In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

Ex Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Rural Emergency Acute Care Hospital 
Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) According to the University of North Carolina's Center 
        for Health Services Research, 55 rural hospitals have closed in 
        the Unites States since January 2010.
            (2) In 2014, iVantage conducted a study for the National 
        Rural Health Association and found 283 hospitals at risk of 
        closure based upon performance indicators that matched those 
        facilities already forced to close in this decade.
            (3) Researchers at the University of North Carolina 
        identified inpatient volume as a substantial contributing 
        factor to the financial performance of rural hospitals, with 
        many of the at-risk hospitals having an average daily bed 
        census of less than 2.
            (4) Adverse impacts to the local economy and the loss of 
        timely access to emergency medical care are 2 major effects of 
        rural hospital closures.
            (5) According to the National Center for Rural Health 
        Works, the typical rural hospital creates over 140 jobs and 
        generates $6,800,000 in compensation while serving an average 
        population of 14,600.
            (6) The 2014 iVantage study estimates that the 283 at-risk 
        hospitals could result in the loss of 36,000 health care jobs, 
        50,000 community jobs, and $10,600,000,000 in gross domestic 
        product.
            (7) Time is the most critical factor for achieving 
        successful outcomes in emergency medicine, and emergency 
        medical clinicians refer to the time-sensitive period during 
        which successful outcomes may be best achieved as the ``golden 
        hour''.
            (8) The National Conference of State Legislatures states 
        that 60 percent of trauma deaths in the United States occur in 
        rural areas, where only 15 percent of the population is 
        represented.
            (9) The disproportionate percentage of trauma deaths in 
        rural areas is likely attributable in large part to a 
        combination of response time to the scene and distance to the 
        nearest emergency room to stabilize trauma victims.
            (10) The percentage of trauma deaths occurring in rural 
        areas could continue to increase as more rural hospitals close, 
        further limiting access to emergency services and requiring 
        patients to travel longer distances to receive emergency 
        medical care.
            (11) The creation of a rural emergency hospital designation 
        under the Medicare program will allow facilities in rural areas 
        to provide emergency medical services without having to 
        maintain inpatient beds.
            (12) In addition to providing emergency care, rural 
        emergency hospitals could convert the space previously used for 
        inpatient services to provide other medical services including, 
        but not limited to, observation care, skilled nursing facility 
        care, infusion services, hemodialysis, home health, hospice, 
        nursing home care, population health, and telemedicine 
        services.

SEC. 3. RURAL EMERGENCY HOSPITAL PROGRAM.

    (a) In General.--
            (1) Rural emergency hospital and services defined.--Section 
        1861 of the Social Security Act (42 U.S.C. 1395x) is amended--
                    (A) in subsection (e), in the last sentence of the 
                matter following paragraph (9), by inserting ``or a 
                rural emergency hospital (as defined in section 
                1861(iii)(1))'' before the period at the end; and
                    (B) by adding at the end the following subsection:

    ``Rural Emergency Hospital; Rural Emergency Hospital Outpatient 
                                Services

