research,training, and services; "(3)the identification of States and localities that have approved mandated helmet use laws for bicyclists and others; and "(4)the health insurance status of individuals with traumtic brain injury. The reporting system should be established to permit the Director to make an accurate assessment of resource needs,provide a basis for the allocation of resources,and track survivors of traumatic brain injury from the provision of initial health care through long-term rehabilitation. "(c)SURVEY AND COOPERATIVE AGREEMENTS-- "(1) SURVEY.-The Director shall determine which Federal, State,local or other entities collect data on traumatic brain injury and the means by which entities collect such data. "(2)COOPERATIVE AGREEMENTS.--The Director may enter into cooperative agreements with other agencies, and provide assistance to other entities with responsibility for data collection, to establish traumatic brain injury as a specific reportable condition in existing and future reporting systems. Any data systems established in conjunction with such agencies should be compatible with other such data systems. "(3)AUTHORIZATION OF APPROPRIATIONS.--There are authorized to be appropriated to carry out this section,$2,000,000 for fiscal year 1993 and such sums as may be necessary for each of the fiscal years 1994 and 1995. "SEC.1225C.SPECIAL PROJECTS AND RESEARCH GRANTS. "(a)RESEARCH AND SUPPORT.-The Secretary may award grants to State and local entities, and to public or non-profit private entities,to support- "(1) special prevention and public awareness initiative projects; "(2)model traumatic brain injury prevention,research and support programs; "(3)projects that study the service needs of individuals with traumatic brain injury; and "(4)projects involving grants for services coordination. "(b)APPLICATION.--To be eligible to receive a grant under subsection (a), an entity shall prepare and submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require. "(c)AUTHORIZATION OF APPROPRIATIONS.-There are authorized to be appropriated to carry out this section, $3,000,000 for fiscal year 1992, and such sums as may be necessary for each of the fiscal years 1994 and 1995. "SEC.1225D.PREVENTION PROGRAMS. "(a)IN GENERAL.--The Secretary shall cooperate with,and may provide assistance to,public and private nonprofit entities to reduce the incidence of traumatic brain injury through the estblishment and effectuation of prevention projects. "(b)REQUIREMENTS.--To be eligible to receive assistance under subsection(a),an entity shall-- "(1)prepare and submit to the Secretary an application at such time, in such manner, and containing such infor- mation as the Secretary may require; and "(2)provide assurances to the Secretary that any preventive measures implemented under a prevention project funded under this section will include-- "(A)behavioral and enviromental interventions (such as physical restraints or helmets for individuals using bicycles,in-line roller skates,and skateboards); "(B) the use of innovative and proven model prevention approaches; "(C)the promotion of activities that will minimize brain injury risk in athletes (such as the use of head protection gear); and "(D) the improvement of community-level access to data-base systems to assist in designing,development, and implementing traumatic brain injury prevention programs. "(c)AUTHORIAZTION OF APPROPRIATIONS.--There are authorized to be appropriated to carry out this section, $4,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 and 1995. "SEC.1225E.BASIC AND APPLIED RESEARCH. "(a)IN GENERAL.--The Secretary, acting through the Director of the National Institutes of Health, may provide assistance to public and private nonprofit entities to support the conduct of basic and applied research concerning traumatic brain injury, especially with respect to the biomechanics of brain injury, the molecular and cellular characteristics of primary and secondary injury to the brain and the development of improved experimental brain injury models. "(b)SPECIFIC RESEARCH.--Research to be conducted with assistance provided under subsection(a) shall be determined by the Secretary,prior to the provision of such assistance, to contribute to the creation of prevention strategies that will limit both primary and secondary mechanical, biochemical and metabolic insults to the brain and minimize the extent,severity and progression of resulting dysfunctions. In implementing this section the Secretary shall emphasize applied research concerning- "(1) the development of new methods and modalities for the more effective measurement of diagnosis,degree of injury,post-injury monitoring and prognostic assessment of head injury for critical,acute,subacute,and prolonged phases of care; "(2)the development,modification and evaluation of therapies that retard,prevent or reverse brain damage after acute head injury,that arest further deterioration during the subacute phase and that provide the restitution