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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.
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.

SECTION 1. FINDINGS.

    Congress finds the following:
            (1) Twice since 1989, the northwestern coast of Maui, 
        Hawaii, has been plagued with massive blooms of the green alga, 
        Cladorphora sericea. Blooms of the red alga, Hypnea 
        musciformis, have also occurred in the area and in the Kihei 
        area.
            (2) The algal blooms have destroyed corals and other reef-
        building organisms, and have washed up on beaches and severely 
        impeded the recreational use of affected coastal areas.
            (3) The algal blooms are particularly detrimental to the 
        natural ecological balance of the near-shore reef environment.
            (4) Although the specific causes of the algal blooms are 
        uncertain, algal growth is stimulated in a proportional manner 
        by concentrations of chemicals such as fertilizers and 
        insecticides, which enter the ocean through freshwater runoff.
            (5) The Department of Health of the State of Hawaii has 
        indicated that the department does not have the resources at 
        this time to determine the cause of the algal blooms.
            (6) Extensive research will be required to determine the 
        factors that contribute to algal growth.
            (7) Potential sources of nutrients that may contribute to 
        algal growth include the near-shore disposal of sewage in 
        injection wells from the Lahaina Wastewater Treatment Plant, 
        surface runoff from agricultural lands and urban resort areas, 
        and subsurface point sources in the areas.
            (8) The long-term environmental impacts of the algal blooms 
        are unknown, but in the short term, reefs exposed to the algae 
        are being destroyed and the deterioration of the coral has 
        detrimental effects on fish and other wildlife that depend on 
        the reefs for survival.
            (9) The algal blooms are generating negative economic 
        impacts as well as negative biological impacts, as additional 
        reports indicate that the algae are decreasing the intake of 
        fish caught by local fishermen in the affected marine waters.
            (10) The Maui Algae Task Force is comprised of community 
        environmental activists and has been assembled to address the 
        problem of algal blooms.
            (11) The Maui Algae Task Force hopes to work in cooperation 
        with the Department of Health of the State of Hawaii and the 
        Environmental Protection Agency to identify and eradicate the 
        causes of the algal blooms.

SEC. 2. STUDY.

    (a) In General.--The Administrator of the Environmental Protection 
Agency (hereafter in this Act referred to as the ``Administrator'') 
shall conduct a study to--
            (1) determine the causes of recent algal blooms off the 
        northwestern coast of Maui, Hawaii; and
            (2) research alternatives for the improved management of 
        chemicals present in wastewater treatment and fresh water 
        runoff.
    (b) Study Requirements.--In carrying out the study under this 
section, the Administrator shall--
            (1) survey and monitor--
                    (A) seaweed populations and animals for which the 
                seaweed is a food source;
                    (B) surface water runoff sediments in the study 
                area; and
                    (C) inputs into the study area from subsurface 
                point sources, including any such inputs from the 
                Lahaina wastewater treatment plant; and
            (2) study the responses of--
                    (A) the seaweed populations referred to in 
                paragraph (1)(A) to different concentrations of 
                nutrients; and
                    (B) the animals referred to in paragraph (1)(A) to 
                pesticides and other biological toxins.
    (c) Equipment; Grants.--
            (1) Acquisition of equipment.--In carrying out the study 
        under this section, the Administrator is authorized to acquire 
        such monitoring and testing equipment as the Administrator 
        determines necessary.
            (2) Grants.--In carrying out the study under this section, 
        the Administrator is authorized to establish a grant program to 
        provide grants to eligible entities that submit approved 
        applications to the Administrator. The following entities may 
        submit an application to conduct study activities under this 
        section:
                    (A) The Department of Health of the State of 
                Hawaii.
                    (B) The Maui Algae Task Force.
                    (C) Appropriate Federal, State, or county 
                departments or agencies.
                    (D) Any other entity that the Administrator 
                determines to be appropriate.
    (d) Demonstration Projects.--In carrying out the study under this 
section, the Administrator is authorized to establish demonstration 
projects to identify and implement best management practices for the 
control of nonpoint source pollution from erosion and agricultural 
runoff.
    (e) Reports.--
            (1) Interim report.--Not later than 1 year after the date 
        of enactment of this Act, the Administrator shall submit to 
        Congress a report that includes interim results of the study 
        conducted under this section, and such recommendations as the 
        Administrator determines to be appropriate.
            (2) Final report.--Not later than January 31, 1996, the 
        Administrator shall submit to Congress a final report that 
        summarizes the results of the study conducted under this 
        section and includes such recommendations as the Administrator 
        determines to be appropriate.
    (f) Authorization of Appropriations.--There are authorized to be 
appropriated to the Environmental Protection Agency to carry out this 
section $500,000 for each of fiscal years 1994 and 1995.
Directs the Administrator of the Environmental Protection Agency to study and report to the Congress on the causes of recent algal blooms off the northwestern coast of Maui, Hawaii, and to research alternatives for the improved management of chemicals present in wastewater treatment and fresh water runoff. 
Authorizes the Administrator to establish:  (1) a grant program to enable eligible entities to conduct study activities; and (2) demonstration projects to implement best management practices for the control of nonpoint source pollution from erosion and agricultural runoff. 
Authorizes appropriations.

