[Federal Register Volume 60, Number 220 (Wednesday, November 15, 1995)]
[Notices]
[Pages 57432-57433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28214]
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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 Health Care Technology (CHCT) (formerly Office of Health
Technology Assessment), announces that it is initiating an assessment
of the safety and effectiveness of lung volume reduction surgery.
The AHCPR is requesting information on the risks, benefits, and
costs associated with the use of this mode of treatment and the
specific indications for which this lung surgery is appropriate. The
AHCPR also requests information on patient selection criteria and
institutional or team criteria necessary to establish acceptable
standards for appropriate benefits and risks.
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)).
This assessment is based on the most current knowledge concerning the
safety, clinical effectiveness, and appropriate uses of a technology. A
recommendation will be formulated to
[[Page 57433]]
assist the Health Care Financing Administration (HCFA) in establishing
Medicare coverage policy. 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 lung volume reduction surgery, as well as
information on the clinical acceptability, effectiveness, and the
extent of use of this technology, is also being sought.
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
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 the sources of the data and 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 individual or entity described in the information, or could
identify an entity or individual supplying the information.
Any person or group wishing to provide AHCPR with information
relevant to this assessment should do so in writing no later than
February 13, 1996 to: Thomas V. Holohan, M.D., FACP, Acting Director,
Center for Health Care Technology, Agency for Health Care Policy and
Research, 6000 Executive Boulevard, Suite 309, Rockville, MD 20852,
Phone: (301) 594-4023.
Dated: November 6, 1995.
Clifton R. Gaus,
Administrator.
[FR Doc. 95-28214 Filed 11-14-95; 8:45 am]
BILLING CODE 4160-90-M