of function for individuals with long-term injuries; "(3)the intergration of basic research into clinical care settings; "(4)a determination of the need for national standards for helmets used on the part of bicyclists and others; and "(5)the development of major outcome research initiatives in traumatic brain injury rehabilitaion that shall include- "(A)an identification of the levels of outcome throughout the continuum of care from coma to community setting; "(B)an identification of the appropriate measure- ment instruments to determine outcome measures; "(C)the development of models of intervention; "(D)the institution of multisetting trials of each model with appropriate outcome measures; "(E)the development of programs that increase the particapation of academic centers of excellence in rehabilitation research, training and treatment; "(F)the conduct of a series of national concensus conferences on rehabilitation outcomes and model programs on traumatic brain injury; and "(G)the publication of findings concerning outcomes of rehabilitation. "(c)AUTHORIZATION OF APPROPRIATIONS.--There are authorized to be appropriated to carry out this section,$5,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 and 1995. "SEC.1225F. PROTECTION AND ADVOCACY DEMONSTRATION PROJECT. "(a) GRANTS.-The Secretary shall award grants to States for the establishment of Statewide protecton and advocacy demonstration projects for individuals affected by traumatic brain injury. "(b)ELIGIBILITY.-To be eligile to receive a grant under subsection(a), a State shall-- "(1)prepare and submit to the Secretary an application at such time,in such manner, and containing such information as the Secretary may require; "(2)provide assurances that it will prepare and submit to the Secretary reports describing the activities undertaken under the State system established under the grant; "(3)provide assurances that it will prepare and submit to the Secretary reports concerning any State efforts undertaken to establish a protection and advocacy system for individuals with traumatic brain injuries; "(4)designate a State coordinator for traumatic brain injuries who-- "(A)shall establish policies and standards for coordinating services within the State for individuals with traumatic brain injury; "(B)make contract with qualified agencies or employ staff to provide services under this section on a statewide basis to eligible individuals; "(C)shall be responsible for a program of activities related to preventing and reducing the rate of traumtic brain injuries in the State according to the standards established by the Centers for Disease Control; "(D)shall establish and maintain a central registry of persons who sustain traumatic injury in order to-- "(i)collect information to facilitate the deve- lopment of head injury prevention,treatment,and rehabilitation programs; "(ii)insure the provision to persons with traumatic brain injury of information regarding the appropriate public or private agencies that provide rehabilitative services so that injured persons may obtain needed service to alleviate injuries and avoid secondary problems,such as mental illness and chemical dependency; and "(iii)report date to the Director on an annual basis for State reporting requirements; "(E)shall,within 30 days of receiving a report that an individual has suffered a traumatic brain injury or spinal cord injury,notify the State agency responsible for jobs and training and shall include the person's name and other identifying information; "(F)shall, after consultation with the State advisory board established under the section 1225G, establish standards regarding the marketing of services (by hospitals and other providers) to traumatic brain injury patients or family members, desseminate the standards to case management programs, and furnish information on such standards to individuals who suffer traumatic brain injuries (and the family members of such individuals)at the earliest appropriate opportunity after the individual has suffered the injury(such standards to include (at a minimum)a rule prohibiting payments under a case management program under this section for referring patients to rehabilitation facilities); "(G)shall collect injury incidence information, analyze the information,and conduct special studies regarding traumatic brain injury; and "(H)shall provide summary registry data to public and private entities to conduct studies using data collected by the traumatic brain injury registry established under subparagraph (C),for which the coordinator may charge a fee for all expenses associated with the provision of data or data analysis; and "(5)provide assurances that a protection and advocacy system established under this section will- "(A)provide legal,administrative and other appropriate remedies or approaches to insure the protection of, and advocacy for,the rights of individuals with traumatic brain injury within the State who are or may be eligible for treatment, services,or rehabilitation; "(B)provide information and referral to programs and services addressing the needs of individuals with traumatic brain injuries; and "(C)provide for the investigation of incidents of abuse and neglect of individuals with traumatic brain injuries when incidents are reported. "(d)AUTHORIZATION OF APPROPRIATIONS.