SECTION 1. SHORT TITLE; REFERENCES IN ACT.

    (a) Short Title.--This Act may be cited as the ``Medicare Rural 
Hospital Amendments of 1993''.
    (b) References in Act.--Except as otherwise specifically provided, 
whenever in this Act, an amendment is expressed in terms of an 
amendment to or repeal of a section or other provision, the reference 
shall be considered to be made to that section or other provision of 
the Social Security Act.

SEC. 2. ESSENTIAL ACCESS COMMUNITY HOSPITAL (EACH) AMENDMENTS.

    (a) Increasing Number of Participating States.--Section 1820(a)(1) 
(42 U.S.C. 1395i4(a)(1)) is amended by striking ``7'' and inserting 
``9''.
    (b) Treatment of Inpatient Hospital Services Provided in Rural 
Primary Care Hospitals.--
            (1) In general.--Section 1820(f)(1)(F) (42 U.S.C. 
        1395i4(f)(1)(F)) is amended to read as follows:
                    ``(F) subject to paragraph (4), provides not more 
                than 6 inpatient beds (meeting such conditions as the 
                Secretary may establish) for providing inpatient care 
                to patients requiring stabilization before discharge or 
                transfer to a hospital, except that the facility may 
                not provide any inpatient hospital services--
                            ``(i) to any patient whose attending 
                        physician does not certify that the patient may 
                        reasonably be expected to be discharged or 
                        transferred to a hospital within 72 hours of 
                        admission to the facility; or
                            ``(ii) consisting of surgery or any other 
                        service requiring the use of general anesthesia 
                        (other than surgical procedures specified by 
                        the Secretary under section 1833(i)(1)(A)), 
                        unless the attending physician certifies that 
                        the risk associated with transferring the 
                        patient to a hospital for such services 
                        outweighs the benefits of transferring the 
                        patient to a hospital for such services.''.
            (2) Limitation on average length of stay.--Section 1820(f) 
        (42 U.S.C. 1395i4(f)) is amended by adding at the end the 
        following new paragraph:
            ``(4) Limitation on average length of inpatient stays.--The 
        Secretary may terminate a designation of a rural primary care 
        hospital under paragraph (1) if the Secretary finds that the 
        average length of stay for inpatients at the facility during 
        the previous year in which the designation was in effect 
        exceeded 72 hours. In determining the compliance of a facility 
        with the requirement of the previous sentence, there shall not 
        be taken into account periods of stay of inpatients in excess 
        of 72 hours to the extent such periods exceed 72 hours because 
        transfer to a hospital is precluded because of inclement 
        weather or other emergency conditions.''.
            (3) Conforming amendment.--Section 1814(a)(8) (42 U.S.C. 
        1395f(a)(8)) is amended by striking ``such services'' and all 
        that follows and inserting ``the individual may reasonably be 
        expected to be discharged or transferred to a hospital within 
        72 hours after admission to the rural primary care hospital.''.
            (4) GAO reports.--Not later than 2 years after the date of 
        the enactment of this Act, the Comptroller General shall submit 
        reports to Congress on--
                    (A) the application of the requirements under 
                section 1820(f) of the Social Security Act (as amended 
                by this subsection) that rural primary care hospitals 
                provide inpatient care only to those individuals whose 
                attending physicians certify may reasonably be expected 
                to be discharged within 72 hours after admission and 
