[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
