I

103D CONGRESS

1ST SESSION H. R. 2606

To amend the Public Health Service Act to provide for the conduct of

expanded studies and the establishment of innovative programs with

respect to traumatic brain injury, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

JULY 1, 1993

Mr. QUILLEN introduced the following bill; which was referred to the

Committee on Energy and Commerce

A BILL

To amend the Public Health Service Act to provide for

the conduct of expanded studies and the establishment

of innovative programs with respect to traumatic brain

injury, 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 ‘‘Traumatic Brain In5 jury Act of 1993’’.

6 SEC. 2. FINDINGS AND PURPOSE.

7 (a) FINDINGS.—Congress finds that—
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1 (1) the incidence of head injury in the United

2 States is increasing, with over 2,000,000 head inju3 ries per year resulting from automobile crashes,

4 sports, recreational activities, assaults, violence and

5 other falls and incidents;

6 (2) a majority of all head injuries are caused by

7 motor vehicle accidents;

8 (3) individuals between the ages of 15 and 24

9 are at greatest risk for sustaining head injuries;

10 (4) of the individuals who sustain head injuries

11 each year, approximately 500,000 require hos12 pitalization, and 75,000 to 100,000 of such individ13 uals die within hours of the injury;

14 (5) of the individuals who survive head injuries

15 each year, approximately 70,000 to 90,000 will suf16 fer irreversible debilitating loss of function, 5,000

17 will develop epilepsy as a result of the injury, and

18 2,000 will exist in a coma;

19 (6) a significant number of individuals with

20 traumatic brain injury are not easily restored to so21 ciety and require years of rehabilitation, medical fol22 low-up and integrated community services, which are

23 costly and frequently not readily available;

24 (7) individuals sustaining traumatic brain in25 jury require coordinated and specialized services, in-
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1 cluding post-injury supervised programs facilitating

2 reentry into the community;

3 (8) many health and social service agencies,

4 both public and private, overlook, exclude or inad5 equately serve individuals surviving traumatic brain

6 injury;

7 (9) society bears an economic cost of approxi8 mately $25,000,000,000 per year for the direct and

9 indirect costs of traumatic brain injury, which in10 clude medical treatment, rehabilitative and support

11 services and lost income;

12 (10) a program to develop national standards

13 for helmets used by bicyclists and others is needed;

14 and

15 (11) a national plan to provide services for indi16 viduals surviving traumatic brain injuries and their

17 families is needed.

18 (b) PURPOSE.—It is the purpose of this Act to—

19 (1) facilitate the conduct of research and the

20 collection and compiling of accurate statistical data

21 on traumatic brain injury;

22 (2) raise public awareness concerning the risks

23 and consequences of such injuries and the distinct

24 needs of individuals (and their families) following

25 survival from traumatic brain injury;
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1 (3) promote the creation of innovative programs

2 and policies to prevent traumatic brain injury and to

3 rehabilitate those individuals who have survived such

4 injuries;

5 (4) designate a Federal agency to oversee and

6 promote projects relating to the prevention of, and

7 rehabilitation from, traumatic brain injury;

8 (5) create State advisory boards to coordinate

9 citizen participation in community programs dealing

10 with traumatic brain injury;

11 (6) create a registry to advance epidemiologic

12 research on such trauma;

13 (7) establish standards for the marketing of

14 brain injury services;

15 (8) require the Secretary to publish various re16 ports concerning the activities of the Department of

17 Health and Human Services in this area, including

18 an annual review of relevant activities; and

19 (9) provide for the initiation of a program to

20 establish national standards for helmets used by

21 bicyclists and others.

22 SEC. 3. AMENDMENT TO PUBLIC HEALTH SERVICE ACT.

23 Title XII of the Public Health Service Act (42 U.S.C.

24 300d et seq.) is amended—
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1 (1) by redesignating parts C through F as parts

2 D through G, respectively; and

3 (2) by inserting after part B the following new

4 part:

5 ‘‘PART C—TRAUMATIC BRAIN INJURY

6 ‘‘SEC. 1225. DEFINITIONS.

