II

106TH CONGRESS

2D SESSION S. 2855

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

of a national program of autism registries.

IN THE SENATE OF THE UNITED STATES

JULY 12, 2000

Mr. TORRICELLI introduced the following bill; which was read twice and

referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Public Health Service Act to provide for

the establishment of a national program of autism 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 ‘‘National Autism Reg5 istry Act’’.

6 SEC. 2. FINDINGS.

7 Congress makes the following findings:

8 (1) Autism Spectrum Disorders (ASD), such as

9 classic autism, Asperger’s syndrome and pervasive

10 developmental disorder (also known as atypical au-
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1 tism), are defined as developmental and behavioral

2 impairments resulting in impaired social inter3 actions, unusual communication styles, and re4 stricted or repetitive behaviors.

5 (2) Children with autism are unable to interact

6 appropriately with other people because they lack a

7 fundamental interest in social contact.

8 (3) Autism affects children of every racial, eth9 nic, and socioeconomic background.

10 (4) Recent studies have found between 12 and

11 15 children per 10,000 who are affected with au12 tism.

13 (5) Studies done in Europe and Asia indicate

14 that as many as 2 out of every 1,000 children have

15 some type of autism.

16 (6) A recent investigation by the Centers for

17 Disease Control and Prevention in Brick Township,

18 New Jersey, found a prevalence rate for autism of

19 4.0 per 1,000 children and a rate of 6.7 per 1,000

20 children for the more broadly defined category of

21 Autistic Spectrum Disorders.

22 (7) It is estimated that there are at least

23 400,000 children and adults in the United States

24 with autism. This rate is 3 to 4 times higher than

25 rates from studies conducted 15 to 20 years ago.
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1 (8) Research has indicated that autism is due

2 to an abnormality of brain development.

3 (9) Because there is no biologic marker for au4 tism, surveillance for this disability presents several

5 technical and logistic challenges that must be over6 come.

7 (10) Reports to the Centers for Disease Control

8 and Prevention of autism clusters are increasing.

9 (11) Families of children with autism experi10 ence tremendous psychologic and financial stress re11 lated to their child’s disability.

12 (12) Children with autism require long-term

13 care and services. Special education costs for a child

14 with autism are more than $8,000 per year, with

15 some specially structure programs costing about

16 $30,000, and care in a residential school costing be17 tween $80,000 and $100,000 per year. These costs

18 continue as children become adults and require

19 round the clock care and assistance. The yearly

20 costs of such care average $50,000 per person.

21 (13) Little is known about causes of autism, al22 though genetic and environmental factors and other

23 early prenatal exposures have been suggested.
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1 (14) There is no cure for autism, although

2 some available medicines may relieve some symp3 toms associated with the disorders.

4 (15) A uniform nationwide system of registries

5 will help better define—

6 (A) who is affected by autism and the im7 pact of autism;

8 (B) the range of impairments and dis9 ability associated with autism; and

10 (C) better mechanisms to refer persons

11 with autism to available services.

12 (16) Establishing a separate trust fund in the

13 Treasury of the United States will allow the Federal

14 Government to increase funding for autism research.

15 SEC. 3. AUTISM PROGRAM.

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

17 241 et seq.) is amended by adding at the end the fol18 lowing:

19 ‘‘PART O—NATIONAL PROGRAM FOR AUTISM

20 REGISTRIES

21 ‘‘SEC. 399O. NATIONAL PROGRAM FOR AUTISM REGISTRIES.

22 ‘‘(a) PROGRAM DEVELOPMENT.—The Secretary, act23 ing through the Director of the Centers for Disease Con24 trol and Prevention, shall—
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1 ‘‘(1) establish a baseline level of data that is to

2 be collected by a State (or its designee) for the oper3 ation of the autism registry of the State; and

4 ‘‘(2) conduct workshops with interested parties

5 including parent groups, physicians, and researchers

6 to reach consensus on the content of the baseline

7 data collection efforts under paragraph (1).

8 ‘‘(b) GRANTS.—The Secretary, acting through the

9 Director of the Centers for Disease Control and Preven10 tion, may make grants to—

11 ‘‘(1) States or their designees for the operation

12 of the State’s autism registry; and

13 ‘‘(2) academic institutions to enable such insti14 tutions, with respect to autism, to—

15 ‘‘(A) conduct population-based surveillance,

16 epidemiologic studies, and possible interventions

17 for developmental disabilities (including au18 tism);

19 ‘‘(B) conduct epidemiologic case-control

20 studies to examine prenatal, perinatal, and

21 postnatal factors involved in causing autism; or

22 ‘‘(C) conduct applied research that will

23 support the development of uniform autism reg24 istries, to—
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1 ‘‘(i) collect demographic information

2 about each case of autism;

3 ‘‘(ii) collect administrative information

4 about the source of the information col5 lected under clause (i), and the dates of

6 hospitalization, care, and treatment;

7 ‘‘(iii) collect information on the out8 comes associated with autism (such as im9 pairments, functional limitations, and dis10 ability);

11 ‘‘(iv) collect monitoring information

12 on State trends in developmental disabil13 ities (including autism) through the use of

14 well defined and reliable case definitions;

15 ‘‘(v) collect information on multiple

16 sites to provide for the conduct of epide17 miological studies into the causes of devel18 opmental disabilities (including autism);

19 ‘‘(vi) conduct evaluations of current

20 and future interventions for developmental

21 disabilities (including autism) prevention;

22 and

23 ‘‘(vii) conduct other activities deter24 mined appropriate by the Secretary.

