
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC1320b-12]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                       CHAPTER 7--SOCIAL SECURITY
 
   SUBCHAPTER XI--GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE 
                             SIMPLIFICATION
 
                       Part A--General Provisions
 
Sec. 1320b-12. Research on outcomes of health care services and 
        procedures
        

(a) Establishment of program

                           (1) In general

        The Secretary, acting through the Director of the Agency for 
    Healthcare Research and Quality, shall--
            (A) conduct and support research with respect to the 
        outcomes, effectiveness, and appropriateness of health care 
        services and procedures in order to identify the manner in which 
        diseases, disorders, and other health conditions can most 
        effectively and appropriately be prevented, diagnosed, treated, 
        and managed clinically; and
            (B) assure that the needs and priorities of the program 
        under subchapter XVIII of this chapter are appropriately 
        reflected in the development and periodic review and updating 
        (through the process set forth in section 299b-2 \1\ of this 
        title) of treatment-specific or condition-specific practice 
        guidelines for clinical treatments and conditions in forms 
        appropriate for use in clinical practice, for use in educational 
        programs, and for use in reviewing quality and appropriateness 
        of medical care.
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    \1\ See References in Text note below.
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       (2) Evaluations of alternative services and procedures

        In carrying out paragraph (1), the Secretary shall conduct or 
    support evaluations of the comparative effects, on health and 
    functional capacity, of alternative services and procedures utilized 
    in preventing, diagnosing, treating, and clinically managing 
    diseases, disorders, and other health conditions.

                       (3) Initial guidelines

        (A) In carrying out paragraph (1)(B) of this subsection, and 
    section 299b-1(d) \1\ of this title, the Secretary shall, by not 
    later than January 1, 1991, assure the development of an initial set 
    of the guidelines specified in paragraph (1)(B) that shall include 
    not less than 3 clinical treatments or conditions that--
            (i)(I) account for a significant portion of expenditures 
        under subchapter XVIII of this chapter; and
            (II) have a significant variation in the frequency or the 
        type of treatment provided; or
            (ii) otherwise meet the needs and priorities of the program 
        under subchapter XVIII of this chapter, as set forth under 
        subsection (b)(3) of this section.

        (B)(i) The Secretary shall provide for the use of guidelines 
    developed under subparagrah \2\ (A) to improve the quality, 
    effectiveness, and appropriateness of care provided under subchapter 
    XVIII of this chapter. The Secretary shall determine the impact of 
    such use on the quality, appropriateness, effectiveness, and cost of 
    medical care provided under such subchapter and shall report to the 
    Congress on such determination by not later than January 1, 1993.
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    \2\ So in original. Probably should be ``subparagraph''.
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        (ii) For the purpose of carrying out clause (i), the Secretary 
    shall expend, from the amounts specified in clause (iii), $1,000,000 
    for fiscal year 1990 and $1,500,000 for each of the fiscal years 
    1991 and 1992.
        (iii) For each fiscal year, for purposes of expenditures 
    required in clause (ii)--
            (I) 60 percent of an amount equal to the expenditure 
        involved is appropriated from the Federal Hospital Insurance 
        Trust Fund (established under section 1395i of this title); and
            (II) 40 percent of an amount equal to the expenditure 
        involved is appropriated from the Federal Supplementary Medical 
        Insurance Trust Fund (established under section 1395t of this 
        title).

(b) Priorities

                           (1) In general

        The Secretary shall establish priorities with respect to the 
    diseases, disorders, and other health conditions for which research 
    and evaluations are to be conducted or supported under subsection 
    (a) of this section. In establishing such priorities, the Secretary 
    shall, with respect to a disease, disorder, or other health 
    condition, consider the extent to which--
            (A) improved methods of prevention, diagnosis, treatment, 
        and clinical management can benefit a significant number of 
        individuals;
            (B) there is significant variation among physicians in the 
        particular services and procedures utilized in making diagnoses 
        and providing treatments or there is significant variation in 
        the outcomes of health care services or procedures due to 
        different patterns of diagnosis or treatment;
            (C) the services and procedures utilized for diagnosis and 
        treatment result in relatively substantial expenditures; and
            (D) the data necessary for such evaluations are readily 
        available or can readily be developed.