7 ‘‘As used in this part:

8 ‘‘(1) ADMINISTRATOR.—The term ‘Adminis9 trator’ means the Administrator for Health Care

10 Policy and Research.

11 ‘‘(2) DIRECTOR.—The term ‘Director’ means

12 the Director of the Centers for Disease Control and

13 Prevention.

14 ‘‘(3) TRAUMATIC BRAIN INJURY.—The term

15 ‘traumatic brain injury’ means an acquired injury to

16 the brain caused by an external physical force. Such

17 term does not include brain dysfunction caused by

18 congenital or degenerative disorders, nor does such

19 term include birth trauma. Such term is synonymous

20 with the term ‘head injury’.
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1 ‘‘SEC. 1225A. AGENCY FOR HEALTH CARE POLICY AND RE2 SEARCH STUDY OF EFFECTIVENESS OF TRAU3 MATIC BRAIN INJURY INTERVENTIONS.

4 ‘‘(a) IN GENERAL.—The Secretary, acting through

5 the Administrator, shall conduct a study concerning trau6 matic brain injury.

7 ‘‘(b) MAJOR FINDINGS.—The study conducted under

8 subsection (a) shall seek to—

9 ‘‘(1) identify common therapeutic interventions

10 which are used for the rehabilitation of individuals

11 with traumatic brain injuries, and shall include an

12 analysis of—

13 ‘‘(A) the effectiveness of each such inter14 vention in improving the functioning of individ15 uals with brain injuries; and

16 ‘‘(B) the comparative effectiveness of inter17 ventions employed in the course of rehabilita18 tion of individuals with brain injuries to achieve

19 the same or similar clinical outcome; and

20 ‘‘(2) develop practice guidelines for the rehabili21 tation of traumatic brain injury.

22 ‘‘(c) REPORTING REQUIREMENTS.—Not later than 4

23 years after the date of enactment of this part, the Sec24 retary shall prepare and submit to the appropriate com25 mittees of Congress, a report containing the results of the

26 studies conducted under this section.
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1 ‘‘(d) AUTHORIZATION OF APPROPRIATION.—There

2 are authorized to be appropriated to carry out this section,

3 $2,000,000 for fiscal year 1994, and such sums as may

4 be necessary for each of the fiscal years 1995 through

5 1996.

6 ‘‘SEC. 1225B. CENTERS FOR DISEASE CONTROL AND PRE7 VENTION STUDY OF TRAUMATIC BRAIN IN8 JURY OCCURRENCE.

9 ‘‘(a) IN GENERAL.—The Secretary, acting through

10 the Director, and in cooperation with other Public Health

11 Service agencies as may be necessary, shall conduct stud12 ies concerning traumatic brain injury, and shall establish

13 a reporting system under subsection (b).

14 ‘‘(b) REPORTING SYSTEM.—To assist in data and in15 formation gathering, the Director shall establish a uniform

16 reporting system under which hospitals, State and local

17 health-related agencies will report to the Director on mat18 ters including—

19 ‘‘(1) the occurrence of traumatic brain injuries;

20 and

21 ‘‘(2) the health insurance status of individuals

22 with traumatic brain injury.

23 The reporting system should be established to permit the

24 Director to make an accurate assessment of resource

25 needs and long term outcomes.
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1 ‘‘(c) SURVEY AND COOPERATIVE AGREEMENTS.—

2 ‘‘(1) SURVEY.—The Director shall determine

3 which Federal, State, local or other entities collect

4 data on traumatic brain injury and the means by

5 which such entities collect such data.

6 ‘‘(2) COOPERATIVE AGREEMENTS.—The Direc7 tor may enter into cooperative agreements with

8 other agencies, and provide assistance to other enti9 ties with responsibility for data collection, to estab10 lish traumatic brain injury as a specific reportable

11 condition in existing and future reporting systems.