    ``(iii)(1) The term `rural emergency hospital' means a facility 
that--
            ``(A)(i) as of December 31, 2014--
                            ``(I) was a critical access hospital; or
                            ``(II) was a hospital with not more than 50 
                        beds located in a county (or equivalent unit of 
                        local government) in a rural area (as defined 
                        in section 1886(d)(2)(D)), or was a hospital 
                        with not more than 50 beds that was treated as 
                        being located in a rural area pursuant to 
                        section 1886(d)(8)(E); or
                    ``(ii) was a critical access hospital described in 
                clause (i)(I) or a hospital described in clause (i)(II) 
                that ceased operations during the period beginning on 
                the date that is 5 years prior to the date of the 
                enactment of this subsection and ending on December 30, 
                2014;
            ``(B) provides 24-hour emergency medical care and 
        observation care that does not exceed an annual per patient 
        average of 24 hours or more than 1 midnight;
            ``(C) does not provide any acute care inpatient beds and 
        has protocols in place for the timely transfer of patients who 
        require acute care inpatient services or other inpatient 
        services;
            ``(D) has elected to be designated as a rural emergency 
        hospital;
            ``(E) has received approval to operate as a rural emergency 
        hospital from the State under section 1834(r)(3)(A); and
            ``(F) is certified by the Secretary under section 
        1834(r)(3)(B).
    ``(2) The term `rural emergency hospital outpatient services' means 
medical and other health services furnished by a rural emergency 
hospital on an outpatient basis.
    ``(3) Nothing in this subsection or section 1834(r)(3) shall be 
construed to prohibit a rural emergency hospital from providing 
extended care services.''.
            (2) Payment for rural emergency hospital services.--
                    (A) In general.--Section 1833(a) of the Social 
                Security Act (42 U.S.C. 1395l(a)) is amended--
                            (i) in paragraph (8), by striking ``and'' 
                        at the end;
                            (ii) in paragraph (9), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by inserting after paragraph (9) the 
                        following new paragraph:
            ``(10) in the case of rural emergency hospital emergency 
        services and services provided by a rural emergency hospital or 
        other provider of ambulance services to transport patients who 
        require acute care inpatient services or other inpatient 
        services from such rural emergency hospital to a hospital or 
        critical access hospital, the amounts described in section 
        1834(r).''.
                    (B) Payment amount.--Section 1834 of the Social 
                Security Act (42 U.S.C. 1395m) is amended by adding at 
                the end the following subsection:
    ``(r) Payment Rules Relating to Rural Emergency Hospitals.--
            ``(1) Payment for rural emergency hospital outpatient 
        services.--
                    ``(A) In general.--The amount of payment for rural 
                emergency hospital outpatient services of a rural 
                emergency hospital is equal to 110 percent of the 
                reasonable costs of providing such services.
                    ``(B) Telehealth services.--For purposes of this 
                paragraph, in determining the reasonable costs of 
                providing rural emergency hospital outpatient services, 
                costs associated with having a backup physician 
                available via a telecommunications system shall be 
                considered reasonable costs.
            ``(2) Payment for transportation services.--The amount of 
        payment for services provided by a rural emergency hospital or 
        other provider of ambulance services to transport patients who 
        require acute care inpatient services or other inpatient 
        services from such rural emergency hospital to a hospital or 
        critical access hospital is equal to 110 percent of the 
        reasonable costs of providing such services.
            ``(3) Requirements for rural emergency hospitals.--
                    ``(A) State approval to operate as a rural 
                emergency hospital.--No payment shall be made under 
                this subsection to a facility, or to a provider of 
                ambulance services providing transportation services 
                from such facility, unless the State in which the 
                facility is located has approved the facility's 
                designation as a rural emergency hospital.
                    ``(B) Certification of rural emergency hospital.--
                            ``(i) In general.--No payment shall be made 
                        under this subsection to a facility, or to a 
                        provider of ambulance services providing 
                        transportation services from such facility, 
                        unless the facility has been certified by the 
