[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