12 Any data systems established in conjunction with

13 such agencies should be compatible with other such

14 data systems.

15 ‘‘(d) MAJOR FINDINGS OF STUDIES.—The studies

16 conducted under subsection (a) shall seek to—

17 ‘‘(1) determine the major causes of traumatic

18 brain injury;

19 ‘‘(2) determine the preventive efforts that are

20 being used by States and non-profit agencies to re21 duce the occurrence of such injuries;

22 ‘‘(3) determine the number of individuals sur23 viving traumatic brain injuries, and the cost of

24 treatment and other related costs;
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1 ‘‘(4) develop a uniform reporting system to fa2 cilitate the reporting to the Centers for Disease Con3 trol and Prevention concerning the occurrence of

4 traumatic brain injury;

5 ‘‘(5) identify States and localities that have ap6 proved mandated helmet use laws for bicyclist and

7 others;

8 ‘‘(6) determine the health insurance status of

9 individuals with traumatic brain injury; and

10 ‘‘(7) initiate a program of prevention research

11 to develop effective prevention of traumatic brain in12 jury.

13 ‘‘(e) REPORTING REQUIREMENTS.—Not later than 4

14 years after the date of enactment of this part, the Sec15 retary shall prepare and submit to the appropriate com16 mittees of Congress, a report containing the results of the

17 studies conducted under this section.

18 ‘‘(f) BIENNIAL REPORT.—The Secretary shall bienni19 ally prepare a report containing recommendations for the

20 prevention of traumatic brain injuries. The report shall

21 also identify States that have mandated helmet laws for

22 bicyclists and others. Such reports shall be disseminated

23 to State health officers.

24 ‘‘(g) AUTHORIZATION OF APPROPRIATION.—There

25 are authorized to be appropriated to carry out this section,
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1 $2,000,000 for fiscal year 1994, and such sums as may

2 be necessary for each of the fiscal years 1995 through

3 1996.

4 ‘‘SEC. 1225C. SPECIAL PREVENTION PROJECTS.

5 ‘‘(a) IN GENERAL.—The Secretary shall cooperate

6 with, and may provide assistance to, public and private

7 nonprofit entities to reduce the incidence of traumatic

8 brain injury through the establishment and effectuation

9 of prevention projects. In carrying out this section, the

10 Secretary may award grants to State and local entities,

11 and to public or non-profit private entities, to support—

12 ‘‘(1) special prevention and public awareness

13 initiative projects;

14 ‘‘(2) model traumatic brain injury prevention,

15 research and support programs;

16 ‘‘(3) projects that study the service needs of in17 dividuals with traumatic brain injury; and

18 ‘‘(4) projects involving grants for services co19 ordination.

20 ‘‘(b) REQUIREMENTS.—To be eligible to receive as21 sistance under subsection (a), an entity shall—

22 ‘‘(1) prepare and submit to the Secretary an

23 application, at such time, in such manner, and con24 taining such information as the Secretary may re25 quire; and
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1 ‘‘(2) provide assurances to the Secretary that

2 any preventive measures implemented under a pre3 vention project funded under this section may in4 clude—

5 ‘‘(A) behavioral and environmental inter6 ventions (such as physical restraints or helmets

7 for individuals using bicycles, in-line roller

8 skates, and skateboards);

9 ‘‘(B) the use of innovative and proven

10 model prevention approaches;

11 ‘‘(C) the promotion of activities that will

12 minimize brain injury risk in athletes (such as

13 the use of head protection gear); and

14 ‘‘(D) the improvement of community-level

15 access to data-base systems to assist in design16 ing, developing, and implementing traumatic

17 brain injury prevention programs.

18 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There

19 are authorized to be appropriated to carry out this section,

20 $4,000,000 for fiscal year 1994, and such sums as may

21 be necessary for each of the fiscal years 1995 and 1996.

22 ‘‘SEC. 1225D. BASIC AND APPLIED RESEARCH.