                maintain an average length of inpatient stay during a 
                year that does not exceed 72 hours; and
                    (B) the extent to which such requirements have 
                resulted in such hospitals providing inpatient care 
                beyond their capabilities or have limited the ability 
                of such hospitals to provide needed services.
    (c) Designation of Hospitals.--
            (1) Permitting designation of hospitals located in urban 
        areas.--
                    (A) In general.--Section 1820 (42 U.S.C. 1395i4) is 
                amended--
                            (i) by striking paragraph (1) of subsection 
                        (e) and redesignating paragraphs (2) through 
                        (6) as paragraphs (1) through (5); and
                            (ii) in subsection (e)(1)(A) (as 
                        redesignated by subparagraph (A))--
                                    (I) by striking ``is located'' and 
                                inserting ``except in the case of a 
                                hospital located in an urban area, is 
                                located'',
                                    (II) by striking ``, (ii)'' and 
                                inserting ``or (ii)'',
                                    (III) by striking ``or (iii)'' and 
                                all that follows through ``section,'', 
                                and
                                    (IV) in subsection (i)(1)(B), by 
                                striking ``paragraph (3)'' and 
                                inserting ``paragraph (2)''.
                    (B) No change in medicare prospective payment.--
                Section 1886(d)(5)(D) (42 U.S.C. 1395ww(d)(5)(D)) is 
                amended--
                            (i) in clause (iii)(III), by inserting 
                        ``located in a rural area and'' after ``that 
                        is'', and
                            (ii) in clause (v), by inserting ``located 
                        in a rural area and'' after ``in the case of a 
                        hospital''.
            (2) Permitting hospitals located in adjoining states to 
        participate in state program.--
                    (A) In general.--Section 1820 (42 U.S.C. 1395i4) is 
                amended--
                            (i) by redesignating subsection (k) as 
                        subsection (l); and
                            (ii) by inserting after subsection (j) the 
                        following new subsection:
    ``(k) Eligibility of Hospitals Not Located in Participating 
States.--Notwithstanding any other provision of this section--
            ``(1) for purposes of including a hospital or facility as a 
        member institution of a rural health network, a State may 
        designate a hospital or facility that is not located in the 
        State as an essential access community hospital or a rural 
        primary care hospital if the hospital or facility is located in 
        an adjoining State and is otherwise eligible for designation as 
        such a hospital;
            ``(2) the Secretary may designate a hospital or facility 
        that is not located in a State receiving a grant under 
        subsection (a)(1) as an essential access community hospital or 
        a rural primary care hospital if the hospital or facility is a 
        member institution of a rural health network of a State 
        receiving a grant under such subsection; and
            ``(3) a hospital or facility designated pursuant to this 
        subsection shall be eligible to receive a grant under 
        subsection (a)(2).''.
                    (B) Conforming amendments.--(i) Section 1820(c)(1) 
                (42 U.S.C. 1395i4(c)(1)) is amended by striking 
                ``paragraph (3)'' and inserting ``paragraph (3) or 
                subsection (k)''.
                    (ii) Paragraphs (1)(A) and (2)(A) of section 
