§299a–2. Health care technology and technology assessment

(a) In general

In carrying out section 299(b) of this title, the Administrator shall promote the development and application of appropriate health care technology assessments-

(1) by identifying needs in, and establishing priorities for, the assessment of specific health care technologies;

(2) by developing and evaluating criteria and methodologies for health care technology assessment;

(3) by conducting and supporting research on the development and diffusion of health care technology;

(4) by conducting and supporting research on assessment methodologies;

(5) by promoting education, training, and technical assistance in the use of health care technology assessment methodologies and results; and

(6) by conducting assessments and reassessments of existing and new health care technologies.

(b) Specific assessments

(1) In general

In carrying out section 299(b) of this title, the Administrator shall conduct and support specific assessments of health care technologies.

(2) Consideration of certain factors

In carrying out paragraph (1), the Administrator shall consider the safety, efficacy, and effectiveness, and, as appropriate, the legal, social, and ethical implications, and appropriate uses of such technologies, including consideration of geographic factors. In carrying out such paragraph, the Administrator shall also consider the cost effectiveness of such technologies where cost information is available and reliable.

(c) Agenda and priorities

(1) Establishment of priorities

In accordance with paragraph (2), the Administrator, in consultation with the Advisory Council established under section 299c of this title, shall establish an annual list of technology assessments under consideration by the Agency, including those assessments performed at the request of the Health Care Financing Administration and the Department of Defense and those assessments performed under subsections (d) and (f) of this section.

(2) Public notice

The Administrator, in consultation with the Advisory Council, shall publish the list established in paragraph (1) annually in the Federal Register.

(d) Conduct of assessments

(1) Recommendations with respect to health care technology

The Administrator shall make recommendations to the Secretary with respect to whether specific health care technologies should be reimbursable under federally financed health programs, including recommendations with respect to any conditions and requirements under which any such reimbursements should be made.

(2) Considerations of certain factors

In making recommendations respecting health care technologies, the Administrator shall consider the safety, efficacy, and effectiveness, and, as appropriate, the appropriate uses of such technologies. The Administrator shall also consider the cost effectiveness of such technologies where cost information is available and reliable.

(3) Additional assessments

The Administrator may conduct technology assessments in addition to those assessments performed at the request of the Administrator of the Health Care Financing Administration or of the Secretary of Defense.

(4) Criteria

The Administrator shall develop criteria for determining the priority of assessments performed under this subsection. Such criteria shall include-

(A) the prevalence of the health condition for which the technology aims to prevent, diagnose, treat and clinically manage;

(B) variations in current practice;

(C) the economic burden posed by the prevention, diagnosis, treatment, and clinical management of the health condition, including the impact on publicly-funded programs;

(D) aggregate cost of the use of technology;

(E) the morbidity and mortality associated with the health condition; and

(F) the potential of an assessment to improve health outcomes or affect costs associated with the prevention, diagnosis, or treatment of the condition.

(5) Consultations

In carrying out this subsection, the Administrator shall cooperate and consult with the Director of the National Institutes of Health, the Commissioner of Food and Drugs, and the heads of any other interested Federal department or agency.

(e) Description of process

Not later than January 1, 1994, the Administrator shall develop and publish a description of the methodology used to establish priorities for technology assessment and the process used to conduct its technology assessments under this section.

(f) Program of innovative assessments

(1) In general

The Administrator may make grants to, or enter cooperative agreements or contracts with, entities described in paragraph (2) for the establishment of collaborative arrangements for the purpose of conducting assessments of experimental, emerging, existing, or potentially outmoded health care technologies, and for related activities. Such assessments may include controlled clinical trials, large simple trials, and other methodologies that can be conducted in partnership between the public and private sectors or among multiple government agencies.

(2) Eligible entities

The entities referred to in paragraph (1) are entities determined to be appropriate by the Administrator, which entities may include academic medical centers, research institutions, nonprofit professional organizations, public or private third party payers, other governmental agencies, and consortia of appropriate research entities established for the purpose of conducting technology assessments.

(3) Use of award

A grant, cooperative agreement, or contract under paragraph (1) may be expended for data collection, data analysis, protocol development, report development, dissemination and evaluation, and other activities determined to be appropriate by the Administrator. Such funds shall not be used for direct services.

(4) Application for award

To be eligible to receive a grant, cooperative agreement, or contract under paragraph (1), an entity shall prepare and submit to the Administrator an application, at such time, in such form, and containing such information as the Administrator may require.