23 ‘‘(a) IN GENERAL.—The Secretary, acting through

24 the Director of the National Institutes of Health, may pro25 vide assistance to public and private nonprofit entities to
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1 support the conduct of basic and applied research concern2 ing traumatic brain injury, especially with respect to the

3 biomechanics of brain injury, the molecular and cellular

4 characteristics of primary and secondary injury to the

5 brain and the development of improved experimental brain

6 injury models.

7 ‘‘(b) SPECIFIC RESEARCH.—Research to be con8 ducted with assistance provided under subsection (a) shall

9 be determined by the Secretary, prior to the provision of

10 such assistance, to contribute to the strategies that will

11 limit primary and secondary mechanical, biochemical and

12 metabolic insults to the brain and minimize the extent,

13 severity and progression of resulting dysfunctions. In im14 plementing this section the Secretary shall emphasize—

15 ‘‘(1) the development of new methods and mo16 dalities for the more effective diagnosis, measure17 ment of degree of injury, post-injury monitoring and

18 prognostic assessment of head injury for acute,

19 subacute and later phases of care;

20 ‘‘(2) the development, modification and evalua21 tion of therapies that retard, prevent or reverse

22 brain damage after acute head injury, that arrest

23 further deterioration following injury and that pro24 vide the restitution of function for individuals with

25 long-term injuries;
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1 ‘‘(3) the integration of basic research into clini2 cal care settings;

3 ‘‘(4) the development of a continuum of care

4 from acute care through rehabilitation, designed, to

5 the extent practicable, to integrate rehabilitation and

6 long-term outcome evaluation with acute care re7 search;

8 ‘‘(5) the development of programs that increase

9 the participation of academic centers of excellence in

10 head injury treatment and rehabilitation research

11 and training; and

12 ‘‘(6) the conduct of national consensus con13 ferences on managing head injury and related reha14 bilitation concerns, the findings of which shall be

15 published.

16 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There

17 are authorized to be appropriated to carry out this section,

18 $5,000,000 for fiscal year 1994, and such sums as may

19 be necessary for each of the fiscal years 1995 and 1996.

20 ‘‘SEC. 1225E. STATEWIDE PROGRAM FOR TRAUMATIC BRAIN

21 INJURY.

22 ‘‘(a) GRANTS.—The Secretary shall award grants to

23 States for the establishment of programs related to trau24 matic brain injury. Such programs shall include State ad25 visory boards, patient advocacy and service coordination
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1 systems, and State registries concerning individuals af2 fected by traumatic brain injuries. Services may also be

3 provided under this section, within the limits of service

4 availability, to individuals whose deficits are not due to

5 traumatic brain injury. To be eligible for such services,

6 such individuals should be comparable to traumatic brain

7 injury patients in regard to the range of services needed,

8 the severity and duration of deficits, and the etiology of

9 their deficits being due to a nonprogressive and non10 recurring disorder.

11 ‘‘(b) GENERAL ELIGIBILITY REQUIREMENTS.—To be

12 eligible to receive a grant under subsection (a), a State

13 shall—

14 ‘‘(1) prepare and submit to the Secretary an

15 application, at such time, in such manner, and con16 taining such information as the Secretary may re17 quire;

18 ‘‘(2) provide assurances that it will prepare and

19 submit to the Secretary reports describing the activi20 ties undertaken under the State system established

21 under the grant; and

22 ‘‘(3) provide for the establishment of a State23 wide program that includes a State registry for trau24 matic brain injury information, a program of patient

25 advocacy and service coordination, and a State advi-
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1 sory board with respect to activities under this sec2 tion.

