[Federal Register Volume 61, Number 16 (Wednesday, January 24, 1996)]
[Notices]
[Pages 1899-1900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-971]



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DEPARTMENT OF DEFENSE

Office of the Secretary


Cancer Treatment Clinical Trials

AGENCY: Office of the Secretary, DoD.

ACTION: Notice of demonstration project.

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SUMMARY: This notice is to advise interested parties of a demonstration 
project in which the DoD will expand a current demonstration for breast 
cancer treatment clinical trials to include all cancer treatment 
clinical trials 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. This 
demonstration project is under the authority of 10 U.S.C. 1092.

EFFECTIVE DATE: January 1, 1996.

FOR FURTHER INFORMATION CONTACT:

SUPPLEMENTARY INFORMATION:

A. Background

    On November 15, 1994, the Department provided notice of a 
demonstration in the Federal Register (59 FR 58834) which provides 
CHAMPUS reimbursement for eligible beneficiaries who receive treatment 
under approved National Cancer Institute trials for high dose 
chemotherapy with stem cell rescue (HDC/SCR) for breast cancer. The 
National Cancer Institute (NCI) is a component of the National 
Institutes of Health (NIH) of the Department of Health and Human 
Services. The demonstration purpose was 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 HDC/SCR in the treatment of breast cancer. 
The November 15, 1994, notice anticipated the possibility of expanding 
the demonstration to include other protocol-based clinical 
investigations which have been NCI approved.
    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 is expanding its current 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 the increased 
access to innovative cancer therapies will occur at a cost comparable 
to that 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.

B. Requirements of participation

    Participation in this demonstration is limited to Phase II or Phase 
III clinical trials sponsored by the National Cancer Institute. 
Sponsorship by the National Cancer Institute is defined as review and 
approval of clinical trials under the Cancer Therapy Evaluation 
Program, NCI Cooperative Group studies, NCI Cancer Center studies, or 
NCI Grant studies. Beneficiaries receiving CHAMPUS treatment in a 
protocol outside one of these four categories are not eligible for 
participation.
    Cancer Therapy Evaluation Program (CTEP). Under this NCI program, 
all protocols which involve the use of NCI investigational drugs or 
studies that have any NCI funding and use an investigational agent. 
CTEP reviews each protocol for completeness, scientific merit, 
duplication of existing studies, patient safety, and adequacy of 
regulatory and human subjects protective aspects. Upon final acceptance 
of the protocol, written approval is sent to the protocol source.
    Cooperative Group Studies. NCI Cooperative Groups are composed of 
academic institutions and cancer treatment centers and practices 
throughout the Untied States and abroad which collaborate in NCI-
sponsored research by contributing patients to NCI approved group-
conducted clinical trials. The groups vary in research focus but share 
a common purpose of developing and conducting large scale trials in 
multi-institutional settings.
    Cancer Center Studies. The NCI Cancer Centers Program includes NCI-
designated institutions which meet NCI criteria as clinical and 
comprehensive cancer centers. NCI sponsored studies at cancer centers 
include all protocols that have been approved by an NCI approved 
institutional peer review and quality control system at the 
institution, as well as cooperative group, CTEP reviewed studies, and 
grant studies.
    NCI Grants. NCI directly supports clinical investigations through a 
variety of contract and grant mechanisms. All clinical trial protocols 
are peer reviewed, quality assured and meet all FDA requirements.
    The Department, through CHAMPUS, will provide reimbursement for all 
medical care required as a result of participation in approved clinical 
trials. This includes purchasing and administering all approved 
chemotherapy agents (except for the investigational agent), all 
inpatient and outpatient care, including diagnostic and laboratory 
services not otherwise reimbursed under an NCI grant program. CHAMPUS 
will not provide reimbursement for costs of non-treatment research 
activities associated with the clinical trials. The Department will not 
provide reimbursement for care rendered in the National Institutes of 
Health Clinical Center. CHAMPUS beneficiaries seeking treatment in an 
NCI sponsored clinical trial must receive preauthorization for proposed 
treatment. All institutional and individual providers must be CHAMPUS 
authorized providers in order to receive reimbursement under this 
demonstration. Evidence of NCI sponsorship for a requested protocol 
will be that it is identified in the NCI comprehensive data base, 
Physician's Data Query (PDQ), or NCI supplements to that data base.

