1.This Act may be cited as the
Stroke Treatment and Ongoing
Prevention Act of 2005
.
2.
(a)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)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.
3.Amendment
regarding stroke prevention, treatment, and rehabilitationTitle III of the
Public Health Service Act
(42 U.S.C.
241 et seq.) is amended by adding at the end the
following:
RStroke
prevention, treatment, and rehabilitation programs
IAuthorities and
duties of the Secretary
399AA.Responsibilities
of the Secretary
(a)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 contractsThe Secretary may make
grants, and enter into cooperative agreements and contracts, for the purpose of
carrying out subsection (a).
(c)
(1)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 guidelinesRecommendations 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.
399BB.Paul
Coverdell National Acute Stroke RegistryThe 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.
IIState stroke
care systems
399DD.Grants to
States for stroke care systems
(a)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)
(1)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)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 systemA 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)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)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)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
subgrantsIn 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)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 paymentsThe 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)
(A)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)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 hearingBefore requiring repayment of payments under paragraph
(1), the Secretary shall provide to the State an opportunity for a
hearing.
(h)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)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)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)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)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 expensesThe 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.
399EE.
(a)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)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)A State is not eligible to receive a grant under this
section if the State previously received a grant under this section.
399FF.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.
III
399GG.
(a)In
carrying out this part, the Secretary shall consult with organizations and
individuals with expertise in stroke prevention, diagnosis, treatment, and
rehabilitation.
(b)In
this part:
(1)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)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)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 appropriationsThere are authorized to be appropriated to
carry out this part such sums as may be necessary for fiscal years 2006 through
2010.
.