--There are authorized to be appropriated to carry out this section, $20,000,000 for fiscal year 1993 and such sums as may be necessary for each of the fiscal years 1994 and 1995. "SEC.1225G.STATE ADVISORY BOARDS. "(a)ESTABLISHMENT.--Each State that receives assistance under this part shall establish a consumer-controlled advisory board within the Department of Health or Human Services of the State or within another department as designated by the chief executive officer of the State. "(b)FUNCTIONS.--An advisory board established under subsection(a) shall coordinate intra- and inter- communications with and between Federal,State and local agencies,citizen's groups, private industry(such as the insurance,health care, pharmaceutical,athletic and automobile industries) and labor and nonprofit organizations. Such advisory boards shall encourage citizen participation through the establishment of public hearings and other types of community outreach programs. "(c)COMPOSITION.--an advisory board established under subsection (a) shall be composed of representatives of-- "(1)the corresponding State agencies involved; "(2)public and private health related organizations; "(3)other disability advisory or planning groups within the State; and "(4)at least on member of an organization or foundation representating traumatic brain injury survivors in that State. The majority of the members of the advisory board shall be individuals with traumtic brain injuries or a family member of such an individual; "(d)SERVICES COORDINATION DEMONSTRATION PROJECT FOR INDIVIDUALS WITH TRAUMATIC BRAIN INJURIES.-- "(1)IN GENERAL.--For purposes of identifying the services required to prevent the institutionalization or to minimize the need for residential rehabilitation in the case of traumatic brain injuries,a services coordination program shall be established in each State. "(2)REQUIREMENTS.--To be eligible to receive funds under this section,a services coordination program established under paragraph (1) shall-- "(A)provide for the initial assessment of the individual's need for traumatic brain injury services; "(B)provide for the reassessment of each patient at regular intervals of at least every 3 months to determine the extent of each patient's progress, to ascertain whether a patient is being kept too long in a given setting or provided services inappropriately,or to determine whether the patient would be better served by other services or in another setting; "(C)prepare a treatment plan for each individual requiring services coordination,within 15 days after the individual suffers the injury, based on a consultation with the individual(other than an individual who is comatose)and any person named by the individual,except that prepration of the plan may be delayed(by one or more periods of not to exceed 15 days each) based on a certification, including a brief explanation of the reason for the delay, by a physician attesting that such a delay is in the individual's best interests(a copy of the treatment plan and any modifications to the plan shall be presented to the individual or the individual's legal representative); "(D)ensure that each individual's treatment plan is regularly updated (based on consultation with the individual and any person named by the individual) with data and information about treatments and services provided,as well as specific outcome measures of the individual's current performance or activity relative to goals previously established; "(E) assist the individual in obtaining services necessary to allow the individual to remain in the community; "(F) coordinate home care services with other services; "(G) insure appropriate,accessable, and cost- effective services; "(H) assist the individual with problems related to the provision of home care services; "(I) ensure the quality of home care services; "(J) assess the individual's need for and level of home care services at appropriate intervals during the course of the individual's treatment under the program; and "(K) explore efforts to include services coordination provisions under the State's medicaid program section 1931 of the Social Security Act. "(3)AUTHORIZATION OF APPROPRIATIONS.-- There are authorized to carry out this subsection, $5,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 and 1995.". SEC.4.NATIONAL HEAD INJURY AWARENESS MONTH. The Month of October, 1992, is hereby designated as "National Head Injury Month" and the President is requested to issue a proclamation calling on the people of the United States to observe such a month with appropriate ceremonies and activities. SEC.5.EFFECTIVE DATE. This Act shall become effective on October 1, 1992. *******