[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