(5) Interagency memoranda of understanding

In carrying out paragraph (1), the Administrator may enter into memoranda of understanding with the heads of other Federal agencies.

(July 1, 1944, ch. 373, title IX, §904, as added Dec. 19, 1989, Pub. L. 101–239, title VI, §6103(a), 103 Stat. 2191 ; amended Oct. 13, 1992, Pub. L. 102–410, §4(a), 106 Stat. 2095 ; June 10, 1993, Pub. L. 103–43, title XX, §2013(1), 107 Stat. 214 .)

Prior Provisions

A prior section 904 of act July 1, 1944, was classified to section 299d of this title prior to repeal by Pub. L. 99–117.

Amendments

1993-Subsec. (d). Pub. L. 103–43 added pars. (1) and (2), substituted "Additional assessments" for "In general" as heading of former par. (1) and redesignated it as (3), redesignated former par. (2) as (4), and added par. (5).

1992-Subsec. (a)(6). Pub. L. 102–410, §4(a)(1), added par. (6).

Subsec. (b)(2). Pub. L. 102–410, §4(a)(2), struck out "cost-effectiveness," before "legal, social, and ethical implications" and inserted at end "In carrying out such paragraph, the Administrator shall also consider the cost effectiveness of such technologies where cost information is available and reliable."

Subsec. (c). Pub. L. 102–410, §4(a)(3), amended subsec. (c) generally, substituting provisions relating to establishment of annual list of technology assessments under consideration for provisions relating to establishment of an information center on health care technologies and health care technology assessment at National Library of Medicine.

Subsec. (d). Pub. L. 102–410, §4(a)(4), amended subsec. (d) generally, substituting provisions relating to conduct of assessments and criteria for determining priority of assessments performed for provisions relating to recommendations and consideration of factors with respect to health care technologies.

Subsecs. (e), (f). Pub. L. 102–410, §4(a)(5), added subsecs. (e) and (f).

Construction

Enactment of subsec. (e) of this section 299a–1 of this title by Pub. L. 102–410 and enactment of section 286d of this title and amendment of subsec. (e) of section 299a–1 of this title by Pub. L. 103–43 not to be construed as terminating the information center on health care technologies and health care technology assessment established under this section, as in effect on the day before Oct. 13, 1992, with such center to be considered to be the center established in and subject to provisions of section 286d of this title, see section 1422(b) of Pub. L. 103–43, set out as a note under section 286d of this title.

Report Regarding Innovative Assessments

Section 4(b) of Pub. L. 102–410 provided that, not later than Jan. 1, 1994, Administrator for Health Care Policy and Research was to submit to Congress, a report concerning the program established in 42 U.S.C. 299a–2(f), including the plan of such Administrator for implementing the program.

Contract for Temporary Assistance to Secretary of Health and Human Services With Respect to Health Care Technology Assessment

Section 6103(d)(2) of Pub. L. 101–239 provided that:

"(A) The Secretary of Health and Human Services shall request the Institute of Medicine of the National Academy of Sciences to enter into a contract-

"(i) to develop and recommend to the Secretary priorities for the assessment of specific health care technologies under section 904 of the Public Health Service Act [42 U.S.C. 299a–2] (as added by subsection (a) of this section); and

"(ii) to assist the Administrator for Health Care Policy and Research, and the Director of the National Library of Medicine, in establishing the information center required under subsection (c)(1) of such section 904.

"(B) In carrying out section 904(c)(1) of the Public Health Service Act (as added by subsection (a) of this section), the Secretary of Health and Human Services shall, as appropriate, provide for the transfer to the Secretary of any information and materials developed by the council on health care technology under section 309(c)(1)(A) of the Public Health Service Act [former section 242n(c)(1)(A) of this title] (as such section was in effect on the day before the effective date of this section [Dec. 19, 1989]).

"(C) The Secretary of Health and Human Services shall ensure that the contract under subparagraph (A) specifies that the activities described in clauses (i) and (ii) of such subparagraph shall be completed not later than 1 year after the date on which the Secretary enters into the contract.

"(D) For the purpose of carrying out the contract under subparagraph (A), there is authorized to be appropriated $300,000 for fiscal year 1990."

Section Referred to in Other Sections

This section is referred to in sections 299b–3, 299c–5 of this title.