                     (2) Preliminary assessments

        For the purpose of establishing priorities under paragraph (1), 
    the Secretary may, with respect to services and procedures utilized 
    in preventing, diagnosing, treating, and clinically managing 
    diseases, disorders, and other health conditions, conduct or support 
    assessments of the extent to which--
            (A) rates of utilization vary among similar populations for 
        particular diseases, disorders, and other health conditions;
            (B) uncertainties exist on the effect of utilizing a 
        particular service or procedure; or
            (C) inappropriate services and procedures are provided.

               (3) Relationship with medicare program

        In establishing priorities under paragraph (1) for research and 
    evaluation, and under section 299b-3(a) \1\ of this title for the 
    agenda under such section, the Secretary shall assure that such 
    priorities appropriately reflect the needs and priorities of the 
    program under subchapter XVIII of this chapter, as set forth by the 
    Administrator of the Health Care Financing Administration.

(c) Methodologies and criteria for evaluations

    For the purpose of facilitating research under subsection (a) of 
this section, the Secretary shall--
        (1) conduct and support research with respect to the improvement 
    of methodologies and criteria utilized in conducting research with 
    respect to outcomes of health care services and procedures;
        (2) conduct and support reviews and evaluations of existing 
    research findings with respect to such treatment or conditions;
        (3) conduct and support reviews and evaluations of the existing 
    methodologies that use large data bases in conducting such research 
    and shall develop new research methodologies, including data-based 
    methods of advancing knowledge and methodologies that measure 
    clinical and functional status of patients, with respect to such 
    research;
        (4) provide grants and contracts to research centers, and 
    contracts to other entities, to conduct such research on such 
    treatment or conditions, including research on the appropriate use 
    of prescription drugs;
        (5) conduct and support research and demonstrations on the use 
    of claims data and data on clinical and functional status of 
    patients in determining the outcomes, effectiveness, and 
    appropriateness of such treatment; and
        (6) conduct and support supplementation of existing data bases, 
    including the collection of new information, to enhance data bases 
    for research purposes, and the design and development of new data 
    bases that would be used in outcomes and effectiveness research.

(d) Standards for data bases

    In carrying out this section, the Secretary shall develop--
        (1) uniform definitions of data to be collected and used in 
    describing a patient's clinical and functional status;
        (2) common reporting formats and linkages for such data; and
        (3) standards to assure the security, confidentiality, accuracy, 
    and appropriate maintenance of such data.

(e) Dissemination of research findings and guidelines

                           (1) In general

        The Secretary shall provide for the dissemination of the 
    findings of research and the guidelines described in subsection (a) 
    of this section, and for the education of providers and others in 
    the application of such research findings and guidelines.

               (2) Cooperative educational activities

        In disseminating findings and guidelines under paragraph (1), 
    and in providing for education under such paragraph, the Secretary 
    shall work with professional associations, medical specialty and 
    subspecialty organizations, and other relevant groups to identify 
    and implement effective means to educate physicians, other 
    providers, consumers, and others in using such findings and 
    guidelines, including training for physician managers within 
    provider organizations.

(f) Evaluations

    The Secretary shall conduct and support evaluations of the 
activities carried out under this section to determine the extent to 
which such activities have had an effect on the practices of physicians 
in providing medical treatment, the delivery of health care, and the 
outcomes of health care services and procedures.

(g) Research with respect to dissemination

    The Secretary may conduct or support research with respect to 
improving methods of disseminating information on the effectiveness and 
appropriateness of health care services and procedures.

(h) Report to Congress

    Not later than February 1 of each of the years 1991 and 1992, and of 
each second year thereafter, the Secretary shall report to the Congress 
on the progress of the activities under this section during the 
preceding fiscal year (or preceding 2 fiscal years, as appropriate), 
including the impact of such activities on medical care (particularly 
medical care for individuals receiving benefits under subchapter XVIII 
of this chapter).

(i) Authorization of appropriations

                           (1) In general

        There are authorized to be appropriated to carry out this 
    section--
            (A) $50,000,000 for fiscal year 1990;
            (B) $75,000,000 for fiscal year 1991;
            (C) $110,000,000 for fiscal year 1992;
            (D) $148,000,000 for fiscal year 1993; and
            (E) $185,000,000 for fiscal year 1994.