                1820(i) (42 U.S.C. 1395i4(i)) are each amended--
                            (I) in clause (i), by striking ``(a)(1)'' 
                        and inserting ``(a)(1) (except as provided in 
                        subsection (k))'', and
                            (II) in clause (ii), by striking 
                        ``subparagraph (B)'' and inserting 
                        ``subparagraph (B) or subsection (k)''.
    (d) Skilled Nursing Services in Rural Primary Care Hospitals.--
Section 1820(f)(3) (42 U.S.C. 1395i4(f)(3)) is amended by striking 
``because the facility'' and all that follows and inserting the 
following: ``because, at the time the facility applies to the State for 
designation as a rural primary care hospital, there is in effect an 
agreement between the facility and the Secretary under section 1883 
under which the facility's inpatient hospital facilities are used for 
the furnishing of extended care services, except that the number of 
beds used for the furnishing of such services may not exceed the total 
number of licensed inpatient beds at the time the facility applies to 
the State for such designation (minus the number of inpatient beds used 
for providing inpatient care pursuant to paragraph (1)(F)). For 
purposes of the previous sentence, the number of beds of the facility 
used for the furnishing of extended care services shall not include any 
beds of a unit of the facility that is licensed as a distinct-part 
skilled nursing facility at the time the facility applies to the State 
for designation as a rural primary care hospital.''.
    (e) Payment for Outpatient Rural Primary Care Hospital Services.--
Section 1834(g)(1) (42 U.S.C. 1395m(g)(1)) is amended by adding at the 
end the following:
        ``The amount of payment shall be determined under either method 
        without regard to the amount of the customary or other 
        charge.''.
    (f) Clarification of Physician Staffing Requirement for Rural 
Primary Care Hospitals.--Section 1820(f)(1)(H) (42 U.S.C. 
1395i4(f)(1)(H)) is amended by striking the period and inserting the 
following: ``, except that in determining whether a facility meets the 
requirements of this subparagraph, subparagraphs (E) and (F) of that 
paragraph shall be applied as if any reference to a `physician' is a 
reference to a physician as defined in section 1861(r)(1).''.
    (g) Technical Amendments Relating to Part A Deductible, 
Coinsurance, and Spell of Illness.--(1) Section 1812(a)(1) (42 U.S.C. 
1395d(a)(1)) is amended--
            (A) by striking ``inpatient hospital services'' the first 
        place it appears and inserting ``inpatient hospital services or 
        inpatient rural primary care hospital services'';
            (B) by striking ``inpatient hospital services'' the second 
        place it appears and inserting ``such services''; and
            (C) by striking ``and inpatient rural primary care hospital 
        services''.
    (2) Sections 1813(a) and 1813(b)(3)(A) (42 U.S.C. 1395e(a), 
1395e(b)(3)(A)) are each amended by striking ``inpatient hospital 
services'' each place it appears and inserting ``inpatient hospital 
services or inpatient rural primary care hospital services''.
    (3) Section 1813(b)(3)(B) (42 U.S.C. 1395e(b)(3)(B)) is amended by 
striking ``inpatient hospital services'' and inserting ``inpatient 
hospital services, inpatient rural primary care hospital services''.
    (4) Section 1861(a) (42 U.S.C. 1395x(a)) is amended--
            (A) in paragraphs (1), by striking ``inpatient hospital 
        services'' and inserting ``inpatient hospital services, 
        inpatient rural primary care hospital services''; and
            (B) in paragraph (2), by striking ``hospital'' and 
        inserting ``hospital or rural primary care hospital''.
    (h) Authorization of Appropriations.--Section 1820(k) (42 U.S.C. 
1395i4(k)) is amended by striking ``1990, 1991, and 1992'' and 
inserting ``1990 through 1995''.
    (i) Effective Date.--The amendments made by this section shall take 
effect on the date of the enactment of this Act.

