II 

109TH CONGRESS 

1ST SESSION S. 1064 

To amend the Public Health Service Act to improve stroke prevention, 

diagnosis, treatment, and rehabilitation. 

IN THE SENATE OF THE UNITED STATES 

MAY 18, 2005 

Mr. COCHRAN (for himself, Mr. KENNEDY, Mr. WARNER, Ms. CANTWELL, Ms. 

COLLINS, and Mr. DAYTON) 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 improve stroke 

prevention, diagnosis, treatment, and rehabilitation.

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 ‘‘Stroke Treatment and 

5 Ongoing Prevention Act of 2005’’. 

6 SEC. 2. FINDINGS AND GOAL. 

7 (a) FINDINGS.—The Congress finds as follows: 

8 (1) Stroke is the third leading cause of death 

9 in the United States. Each year approximately 
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1 700,000 Americans suffer a new or recurrent stroke 

2 and over 160,000 Americans die from stroke. 

3 (2) Stroke costs the United States 

4 $35,000,000,000 in direct costs and 

5 $56,800,000,000 in indirect costs each year. 

6 (3) Stroke is one of the leading causes of adult 

7 disability in the United States. Between 15 percent 

8 and 30 percent of stroke survivors are permanently 

9 disabled. Presently, there are 4,700,000 stroke sur10 vivors living in the United States. 

11 (4) Members of the general public have dif12 ficulty recognizing the symptoms of stroke and are 

13 unaware that stroke is a medical emergency. Fre14 quently, stroke patients wait as many as 22 hours 

15 or more before presenting at the emergency room. 

16 Forty-two percent of individuals over the age of 50 

17 do not recognize numbness or paralysis in the face, 

18 arm, or leg as a sign of stroke and 17 percent of 

19 them cannot name a single stroke symptom. 

20 (5) Recent advances in stroke treatment can 

21 significantly improve the outcome for stroke pa22 tients, but these therapies must be administered 

23 properly and promptly. Only 3 percent of stroke pa24 tients who are candidates for acute stroke intra-
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1 venous thrombolytic drug therapy receive the appro2 priate medication. 

3 (6) New technologies, therapies, and diagnostic 

4 approaches are currently being developed that will 

5 extend the therapeutic timeframe and result in 

6 greater treatment efficacy for stroke patients. 

7 (7) Few States and communities have developed 

8 and implemented stroke awareness programs, pre9 vention programs, or comprehensive stroke care sys10 tems. 

11 (8) The degree of disability resulting from 

12 stroke can be reduced substantially by educating the 

13 general public about stroke and by improving the 

14 systems for the provision of stroke care in the 

15 United States. 

16 (b) GOAL.—It is the goal of this Act to improve the 

17 provision of stroke care in every State and territory and 

18 in the District of Columbia, and to increase public aware19 ness about the prevention, detection, and treatment of 

20 stroke. 

21 SEC. 3. AMENDMENT REGARDING STROKE PREVENTION, 

22 TREATMENT, AND REHABILITATION. 

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

24 241 et seq.) is amended by adding at the end the fol25 lowing: 
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1 ‘‘PART R—STROKE PREVENTION, TREATMENT, 

2 AND REHABILITATION PROGRAMS 

3 ‘‘Subpart I—Authorities and Duties of the Secretary 

4 ‘‘SEC. 399AA. RESPONSIBILITIES OF THE SECRETARY. 

5 ‘‘(a) IN GENERAL.—The Secretary shall, with respect 

6 to stroke care— 

7 ‘‘(1) establish and evaluate a grant program 

8 under section 399DD to enable States to develop 

9 statewide stroke care systems; 

10 ‘‘(2) foster the development of appropriate, 

11 modern systems of stroke care through the sharing 

12 of information among agencies and individuals in13 volved in the study and provision of such care; 

14 ‘‘(3) provide to State and local agencies tech15 nical assistance; 

16 ‘‘(4) develop a model curriculum for training 

17 emergency medical services personnel, including dis18 patchers, first responders, emergency medical techni19 cians, and paramedics, in the identification, assess20 ment, stabilization, and prehospital treatment of 

21 stroke patients; 

22 ‘‘(5) issue recommendations or guidelines on 

23 best practices for the establishment and operation of 

24 statewide stroke systems, including recommendations 

25 or guidelines on best practices for the establishment 

26 and operation of stroke care centers; and 
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1 ‘‘(6) provide, to the extent practicable, informa2 tion to the public on the recognition of the signs and 

3 symptoms of stroke and the appropriate actions to 

4 take to assist an individual in obtaining appropriate 

5 and timely care following a stroke. 

