[Federal Register: November 16, 1998 (Volume 63, Number 220)]
[Notices]               
[Page 63710]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no98-47]

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DEPARTMENT OF DEFENSE

Office of the Secretary

 
Civilian Health and Medical Program of the Uniformed Services 
(CHAMPUS)

AGENCY: Office of the Secretary, DoD.

ACTION: Notice of extension of cancer treatment clinical trials 
demonstration project.

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SUMMARY: This notice is to advise interested parties of a one-year 
extension of a demonstration project in which the DoD provides CHAMPUS 
reimbursement for eligible beneficiaries who receive cancer treatment 
under approved National Institutes of Health, National Cancer Institute 
(NCI) clinical trials. Participation in these clinical trials will 
improve access to promising cancer therapies for CHAMPUS eligible 
beneficiaries when their conditions meet protocol eligibility criteria. 
DoD financing of these procedures will assist in meeting clinical trial 
goals and arrival at conclusions regarding the safety and efficacy of 
emerging therapies in the treatment of cancer. At this time, there is 
insufficient demonstration data for a full evaluation of costs 
associated with enrollment in clinical trials. Extending the 
demonstration for an additional year will allow sufficient time for 
patient accrual to clinical trials and collection of data which allows 
for comprehensive economic analysis. This demonstration also affects 
TRICARE, the managed health care program that includes CHAMPUS. This 
demonstration project, which is under the authority of 10 U.S.C., 
section 1092, will expire December 31, 1999.

EFFECTIVE DATE: January 1, 1999.

FOR FURTHER INFORMATION CONTACT:
Kathleen K. Larkin, Office of the Assistant Secretary of Defense 
(Health Affairs), TRICARE Management Activity, (703) 681-1745.

SUPPLEMENTARY INFORMATION:

A. Background

    On January 24, 1996, the Department provided notice in the Federal 
Register (61 FR 1899) of an expansion of an existing demonstration for 
breast cancer treatment clinical trials to include all cancer treatment 
clinical trials under approved National Cancer Institute (NCI) clinical 
trials. The demonstration purpose is to improve beneficiary access to 
promising new therapies, assist in meeting the National Cancer 
Institute's clinical trial goals, and arrival at conclusions regarding 
the safety and efficacy of emerging therapies in the treatment of 
cancer. The January 24, 1996, notice anticipated the possibility of 
extending the demonstration.
    The NCI trials program is the principal means by which the oncology 
community has developed clinical evidence for the efficacy of various 
treatment approaches in cancer therapy. Participating institutions 
include NCI's network of comprehensive and clinical cancer centers, 
university and community hospitals and practices, and military 
treatment facilities. Despite this extensive network which includes the 
nation's premier medical centers, cure rates for most types of cancer 
remain disappointing, highlighting the significant effort still 
required for improvement. The principal means by which advances in 
therapy will be realized is through application of research to victims 
of cancer. In support of NCI's efforts to further the science of cancer 
treatment, the Department expanded its breast cancer demonstration to 
include all NCI-sponsored phase II and phase III clinical trials. This 
expanded demonstration will enhance current NCI efforts to determine 
safety and efficacy of promising cancer therapies by expanding the 
patient population available for entry into clinical trials and 
stabilizing the referral base for these clinical activities. While this 
demonstration provides an exception to current CHAMPUS benefit 
limitations, the Department hypothesizes that this increased access to 
innovative cancer therapies will occur at a cost comparable to that 
which the Department has experienced in paying for conventional 
therapies under the standard CHAMPUS program. Results of this 
demonstration will provide a framework for determining the scope of 
DoD's continued participation in the NCI's research efforts.

    Dated: November 9, 1998.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 98-30477 Filed 11-13-98; 8:45 am]
BILLING CODE 5000-04-M