                        Secretary as a rural emergency hospital.
                            ``(ii) Certification requirements.--The 
                        Secretary shall certify a facility as a rural 
                        emergency hospital if the facility--
                                    ``(I) meets the criteria for rural 
                                emergency hospitals described in 
                                subparagraphs (A) through (E) of 
                                section 1861(iii)(1);
                                    ``(II) either--
                                            ``(aa) is verified by the 
                                        American College of Surgeons as 
                                        having the resources required 
                                        of a level IV trauma center or 
                                        higher; or
                                            ``(bb) employs healthcare 
                                        professionals that successfully 
                                        completed the Advanced Trauma 
                                        Life Support Course offered by 
                                        the American College of 
                                        Surgeons within the preceding 4 
                                        years;
                                    ``(III) has in effect a transfer 
                                agreement with a level I or level II 
                                trauma center; and
                                    ``(IV) meets such staff training 
                                and certification requirements as the 
                                Secretary may require.
            ``(4) Coinsurance.--
                    ``(A) In general.--The amount of payment for rural 
                emergency hospital services or transportation services 
                made to a rural emergency hospital or other provider of 
                ambulance services under this subsection shall be 
                reduced by the coinsurance amount described in 
                subparagraph (B).
                    ``(B) Coinsurance amount.--The coinsurance amount 
                described in this subparagraph, with respect to an item 
                or service provided by a rural emergency hospital or 
                provider of ambulance services, shall be calculated in 
                the same manner as the coinsurance amount for an 
                outpatient critical access hospital service is 
                calculated under section 1866(a)(2).''.
    (b) Waiver of Distance Requirement for Replacement CAHs; Subsequent 
Redesignation of Rural Emergency Hospitals as CAHs.--Section 1820(c)(2) 
of the Social Security Act (42 U.S.C. 1395i-4(c)(2)) is amended--
            (1) in subparagraph (B)(i)(I), by inserting ``subject to 
        subparagraph (F),'' before ``is located''; and
            (2) by adding at the end the following new subparagraphs:
                    ``(F) Option to waive distance requirement.--
                Beginning on the date of the enactment of this 
                subparagraph, for every critical access hospital 
                located in a State that is certified as a rural 
                emergency hospital under section 1834(r)(3)(B), the 
                State shall have the option of waiving the distance 
                requirement described in subparagraph (B)(i)(I) with 
                respect to another facility located in the State that 
                is seeking designation as a critical access hospital 
                under this paragraph.
                    ``(G) Redesignation of a rural emergency hospital 
                as a critical access hospital.--A rural emergency 
                hospital that was previously designated as a critical 
                access hospital under this paragraph may elect to be 
                redesignated as a critical access hospital (in the same 
                manner that the hospital was originally designated as a 
                critical access hospital) at any time, subject to such 
                conditions as the Secretary may establish.''.
    (c) Studies and Reports.--
            (1) Studies.--The Secretary of Health & Human Services 
        shall conduct 3 studies to evaluate the impact of rural 
        emergency hospitals on the availability of health care and 
        health outcomes in rural areas (as defined in section 
        1886(d)(2)(D) of the Social Security Act (42 U.S.C. 1395ww)). 
        The Secretary shall conduct a study--
                    (A) 2 years after the date of the enactment of this 
                Act;
                    (B) 5 years after the date of the enactment of this 
                Act; and
                    (C) 10 years after the date of the enactment of 
                this Act.
            (2) Reports.--Not later than 6 months after each date that 
        the Secretary of Health & Human Services is required to conduct 
        a study under paragraph (1), the Secretary shall submit a 
        report to Congress containing the results of each such study.
    (d) Effective Date.--The amendments made by this section shall 
apply to items and services furnished on or after the date that is 1 
year after the date of the enactment of this Act.

