I

103D CONGRESS

1ST SESSION H. R. 2990

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

AUGUST 6, 1993

Mr. PALLONE (for himself, Mr. QUILLEN, and Mr. GREENWOOD) 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

5 Injury Act of 1993’’.

6 SEC. 2. FINDINGS AND PURPOSE.

7 (a) FINDINGS.—Congress finds that—
2

•HR 2990 IH

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-
3

•HR 2990 IH

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;
4

•HR 2990 IH

1 (3) to provide the public with all necessary and

2 relevant information about the prevention of trau3 matic brain injury, in order for individuals to make

4 informed and educated safety decisions;

5 (4) promote the creation of innovative programs

6 and policies to prevent traumatic brain injury and to

7 rehabilitate those individuals who have survived such

8 injuries;

9 (5) designate a Federal agency to oversee and

10 promote projects relating to the prevention of, and

11 rehabilitation from, traumatic brain injury;

12 (6) create State advisory boards to coordinate

13 citizen participation in community programs dealing

14 with traumatic brain injury;

15 (7) create a registry to advance epidemiologic

16 research on such trauma;

17 (8) establish standards for the marketing of

18 brain injury services;

19 (9) require the Secretary to publish various re20 ports concerning the activities of the Department of

21 Health and Human Services in this area, including

22 an annual review of relevant activities; and

23 (10) provide for the initiation of a program to

24 establish national standards for helmets used by

25 bicyclists and others.
5

•HR 2990 IH

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

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

3 300d et seq.) is amended—

4 (1) by redesignating parts C through F as parts

5 D through G, respectively; and

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

7 part:

8 ‘‘PART C—TRAUMATIC BRAIN INJURY

9 ‘‘SEC. 1225. DEFINITIONS.

10 ‘‘As used in this part:

11 ‘‘(1) ADMINISTRATOR.—The term ‘Adminis12 trator’ means the Administrator of the Agency for

13 Health Care Policy and Research.

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

15 the Director of the Centers for Disease Control and

16 Prevention.

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

18 ‘traumatic brain injury’ means an acquired injury to

19 the brain caused by an external physical force. Such

20 term does not include brain dysfunction caused by

21 congenital or degenerative disorders, nor does such

22 term include birth trauma. Such term is synonymous

23 with the term ‘head injury’.
6

•HR 2990 IH

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.
7

•HR 2990 IH

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

18 matters 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.
8

•HR 2990 IH

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;
9

•HR 2990 IH

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;

7 ‘‘(6) identify States and localities that have im8 plemented unique approaches to encouraging bicycle

9 helmet use;

10 ‘‘(7) determine the health insurance status of

11 individuals with traumatic brain injury; and

12 ‘‘(8) initiate a program of prevention research

13 to develop effective prevention of traumatic brain in14 jury.

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

16 years after the date of enactment of this part, the Sec17 retary shall prepare and submit to the appropriate com18 mittees of Congress, a report containing the results of the

19 studies conducted under this section.

20 ‘‘(f) BIENNIAL REPORT.—The Secretary shall bienni21 ally prepare a report containing recommendations for the

22 prevention of traumatic brain injuries. The report shall

23 also identify States that have mandated helmet laws for

24 bicyclists, as well as States that have unique bicycle hel-
10

•HR 2990 IH

1 met-use promotion programs in place. Such reports shall

2 be disseminated to State health officers.

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

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

5 $2,000,000 for fiscal year 1994, and such sums as may

6 be necessary for each of the fiscal years 1995 through

7 1996.

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

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

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

11 nonprofit entities to reduce the incidence of traumatic

12 brain injury through the establishment and effectuation

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

14 Secretary may award grants to State and local entities,

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

16 ‘‘(1) special prevention and public awareness

17 initiative projects;

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

19 research and support programs;

20 ‘‘(3) projects that study the service needs of in21 dividuals with traumatic brain injury; and

22 ‘‘(4) projects involving grants for services co23 ordination.