25 ‘‘(c) ELIGIBILITY FOR GRANTS.—
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1 ‘‘(1) IN GENERAL.—No grant shall be made by

2 the Secretary under subsection (b) unless an appli3 cation has been submitted to, and approved by, the

4 Secretary. Such application shall be in such form,

5 submitted in such a manner, and be accompanied by

6 such information, as the Secretary may specify. No

7 such application may be approved unless it contains

8 assurances that the applicant will use the funds pro9 vided only for the purposes specified in the approved

10 application and in accordance with the requirements

11 of subsection (b), that the application will establish

12 such fiscal control and fund accounting procedures

13 as may be necessary to assure proper disbursement

14 and accounting of Federal funds paid to the appli15 cant under subsection (b), and that the applicant

16 will comply with review requirements under sections

17 491 and 492.

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

19 applicant, prior to receiving Federal funds under

20 subsection (b), shall provide for the establishment of

21 a registry that will—

22 ‘‘(A) comply with the uniform data collec23 tion methods established under subsection (a);
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1 ‘‘(B) comply with appropriate standards of

2 completeness, timeliness, and quality of data

3 collection;

4 ‘‘(C) provide for periodic reports of autism

5 registry data; and

6 ‘‘(D) provide for the authorization under

7 State law of the statewide autism registry, in8 cluding the promulgation of regulations

9 providing—

10 ‘‘(i) a means to assure timely and

11 complete reporting of autism cases (as de12 scribed in subsection (b)) to the statewide

13 autism registry by hospitals or other facili14 ties providing care or social services to pa15 tients with autism;

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

17 reporting of autism cases (as defined in

18 subsection (b)) to the statewide autism

19 registry by physicians, and all other health

20 care practitioners diagnosing or providing

21 treatment for autistic patients, except for

22 cases directly referred to or previously ad23 mitted to a hospital or other facility pro24 viding care or services to patients in that

25 State and reported by those facilities;
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1 ‘‘(iii) a means for the statewide au2 tism registry to access all records of physi3 cians, hospitals, clinics, treatment centers,

4 and all other facilities, individuals, or

5 agencies providing such services to patients

6 or individuals who care for autistic individ7 uals, or that identify cases of autism or

8 would establish characteristics of autism,

9 treatment of autism, or medical status of

10 any identified patient; and

11 ‘‘(iv) for the reporting of autism case

12 data to the statewide autism registry in

13 such a format, with such data elements,

14 and in accordance with such standards of

15 quality timeliness and completeness, as

16 may be established by the Secretary.

17 ‘‘(3) APPLIED RESEARCH.—Applicants for ap18 plied research shall conduct applied research as de19 termined by the Secretary, acting through the Direc20 tor of the Centers for Disease Control and Preven21 tion, to be necessary to support the development of

22 registry activities as defined in this section.

23 ‘‘(4) ASSURANCES FOR CONFIDENTIALITY OF

24 REGISTRY DATA.—Each applicant shall provide to

25 the satisfaction of the Secretary for—
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1 ‘‘(A) a means by which confidential case

2 data may, in accordance with State law, be dis3 closed to autism researchers for the purposes of

4 the prevention, control and research of autism;

5 ‘‘(B) the authorization or the conduct, by

6 the statewide autism registry or other persons

7 and organizations, of studies utilizing statewide

8 autism registry data, including studies of the

9 sources and causes of autism, evaluations of the

10 cost, quality, efficacy, and appropriateness of

11 preventative and other services and programs

12 relating to autism, and any other clinical, epide13 miological, or other autism research;

14 ‘‘(C) the protection of individuals com15 plying with the law, including provisions speci16 fying that no person shall be held liable in any

17 civil action with respect to an autism case re18 port provided to the statewide autism registry,

19 or with respect to access to autism case infor20 mation provided to the statewide autism reg21 istry; and

22 ‘‘(D) the protection of individual privacy

23 and confidentiality consistent with Federal and

24 State laws.
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1 ‘‘SEC. 399P. TECHNICAL ASSISTANCE IN OPERATIONS OF

2 STATEWIDE REGISTRIES.

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

4 Centers for Disease Control and Prevention, may, directly

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

6 assistance to the States in the establishment and operation

7 of statewide registries, including assistance in the develop8 ment of model legislation for statewide autism registries

9 and assistance in establishing a computerized reporting

10 and data processing system. In providing such assistance,

11 the Secretary shall encourage States to utilize standard12 ized procedures where appropriate.

13 ‘‘SEC. 399Q. AUTHORIZATION OF APPROPRIATIONS.

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

15 authorized to be appropriated $50,000,000 for fiscal year

16 2001, and such sums as may be necessary for each of the

17 fiscal years 2002 through 2006.’’.

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