[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1064 Introduced in Senate (IS)]







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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Stroke Treatment and Ongoing 
Prevention Act of 2005''.

SEC. 2. FINDINGS AND GOAL.

    (a) Findings.--The Congress finds as follows:
            (1) Stroke is the third leading cause of death in the 
        United States. Each year approximately 700,000 Americans suffer 
        a new or recurrent stroke and over 160,000 Americans die from 
        stroke.
            (2) Stroke costs the United States $35,000,000,000 in 
        direct costs and $56,800,000,000 in indirect costs each year.
            (3) Stroke is one of the leading causes of adult disability 
        in the United States. Between 15 percent and 30 percent of 
        stroke survivors are permanently disabled. Presently, there are 
        4,700,000 stroke survivors living in the United States.
            (4) Members of the general public have difficulty 
        recognizing the symptoms of stroke and are unaware that stroke 
        is a medical emergency. Frequently, stroke patients wait as 
        many as 22 hours or more before presenting at the emergency 
        room. Forty-two percent of individuals over the age of 50 do 
        not recognize numbness or paralysis in the face, arm, or leg as 
        a sign of stroke and 17 percent of them cannot name a single 
        stroke symptom.
            (5) Recent advances in stroke treatment can significantly 
        improve the outcome for stroke patients, but these therapies 
        must be administered properly and promptly. Only 3 percent of 
        stroke patients who are candidates for acute stroke intravenous 
        thrombolytic drug therapy receive the appropriate medication.
            (6) New technologies, therapies, and diagnostic approaches 
        are currently being developed that will extend the therapeutic 
        timeframe and result in greater treatment efficacy for stroke 
        patients.
            (7) Few States and communities have developed and 
        implemented stroke awareness programs, prevention programs, or 
        comprehensive stroke care systems.
            (8) The degree of disability resulting from stroke can be 
        reduced substantially by educating the general public about 
        stroke and by improving the systems for the provision of stroke 
        care in the United States.
    (b) Goal.--It is the goal of this Act to improve the provision of 
stroke care in every State and territory and in the District of 
Columbia, and to increase public awareness about the prevention, 
detection, and treatment of stroke.

SEC. 3. AMENDMENT REGARDING STROKE PREVENTION, TREATMENT, AND 
              REHABILITATION.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by adding at the end the following:

  ``PART R--STROKE PREVENTION, TREATMENT, AND REHABILITATION PROGRAMS

          ``Subpart I--Authorities and Duties of the Secretary

``SEC. 399AA. RESPONSIBILITIES OF THE SECRETARY.

    ``(a) In General.--The Secretary shall, with respect to stroke 
care--
            ``(1) establish and evaluate a grant program under section 
        399DD to enable States to develop statewide stroke care 
        systems;
            ``(2) foster the development of appropriate, modern systems 
        of stroke care through the sharing of information among 
        agencies and individuals involved in the study and provision of 
        such care;
            ``(3) provide to State and local agencies technical 
        assistance;
            ``(4) develop a model curriculum for training emergency 
        medical services personnel, including dispatchers, first 
        responders, emergency medical technicians, and paramedics, in 
        the identification, assessment, stabilization, and prehospital 
        treatment of stroke patients;
            ``(5) issue recommendations or guidelines on best practices 
        for the establishment and operation of statewide stroke 
        systems, including recommendations or guidelines on best 
        practices for the establishment and operation of stroke care 
        centers; and
            ``(6) provide, to the extent practicable, information to 
        the public on the recognition of the signs and symptoms of 
        stroke and the appropriate actions to take to assist an 
        individual in obtaining appropriate and timely care following a 
        stroke.
    ``(b) Grants, Cooperative Agreements, and Contracts.--The Secretary 
may make grants, and enter into cooperative agreements and contracts, 
for the purpose of carrying out subsection (a).
    ``(c) Rules of Construction.--
            ``(1) Existing guidelines.--Nothing in subsection (a)(5) 
        shall be construed to require the Secretary to issue new 
        recommendations or guidelines where existing recommendations or 
        guidelines issued or adopted by the Secretary are applicable to 
        the establishment of statewide stroke systems. Where an 
        existing recommendation or guideline is applicable to the 
        establishment of statewide stroke systems, the Secretary may 
        deem such recommendation or guideline to have been issued under 
        subsection (a)(5).
            ``(2) Advisory nature of guidelines.--Recommendations or 
        guidelines issued under subsection (a)(5) shall be considered 
        advisory in nature and shall not be construed to constitute a 
        standard of care for the treatment of stroke.

