S 2069
Version: Introduced
Author: Mikulski
112th CONGRESS
2d Session
S. 2069
To amend the Public Health Service Act to speed American innovation in research
and drug development for the leading causes of death that are the most costly
chronic conditions for our Nation, to save American families and the Federal
and State governments money, and to help family caregivers.
IN THE SENATE OF THE UNITED STATES
February 2, 2012
MS. MIKULSKI (for herself, Mr. Kerry, Ms. Collins, Mr. Blumenthal, and Mr.
Warner ) 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 speed American innovation in research
and drug development for the leading causes of death that are the most costly
chronic conditions for our Nation, to save American families and the Federal
and State governments money, and to help family caregivers.
Be it enacted by the Senate and House of Representatives of the United States
of America in Congress assembled,
SEC. 1. Short title - This Act may be cited as the " Spending Reductions
through Innovations in Therapies Agenda Act of 2012 " or the " SPRINT Act ".
SEC. 2. Findings - Congress finds as follows:
(1) Half of health care expenses in the United States are spent on 5 percent of
the population. Many of the most expensive health conditions to treat are also
the leading causes of death.
(2) Improving a patient's quality of life by developing innovative treatments
that improve health outcomes and lead to a cure will improve productivity in
the United States, reduce government spending, and enhance public health.
(3) More than a quarter of all Americans -- and 2 out of 3 older Americans --
have multiple chronic conditions, and treatment for these individuals accounts
for 66 percent of the health care budget of the United States.
(4) Alzheimer's disease and related dementias, for instance, have a
disproportionate health and economic impact on patients, particularly those
suffering from multiple chronic conditions. In 2004, Medicare payments per
person for beneficiaries aged 65 and older with Alzheimer's disease and other
dementias were almost 3 times as high as average Medicare payments for other
Medicare beneficiaries in the same age group. In addition, Alzheimer's patients
often depend on full-time at home or institutional care. Medicaid payments per
person for Medicare beneficiaries aged 65 and older with Alzheimer's disease
and other dementias were more than 9 times as great as average Medicaid
payments for other Medicare beneficiaries in the same age group.
(5) The Medicare program under title XVIII of the Social Security Act ( 42
U.S.C. 1395 et seq. ) and the Medicaid program under title XIX of the Social
Security Act (42 U.S.C. 1396 et seq.) cover about 70 percent of the total costs
of caring for people with Alzheimer's disease. In 2011, Medicare is expected to
spend approximately $93,000,000,000 for the care of individuals with
Alzheimer's disease and other dementias, and this amount is projected to
increase to $627,000,000,000 in 2050. Medicaid costs are expected to increase
nearly 400 percent, from $34,000,000,000 in 2011 to $178,000,000,000 in 2050.
(6) Researchers believe sustained and targeted investment in outcomes oriented
research for the leading causes of death will improve health treatments and
make cures more obtainable.
(7) The United States Government has, in the past, successfully addressed major
research challenges by committing resources in high-risk and high-reward basic
and applied research.
SEC. 3. SPRINT program - Part A of title II of the Public Health Service Act (
42 U.S.C. 202 et seq. ) is amended by adding at the end the following:
"SEC. 230. SPRINT program -
" (a) Definitions - In this section:
" (1) Advanced research and development - The term "advanced research and
development " means activities that predominantly are conducted after basic
research through early clinical development of novel therapies, naturally
occurring compounds, and repurposed or reformulated drugs, biological products,
and devices in use to treat chronic conditions.
" (2) Biological product - The term "biological product " has the meaning given
such term in section 351.
" (3) Device; drug - The terms "device " and "drug " have the meanings given
such terms in section 201 of the Federal Food, Drug, and Cosmetic Act.
" (4) Early-stage company - The term "early-stage company " means a business
enterprise with a limited operating history, such as a start-up enterprise.
" (5) Federal health care program - The term "Federal health care program " has
the meaning given such term in section 1128B(f) of the Social Security Act.
" (6) Growth company - The term "growth company " means a business enterprise
that grows at a greater rate than the United States economy as a whole and that
usually directs a relatively high proportion of income back into the business.
" (7) High-cost chronic condition - The term "high-cost chronic condition "
means a condition as determined by the Secretary under subsection (c)(1).
" (8) Therapy - The term "therapy " means any drug, device, biological product,
or diagnostic identified by the Secretary to treat, prevent, diagnose,
delay-onset, cure, or aid recovery of a high-cost chronic condition.
