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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 2069 Introduced in Senate (IS)]

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,

SECTION 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).
                                 <all>
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