[Federal Register Volume 65, Number 171 (Friday, September 1, 2000)]
[Notices]
[Pages 53273-53274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22407]


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DEPARTMENT OF DEFENSE

Office of the Secretary


TRICARE; Civilian Health and Medical Program of the Uniformed 
Services (CHAMPUS); Defense and Veterans Head Injury Program (DVHIP) 
Demonstration Project.

AGENCY: Office of the Secretary, Department of Defense (DoD).

ACTION:  Notice.

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SUMMARY: This notice is to advise interested parties of an extension of 
a demonstration project in which the DoD is participating in the 
Defense and Veterans Head Injury Program (DVHIP) Protocol II Traumatic 
Brain Injury (TBI) Rehabilitation: A Controlled, Rendomized Multicenter 
Study of Two Interdisciplinary Programs with Adjuvant Pharmacotherapy. 
Under the demonstration, DoD will participate in a controlled trial of 
cognitive therapy for TBI at four participating Department of Veterans 
Affairs medical facilities. Participation in these clinical trials will 
provide access to cognitive rehabilitation for TRICARE/CHAMPUS 
beneficiaries when their conditions meet the study protocol eligibility 
criteria. The extension of the demonstration project will assist in 
meeting clinical trial goals and arrival at conclusions regarding the 
safety and efficacy of cognitive rehabilitation in the treatment of 
TBI. This demonstration project is under the authority of Title 10, 
United States Code (U.S.C.), Chapter 55, Section 1092.

EFFECTIVE DATE: August 1, 2000.

FOR FURTHER INFORMATION CONTACT: Mr. Tariq Shahid, Medical Benefits and 
Reimbursement Systems, TRICARE Management Activity, Aurora, CO, 80045-
6900, telephone (303) 676-3801.

SUPPLEMENTARY INFORMATION:

A. Background

    On July 29, 1997, the Department provided notice in the Federal 
Register (62 FR 40506) regarding the DVHIP demonstration. The 
demonstration purpose is to compare traditional and cognitive 
rehabilitation for patients with Traumatic Brain Injury (TBI) under 
DVHIP Protocol II TBI Rehabilitation: A Controlled Randomized 
Multicenter Study of Two Interdisciplinary Programs with Adjuvant 
Pharmacotherapy.
    TBI is the principal cause of death and disability for young 
Americans, at an estimated cost of over $39 billion per year. Important 
advances have been made in prevention and acute care, yet the costs of 
TBI rehabilitation have been growing exponentially. This is in spite of 
the fact that few, if any, TBI rehabilitation modalities have been 
subjected to the degree of scientific scrutiny for efficacy and cost 
efficiency that is usually applied to other medical treatments. The 
escalating economic burden that TBI places on individual families, as 
well as on society, is unlikely to be controlled until this issue is 
resolved.
    The Conference Report on the Defense Appropriations Act for Fiscal 
Year 1992 (House Report 102-328) supported the Department of Defense 
(DoD) to start an initiative for DoD victims of head injuries. The 
DVHIP was established in February 1992, and funded in part by direct 
appropriations to DoD (Health Affairs) from Congress. The DVHIP 
represents a unique collaboration among the DoD, Department of Veterans 
Affairs (DVA), and the Brain Injury Association. DVHIP objectives 
ensure that all DVA-eligible TBI patients receive TBI-specific 
evaluation and follow-up, while at the same time collecting patient 
outcome data that will allow the DVHIP to compare the relative efficacy 
and cost of various TBI treatment and rehabilitation strategies, and to 
help define optimal care for victims of TBI.
    There are four DVA facilities participating in the DVHIP study. 
These are located in Palo Alto, California; Minneapolis, Minnesota; 
Richmond, Virginia; and, Tampa, Florida. The DVHIP would provide 
services at its DVA facilities only for those patients who are eligible 
for care within the DVA system. This excluded TRICARE/CHAMPUS patients 
from participation in the DVHIP. The demonstration project provided 
access to cognitive rehabilitation for TRICARE/CHAMPUS

[[Page 53274]]

patients between the ages of 17-55 years.
    Cognitive rehabilitation is a generic term lacking a standard 
definition. The term is used to describe varied systems of 
multidisciplinary services intended to remedy related cognitive, daily 
living and psychosocial ability impairments which are secondary to 
organic brain damage.
    The current state of the medical literature does not allow for a 
TRICARE/CHAMPUS benefit for cognitive rehabilitation in the treatment 
of TBI patients. The DVHIP is conducting a randomized, prospective 
trial that would hasten the answers to the current questions of the 
contribution(s), if any, of cognitive rehabilitation. The study will 
address the efficacy of cognitive rehabilitation versus traditional 
rehabilitation of beneficiaries with TBI (moderate to severe closed 
head injury) in prospective randomized clinical trials.

B. TRICARE/CHAMPUS Policy

    TRICARE/CHAMPUS cost shares TBI rehabilitative services such as 
speech therapy, physical therapy and occupational therapy. However, 
cognitive rehabilitation therapy, which is frequently provided as a 
component of TBI care, is considered unproven for brain injury under 
TRICARE/CHAMPUS.
    TRICARE/CHAMPUS, by regulation, does not approve payment for 
unproven procedures. Any change in the unproven status of cognitive 
rehabilitation in the treatment of TBI logically awaits the findings 
from well-controlled studies of clinically meaningful endpoints such as 
the DVHIP Demonstration Project.
    Because CHAMPUS relies upon outcome-based medical literature in the 
formulation of its coverage policy regarding cognitive rehabilitation, 
the DoD should assist with research protocols that will directly 
contribute to the body of science regarding cognitive rehabilitation. 
Extension of the demonstration project will assist in meeting clinical 
trial goals of the DVHIP study and arrival at conclusions regarding the 
safety and efficacy of cognitive rehabilitation in treatment of TBI.

C. Operation of the Demonstration

    The Extension of the Demonstration is projected to last for no more 
than two years. Under the Demonstration, DoD reimburses the four 
participating DVA facilities at a negotiated rate which covers all 
professional and institutional services associated with the inpatient 
bed days required for the initial evaluation, rehabilitation and 
subsequent re-evaluations of TRICARE/CHAMPUS patients. The beneficiary 
cost-shares applicable under TRICARE/CHAMPUS apply under the 
Demonstration Project.
    The TRICARE Management Activity provides for demonstration claim 
processing via specific contractual arrangement with a contractor. The 
contractors are not involved in clinical issues but direct patients to 
the nearest participating DVA facility for evaluation.

    Dated: August 28, 2000.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer Department of Defense.
[FR Doc. 00-22407 Filed 8-31-00; 8:45 am]
BILLING CODE 5001-10-M