3 ‘‘(c) SPECIFIC PROGRAM REQUIREMENTS.—

4 ‘‘(1) STATE REGISTRY.—To be eligible to re5 ceive a grant under subsection (a), a State shall—

6 ‘‘(A)(i) establish and maintain, through

7 the utilization of procedures to ensure privacy

8 and maintain the confidentiality of information,

9 which are acceptable to the Secretary, a central

10 registry of persons who sustain traumatic brain

11 injury in order to—

12 ‘‘(I) collect information to facilitate

13 the development of injury prevention,

14 treatment, and rehabilitation programs;

15 and

16 ‘‘(II) report data to the Director on

17 an annual basis for State reporting re18 quirements; and

19 ‘‘(ii) a violation of such privacy and con20 fidentiality procedures or the unauthorized use

21 of such information may result in a loss of sup22 port under this section; and

23 ‘‘(B) provide summary registry data or

24 data that is not personally identifiable to public

25 and private entities to conduct studies using
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1 data collected by the traumatic brain injury

2 registry established under subparagraph (A),

3 for which the coordinator may charge a fee for

4 all expenses associated with the provision of

5 data or data analysis.

6 ‘‘(2) ADVOCACY AND SERVICE COORDINA7 TION.—To be eligible to receive a grant under sub8 section (a), a State shall—

9 ‘‘(A) designate a State coordinator for

10 traumatic brain injuries who—

11 ‘‘(i) shall establish policies and stand12 ards for coordinating services within the

13 State for individuals with traumatic brain

14 injury;

15 ‘‘(ii) may contract with qualified agen16 cies or employ staff to provide services

17 under this section on a statewide basis to

18 eligible individuals;

19 ‘‘(iii) shall be responsible for a pro20 gram of activities related to preventing and

21 reducing the rate of traumatic brain inju22 ries in the State according to standards es23 tablished by the Centers for Disease Con24 trol and Prevention; and
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1 ‘‘(iv) shall, after consultation with the

2 State advisory board established under

3 paragraph (3), establish standards regard4 ing the marketing of services (by hospitals

5 and other providers) to traumatic brain in6 jury patients or family members, dissemi7 nate the standards to case management

8 programs, and furnish information on such

9 standards to individuals who sustain trau10 matic brain injuries (and the family mem11 bers of such individuals) at the earliest ap12 propriate opportunity after the individual

13 has sustained the injury (such standards to

14 include (at a minimum) a rule prohibiting

15 payments under a case management pro16 gram under this section for referring pa17 tients);

18 ‘‘(B) provide assurances that a protection

19 and advocacy system established under this sec20 tion will—

21 ‘‘(i) provide legal, administrative and

22 other appropriate remedies or approaches

23 to ensure the protection of, and advocacy

24 for, the rights of individuals with trau25 matic brain injury within the State who
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1 are or may be eligible for treatment, serv2 ices, or rehabilitation;

3 ‘‘(ii) provide information and referral

4 to programs and services addressing the

5 needs of individuals with traumatic brain

6 injuries; and

7 ‘‘(iii) provide for the investigation of

8 incidents of abuse and neglect of individ9 uals with traumatic brain injuries when in10 cidents are reported for the provision of

11 excessive or unnecessary services or other

12 complaints relating to the care of such in13 dividuals, and payment for the referral of

14 patients;

15 ‘‘(C) ensure the provision to persons with

16 traumatic brain injury of information regarding

17 appropriate public or private agencies that pro18 vide rehabilitative services so that injured per19 sons or individuals responsible for such persons

20 may obtain needed service to alleviate injuries

21 and avoid secondary problems; and

22 ‘‘(D) for purposes of identifying the serv23 ices required to prevent the institutionalization

24 or to minimize the need for residential rehabili25 tation in the case of traumatic brain injuries,
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1 establish a services coordination program that

2 shall—

3 ‘‘(i) provide for the initial assessment

4 of the individual’s need for traumatic brain

5 injury services;

6 ‘‘(ii) provide for the reassessment of

7 each patient at regular intervals to deter8 mine the extent of each patient’s progress,

9 to ascertain whether a patient is being

10 kept too long in a given setting or provided

11 services inappropriately, or to determine

12 whether the patient would be better served

13 by other services or in another setting;

14 ‘‘(iii) prepare a treatment plan for

15 each individual requiring services coordina16 tion, within an appropriate period after the