SEC. 4. INCLUSION OF EMERGENCY MEDICINE AS HEALTH SERVICES UNDER THE 
              NATIONAL HEALTH SERVICE CORPS.

    Section 331(a)(3)(D) of the Public Health Service Act (42 U.S.C. 
254d(a)(3)(D)) is amended by inserting ``, and includes emergency 
medicine provided by physicians in a rural emergency hospital (as 
defined in section 1861(iii) of the Social Security Act)'' before the 
period.

SEC. 5. PERMITTING HOSPITALS WITH APPROVED RESIDENCY PROGRAMS IN 
              EMERGENCY MEDICINE TO INCLUDE TIME SPENT BY INTERNS AND 
              RESIDENTS IN THE EMERGENCY DEPARTMENT OF A RURAL HOSPITAL 
              IN FULL-TIME EQUIVALENT COUNT.

    (a) Indirect Medical Education.--Section 1886(d)(5)(B)(iv) of the 
Social Security Act (42 U.S.C. 1395ww(d)(5)(B)(iv)) is amended by 
adding at the end the following new subclause:
            ``(III) Effective for discharges occurring on or after 
        October 1, 2015, all of the time spent in patient care 
        activities in the emergency department of a rural hospital by 
        interns and residents in emergency medicine from a hospital 
        with an approved medical residency training program (as defined 
        in subsection (h)(5)(A)) in such specialty shall be included in 
        determining the number of full-time equivalent interns and 
        residents in such program if the hospital with such program 
        incurs the costs of the stipends and fringe benefits of the 
        interns or residents during the time the interns or residents 
        spend in that rural hospital in accordance with subclause (II). 
        In this subclause, the term `rural hospital' means a hospital 
        that is located in a rural area (as defined for purposes of 
        paragraph (2)(D)).''.
    (b) Direct Medical Education.--Section 1886(h)(4)(E) of the Social 
Security Act (42 U.S.C. 1395(h)(4)) is amended--
            (1) in clause (ii), by striking the period at the end and 
        inserting ``; and'';
            (2) by inserting after clause (ii) the following new 
        clause:
                            ``(iii) effective for cost reporting 
                        periods beginning on or after July 1, 2015, all 
                        of the time so spent in the emergency 
                        department of a rural hospital by residents in 
                        emergency medicine from a hospital with an 
                        approved medical residency training program in 
                        such specialty shall be counted towards the 
                        determination of full-time equivalency in such 
                        program if the hospital with such program bears 
                        all, or substantially all, of the costs of 
                        training such residents in the rural hospital. 
                        In this subparagraph, the term `rural hospital' 
                        means a hospital that is located in a rural 
                        area (as defined for purposes of subsection 
                        (d)(2)(D)).''; and
            (3) by adding at the end the following new sentence: ``For 
        purposes of this subparagraph, the emergency department of a 
        rural hospital described in clause (iii) is a nonprovider 
        setting.''.

Ex Output:
Rural Emergency Acute Care Hospital Act  This bill amends title XVIII (Medicare) of the Social Security Act to designate as a rural emergency hospital any facility that as of December 31, 2014, was:   a critical access hospital (CAH) or a hospital with at most 50 beds located in a county in a rural area or treated as located in a rural area, or one of such hospitals that ceased operations during the period beginning five years before enactment of this Act and ending on December 30, 2014.  A rural emergency hospital:  must provide 24-hour emergency medical care and observation care not exceeding an annual per patient average of 24 hours or more than 1 midnight, does not provide any acute care inpatient beds and has protocols in place for the timely transfer of patients who require acute care inpatient services or other inpatient services, has elected to be designated as a rural emergency hospital, has received approval to operate as one from the state, and is certified by the Department of Health and Human Services (HHS).  Medicare part B (Supplementary Medical Insurance Benefits) shall cover rural emergency hospital emergency services as well as ambulance services provided by a rural emergency hospital or other provider to transport patients who require acute care inpatient services or other inpatient services from the rural emergency hospital to a hospital or a CAH. Payment for rural emergency hospital outpatient services of a rural emergency hospital, including telehealth and ambulance services, shall be 110% percent of their reasonable costs. Rural emergency hospitals must be approved by the state and certified by HHS. States shall have the option of waiving a specified distance requirement between a CAH certified as a rural emergency hospital and another facility located in the state that is seeking designation as a CAH. Primary health services which the National Health Service Corps may provide under the Public Health Service Act shall include emergency medicine provided by physicians in a rural emergency hospital. Hospitals with approved residency programs in emergency medicine shall include time spent by interns and residents in the emergency department of a rural hospital in the full-time equivalent count with respect to reimbursement for the indirect (stipend, fringe benefit) and direct (all or substantially all training) costs of medical education in subsection (d) hospitals. (Generally, a subsection [d] hospital is an acute care hospital, particularly one that receives payments under Medicare's inpatient prospective payment system [IPPS] when providing covered inpatient services to eligible beneficiaries.)


Ex Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Helping Effective Antibiotics Last 
Act of 2015'' or the ``HEAL Act''.

SEC. 2. APPROVAL OF CERTAIN DRUGS FOR USE IN A WELL-DEFINED POPULATION 
              OF PATIENTS.