SEC. 3. REAUTHORIZATION OF RURAL TRANSITION GRANT PROGRAM.

    Section 4005(e)(9) of the Omnibus Budget Reconciliation Act of 1987 
is amended--
            (1) by striking ``1989 and'' and inserting ``1989,''; and
            (2) by striking ``1992'' and inserting ``1992 and 
        $30,000,000 for each of fiscal years 1993 through 1997''.

SEC. 4. REGIONAL REFERRAL CENTERS.

    (a) Extension Through Fiscal Year 1994.--Section 6003(d) of the 
Omnibus Budget Reconciliation Act of 1989 (42 U.S.C. 1395ww note) is 
amended by striking ``October 1, 1992'' and inserting ``October 1, 
1994''.
    (b) Permitting Hospitals to Decline Reclassification.--If any 
hospital fails to qualify as a rural referral center under section 
1886(d)(5)(C) of the Social Security Act as a result of a decision by 
the Medicare Geographic Classification Review Board under section 
1886(d)(10) of such Act to reclassify the hospital as being located in 
an urban area for fiscal year 1994, the Secretary of Health and Human 
Services shall--
            (1) notify such hospital of such failure to qualify,
            (2) provide an opportunity for such hospital to decline 
        such reclassification, and
            (3) if the hospital declines such reclassification, 
        administer the Social Security Act (other than section 
        1886(d)(8)(D)) for fiscal year 1994 as if the decision by the 
        Review Board had not occurred.

SEC. 5. MEDICARE-DEPENDENT, SMALL RURAL HOSPITALS.

    (a) In General.--Section 1886(d)(5)(G) (42 U.S.C. 1395ww(d)(5)(G)) 
is amended--
            (1) by amending clause (i) to read as follows:
    ``(i) In the case of a subsection (d) hospital which is a medicare-
dependent, small rural hospital, payment under paragraph (1)(A) for 
discharges occurring before October 1, 1994, shall be equal to the sum 
of the amount determined under clause (ii) and the amount determined 
under paragraph (1)(A)(iii).'';
            (2) by redesignating clauses (ii) and (iii) as clauses 
        (iii) and (iv); and
            (3) by inserting after clause (i) the following new clause:
    ``(ii) The amount determined under this clause is--
            ``(I) for discharges occurring during the first 3 12-month 
        cost reporting periods that begin on or after April 1, 1990, 
        the amount by which the hospital's target amount for the cost 
        reporting period (as defined in subsection (b)(3)(D)) exceeds 
        the amount determined under paragraph (1)(A)(iii); and
            ``(II) for discharges occurring during any subsequent cost 
        reporting period (or portion thereof), 50 percent of the amount 
        by which the hospital's target amount for the cost reporting 
        period (as defined in subsection (b)(3)(D)) exceeds the amount 
        determined under paragraph (1)(A)(iii).''.
    (b) Permitting Hospitals to Decline Reclassification.--If any 
hospital fails to qualify as a medicare-dependent, small rural hospital 
under section 1886(d)(5)(G)(i) of the Social Security Act as a result 
of a decision by the Medicare Geographic Classification Review Board 
under section 1886(d)(10) of such Act to reclassify the hospital as 
being located in an urban area for fiscal year 1994, the Secretary of 
Health and Human Services shall--
            (1) notify such hospital of such failure to qualify,
            (2) provide an opportunity for such hospital to decline 
        such reclassification, and
            (3) if the hospital declines such reclassification, 
        administer the Social Security Act (other than section 
        1886(d)(8)(D)) for fiscal year 1994 as if the decision by the 
        Review Board had not occurred.

Medicare Rural Hospital Amendments of 1993 - Amends title XVIII (Medicare) of the Social Security Act to extend and revise programs to assist rural hospitals under Medicare part A (Hospital Insurance). Authorizes appropriations. 
Amends the Omnibus Budget Reconciliation Act of 1987 to reauthorize and extend the rural transition grant program. 
Amends the Omnibus Budget Reconciliation Act of 1989 to extend regional referral centers. 
Revises Medicare-dependent, small rural hospital provisions under Medicare. 
Requires the Secretary of Health and Human Services to provide rural referral centers and Medicare-dependent, small rural hospitals which have been reclassified as urban the opportunity to decline such reclassification.