6 ‘‘(b) GRANTS, COOPERATIVE AGREEMENTS, AND

7 CONTRACTS.—The Secretary may make grants, and enter 

8 into cooperative agreements and contracts, for the purpose 

9 of carrying out subsection (a). 

10 ‘‘(c) RULES OF CONSTRUCTION.— 

11 ‘‘(1) EXISTING GUIDELINES.—Nothing in sub12 section (a)(5) shall be construed to require the Sec13 retary to issue new recommendations or guidelines 

14 where existing recommendations or guidelines issued 

15 or adopted by the Secretary are applicable to the es16 tablishment of statewide stroke systems. Where an 

17 existing recommendation or guideline is applicable to 

18 the establishment of statewide stroke systems, the 

19 Secretary may deem such recommendation or guide20 line to have been issued under subsection (a)(5). 

21 ‘‘(2) ADVISORY NATURE OF GUIDELINES.—Rec22 ommendations or guidelines issued under subsection 

23 (a)(5) shall be considered advisory in nature and 

24 shall not be construed to constitute a standard of 

25 care for the treatment of stroke. 
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1 ‘‘SEC. 399BB. PAUL COVERDELL NATIONAL ACUTE STROKE 

2 REGISTRY. 

3 ‘‘The Secretary shall maintain the Paul Coverdell Na4 tional Acute Stroke Registry by— 

5 ‘‘(1) continuing to develop and collect specific 

6 data points as well as appropriate benchmarks for 

7 analyzing care of acute stroke patients; 

8 ‘‘(2) continuing to develop a national registry 

9 model that measures the delivery of care to patients 

10 with acute stroke in order to provide real-time data 

11 and analysis to reduce death and disability from 

12 stroke and improve the quality of life for acute 

13 stroke survivors; 

14 ‘‘(3) fostering the development of effective, 

15 modern stroke care systems (including the develop16 ment of policies related to emergency services sys17 tems) through the sharing of information among 

18 agencies and individuals involved in planning, fur19 nishing, and studying such systems; 

20 ‘‘(4) collecting, compiling, and disseminating in21 formation on the achievements of, and problems ex22 perienced by, State and local agencies and private 

23 entities in developing and implementing stroke care 

24 systems and, in carrying out this paragraph, giving 

25 special consideration to the unique needs of rural fa26 cilities and those facilities with inadequate resources 
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1 for providing high-quality prevention, acute treat2 ment, post-acute treatment, and rehabilitation serv3 ices for stroke patients; and 

4 ‘‘(5) carrying out any other activities the Sec5 retary determines to be useful to fulfill the purposes 

6 of the Paul Coverdell National Acute Stroke Reg7 istry. 

8 ‘‘Subpart II—State Stroke Care Systems 

9 ‘‘SEC. 399DD. GRANTS TO STATES FOR STROKE CARE SYS10 TEMS. 

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

12 States for the development and implementation of stroke 

13 care systems that provide high-quality prevention, diag14 nosis, treatment, and rehabilitation. 

15 ‘‘(b) REQUIRED USES.— 

16 ‘‘(1) IN GENERAL.—In carrying out activities 

17 described in subsection (a), each State that is 

18 awarded a grant under this section shall— 

19 ‘‘(A) establish, enhance, or expand a state20 wide stroke care system for the purpose of en21 suring access to high-quality stroke prevention, 

22 diagnosis, treatment, and rehabilitation, except 

23 that activities conducted under this subpara24 graph shall be consistent with guidelines or rec25 ommendations issued by the Secretary under 
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1 section 399AA(a)(5) to the extent that such 

2 guidelines or recommendations have been 

3 issued; 

4 ‘‘(B) establish, enhance, or expand, as ap5 propriate, stroke care centers, except that ac6 tivities conducted under this subparagraph shall 

7 be consistent with guidelines or recommenda8 tions issued by the Secretary under section 

9 399AA(a)(5), to the extent that such guidelines 

10 or recommendations have been issued; 