    (a) Approval of Certain Antibacterial.--Section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at 
the end the following:
    ``(x) Approval of Certain Antibacterial Drugs for Use in a Well-
Defined Population of Patients.--
            ``(1) Unmet medical need defined.--In this subsection, the 
        term `unmet medical need' means that the antibacterial drug 
        involved--
                    ``(A) has improved efficacy, as demonstrated in 
                adequate, well-controlled studies in humans, for 
                specific diseases or conditions, where current 
                therapies have been shown to be less effective;
                    ``(B) has clinically meaningful decreased harms, 
                demonstrated in adequate, well-controlled studies in 
                humans, for diseases or conditions, where current 
                therapies have unacceptable adverse effects; or
                    ``(C) has improved convenience, as demonstrated in 
                adequate, well-controlled studies in humans, where 
                improved convenience results in improved effectiveness 
                or decreased harms.
            ``(2) Approval.--Upon receipt of an application under 
        subsection (b) for an antibacterial drug that is intended to 
        treat a serious or life-threatening disease or condition, 
        irrespective of whether the drug is intended to address an 
        unmet medical need, the Secretary--
                    ``(A) may approve the drug under subsection (c) 
                only for treating a well-defined population of 
                patients, and based upon the results of clinical trials 
                inclusive of human subjects representative of such 
                well-defined population;
                    ``(B) in determining whether to grant such 
                approval, shall rely on superior outcomes over 
                available therapies based on direct measures of patient 
                benefits, as demonstrated in adequate, well-controlled 
                studies in the well-defined patient population, such 
                as--
                            ``(i) decreased mortality;
                            ``(ii) irreversible morbidity; or
                            ``(iii) validated surrogate endpoints that 
                        reflect mortality or irreversible morbidity; 
                        and
                    ``(C) shall require the labeling of drugs approved 
                pursuant to this subsection to prominently include in 
                the prescribing information required by section 201.57 
                of title 21, Code of Federal Regulations (or any 
                successor regulation)--
                            ``(i) the population of patients with 
                        respect to which the added benefit over 
                        available therapies is expected as studied in 
                        adequate, well-controlled studies that form the 
                        basis for approval; and
                            ``(ii) the method for identifying members 
                        of that population.
            ``(3) Risk evaluation and mitigation strategy.--The 
        Secretary--
                    ``(A) shall require a risk evaluation and 
                mitigation strategy (REMS) under section 505-1 for each 
                drug approved under this subsection; and
                    ``(B) may include in any such strategy additional 
                elements to assure the safe use of the drug under 
                subsections (e) and (f) of section 505-1.
            ``(4) Rule of construction.--Nothing in this subsection 
        shall be construed to alter the standards of evidence under 
        subsection (c) or (d) (including the substantial evidence 
        standard in subsection (d)). Subsections (c) and (d) and such 
        standards of evidence apply to the review and approval of drugs 
        under this subsection, including whether a drug is safe and 
        effective. Nothing in this subsection shall be construed to 
        limit the authority of the Secretary to approve products 
        pursuant to this Act and the Public Health Service Act as 
        authorized prior to the date of enactment of this subsection.
            ``(5) Effective immediately.--The Secretary shall have the 
        authorities vested in the Secretary by this subsection 
        beginning on the date of enactment of this subsection, 
        irrespective of when and whether the Secretary promulgates 
        final regulations to carry out this subsection.''.
    (b) Licensure of Certain Biological Products.--Section 351(j) of 
the Public Health Service Act (42 U.S.C. 262(j)) is amended--
            (1) by striking ``(j)'' and inserting ``(j)(1)'';
            (2) by inserting ``505(x),'' after ``505(p),''; and
            (3) by adding at the end the following:
    ``(2) In applying section 505(x) of the Federal Food, Drug, and 
Cosmetic Act to the licensure of biological products under this 
section--
            ``(A) references to an antibacterial drug with added 
        benefits over available therapies for a well-defined population 
        that is intended to treat a serious or life-threatening disease 
        or condition shall be construed to refer to biological products 
        with added benefits over available therapies for a well-defined 
        population intended to treat a bacterial infection associated 
        with a serious or life-threatening disease; and
            ``(B) references to an application submitted under section 
        505(b) of such Act and to approval of a drug under section 
        505(c) of such Act shall be construed to refer to an 
        application submitted under subsection (a) of this section and 
        to licensure of a biological product under such subsection (a), 
        respectively.''.
    (c) Monitoring.--Title III of the Public Health Service Act is 
amended by inserting after section 317T (42 U.S.C. 247b-22) the 
following:

``SEC. 317U. MONITORING OF ANTIBACTERIAL DRUG USE, PATIENT OUTCOMES, 
              AND RESISTANCE.

