[Federal Register Volume 65, Number 3 (Wednesday, January 5, 2000)]
[Notices]
[Pages 439-440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-174]


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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 an 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 prevention and 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 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. Extending the 
demonstration until the termination of the NCI/DoD Interagency 
Agreement 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 is under 
the authority of 10 U.S.C., section 1092, and expires upon the 
termination of the NCI/DoD Interagency Agreement.

EFFECTIVE DATE: January 1, 2000.

FOR FURTHER INFORMATION CONTACT: COL Karen Ferguson, Office of the 
Assistant Secretary of Defense (Health Affairs), TRICARE Management 
Activity, (703) 681-3628.

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 prevention and 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 principoal 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 
prevention and treatment, the Department expended its breast cancer 
demonstration to include all NCI-sponsored phase II and phase III 
clinical trials. It further expanded the Interagency Agreement to cover 
cancer prevention clinical trials on June 21, 1999. This expanded 
demonstration will enhance current NCI efforts to determine safety and 
efficacy of promising cancer prevention and treatment 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 and cancer treatment therapies 
will occur at a cost comparable to that which the Department has 
experienced in paying for conventional therapies under the standard 
CHAMPUS program.


[[Page 440]]


    Dated: December 29, 1999.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 00-174 Filed 01-04-00; 8:45 am]
BILLING CODE 5001-10-M