24 ‘‘(b) REQUIREMENTS.—To be eligible to receive as25 sistance under subsection (a), an entity shall—
11

•HR 2990 IH

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

2 application, at such time, in such manner, and con3 taining such information as the Secretary may re4 quire; and

5 ‘‘(2) provide assurances to the Secretary that

6 any preventive measures implemented under a pre7 vention project funded under this section may in8 clude—

9 ‘‘(A) behavioral and environmental tech10 niques, as well as educational and responsible11 use programs;

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

13 model prevention approaches;

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

15 minimize brain injury risk in athletes (such as

16 the use of head protection gear); and

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

18 access to data-base systems to assist in design19 ing, developing, and implementing traumatic

20 brain injury prevention programs.

21 ‘‘(c) RESTRICTION ON USE OF FUNDS.—A grant

22 under subsection (a) may not be expended to engage in

23 advocacy regarding Federal, State, or local laws.

24 ‘‘(d) RULE OF CONSTRUCTION.—The Secretary may

25 not require that, as a condition of the receipt of a grant
12

•HR 2990 IH

1 under subsection (a), a State have in effect a law regard2 ing the use of helmets while operating motorcycles.

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

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

5 $4,000,000 for fiscal year 1994, and such sums as may

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

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

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

9 the Director of the National Institutes of Health, may pro10 vide assistance to public and private nonprofit entities to

11 support the conduct of basic and applied research concern12 ing traumatic brain injury, especially with respect to the

13 biomechanics of brain injury, the molecular and cellular

14 characteristics of primary and secondary injury to the

15 brain and the development of improved experimental brain

16 injury models.

17 ‘‘(b) SPECIFIC RESEARCH.—Research to be con18 ducted with assistance provided under subsection (a) shall

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

20 such assistance, to contribute to the strategies that will

21 limit primary and secondary mechanical, biochemical and

22 metabolic insults to the brain and minimize the extent,

23 severity and progression of resulting dysfunctions. In im24 plementing this section the Secretary shall emphasize—
13

•HR 2990 IH

1 ‘‘(1) the development of new methods and mo2 dalities for the more effective diagnosis, measure3 ment of degree of injury, post-injury monitoring and

4 prognostic assessment of head injury for acute,

5 subacute and later phases of care;

6 ‘‘(2) the development, modification and evalua7 tion of therapies that retard, prevent or reverse

8 brain damage after acute head injury, that arrest

9 further deterioration following injury and that pro10 vide the restitution of function for individuals with

11 long-term injuries;

12 ‘‘(3) the integration of basic research into clini13 cal care settings;

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

15 from acute care through rehabilitation, designed, to

16 the extent practicable, to integrate rehabilitation and

17 long-term outcome evaluation with acute care re18 search;

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

20 the participation of academic centers of excellence in

21 head injury treatment and rehabilitation research

22 and training; and

23 ‘‘(6) the conduct of national consensus con24 ferences on managing head injury and related reha-
14

•HR 2990 IH

1 bilitation concerns, the findings of which shall be

2 published.

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

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

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

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

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

8 INJURY.

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

10 States for the establishment of programs related to trau11 matic brain injury. Such programs shall include State ad12 visory boards, patient advocacy and service coordination

13 systems, and State registries concerning individuals af14 fected by traumatic brain injuries. Services may also be

15 provided under this section, within the limits of service

16 availability, to individuals whose deficits are not due to

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

18 such individuals should be comparable to traumatic brain

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

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

21 their deficits being due to a nonprogressive and non22 recurring disorder.

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

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

25 shall—
15

•HR 2990 IH

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

2 application, at such time, in such manner, and con3 taining such information as the Secretary may re4 quire;

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

6 submit to the Secretary reports describing the activi7 ties undertaken under the State system established

8 under the grant; and

9 ‘‘(3) provide for the establishment of a State10 wide program that includes a State registry for trau11 matic brain injury information, a program of patient

12 advocacy and service coordination, and a State advi13 sory board with respect to activities under this

14 section.