``SEC. 399BB. PAUL COVERDELL NATIONAL ACUTE STROKE REGISTRY.

    ``The Secretary shall maintain the Paul Coverdell National Acute 
Stroke Registry by--
            ``(1) continuing to develop and collect specific data 
        points as well as appropriate benchmarks for analyzing care of 
        acute stroke patients;
            ``(2) continuing to develop a national registry model that 
        measures the delivery of care to patients with acute stroke in 
        order to provide real-time data and analysis to reduce death 
        and disability from stroke and improve the quality of life for 
        acute stroke survivors;
            ``(3) fostering the development of effective, modern stroke 
        care systems (including the development of policies related to 
        emergency services systems) through the sharing of information 
        among agencies and individuals involved in planning, 
        furnishing, and studying such systems;
            ``(4) collecting, compiling, and disseminating information 
        on the achievements of, and problems experienced by, State and 
        local agencies and private entities in developing and 
        implementing stroke care systems and, in carrying out this 
        paragraph, giving special consideration to the unique needs of 
        rural facilities and those facilities with inadequate resources 
        for providing high-quality prevention, acute treatment, post-
        acute treatment, and rehabilitation services for stroke 
        patients; and
            ``(5) carrying out any other activities the Secretary 
        determines to be useful to fulfill the purposes of the Paul 
        Coverdell National Acute Stroke Registry.

                ``Subpart II--State Stroke Care Systems

``SEC. 399DD. GRANTS TO STATES FOR STROKE CARE SYSTEMS.