    ``(a) Monitoring.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall use the National 
Healthcare Safety Network or another appropriate monitoring system to 
monitor--
            ``(1) changes in patient outcomes such as mortality and 
        irreversible morbidity causally related to antibacterial 
        resistance; and
            ``(2) changes in bacterial resistance to drugs in relation 
        to patient outcomes.
    ``(b) Public Availability of Data.--The Secretary, acting through 
the Director of the Centers for Disease Control and Prevention, shall 
make the data derived from monitoring under this section publicly 
available for the purposes of--
            ``(1) improving the monitoring of important trends in 
        patient outcomes in relation to antibacterial resistance; and
            ``(2) ensuring appropriate stewardship of antibacterial 
        drugs, including those receiving approval or licensure for a 
        well-defined population pursuant to section 505(x) of the 
        Federal Food, Drug, and Cosmetic Act.''.

SEC. 3. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROBIAL 
              ORGANISMS.

    (a) In General.--Section 511 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360a) is amended to read as follows:

``SEC. 511. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROBIAL 
              ORGANISMS.

    ``(a) In General.--The Secretary shall--
            ``(1) identify upon approval or licensing of antibacterial 
        drugs (including biological products intended to treat a 
        bacterial infection and other types of antimicrobial drugs, as 
        deemed appropriate by the Secretary), including qualified 
        infectious disease products, susceptibility test interpretive 
        criteria for such drugs based upon patient outcomes of 
        mortality and morbidity from adequate and well-controlled 
        studies and such other confirmatory evidence as the Secretary 
        deems necessary; and
            ``(2) update, consistent with subsection (b), such criteria 
        as needed based upon scientific evidence of changes in patient 
        outcomes.
    ``(b) Responding to Changes in Patient Outcomes To Evaluate 
Susceptibility Test Interpretive Criteria.--
            ``(1) In general.--As needed based on evidence related to 
        changes in patient outcomes, the Secretary shall--
                    ``(A) evaluate any new scientific studies on 
                changes in patient outcomes in relation to 
                susceptibility test interpretive criteria; and
                    ``(B) publish on the public Website of the Food and 
                Drug Administration a notice--
                            ``(i) presenting suggested new or updated 
                        interpretive criteria; and
                            ``(ii) if needed, hold a public advisory 
                        committee to discuss scientific evidence 
                        related to changes in interpretative criteria.
            ``(2) Annual compilation of notices.--Each year, the 
        Secretary shall compile the notices published under paragraph 
        (1)(B) noting any changes from prior notices and publish such 
        compilation in the Federal Register.
    ``(c) Definition.--In this section, the term `susceptibility test 
interpretive criteria' means one or more specific values which 
characterize patient outcomes in relation to the degree to which 
bacteria or other microbes are more resistant to treatment as measured 
by patient outcomes.''.
    (b) Conforming Amendment.--Section 1111 of the Food and Drug 
Administration Amendments Act of 2007 (42 U.S.C. 247d-5a; relating to 
identification of clinically susceptible concentrations of 
antimicrobials) is repealed.
    (c) Report to Congress.--Not later than one year after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the progress made in implementing 
section 511 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360a), as amended by this section.

SEC. 4. REQUIRING DEMONSTRATION OF SUPERIOR OUTCOMES FOR QUALIFIED 
              INFECTIOUS DISEASE PRODUCTS TO RECEIVE AN EXTENDED 
              EXCLUSIVITY PERIOD.

    Section 505E(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355f(g)) is amended by striking ``means an antibacterial or 
antifungal drug for human use intended to treat'' and inserting ``means 
an antibacterial or antifungal drug for human use that is demonstrated 
to produce superior outcomes over available therapies, based on direct 
measures of patient benefits in clinical trials, and that is intended 
to treat''.

SEC. 5. GUIDANCE ON TARGET PRODUCT PROFILES.

    Not later than 18 months after the date of enactment of this Act, 
the Commissioner of Food and Drugs, in consultation with the 
Administrator of the Centers for Medicare & Medicaid Services, the 
Director of the Indian Health Service, the Secretary of Defense, and 
the Secretary of Veterans Affairs, shall issue guidance on the 
development of target product profiles for novel antibacterial drugs 
focused on public health priorities.

