[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 

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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