    ``(a) Grants.--The Secretary shall award grants to States for the 
development and implementation of stroke care systems that provide 
high-quality prevention, diagnosis, treatment, and rehabilitation.
    ``(b) Required Uses.--
            ``(1) In general.--In carrying out activities described in 
        subsection (a), each State that is awarded a grant under this 
        section shall--
                    ``(A) establish, enhance, or expand a statewide 
                stroke care system for the purpose of ensuring access 
                to high-quality stroke prevention, diagnosis, 
                treatment, and rehabilitation, except that activities 
                conducted under this subparagraph shall be consistent 
                with guidelines or recommendations issued by the 
                Secretary under section 399AA(a)(5) to the extent that 
                such guidelines or recommendations have been issued;
                    ``(B) establish, enhance, or expand, as 
                appropriate, stroke care centers, except that 
                activities conducted under this subparagraph shall be 
                consistent with guidelines or recommendations issued by 
                the Secretary under section 399AA(a)(5), to the extent 
                that such guidelines or recommendations have been 
                issued;
                    ``(C) conduct evaluation activities to monitor 
                clinical outcomes and procedures and to verify 
                resources, infrastructure, and operations devoted to 
                stroke care;
                    ``(D) enhance, develop, and implement model 
                curricula for training emergency medical services 
                personnel in the identification, assessment, 
                stabilization, and prehospital treatment of stroke 
                patients which may, at the discretion of the State, 
                consist of or be based on the model curriculum 
                developed by the Secretary under section 399AA(a)(4);
                    ``(E) enhance coordination of emergency medical 
                services with respect to stroke care;
                    ``(F) establish, enhance, or improve a central data 
                reporting and analysis system described in subsection 
                (c);
                    ``(G) establish, enhance, or improve a support 
                network described in subsection (d) to provide 
                assistance to facilities with smaller populations of 
                stroke patients or less advanced on-site stroke 
                treatment resources;
                    ``(H) consult with organizations and individuals 
                with expertise in stroke prevention, diagnosis, 
                treatment, and rehabilitation; and
                    ``(I) with respect to carrying out subparagraph (C) 
                through (H), use the best available evidence and 
                consensus recommendations of professional associations.
            ``(2) Permissible uses.--In developing and implementing a 
        stroke care system described in paragraph (1), each State that 
        is awarded a grant under this section may--
                    ``(A) improve existing State stroke prevention 
                programs;
                    ``(B) conduct a stroke education and information 
                campaign, including by--
                            ``(i) making public service announcements 
                        about the warning signs of stroke and the 
                        importance of treating stroke as a medical 
                        emergency; and
                            ``(ii) providing education regarding ways 
                        to prevent stroke and the effectiveness of 
                        stroke treatment; and
                    ``(C) make grants to public and non-profit private 
                entities for medical professional development in 
                accordance with subsection (e).
    ``(c) Central Data Reporting and Analysis System.--A central data 
reporting and analysis system described in this subsection is a system 
that collects data from facilities that provide direct care to stroke 
patients and uses the data--
            ``(1) to identify the number of stroke patients treated in 
        the State;
            ``(2) to monitor patient care in the State for stroke 
        patients at all phases of stroke for the purpose of evaluating 
        the diagnosis, treatment, and treatment outcome of such stroke 
        patients;
            ``(3) to identify the total amount of uncompensated and 
        under-compensated stroke care expenditures for each fiscal year 
        by each stroke care facility in the State;
            ``(4) to identify the number of acute stroke patients who 
        receive advanced drug therapy;
            ``(5) to identify patients transferred within the statewide 
        stroke care system, including reasons for such transfer; and
            ``(6) to communicate to the greatest extent practicable 
        with the Paul Coverdell National Acute Stroke Registry.
    ``(d) Support Network.--A support network described in this 
subsection may include the following:
            ``(1) The use of telehealth technology to connect 
        facilities described in subsection (b)(1)(G) to more advanced 
        stroke care facilities.
            ``(2) The provision of neuroimaging, laboratory, and any 
        other equipment necessary to facilitate the establishment of a 
        telehealth network.
            ``(3) The use of phone consultation, where useful.
            ``(4) The use of referral links when a patient needs more 
        advanced care than is available at the facility providing 
        initial care.
            ``(5) Any other assistance determined appropriate by the 
        State.
    ``(e) Medical Professional Development in Advanced Stroke Treatment 
and Prevention.--
            ``(1) In general.--A State may use funds received under a 
        grant under this section to make subgrants to public and non-
        profit private entities for the development and implementation 
        of education programs for appropriate medical personnel and 
        health professionals in the use of newly developed diagnostic 
        approaches, technologies, and therapies for the prevention and 
        treatment of stroke.
            ``(2) Use of funds.--A public or non-profit private entity 
        shall use amounts received under a subgrant under this 
        subsection for the continuing education of appropriate medical 
        personnel in the use of newly developed diagnostic approaches, 
        technologies, and therapies for the prevention and treatment of 
        stroke.
            ``(3) Distribution of subgrants.--In awarding subgrants 
        under this subsection, the Secretary shall ensure that such 
        subgrants are equitably distributed among the geographical 
        regions of the State and between urban and rural populations.
            ``(4) Application.--A public or non-profit private entity 
        desiring a subgrant under this subsection shall prepare and 
        submit to the State involved an application at such time, in 
        such manner, and containing such information as the State may 
        require, including a plan for the rigorous evaluation of 
        activities carried out with amounts received under such a 
        subgrant.
    ``(f) Restrictions on Use of Payments.--The Secretary may not, 
except as provided in paragraph (2), make payments to a State under 
this section for a fiscal year unless the State agrees that the 
payments will not be expended--
            ``(1) to make cash payments to intended recipients of 
        services provided pursuant to this section;
            ``(2) to satisfy any requirement for the expenditure of 
        non-Federal funds as a condition for the receipt of Federal 
        funds;
            ``(3) to provide financial assistance to any entity other 
        than a public or nonprofit private entity; or
            ``(4) for construction, alteration, or improvement of any 
        building or facility.
    ``(g) Failure to Comply With Agreements.--
            ``(1) Repayment of payments.--
                    ``(A) Requirement.--The Secretary may, in 
                accordance with paragraph (2), require a State to repay 
                any payments received by the State under this section 
                that the Secretary determines were not expended by the 
                State in accordance with the agreements required to be 
                made by the State as a condition of the receipt of 
                payments.
                    ``(B) Offset of amounts.--If a State fails to make 
                a repayment required in subparagraph (A), the Secretary 
                may offset the amount of the repayment against any 
                amount due to be paid to the State under this section.
            ``(2) Opportunity for a hearing.--Before requiring 
        repayment of payments under paragraph (1), the Secretary shall 
        provide to the State an opportunity for a hearing.
    ``(h) Application Requirements.--The Secretary may not award a 
grant to a State under this section unless--
            ``(1) the State submits an application containing 
        agreements in accordance with this section;
            ``(2) the agreements are made through certification from 
        the chief executive officer of the State;
            ``(3) with respect to such agreements, the application 
        provides assurances of compliance satisfactory to the 
        Secretary;
            ``(4) the application contains the plan provisions and the 
        information required to be submitted to the Secretary; and
            ``(5) the application otherwise is in such form, is made in 
        such manner, and contains such agreements, assurances, and 
        information as the Secretary determines to be necessary to 
        carry out this section.
    ``(i) Technical Assistance.--The Secretary shall, without charge to 
a State receiving payments under this section, provide to the State (or 
to any public or nonprofit entity designated by the State) technical 
assistance with respect to the planning, development, and operation of 
any program carried out pursuant to this section. The Secretary may 
provide such technical assistance directly, through contract, or 
through grants.
    ``(j) Supplies and Services in Lieu of Grant Funds.--
            ``(1) In general.--Upon the request of a State receiving 
        payments under this section, the Secretary may, subject to 
        paragraph (2), provide supplies, equipment, and services to the 
        State and may detail to the State any officer or employee of 
        the Department of Health and Human Services, for the purpose of 
        assisting the State to achieve the purpose of the payments.
            ``(2) Reduction in payments.--With respect to a request 
        described in paragraph (1), the Secretary shall reduce the 
        amount of payments to the State under this section by an amount 
        equal to the costs of detailing personnel and the fair market 
        value of any supplies, equipment, or services provided by the 
        Secretary. The Secretary shall, for the payment of expenses 
        incurred in complying with such request, expend the amounts 
        withheld.
    ``(k) Report.--Not later than 3 years after the date of the 
enactment of the Stroke Treatment and Ongoing Prevention Act of 2005, 
the Secretary shall report to the appropriate committees of the 
Congress on the activities of the States carried out pursuant to this 
section and section 399EE. Such report shall include an assessment of 
the extent to which Federal and State efforts to identify stroke 
centers, develop support networks, and enhance emergency medical 
services coordination and the training of emergency medical personnel, 
have increased the number of stroke patients who have received acute 
stroke consultation or therapy within the appropriate timeframe and 
reduced the level of disability due to stroke.
    ``(l) Limitation on Administrative Expenses.--The Secretary may not 
award a grant to a State under this section unless the State agrees to 
use not more than 10 percent of amounts received under the grant for 
administrative expenses.