Ex Output:
Helping Effective Antibiotics Last Act of 2015 or the HEAL Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to approve an antibacterial drug or biological product that is intended to treat a serious or life-threatening condition only for treating a well-defined population of patients. To be approved, the antibacterial product must produce superior outcomes over available therapies in the well-defined patient population. A product approved by this pathway must include in its prescribing information the population of patients expected to benefit from using the product and the method for identifying members of that population. The FDA must require each product to have a risk evaluation and mitigation strategy. The Centers for Disease Control and Prevention must monitor changes to bacterial drug resistance and changes to patient outcomes caused by bacterial drug resistance. Upon approval of antibacterial products, the FDA must identify susceptibility test interpretive criteria (the drug concentrations where a type of bacteria is categorized as susceptible, intermediate, or resistant) and update the criteria as needed based upon evidence of changes in patient outcomes.  To be eligible for an exclusivity period extension, a qualified infectious disease product must be demonstrated to produce superior outcomes over available therapies. The FDA must issue guidance on the development of target product profiles for antibacterial drugs.


Ex Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Living Independently for Extended 
Time Act'' or the ``LIFETIME Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) The number of Americans over age 65 or living with a 
        disability is growing, and over 70 percent of these individuals 
        will need some form of long-term services and supports, with a 
        majority of individuals preferring home and community-based 
        care.
            (2) This is a major demographic shift and provides an 
        opportunity for innovative solutions in long-term services and 
        supports.
            (3) Developing programs to facilitate high-quality 
        independent community-based living, create and improve jobs, 
        and address and improve upon gaps in existing systems will be 
        essential to providing necessary services and supports to these 
        individuals and families.
            (4) It is imperative that Congress act to address the 
        looming long-term services and supports crisis.

SEC. 3. PURPOSE.

    It is the purpose of this Act to establish a grant program to 
provide incentives to States for the development of solutions to the 
increased need of individuals for long-term services and supports and 
to increase State support and systems in long-term care.

SEC. 4. ESTABLISHMENT OF LONG-TERM SERVICES AND SUPPORTS INNOVATION 
              GRANT PROGRAM.