" (b) Establishment of Program - The Secretary shall establish the Spending
Reductions through Innovations in Therapies Program (referred to in this
section as the "SPRINT Program ") to support development of therapies to reduce
spending by Federal health care programs for high-cost chronic conditions.
" (c) High-Cost chronic conditions -
" (1) In general - The Secretary shall determine the high-cost chronic
conditions that shall be the focus of the SPRINT Program. In making such
determination, the Secretary shall select chronic conditions, from the top 10
leading causes of death designated by the Centers for Disease Control and
Prevention, that have --
" (A) the highest current and projected cost to Federal health care programs
and high long-term care costs;
" (B) a likelihood of reducing the day-to-day functioning of an individual and
impairing the ability of the individual to carry out activities of daily
living, which can result in the individual becoming dependent on caregivers;
" (C) a death rate that has increased and is projected to increase
significantly in future years; and
" (D) a lack of existing therapies to prevent, control, or cure the condition
or delay cognitive decline, if applicable.
" (2) Allocation - In carrying out the SPRINT Program, the Secretary shall
allocate funding towards the chronic conditions as determined in paragraph (1).
" (d) Goals - The SPRINT Program shall be guided by national plans and
strategies, as appropriate, and shall --
" (1) accelerate advanced research and development of therapies for high-cost
chronic conditions; and
" (2) encourage innovation in technologies that may assist advanced research
and development to reduce the time and cost of therapy development.
" (e) Duties - The Secretary shall carry out the following duties under this
section:
" (1) Convene meetings and working groups with representatives from relevant
industries, academia, other Federal agencies, States, patients, patient and
consumer advocacy organizations, international agencies (as appropriate), and
other interested persons as the Secretary deems necessary.
" (2) Ensure that the activities described in paragraph (1) are coordinated
among agencies within the Department of Health and Human Services.
" (3) Partner with a nonprofit strategic investment entity or entities that
will advise the Department of Health and Human Services regarding, and may make
on behalf of such Department, investments in public entities, nonprofit
entities, early-stage companies, or growth companies with expertise in advanced
research and development of therapies for high-cost chronic conditions that can
demonstrate a reasonable likelihood of reducing net spending under the Medicare
program under title XVIII of the Social Security Act and the Medicaid program
under title XIX of such Act within 10 years after the date of enactment of the
Spending Reductions through Innovations in Therapies Agenda Act of 2012 .
" (4) Award contracts, grants, cooperative agreements, or enter into other
transactions, such as prize payments, to accelerate advanced research and
development of therapies that have the potential to prevent, diagnose,
delay-onset, cure, aid recovery, or improve health outcomes for high-cost
chronic conditions, through the SPRINT Award Program under subsection (f).
" (5) Reduce the time and cost barriers between laboratory discoveries and
clinical trials for therapies used to treat high-cost chronic conditions.
" (6) Facilitate innovative and expedited review by the Food and Drug
Administration of the therapies developed under subsection (f), which may
include --
" (A) facilitating regular and ongoing communication between the sponsors of
such drugs, devices, diagnostics, and biological products and the Food and Drug
Administration regarding the status of activities related to such drugs,
devices, diagnostics, and biological products;
" (B) ensuring that such activities are coordinated with the approval
requirements of the Food and Drug Administration, with the goal of expediting
the development and approval of therapies; and
" (C) developing regulatory science, processes, and mechanisms to provide
clear, efficient pathways for developing and manufacturing therapies for
high-cost chronic conditions.
" (f) SPRINT Award Program -
" (1) In general - There is established a SPRINT Award Program, under which the
Secretary may, in consultation or partnership with a nonprofit strategic
investment entity, award contracts, grants, cooperative agreements, or enter
into other transactions, such as prize payments, to support advanced research
and the development of therapies, in order to carry out paragraphs (4) and (6)
of subsection (e). Awards granted through the SPRINT Award Program shall be
funded by the SPRINT Program.
" (2) Eligibility; application -
" (A) Eligibility - To be eligible to receive an award under this section, an
entity shall be a public, nonprofit, early stage company, or growth company,
which may include a private or public research institution, an institution of
higher education, a medical center, a biotechnology company, a pharmaceutical
company, a medical device company, an academic research institution, or other
organization specializing in advanced research and development, and shall
submit an application to the Secretary as described in subparagraph (B).