C. Caseload, Costs

    Approximately 11,760 CHAMPUS eligibles are diagnosed with some form 
of cancer each year, based on age 

[[Page 1900]]
adjusted incidence rates. Recognizing that some individuals 
participating in Phase III trials would be randomized for conventional 
treatment as part of a control group, the number of cases receiving 
treatment under NCI-sponsored Phase II and Phase III clinical trials is 
roughly estimated to be between 120 and 350. The number may grow as 
awareness of the expended demonstration increases the potential pool of 
patients meeting protocol eligibility requirements, and as new NCI 
studies are established for a wider variety of cancer treatments.

D. Operation of the Demonstration

    The Director, OCHAMPUS will designate a first line determiner 
(which may be a CHAMPUS contractor) regarding eligibility of specific 
protocols, specific institutions conducting those protocols and the 
eligibility of each specific CHAMPUS patient's participation in 
protocols under the terms of the Demonstration. The Assistant Secretary 
of Defense (Health Affairs) will designate a Project Officer in the 
Office of the Deputy Assistant Secretary of Defense for Clinical 
Services who will provide clinical oversight for the demonstration and 
resolve any clinical issues that cannot be resolved by the Director, 
OCHAMPUS, or designee.
    Demonstration participation will be available to all CHAMPUS 
eligible beneficiaries. Active duty members continue to be eligible for 
direct care system services. OCHAMPUS will contract for and provide day 
to day oversight of contractor case referral, case coordination, 
demonstration funds disbursements and maintaining the integrity of 
those funds, identification of the services that are payable under 
CHAMPUS and TRICARE, and all related tracking and reporting 
requirements.
    Each patient with cancer would undergo an initial evaluation by his 
or her physician. After discussing the various treatment options with 
the patient, if the patient agrees to enter a clinical study, the 
physician will determine available NCI clinical trials and 
participating institutions. The physician will then arrange for 
evaluation of the patient at the selected center. Physicians at the 
center involved in the clinical trial would make the actual patient 
selection based upon the clinical criteria for their study.
    The contractor(s) would not be involved in clinical issues or in 
directing patients to a particular institution or a specific clinical 
trial. The contractor(s) would be the single point of contact for 
nationwide provider and patient information and claims adjudication and 
payment.
    The HDC/SCR clinical trials for breast cancer demonstration project 
is hereby terminated as a separate project. It is fully incorporated 
into this NCI clinical trials demonstration project.

E. Limitations of the Demonstration

    This demonstration is limited to protocols which are NCI-sponsored 
Phase II and Phase III clinical trials. All care reimbursed as part of 
this demonstration must fall into one of the four NCI sponsorship 
categories described in this demonstration notice. No CHAMPUS 
reimbursement will be allowed for participation in clinical trials that 
are not sponsored by the NCI. All standard CHAMPUS and TRICARE rule, 
policies, and regulations will continue to apply, except where 
otherwise noted in this demonstration. Treatment under this 
demonstration is exempt from Specialized Treatment Services (STS) 
Program requirements.

F. Effective Date.

    The final terms and conditions of this demonstration were approved 
by the Assistant Secretary of Defense (Health Affairs) during the first 
days of January, 1996. We are aware of specific cases in which therapy 
under NCI sponsored clinical trials was required to begin immediately. 
We have therefore established an effective date of January 1, 1996, for 
this demonstration. We are waiving the normal 30-day advance notice in 
order to accommodate these urgent cases. This demonstration will end 
December 31, 1996, unless extended by another notice. If, after the 
year under demonstration there is evidence of significant increases in 
cost as a result of beneficiary participation in clinical trials for 
cancer, the Department will re-evaluate the continuation of the 
demonstration.

    Dated: January 19, 1996.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 96-971 Filed 1-23-96; 8:45 am]
BILLING CODE 5000-04-M