17 individual sustains the injury, based on a

18 consultation with the individual (other

19 than an individual who is comatose in

20 which case consultation shall be with a

21 person with legal responsibility over such

22 individual) and any person named by the

23 individual (preparation of the plan may be

24 delayed based on a certification, including

25 a brief explanation of the reason for the
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1 delay, by a physician attesting that such a

2 delay is in the individual’s best interests

3 with a copy of the treatment plan and any

4 modifications to the plan being presented

5 to the individual or the individual’s legal

6 representative);

7 ‘‘(iv) ensure that each individual’s

8 treatment plan is regularly updated (based

9 on consultation with the individual and the

10 person responsible for the injured individ11 ual) with data and information about

12 treatments and services provided, as well

13 as specific measures of the individual’s

14 current performance or activity relative to

15 goals previously established;

16 ‘‘(v) assist the individual in obtaining

17 services necessary to allow the individual to

18 remain in the community;

19 ‘‘(vi) coordinate home care services

20 with other services;

21 ‘‘(vii) ensure appropriate, accessible,

22 and cost-effective services;

23 ‘‘(viii) assist the individual with prob24 lems related to the provision of home care

25 services;
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1 ‘‘(ix) ensure the quality of home care

2 services;

3 ‘‘(x) assess the individual’s need for

4 and level of home care services at appro5 priate intervals during the course of the in6 dividual’s treatment under the program;

7 and

8 ‘‘(xi) explore efforts to include serv9 ices coordination provisions under the

10 State’s medicaid program under section

11 1931 of the Social Security Act.

12 ‘‘(3) STATE ADVISORY BOARD.—

13 ‘‘(A) IN GENERAL.—To be eligible to re14 ceive a grant under subsection (a), a State shall

15 establish an advisory board within the appro16 priate health department of the State or within

17 another department as designated by the chief

18 executive officer of the State.

19 ‘‘(B) FUNCTIONS.—An advisory board es20 tablished under subparagraph (A) shall be cog21 nizant of findings and concerns of Federal,

22 State and local agencies, citizens groups, and

23 private industry (such as insurance, health care,

24 automobile, and other industry entities). Such

25 advisory boards shall encourage citizen partici-
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1 pation through the establishment of public

2 hearings and other types of community out3 reach programs.

4 ‘‘(C) COMPOSITION.—An advisory board

5 established under subparagraph (A) shall be

6 composed of—

7 ‘‘(i) representatives of—

8 ‘‘(I) the corresponding State

9 agencies involved;

10 ‘‘(II) public and nonprofit private

11 health related organizations;

12 ‘‘(III) other disability advisory or

13 planning groups within the State;

14 ‘‘(IV) members of an organiza15 tion or foundation representing trau16 matic brain injury survivors in that

17 State; and

18 ‘‘(V) injury control programs at

19 the State or local level if such pro20 grams exist; and

21 ‘‘(ii) a substantial number of individ22 uals who are survivors of traumatic brain

23 injury, or the family members of such indi24 viduals.
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1 ‘‘(d) REPORT.—Not later than 2 years after the date

2 of enactment of this part, the Secretary shall prepare and

3 submit to the appropriate committees of Congress a report

4 concerning the findings and results of the programs estab5 lished under this section, including measures of outcomes

6 and consumer and surrogate satisfaction.

7 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There

8 are authorized to be appropriated to carry out this section,

9 $27,000,000 for fiscal year 1994, and such sums as may

10 be necessary for each of the fiscal years 1995 and 1996.’’.

11 SEC. 4. NATIONAL HEAD INJURY AWARENESS MONTH.

12 The month of October, 1993, is hereby designated as

13 ‘‘National Head Injury Month’’ and the President is re14 quested to issue a proclamation calling on the people of

15 the United States to observe such month with appropriate

16 ceremonies and activities.

17 SEC. 5. EFFECTIVE DATE.

18 This Act shall become effective on October 1, 1993.

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