[Federal Register Volume 63, Number 220 (Monday, November 16, 1998)]
[Notices]
[Page 63710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30477]
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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