                         (2) Specifications

        For the purpose of carrying out this section, for each of the 
    fiscal years 1990 through 1992 an amount equal to two-thirds of the 
    amounts authorized to be appropriated under paragraph (1), and for 
    each of the fiscal years 1993 and 1994 an amount equal to 70 percent 
    of such amounts, are to be appropriated in the following proportions 
    from the following trust funds:
            (A) 60 percent from the Federal Hospital Insurance Trust 
        Fund (established under section 1395i of this title).
            (B) 40 percent from the Federal Supplementary Medical 
        Insurance Trust Fund (established under section 1395t of this 
        title).

                           (3) Allocations

        (A) For each fiscal year, of the amounts transferred or 
    otherwise appropriated to carry out this section, the Secretary 
    shall reserve appropriate amounts for each of the purposes specified 
    in clauses (i) through (iv) of subparagraph (B).
        (B) The purposes referred to in subparagraph (A) are--
            (i) the development of guidelines, standards, performance 
        measures, and review criteria;
            (ii) research and evaluation;
            (iii) data-base standards and development; and
            (iv) education and information dissemination.

(Aug. 14, 1935, ch. 531, title XI, Sec. 1142, as added Pub. L. 101-239, 
title VI, Sec. 6103(b)(1), Dec. 19, 1989, 103 Stat. 2195; amended Pub. 
L. 106-129, Sec. 2(b)(2), Dec. 6, 1999, 113 Stat. 1670.)

                       References in Text

    Sections 299b-1 to 299b-3 of this title, referred to in subsecs. (a) 
and (b), were in the original references to sections 912 to 914 of act 
July 1, 1944, which were omitted in the general amendment of subchapter 
VII of chapter 6A of this title by Pub. L. 106-129, Sec. 2(a), Dec. 6, 
1999, 113 Stat. 1653. Section 2(a) of Pub. L. 106-129 enacted new 
sections 912 to 914 of act July 1, 1944, which are classified to 
sections 299b-1 to 299b-3, respectively, of this title.

                          Codification

    Another section 1142 of act Aug. 14, 1935, was renumbered section 
1143 by Pub. L. 101-508, title V, Sec. 5111(a)(1), Nov. 5, 1990, 104 
Stat. 1388-272, and is classified to section 1320b-13 of this title.


                               Amendments

    1999--Subsec. (a)(1). Pub. L. 106-129 substituted ``Director of the 
Agency for Healthcare Research and Quality'' for ``Administrator for 
Health Care Policy and Research'' in introductory provisions.


AHCPR Study on Effect of Credentialing of Technologists and Sonographers 
                        on Quality of Ultrasound

    Pub. L. 106-113, div. B, Sec. 1000(a)(6) [title II, Sec. 229(b)], 
Nov. 29, 1999, 113 Stat. 1536, 1501A-357, provided that:
    ``(1) Study.--The Administrator for Health Care Policy and Research 
shall provide for a study that, with respect to the provision of 
ultrasound under the medicare and medicaid programs under titles XVIII 
and XIX of the Social Security Act [subchapters XVIII and XIX of this 
chapter], compares differences in quality between ultrasound furnished 
by individuals who are credentialed by private entities or organizations 
and ultrasound furnished by those who are not so credentialed. Such 
study shall examine and evaluate differences in error rates, resulting 
complications, and patient outcomes as a result of the differences in 
credentialing. In designing the study, the Administrator shall consult 
with organizations nationally recognized for their expertise in 
ultrasound.
    ``(2) Report.--Not later than two years after the date of the 
enactment of this Act [Nov. 29, 1999], the Administrator shall submit a 
report to Congress on the study conducted under paragraph (1).''


      Report on Linkage of Public and Private Research Related Data

    Section 6103(b)(2) of Pub. L. 101-239 provided that: ``Not later 
than 1 year after the date of the enactment of this Act [Dec. 19, 1989], 
the Secretary of Health and Human Services shall report to the Congress 
on the feasibility of linking research-related data described in section 
1142(d) of the Social Security Act [subsec. (d) of this section] (as 
added by paragraph (1) of this subsection) with similar data collected 
or maintained by non-Federal entities and by Federal agencies other than 
the Department of Health and Human Services (including the Departments 
of Defense and Veterans Affairs and the Office of Personnel 
Management).''

                  Section Referred to in Other Sections

    This section is referred to in sections 299a, 299c, 299c-2, 1395y of 
this title.