15 ‘‘(c) SPECIFIC PROGRAM REQUIREMENTS.—

16 ‘‘(1) STATE REGISTRY.—To be eligible to re17 ceive a grant under subsection (a), a State shall—

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

19 the utilization of procedures to ensure privacy

20 and maintain the confidentiality of information,

21 which are acceptable to the Secretary, a central

22 registry of persons who sustain traumatic brain

23 injury in order to—

24 ‘‘(I) collect information to facilitate

25 the development of injury prevention,
16

•HR 2990 IH

1 treatment, and rehabilitation programs;

2 and

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

4 an annual basis for State reporting re5 quirements; and

6 ‘‘(ii) a violation of such privacy and con7 fidentiality procedures or the unauthorized use

8 of such information may result in a loss of sup9 port under this section; and

10 ‘‘(B) provide summary registry data or

11 data that is not personally identifiable to public

12 and private entities to conduct studies using

13 data collected by the traumatic brain injury

14 registry established under subparagraph (A),

15 for which the coordinator may charge a fee for

16 all expenses associated with the provision of

17 data or data analysis.

18 ‘‘(2) ADVOCACY AND SERVICE COORDINA19 TION.—To be eligible to receive a grant under sub20 section (a), a State shall—

21 ‘‘(A) designate a State coordinator for

22 traumatic brain injuries who—

23 ‘‘(i) shall establish policies and stand24 ards for coordinating services within the
17

•HR 2990 IH

1 State for individuals with traumatic brain

2 injury;

3 ‘‘(ii) may contract with qualified agen4 cies or employ staff to provide services

5 under this section on a statewide basis to

6 eligible individuals;

7 ‘‘(iii) shall be responsible for a pro8 gram of activities related to preventing and

9 reducing the rate of traumatic brain inju10 ries in the State; and

11 ‘‘(iv) shall, after consultation with the

12 State advisory board established under

13 paragraph (3), establish standards regard14 ing the marketing of services (by hospitals

15 and other providers) to traumatic brain in16 jury patients or family members, dissemi17 nate the standards to case management

18 programs, and furnish information on such

19 standards to individuals who sustain trau20 matic brain injuries (and the family mem21 bers of such individuals) at the earliest ap22 propriate opportunity after the individual

23 has sustained the injury (such standards to

24 include (at a minimum) a rule prohibiting

25 payments under a case management pro-
18

•HR 2990 IH

1 gram under this section for referring pa2 tients);

3 ‘‘(B) provide assurances that a protection

4 and advocacy system established under this sec5 tion will—

6 ‘‘(i) provide legal, administrative and

7 other appropriate remedies or approaches

8 to ensure the protection of, and advocacy

9 for, the rights of individuals with trau10 matic brain injury within the State who

11 are or may be eligible for treatment, serv12 ices, or rehabilitation;

13 ‘‘(ii) provide information and referral

14 to programs and services addressing the

15 needs of individuals with traumatic brain

16 injuries; and

17 ‘‘(iii) provide for the investigation of

18 incidents of abuse and neglect of individ19 uals with traumatic brain injuries when in20 cidents are reported for the provision of

21 excessive or unnecessary services or other

22 complaints relating to the care of such in23 dividuals, and payment for the referral of

24 patients;
19

•HR 2990 IH

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

2 traumatic brain injury of information regarding

3 appropriate public or private agencies that pro4 vide rehabilitative services so that injured per5 sons or individuals responsible for such persons

6 may obtain needed service to alleviate injuries

7 and avoid secondary problems; and

8 ‘‘(D) for purposes of identifying the serv9 ices required to prevent the institutionalization

10 or to minimize the need for residential rehabili11 tation in the case of traumatic brain injuries,

12 establish a services coordination program that

13 shall—

14 ‘‘(i) provide for the initial assessment

15 of the individual’s need for traumatic brain

16 injury services;

17 ‘‘(ii) provide for the reassessment of

18 each patient at regular intervals to deter19 mine the extent of each patient’s progress,