11 ‘‘(C) conduct evaluation activities to mon12 itor clinical outcomes and procedures and to 

13 verify resources, infrastructure, and operations 

14 devoted to stroke care; 

15 ‘‘(D) enhance, develop, and implement 

16 model curricula for training emergency medical 

17 services personnel in the identification, assess18 ment, stabilization, and prehospital treatment 

19 of stroke patients which may, at the discretion 

20 of the State, consist of or be based on the 

21 model curriculum developed by the Secretary 

22 under section 399AA(a)(4); 

23 ‘‘(E) enhance coordination of emergency 

24 medical services with respect to stroke care; 
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1 ‘‘(F) establish, enhance, or improve a cen2 tral data reporting and analysis system de3 scribed in subsection (c); 

4 ‘‘(G) establish, enhance, or improve a sup5 port network described in subsection (d) to pro6 vide assistance to facilities with smaller popu7 lations of stroke patients or less advanced on8 site stroke treatment resources; 

9 ‘‘(H) consult with organizations and indi10 viduals with expertise in stroke prevention, di11 agnosis, treatment, and rehabilitation; and 

12 ‘‘(I) with respect to carrying out subpara13 graph (C) through (H), use the best available 

14 evidence and consensus recommendations of 

15 professional associations. 

16 ‘‘(2) PERMISSIBLE USES.—In developing and 

17 implementing a stroke care system described in 

18 paragraph (1), each State that is awarded a grant 

19 under this section may— 

20 ‘‘(A) improve existing State stroke preven21 tion programs; 

22 ‘‘(B) conduct a stroke education and infor23 mation campaign, including by— 

24 ‘‘(i) making public service announce25 ments about the warning signs of stroke 
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1 and the importance of treating stroke as a 

2 medical emergency; and 

3 ‘‘(ii) providing education regarding 

4 ways to prevent stroke and the effective5 ness of stroke treatment; and 

6 ‘‘(C) make grants to public and non-profit 

7 private entities for medical professional develop8 ment in accordance with subsection (e). 

9 ‘‘(c) CENTRAL DATA REPORTING AND ANALYSIS

10 SYSTEM.—A central data reporting and analysis system 

11 described in this subsection is a system that collects data 

12 from facilities that provide direct care to stroke patients 

13 and uses the data— 

14 ‘‘(1) to identify the number of stroke patients 

15 treated in the State; 

16 ‘‘(2) to monitor patient care in the State for 

17 stroke patients at all phases of stroke for the pur18 pose of evaluating the diagnosis, treatment, and 

19 treatment outcome of such stroke patients; 

20 ‘‘(3) to identify the total amount of uncompen21 sated and under-compensated stroke care expendi22 tures for each fiscal year by each stroke care facility 

23 in the State; 

24 ‘‘(4) to identify the number of acute stroke pa25 tients who receive advanced drug therapy; 
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1 ‘‘(5) to identify patients transferred within the 

2 statewide stroke care system, including reasons for 

3 such transfer; and 

4 ‘‘(6) to communicate to the greatest extent 

5 practicable with the Paul Coverdell National Acute 

6 Stroke Registry. 

7 ‘‘(d) SUPPORT NETWORK.—A support network de8 scribed in this subsection may include the following: 

9 ‘‘(1) The use of telehealth technology to connect 

10 facilities described in subsection (b)(1)(G) to more 

11 advanced stroke care facilities. 

12 ‘‘(2) The provision of neuroimaging, laboratory, 

13 and any other equipment necessary to facilitate the 

14 establishment of a telehealth network. 

15 ‘‘(3) The use of phone consultation, where use16 ful. 

17 ‘‘(4) The use of referral links when a patient 

18 needs more advanced care than is available at the 

19 facility providing initial care. 

20 ‘‘(5) Any other assistance determined appro21 priate by the State. 

22 ‘‘(e) MEDICAL PROFESSIONAL DEVELOPMENT IN AD23 VANCED STROKE TREATMENT AND PREVENTION.— 

24 ‘‘(1) IN GENERAL.—A State may use funds re25 ceived under a grant under this section to make sub-
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1 grants to public and non-profit private entities for 

2 the development and implementation of education 

3 programs for appropriate medical personnel and 

4 health professionals in the use of newly developed di5 agnostic approaches, technologies, and therapies for 

6 the prevention and treatment of stroke. 

