[Federal Register Volume 64, Number 109 (Tuesday, June 8, 1999)]
[Notices]
[Pages 30490-30491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14391]
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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 expansion of cancer treatment clinical trials
demonstration project.
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SUMMARY: This notice is to advise interested parties of an expansion of
a demonstration project in which the DoD provides CHAMPUS reimbursement
for eligible beneficiaries who receive cancer treatment under approved
National Cancer Institute (NCI) clinical trials to include NCI
sponsored cancer prevention clinical trials. Participation in these
clinical trials will improve TRICARE/CHAMPUS eligible beneficiary
access to emerging new therapies that have significant promise for the
prevention and successful treatment of cancers. 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 prevention and treatment of cancer. At this time, there is
insufficient demonstration data for a full evaluation of costs
associated with enrollment in clinical trials. Expanding the current
[[Page 30491]]
demonstration to provide reimbursement for costs associated with NCI
sponsored clinical trials for cancer prevention will augment current
patient accruals to clinical trials and allow for data collection in
order to perform a 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: June 21, 1999.
FOR FURTHER INFORMATION CONTACT: Kathy Larkin, Office of the Assistant
Secretary of Defense (Health Affairs), TRICARE Management Activity,
(703) 681-3628.
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.
In recognition of the successful partnership with the NCI, the
current demonstration is being expanded to allow DoD beneficiaries to
participate in NCI sponsored clinical trials in cancer prevention in
addition to caner treatment. This expansion of the current
demonstration will enhance continued 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 prevention therapies will occur at a cost
comparable to that which 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.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 99-14391 Filed 6-7-99; 8:45 am]
BILLING CODE 1001-10-M