    (a) State Planning Grants.--
            (1) In general.--Not later than 90 days after the date on 
        which grant announcements are made under subsection (d), the 
        Secretary of Health and Human Services (referred to in this Act 
        as the ``Secretary'') shall award grants to eligible States to 
        enable such States to develop innovative programs to meet the 
        unique need for long-term services and supports in the State.
            (2) Eligibility.--To be eligible to receive a grant under 
        paragraph (1), a State shall--
                    (A) submit to the Secretary an application, at such 
                time, in such manner, and containing such information 
                as the Secretary may require;
                    (B) demonstrate to the Secretary that the State 
                will work in conjunction with both public and private 
                long-term services and supports stakeholder groups 
                described in paragraph (3) to develop a coordinated 
                statewide long-term services and supports program for 
                the State that is not duplicative of other programs 
                providing such services and supports in the State; and
                    (C) provide assurances that the State will, not 
                later than 1 year after the date on which the grant is 
                awarded, submit to the Secretary a comprehensive plan 
                for the implementation of innovative long-term services 
                and supports program in the State, which shall include 
                the utilization of existing State or local frameworks.
            (3) Stakeholder groups.--Stakeholder groups described in 
        this paragraph shall be groups that--
                    (A) represent the interests of--
                            (i) consumers of long-term services and 
                        supports and related insurance products, as 
                        well as their representatives;
                            (ii) older adults;
                            (iii) individuals with cognitive or 
                        functional limitations;
                            (iv) family caregivers for individuals 
                        described in clause (i), (ii), or (iii);
                            (v) the health care workforce who directly 
                        provide long-term services and supports;
                            (vi) private long-term services and 
                        supports insurance providers;
                            (vii) employers;
                            (viii) State insurance departments;
                            (ix) area agency on aging or State agency 
                        on aging;
                            (x) direct care workforce; and
                            (xi) State Medicaid agencies;
                    (B) have demonstrated experience in dealing with 
                issues related to long-term services and supports, 
                health care policy, and public and private insurance; 
                and
                    (C) represent the health care interests and needs 
                of a variety of geographic areas and demographic 
                groups.
    (b) State Implementation Grants.--
            (1) In general.--The Secretary shall award grants to 
        eligible States to enable such States to implement the 
        comprehensive plans submitted under subsection (a)(2)(C) to 
        meet the long-term services and supports needs of such States.
            (2) Eligibility.--To be eligible to receive a grant under 
        paragraph (1), a State shall--
                    (A) submit to the Secretary an application, at such 
                time, in such manner, and containing such information 
                as the Secretary may require;
                    (B) have submitted a comprehensive plan under 
                subsection (a)(2)(C) that has been approved by the 
                Secretary or, if the State has not applied for a grant 
                under subsection (a), submit a plan (that is similar to 
                the plans required under subsection (a)(2)(C)) to the 
                Secretary for the implementation of new, or continued 
                operation of existing, long-term services and supports 
                activities;
                    (C) provide assurances that the State will provide 
                long-term services and supports under the grant to 
                individuals who demonstrate a need for such services 
                regardless of age;
                    (D) provide assurances that the State will provide 
                matching funds in accordance with paragraph (3); and
                    (E) submit to the Secretary progress and outcomes 
                reports containing uniform data as determined 
                appropriate by the Secretary.
            (3) Matching requirement.--To be eligible to receive a 
        grant under paragraph (1), a State shall agree, with respect to 
        the costs to be incurred by the State in implementing the 
        comprehensive plan under subsection (a)(2)(C), to make 
        available non-Federal contributions (in cash or in-kind) toward 
        such costs in an amount equal to not less than $1 for each $4 
        of Federal funds provided under the grant. Such contributions 
        may be made directly or through donations from public or 
        private entities.
            (4) Preference.--In awarding grants under paragraph (1), 
        the Secretary shall give preference to States that 
        demonstrate--
                    (A) the activities to be carried out under the 
                grant will enhances access to quality, affordable long-
                term services and supports for consumers; and
                    (B) the sustainability and scalability of the 
                program to be carried out under the grant beyond the 
                grant period.
            (5) Limitation.--A State shall not use in excess of 5 
        percent of the amount awarded under a grant under paragraph (1) 
        for the administrative expenses associated with carrying out 
        activities under the grant.
    (c) Technical Assistance and Outcomes Data.--The Secretary may use 
not to exceed 5 percent of the amount appropriated for each fiscal year 
under subsection (f) to--
            (1) provide technical assistance to States in carrying out 
        programs under this section; and
            (2) collect and disseminate data, including from the 
        reports submitted by the States under subsection (b)(2)(D), on 
        improvements to long-term services and supports provided in the 
        States and the effect that grants under this section had on the 
        availability of such services and supports.
    (d) Grant Announcements.--Not later than 1 year after the date of 
enactment of this Act, the Secretary shall announce the opportunity to 
apply for the initial series of grants under this section. Not later 
than 2 years after such date, the Secretary shall announce the 
opportunity to apply for the remaining grants under this section.
    (e) Report.--Not later than 1 year after the date on which grants 
are awarded under subsection (b), and annually thereafter, the 
Secretary shall submit to Congress a report on the activities carried 
out under grants under this section, including a description of 
improvements to long-term services and supports provided in the States 
and the effect that grants under this section had on the availability 
of such services and supports.
    (f) Appropriations.--
            (1) In general.--There is authorized to be appropriated--
                    (A) to award grants under subsection (a), 
                $50,000,000, to be used during the first fiscal year 
                for which such grants are awarded; and
                    (B) to award grants under subsection (b), 
                $250,000,000, to be available until expended.
            (2) Additional amounts.--In addition to amounts 
        appropriated under paragraph (1)(B) for a fiscal year, the 
        Secretary may use any amounts appropriated under paragraph 
        (1)(A) and remaining unexpended after fiscal year 2015 to award 
        grants under subsection (b).
    (g) Definition.--In this Act, the term ``long-term services and 
supports'' means the services and supports described in section 321(a) 
of the Older Americans Act of (42 U.S.C. 3030d(a) et seq.).

Ex Output:

Living Independently for Extended Time Act or the LIFETIME Act  This bill requires the Department of Health and Human Services to award grants to enable eligible states to develop innovative programs to meet the unique need for long-term services and supports in the state.