[Federal Register Volume 62, Number 245 (Monday, December 22, 1997)]
[Notices]
[Page 66871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Health Care Policy and Research


Notice of Assessment of Medical Technology

    The Agency for Health Care Policy and Research (AHCPR), through the 
Center for Practice and Technology Assessment (CPTA), announces that it 
is initiating an assessment of the effectiveness of Prostate-specific 
antigen (PSA) testing in patients with benign prostatic hyperplasia 
(BPH).
    The AHCPR is requesting information on the utility, and costs 
associated with the use of PSA testing and the specific indications for 
which this testing is appropriate. The AHCPR also requests information 
on patient selection criteria.
    The assessment consists of a synthesis of information found in 
published literature and obtained from appropriate organizations in the 
private sector, Public Health Service (PHS) agencies and others in the 
Federal Government. AHCPR assessments are conducted in accordance with 
sections 904(b) and (d) of the PHS Act (42 U.S.C. 299a-2(b) and (d)). 
The assessment is based on the most current knowledge concerning the 
clinical effectiveness and appropriate uses of the technology being 
evaluated. The information being sought by this notice is a review and 
evaluation of past, current, and planned research related to this 
technology, as well as a bibliography of published, controlled clinical 
trials and other well-designed clinical studies. Information related to 
the characteristics of the patient population most likely to benefit 
from PSA testing as well as information on the clinical acceptability, 
effectiveness, and the extent of use of this technology, is also being 
sought. Following completion of the assessment, a recommendation will 
be formulated to assist the Health Care Financing Administration (HCFA) 
in establishing Medicare coverage policy.
    The AHCPR is interested in receiving information which would help 
in the evaluation or review of the technology as described above. To 
enable the interested scientific community to evaluate the information 
and analysis included in the assessment, AHCPR will discuss in the 
assessment only those data and analyses for which a source(s) can be 
cited. Respondents are therefore encouraged to include with their 
submissions a written consent permitting AHCPR ``to cite and make 
public the sources of the data and the comments provided''. Otherwise, 
in accordance with the confidentiality statute governing information 
collected by AHCPR, 42 U.S.C. 299a-1(c), no information received will 
be published or disclosed which could identify an entity or individual 
supplying the information or any individual or entity described in the 
information. In addition, clearly market proprietary information may be 
kept confidential in accordance with the Freedom of Information Act, 5 
U.S.C. Sec. 552(b)(4).
    Any person or group wishing to provide AHCPR with information 
relevant to this assessment should do so in writing no later than March 
23, 1998 to: Douglas B. Kamerow, M.D., M.P.H., Director, Center for 
Practice and Technology Assessment, Agency for Health Care Policy and 
Research, 6000 Executive Boulevard, Suite 310, Rockville, MD 20852, 
Phone: (301) 594-4015.

    Dated: December 15, 1997.
John M. Eisenberg,
Administrator.
[FR Doc. 97-33252 Filed 12-19-97; 8:45 am]
BILLING CODE 4160-90-M