I

105TH CONGRESS

2D SESSION H. R. 4800

To amend the Public Health Service Act to provide for the establishment

of a national program of traumatic brain injury and spinal cord injury

registries.

IN THE HOUSE OF REPRESENTATIVES

OCTOBER 10, 1998

Mr. PASCRELL (for himself and Mr. GREENWOOD) introduced the following

bill; which was referred to the Committee on Commerce

A BILL

To amend the Public Health Service Act to provide for

the establishment of a national program of traumatic

brain injury and spinal cord injury registries.

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 and Spinal Cord Injury Registry Act’’.

6 SEC. 2. FINDINGS.

7 Congress finds that—
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1 (1) traumatic brain and spinal cord injury are

2 severe and disabling, have enormous personal and

3 societal costs;

4 (2) 51,000 people die each year from traumatic

5 brain injury and 4,500,000 people live with lifelong

6 and severe disability as a result of a traumatic brain

7 injury;

8 (3) approximately 10,000 people sustain spinal

9 cord injuries each year, and 200,000 live with life10 long and severe disability; and

11 (4) a nationwide system of registries will help

12 better define—

13 (A) who sustains such injuries and the im14 pact of such injuries;

15 (B) the range of impairments and disabil16 ity associated with such injuries; and

17 (C) better mechanisms to refer persons

18 with traumatic brain injuries or spinal cord in19 juries to available services.

20 SEC. 3. TRAUMATIC BRAIN INJURY AND SPINAL CORD IN21 JURY REGISTRIES PROGRAM.

22 Title III of the Public Health Service Act (42 U.S.C.

23 241 et seq.) is amended by adding at the end the follow24 ing:
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1 ‘‘PART O—NATIONAL PROGRAM FOR TRAUMATIC BRAIN

2 INJURY AND SPINAL CORD INJURY REGISTRIES

3 ‘‘SEC. 399N. NATIONAL PROGRAM FOR TRAUMATIC BRAIN

4 INJURY AND SPINAL CORD INJURY REG5 ISTRIES.

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

7 the Director of the Centers for Disease Control and Pre8 vention, may make grants to States or their designees to

9 operate the State’s traumatic brain injury and spinal cord

10 injury registry, and to academic institutions to conduct

11 applied research that will support the development of such

12 registries, to collect data concerning—

13 ‘‘(1) demographic information about each trau14 matic brain injury or spinal cord injury;

15 ‘‘(2) information about the circumstances sur16 rounding the injury event associated with each trau17 matic brain injury and spinal cord injury;

18 ‘‘(3) administrative information about the

19 source of the collected information, dates of hos20 pitalization and treatment, and the date of injury;

21 ‘‘(4) information characterizing the clinical as22 pects of the traumatic brain injury or spinal cord in23 jury, including the severity of the injury, the types

24 of treatments received, and the types of services uti25 lized;
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1 ‘‘(5) information on the outcomes associated

2 with traumatic brain injuries and spinal cord inju3 ries, such as impairments, functional limitations,

4 and disability;

5 ‘‘(6) information on the outcomes associated

6 with traumatic brain injuries and spinal cord inju7 ries which do not result in hospitalization; and

8 ‘‘(7) other elements determined appropriate by

9 the Secretary.

10 ‘‘(b) ELIGIBILITY FOR GRANTS.—

11 ‘‘(1) IN GENERAL.—No grant shall be made by

12 the Secretary under subsection (a) unless an appli13 cation has been submitted to, and approved by, the

14 Secretary. Such application shall be in such form,

15 submitted in such a manner, and be accompanied by

16 such information, as the Secretary may specify. No

17 such application may be approved unless it contains

18 assurances that the applicant will use the funds pro19 vided only for the purposes specified in the approved

20 application and in accordance with the requirements

21 of subsection (a), that the application will establish

22 such fiscal control and fund accounting procedures

23 as may be necessary to assure proper disbursement

24 and accounting of Federal funds paid to the appli25 cant under subsection (a) of this section, and that
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1 the applicant will comply with review requirements

2 under sections 491 and 492.

3 ‘‘(2) ESTABLISHMENT OF REGISTRIES.—Each

4 applicant, prior to receiving Federal funds under

5 subsection (a), shall provide for the establishment of

6 a registry that will—

7 ‘‘(A) comply with appropriate standards of

8 completeness, timeliness, and quality of data

9 collection;

10 ‘‘(B) provide for periodic reports of trau11 matic brain injury and spinal cord injury reg12 istry data; and

13 ‘‘(C) provide for the authorization under

14 State law of the statewide traumatic brain in15 jury and spinal cord injury registry, including

16 promulgation of regulations providing—

17 ‘‘(i) a means to assure timely and

18 complete reporting of brain injuries and

19 spinal cord injuries (as described in sub20 section (a)) to the statewide traumatic

21 brain injury and spinal cord injury registry

22 by hospitals or other facilities providing di23 agnostic or acute care or rehabilitative so24 cial services to patients with respect to
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1 traumatic brain injury and spinal cord in2 jury;