7 ‘‘(2) USE OF FUNDS.—A public or non-profit 

8 private entity shall use amounts received under a 

9 subgrant under this subsection for the continuing 

10 education of appropriate medical personnel in the 

11 use of newly developed diagnostic approaches, tech12 nologies, and therapies for the prevention and treat13 ment of stroke. 

14 ‘‘(3) DISTRIBUTION OF SUBGRANTS.—In 

15 awarding subgrants under this subsection, the Sec16 retary shall ensure that such subgrants are equitably 

17 distributed among the geographical regions of the 

18 State and between urban and rural populations. 

19 ‘‘(4) APPLICATION.—A public or non-profit pri20 vate entity desiring a subgrant under this subsection 

21 shall prepare and submit to the State involved an 

22 application at such time, in such manner, and con23 taining such information as the State may require, 

24 including a plan for the rigorous evaluation of activi-
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1 ties carried out with amounts received under such a 

2 subgrant. 

3 ‘‘(f) RESTRICTIONS ON USE OF PAYMENTS.—The 

4 Secretary may not, except as provided in paragraph (2), 

5 make payments to a State under this section for a fiscal 

6 year unless the State agrees that the payments will not 

7 be expended— 

8 ‘‘(1) to make cash payments to intended recipi9 ents of services provided pursuant to this section; 

10 ‘‘(2) to satisfy any requirement for the expendi11 ture of non-Federal funds as a condition for the re12 ceipt of Federal funds; 

13 ‘‘(3) to provide financial assistance to any enti14 ty other than a public or nonprofit private entity; or 

15 ‘‘(4) for construction, alteration, or improve16 ment of any building or facility. 

17 ‘‘(g) FAILURE TO COMPLY WITH AGREEMENTS.— 

18 ‘‘(1) REPAYMENT OF PAYMENTS.— 

19 ‘‘(A) REQUIREMENT.—The Secretary may, 

20 in accordance with paragraph (2), require a 

21 State to repay any payments received by the 

22 State under this section that the Secretary de23 termines were not expended by the State in ac24 cordance with the agreements required to be 
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1 made by the State as a condition of the receipt 

2 of payments. 

3 ‘‘(B) OFFSET OF AMOUNTS.—If a State 

4 fails to make a repayment required in subpara5 graph (A), the Secretary may offset the amount 

6 of the repayment against any amount due to be 

7 paid to the State under this section. 

8 ‘‘(2) OPPORTUNITY FOR A HEARING.—Before 

9 requiring repayment of payments under paragraph 

10 (1), the Secretary shall provide to the State an op11 portunity for a hearing. 

12 ‘‘(h) APPLICATION REQUIREMENTS.—The Secretary 

13 may not award a grant to a State under this section un14 less— 

15 ‘‘(1) the State submits an application con16 taining agreements in accordance with this section; 

17 ‘‘(2) the agreements are made through certifi18 cation from the chief executive officer of the State; 

19 ‘‘(3) with respect to such agreements, the appli20 cation provides assurances of compliance satisfactory 

21 to the Secretary; 

22 ‘‘(4) the application contains the plan provi23 sions and the information required to be submitted 

24 to the Secretary; and 
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1 ‘‘(5) the application otherwise is in such form, 

2 is made in such manner, and contains such agree3 ments, assurances, and information as the Secretary 

4 determines to be necessary to carry out this section. 

5 ‘‘(i) TECHNICAL ASSISTANCE.—The Secretary shall, 

6 without charge to a State receiving payments under this 

7 section, provide to the State (or to any public or nonprofit 

8 entity designated by the State) technical assistance with 

9 respect to the planning, development, and operation of any 

10 program carried out pursuant to this section. The Sec11 retary may provide such technical assistance directly, 

12 through contract, or through grants. 

13 ‘‘(j) SUPPLIES AND SERVICES IN LIEU OF GRANT

14 FUNDS.— 

15 ‘‘(1) IN GENERAL.—Upon the request of a 

16 State receiving payments under this section, the Sec17 retary may, subject to paragraph (2), provide sup18 plies, equipment, and services to the State and may 

19 detail to the State any officer or employee of the De20 partment of Health and Human Services, for the 

21 purpose of assisting the State to achieve the purpose 

22 of the payments. 