``SEC. 399EE. PLANNING GRANTS.

    ``(a) Grants.--The Secretary may award a grant to a State to assist 
such State in formulating a plan to develop a stroke care system in 
accordance with section 399DD or in otherwise meeting the requirements 
of such section.
    ``(b) Submission to Secretary.--The chief executive officer of a 
State that receives a grant under this section shall submit to the 
Secretary a copy of the plan developed using the amounts provided under 
such grant. Such plan shall be submitted to the Secretary as soon as 
practicable after the plan has been developed.
    ``(c) Single Grant Limitation.--A State is not eligible to receive 
a grant under this section if the State previously received a grant 
under this section.

``SEC. 399FF. SPECIAL CONSIDERATION.

    ``In awarding grants under this subpart, the Secretary shall give 
special consideration to any State that has submitted an application 
for carrying out programs under such a grant--
            ``(1) in geographic areas in which there is--
                    ``(A) an elevated incidence or prevalence of 
                disability resulting from stroke; or
                    ``(B) an elevated incidence or prevalence of 
                stroke; or
            ``(2) that demonstrates a significant need for assistance 
        in establishing a comprehensive stroke care system.

                   ``Subpart III--General Provisions

``SEC. 399GG. GENERAL PROVISIONS.

    ``(a) Consultations.--In carrying out this part, the Secretary 
shall consult with organizations and individuals with expertise in 
stroke prevention, diagnosis, treatment, and rehabilitation.
    ``(b) Definitions.--In this part:
            ``(1) State.--The term `State' means each of the several 
        States, the District of Columbia, the Commonwealth of Puerto 
        Rico, the Indian tribes, the Virgin Islands, Guam, American 
        Samoa, and the Commonwealth of the Northern Mariana Islands.
            ``(2) Stroke care system.--The term `stroke care system' 
        means a statewide system to provide for the diagnosis, 
        prehospital care, hospital definitive care, and rehabilitation 
        of stroke patients.
            ``(3) Stroke.--The term `stroke' means a `brain attack' in 
        which blood flow to the brain is interrupted or in which a 
        blood vessel or aneurysm in the brain breaks or ruptures.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this part such sums as may be necessary for 
fiscal years 2006 through 2010.''.
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