3 ‘‘(ii) a means to assure the complete

4 reporting of brain injuries and spinal cord

5 injuries (as defined in subsection (a)) to

6 the statewide traumatic brain injury and

7 spinal cord injury registry by physicians,

8 surgeons, and all other health care practi9 tioners diagnosing or providing treatment

10 for traumatic brain injury and spinal cord

11 injury patients, except for cases directly re12 ferred to or previously admitted to a hos13 pital or other facility providing diagnostic

14 or acute care or rehabilitative services to

15 patients in that State and reported by

16 those facilities;

17 ‘‘(iii) a means for the statewide trau18 matic brain injury and spinal cord injury

19 registry to access all records of physicians

20 and surgeons, hospitals, outpatient clinics,

21 nursing homes, and all other facilities, in22 dividuals, or agencies providing such serv23 ices to patients which would identify cases

24 of traumatic brain injury or spinal cord in25 jury or would establish characteristics of
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1 the injury, treatment of the injury, or med2 ical status of any identified patient; and

3 ‘‘(iv) for the reporting of traumatic

4 brain injury and spinal cord injury case

5 data to the statewide traumatic brain in6 jury and spinal cord injury registry in such

7 a format, with such data elements, and in

8 accordance with such standards of quality

9 timeliness and completeness, as may be es10 tablished by the Secretary.

11 ‘‘(3) APPLIED RESEARCH.—Applicants for ap12 plied research shall conduct applied research as de13 termined by the Secretary, acting through the Direc14 tor of the Centers for Disease Control and Preven15 tion, to be necessary to support the development of

16 registry activities as defined in this section.

17 ‘‘(4) ASSURANCES FOR CONFIDENTIALITY OF

18 REGISTRY DATA.—Each applicant shall provide to

19 the satisfaction of the Secretary for—

20 ‘‘(A) a means by which confidential case

21 data may in accordance with State law be dis22 closed to traumatic brain injury and spinal cord

23 injury researchers for the purposes of the pre24 vention, control and research of brain injuries

25 and spinal cord injuries;
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1 ‘‘(B) the authorization or the conduct, by

2 the statewide traumatic brain injury and spinal

3 cord injury registry or other persons and orga4 nizations, of studies utilizing statewide trau5 matic brain injury and spinal cord injury reg6 istry data, including studies of the sources and

7 causes of traumatic brain injury and spinal

8 cord injury, evaluations of the cost, quality, ef9 ficacy, and appropriateness of diagnostic, reha10 bilitative, and preventative services and pro11 grams relating to traumatic brain injury and

12 spinal cord injury, and any other clinical, epide13 miological, or other traumatic brain injury and

14 spinal cord injury research;

15 ‘‘(C) the protection of individuals comply16 ing with the law, including provisions specifying

17 that no person shall be held liable in any civil

18 action with respect to a traumatic brain injury

19 and spinal cord injury case report provided to

20 the statewide traumatic brain injury and spinal

21 cord injury registry, or with respect to access to

22 traumatic brain injury and spinal cord injury

23 case information provided to the statewide trau24 matic brain injury and spinal cord injury reg25 istry; and
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1 ‘‘(D) the protection of individual privacy

2 and confidentiality consistent with Federal and

3 State laws.

4 ‘‘SEC. 399O. TECHNICAL ASSISTANCE IN OPERATIONS OF

5 STATEWIDE REGISTRIES.

6 ‘‘The Secretary, acting through the Director of the

7 Centers for Disease Control and Prevention, may, directly

8 or through grants and contracts, or both, provide technical

9 assistance to the States in the establishment and operation

10 of statewide registries, including assistance in the develop11 ment of model legislation for statewide traumatic brain in12 jury and spinal cord injury registries and assistance in es13 tablishing a computerized reporting and data processing

14 system. In providing such assistance, the Secretary shall

15 encourage States to utilize standardized procedures where

16 appropriate.

17 ‘‘SEC. 399P. AUTHORIZATION OF APPROPRIATIONS.

18 ‘‘For the purpose of carrying out this part, there are

19 authorized to be appropriated $10,000,000 for fiscal year

20 1999, and such sums as may be necessary for each of the

21 fiscal years 2000 through 2004.

22 ‘‘SEC. 399Q. DEFINITIONS.

23 ‘‘In this part:

24 ‘‘(1) SPINAL CORD INJURY.—The term ‘spinal

25 cord injury’ means an acquired injury to the spinal
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1 cord. Such term does not include spinal cord dys2 function caused by congenital or degenerative dis3 orders, vascular disease, or tumors, or spinal column

4 fractures without a spinal cord injury.

5 ‘‘(2) TRAUMATIC BRAIN INJURY.—The term

6 ‘traumatic brain injury’ means an acquired injury to

7 the brain, including brain injuries caused by anoxia

8 due to near-drowning. Such term does not include

9 brain dysfunction caused by congenital or degenera10 tive disorders, cerebral vascular disease, tumors, or

11 birth trauma. The Secretary may revise the defini12 tion of such term as the Secretary determines appro13 priate.’’.

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