23 ‘‘(2) REDUCTION IN PAYMENTS.—With respect 

24 to a request described in paragraph (1), the Sec25 retary shall reduce the amount of payments to the 
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1 State under this section by an amount equal to the 

2 costs of detailing personnel and the fair market 

3 value of any supplies, equipment, or services pro4 vided by the Secretary. The Secretary shall, for the 

5 payment of expenses incurred in complying with 

6 such request, expend the amounts withheld. 

7 ‘‘(k) REPORT.—Not later than 3 years after the date 

8 of the enactment of the Stroke Treatment and Ongoing 

9 Prevention Act of 2005, the Secretary shall report to the 

10 appropriate committees of the Congress on the activities 

11 of the States carried out pursuant to this section and sec12 tion 399EE. Such report shall include an assessment of 

13 the extent to which Federal and State efforts to identify 

14 stroke centers, develop support networks, and enhance 

15 emergency medical services coordination and the training 

16 of emergency medical personnel, have increased the num17 ber of stroke patients who have received acute stroke con18 sultation or therapy within the appropriate timeframe and 

19 reduced the level of disability due to stroke. 

20 ‘‘(l) LIMITATION ON ADMINISTRATIVE EXPENSES.—

21 The Secretary may not award a grant to a State under 

22 this section unless the State agrees to use not more than 

23 10 percent of amounts received under the grant for admin24 istrative expenses. 
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1 ‘‘SEC. 399EE. PLANNING GRANTS. 

2 ‘‘(a) GRANTS.—The Secretary may award a grant to 

3 a State to assist such State in formulating a plan to de4 velop a stroke care system in accordance with section 

5 399DD or in otherwise meeting the requirements of such 

6 section. 

7 ‘‘(b) SUBMISSION TO SECRETARY.—The chief execu8 tive officer of a State that receives a grant under this sec9 tion shall submit to the Secretary a copy of the plan devel10 oped using the amounts provided under such grant. Such 

11 plan shall be submitted to the Secretary as soon as prac12 ticable after the plan has been developed. 

13 ‘‘(c) SINGLE GRANT LIMITATION.—A State is not eli14 gible to receive a grant under this section if the State pre15 viously received a grant under this section. 

16 ‘‘SEC. 399FF. SPECIAL CONSIDERATION. 

17 ‘‘In awarding grants under this subpart, the Sec18 retary shall give special consideration to any State that 

19 has submitted an application for carrying out programs 

20 under such a grant— 

21 ‘‘(1) in geographic areas in which there is— 

22 ‘‘(A) an elevated incidence or prevalence of 

23 disability resulting from stroke; or 

24 ‘‘(B) an elevated incidence or prevalence of 

25 stroke; or 
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1 ‘‘(2) that demonstrates a significant need for 

2 assistance in establishing a comprehensive stroke 

3 care system. 

4 ‘‘Subpart III—General Provisions 

5 ‘‘SEC. 399GG. GENERAL PROVISIONS. 

6 ‘‘(a) CONSULTATIONS.—In carrying out this part, the 

7 Secretary shall consult with organizations and individuals 

8 with expertise in stroke prevention, diagnosis, treatment, 

9 and rehabilitation. 

10 ‘‘(b) DEFINITIONS.—In this part: 

11 ‘‘(1) STATE.—The term ‘State’ means each of 

12 the several States, the District of Columbia, the 

13 Commonwealth of Puerto Rico, the Indian tribes, 

14 the Virgin Islands, Guam, American Samoa, and the 

15 Commonwealth of the Northern Mariana Islands. 

16 ‘‘(2) STROKE CARE SYSTEM.—The term ‘stroke 

17 care system’ means a statewide system to provide 

18 for the diagnosis, prehospital care, hospital definitive 

19 care, and rehabilitation of stroke patients. 

20 ‘‘(3) STROKE.—The term ‘stroke’ means a 

21 ‘brain attack’ in which blood flow to the brain is in22 terrupted or in which a blood vessel or aneurysm in 

23 the brain breaks or ruptures. 

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

25 are authorized to be appropriated to carry out this part 
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1 such sums as may be necessary for fiscal years 2006 

2 through 2010.’’.

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