To amend the Public Health Service Act to improve stroke prevention, diagnosis, treatment, and rehabilitation.

November 20, 2003

Mr. COCHRAN (for himself and Mr. KENNEDY) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

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 2003'.

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 over 750,000 Americans suffer a new or recurrent stroke and 160,000 Americans die from stroke.

(2) Stroke costs the United States $31,000,000,000 in direct costs and $20,200,000,000 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 2003, 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 2004 through 2008.'.

END