" (B) Application - An entity desiring an award under this subsection shall
submit to the Secretary an application at such time, in such manner, and
containing such information as the Secretary may require, such as --
" (i) a detailed description of the project for which the entity seeks an
award;
" (ii) a timetable for carrying out such project;
" (iii) an assurance that the entity will submit interim reports and a final
report at the conclusion of the award period, as determined appropriate by the
Secretary under paragraph (3);
" (iv) a description of how the project will lead to the development of
therapies aimed at preventing, curing, reversing, or slowing the progression of
an underlying chronic condition; and
" (v) a description of how the project will support efforts to reduce long-term
Federal spending on health care.
" (3) Awardee reporting requirements - An entity that receives an award under
this subsection shall submit reports to the Secretary which may include --
" (A) interim reports describing the progress in carrying out the project and
compliance with all conditions of receipt of such award;
" (B) a final report at the conclusion of the award period describing --
" (i) the outcomes of the project, including whether the entity achieved the
goals set forth in the application;
" (ii) the protocols the entity followed to carry out the research and comply
with the research and ethical standards of the National Institutes of Health,
if applicable; and
" (iii) the standards and regulatory requirements of the Food and Drug
Administration at all stages of development, manufacturing, review, approval,
and safety surveillance, if applicable; and
" (C) such additional information required by the Secretary.
" (4) Termination of funding - The Secretary may modify or terminate a
contract, grant, cooperative agreement, other transaction, or prize to an
awardee that does not meet milestones that are conditions of the contract,
grant, cooperative agreement, other transaction, or prize.
" (5) Consultation with nonprofit strategic investment entity - In making
awards under this subsection, the Secretary may consult or partner with a
nonprofit strategic investment entity or entities that --
" (A) operate independently of the Department of Health and Human Services and
consist of experts in neurology, biomedical research, drug and medical
technology innovation and discovery, economics, and venture financing; and
" (B) have a record of --
" (i) promoting the development of therapies; and
" (ii) supporting novel technologies that have the potential to improve the
development of therapies.
" (6) Matching funds -
" (A) In general - The Secretary may not make an award under this section
unless the recipient involved agrees to make available non-Federal
contributions, in cash or in-kind, toward the costs of the project in an amount
equal to not less than $2 for each $1 of Federal funds provided in the award.
Such contributions may be made directly or through donations from public or
private entities. Amounts provided by the Federal Government, or services
assisted or subsidized to any significant extent by the Federal Government, may
not be included in determining the amount of such contributions.
" (B) Exception - The Secretary may waive or modify the matching requirement
under subparagraph (A) on a case-by-case basis for each award if the Secretary
determines that the goals and objectives of the SPRINT Award Program cannot
adequately be carried out unless such requirement is waived.
" (g) Non-Duplication of efforts - The Secretary shall ensure that the
activities under this section complement and extend other efforts of the
Department of Health and Human Services.
" (h) Gifts in support of the SPRINT Award Program - The Secretary may accept
on behalf of the United States money gifts and bequests made unconditionally to
the SPRINT Award Program under subsection (f) for the benefit of the Award
Program or any activity financed through such Award Program.
" (i) Authorization of appropriations - To carry out this section, there are
authorized to be appropriated $50,000,000 for fiscal year 2013, and such sums
as may be necessary for each of fiscal years 2014 through 2017. Funds
appropriated under this section shall be available until expended. " .
SEC. 4. Evaluation and report -
(a) Evaluation - The Secretary of Health and Human Services shall evaluate the
projects funded under section 230 of the Public Health Service Act (as added by
section 3) as necessary and shall make publicly available and disseminate the
results of such evaluations on as wide a basis as practicable.
(b) Reports - Not later than 2 years after the date of enactment of this Act,
and annually thereafter, the Secretary of Health and Human Services shall
submit to Congress a report that --
(1) describes the specific projects supported under section 230 of the Public
Health Service Act (as added by section 3) and progress towards meeting
science-based metrics;
(2) provides recommendations for Congress to improve the effectiveness of the
programs under such section 230;
(3) explains why the Secretary waived or modified matching funds requirements
for an award under subsection (f) of such section 230, if applicable; and
(4) describes how advanced research and development supported through the
SPRINT Program under such section 230 is directed towards reducing Federal
spending on high-cost chronic conditions (as defined in such section).