20 to ascertain whether a patient is being

21 kept too long in a given setting or provided

22 services inappropriately, or to determine

23 whether the patient would be better served

24 by other services or in another setting;
20

•HR 2990 IH

1 ‘‘(iii) prepare a treatment plan for

2 each individual requiring services coordina3 tion, within an appropriate period after the

4 individual sustains the injury, based on a

5 consultation with the individual (other

6 than an individual who is comatose in

7 which case consultation shall be with a

8 person with legal responsibility over such

9 individual) and any person named by the

10 individual (preparation of the plan may be

11 delayed based on a certification, including

12 a brief explanation of the reason for the

13 delay, by a physician attesting that such a

14 delay is in the individual’s best interests

15 with a copy of the treatment plan and any

16 modifications to the plan being presented

17 to the individual or the individual’s legal

18 representative);

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

20 treatment plan is regularly updated (based

21 on consultation with the individual and the

22 person responsible for the injured individ23 ual) with data and information about

24 treatments and services provided, as well

25 as specific measures of the individual’s
21

•HR 2990 IH

1 current performance or activity relative to

2 goals previously established;

3 ‘‘(v) assist the individual in obtaining

4 services necessary to allow the individual to

5 remain in the community;

6 ‘‘(vi) coordinate home care services

7 with other services;

8 ‘‘(vii) ensure appropriate, accessible,

9 and cost-effective services;

10 ‘‘(viii) assist the individual with prob11 lems related to the provision of home care

12 services;

13 ‘‘(ix) ensure the quality of home care

14 services;

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

16 and level of home care services at appro17 priate intervals during the course of the in18 dividual’s treatment under the program;

19 and

20 ‘‘(xi) explore efforts to include serv21 ices coordination provisions under the

22 State’s medicaid program under section

23 1931 of the Social Security Act.

24 ‘‘(3) STATE ADVISORY BOARD.—
22

•HR 2990 IH

1 ‘‘(A) IN GENERAL.—To be eligible to re2 ceive a grant under subsection (a), a State shall

3 establish an advisory board within the appro4 priate health department of the State or within

5 another department as designated by the chief

6 executive officer of the State.

7 ‘‘(B) FUNCTIONS.—An advisory board es8 tablished under subparagraph (A) shall be cog9 nizant of findings and concerns of Federal,

10 State and local agencies, citizens groups, and

11 private industry (such as insurance, health care,

12 automobile, and other industry entities). Such

13 advisory boards shall encourage citizen partici14 pation through the establishment of public

15 hearings and other types of community out16 reach programs.

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

18 established under subparagraph (A) shall be

19 composed of—

20 ‘‘(i) representatives of—

21 ‘‘(I) the corresponding State

22 agencies involved;

23 ‘‘(II) public and nonprofit private

24 health related organizations;
23

•HR 2990 IH

1 ‘‘(III) other disability advisory or

2 planning groups within the State;

3 ‘‘(IV) members of an organiza4 tion or foundation representing trau5 matic brain injury survivors in that

6 State; and

7 ‘‘(V) injury control programs at

8 the State or local level if such pro9 grams exist; and

10 ‘‘(ii) a substantial number of individ11 uals who are survivors of traumatic brain

12 injury, or the family members of such indi13 viduals; and

14 ‘‘(d) REPORT.—Not later than 2 years after the date

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

16 submit to the appropriate committees of Congress a report

17 concerning the findings and results of the programs estab18 lished under this section, including measures of outcomes

19 and consumer and surrogate satisfaction.

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

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

22 $27,000,000 for fiscal year 1994, and such sums as may

23 be necessary for each of the fiscal years 1995 and 1996.’’.
24

•HR 2990 IH

1 SEC. 4. NATIONAL HEAD INJURY AWARENESS MONTH.

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

3 ‘‘National Head Injury Month’’ and the President is re4 quested to issue a proclamation calling on the people of

5 the United States to observe such month with appropriate

6 ceremonies and activities.

7 SEC. 5. EFFECTIVE DATE.

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

Æ

HR 2990 IS——2