§1320b–12 — Title 42 The Public Health and Welfare | U.S. Code

Summary

The Secretary of Health and Human Services, acting through the Director of the Agency for Healthcare Research and Quality (AHRQ), must fund and run research to find how to best prevent, diagnose, treat, and manage health problems. The work must show which services and procedures are effective and appropriate. The Secretary must also make and update treatment- or condition-specific practice guidelines for clinical care, education, and quality review, and make sure Medicare’s needs are included. The Secretary must compare different treatments to see how they affect health and function. By January 1, 1991 the Secretary must create at least three initial guidelines for treatments or conditions that either use a large share of Medicare spending and show big variation in care, or meet Medicare priorities. The Secretary must use the guidelines to try to improve care and report results to Congress by January 1, 1993. For that work the Secretary must spend $1,000,000 for fiscal year 1990 and $1,500,000 for each of fiscal years 1991 and 1992, paid 60 percent from the Federal Hospital Insurance Trust Fund and 40 percent from the Federal Supplementary Medical Insurance Trust Fund. The Secretary must set research priorities by looking at how many people could benefit, how much doctors’ care varies, how much is spent, and whether needed data are available or can be developed. The Secretary may study use-rate differences, uncertain benefits, and inappropriate care. The work must reflect priorities given by the Administrator of the Centers for Medicare & Medicaid Services. The Secretary must improve research methods, review existing studies, use and build large databases (including clinical and claims data), fund research centers and contracts (including on drugs), and create uniform data definitions, reporting formats, and rules to keep data secure and accurate. The Secretary must share findings and train providers by working with professional groups, check how the activities change care and outcomes, and study better ways to spread this information. Authorized funding is $50,000,000 for FY1990; $75,000,000 for FY1991; $110,000,000 for FY1992; $148,000,000 for FY1993; and $185,000,000 for FY1994. For FY1990–1992 two-thirds of each amount, and for FY1993–1994 70 percent of each amount, are to be appropriated with 60 percent from the Hospital Insurance Trust Fund and 40 percent from the Supplementary Medical Insurance Trust Fund. Each year the Secretary must reserve funds for guideline and standard development, research and evaluation, database work, and education and information sharing.

Title 42, §1320b–12

The Public Health and Welfare — Source: USLM XML via OLRC

(a)(1)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 are appropriately reflected in the development and periodic review and updating (through the process set forth in section 299b–2 11 See References in Text note below. 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.

(2)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)(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; 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, as set forth under subsection (b)(3).

(B)(i)The Secretary shall provide for the use of guidelines developed under subparagrah 22 So in original. Probably should be “subparagraph”. (A) to improve the quality, effectiveness, and appropriateness of care provided under subchapter XVIII. 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.

(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)(1)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). 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)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)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, as set forth by the Administrator of the Centers for Medicare & Medicaid Services.

(c)For the purpose of facilitating research under subsection (a), 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)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)(1)The Secretary shall provide for the dissemination of the findings of research and the guidelines described in subsection (a), and for the education of providers and others in the application of such research findings and guidelines.

(2)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)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)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)

(i)(1)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)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)(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.

Notes & Related Subsidiaries

Editorial Notes

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, § 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 Subsec. (h) of this section, which required the Secretary to report biennially to Congress on the progress of the activities under this section during the preceding 2 fiscal years, including the impact of such activities on medical care (particularly medical care for individuals receiving benefits under subchapter XVIII of this chapter), terminated, effective

May 15, 2000, pursuant to section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance. See, also, item 10 on page 94 of House Document No. 103–7. Another section 1142 of act Aug. 14, 1935, was renumbered section 1143 by Pub. L. 101–508, title V, § 5111(a)(1), Nov. 5, 1990, 104 Stat. 1388–272, and is classified to section 1320b–13 of this title.

Amendments

2003—Subsec. (b)(3). Pub. L. 108–173, § 900(e)(1)(C), substituted “Centers for Medicare & Medicaid Services” for “Health Care Financing Administration”. 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.

Statutory Notes and Related Subsidiaries

AHCPR Study on Effect of Credentialing of Technologists and Sonographers on Quality of Ultrasound Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 229(b)], Nov. 29, 1999, 113 Stat. 1536, 1501A–357, required a study on the effect of credentialing of technologists and sonographers on the quality of ultrasounds and submission of a report to Congress no later than two years after Nov. 29, 1999. Report on Linkage of Public and Private Research Related Data Pub. L. 101–239, title VI, § 6103(b)(2), Dec. 19, 1989, 103 Stat. 2198, provided that, no later than 1 year after Dec. 19, 1989, the Secretary of Health and Human Services would report to Congress on the feasibility of linking research-related data described in subsec. (d) of this section 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).

§1320b–12 Research on outcomes of health care services and procedures