[Federal Register Volume 62, Number 145 (Tuesday, July 29, 1997)]
[Notices]
[Pages 40506-40507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19829]



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DEPARTMENT OF DEFENSE

Office of the Secretary


Civilian Health and Medical Program of the Uniform 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 parties of a demonstration project 
where the DoD will participate in the Defense and Veterans Head Injury 
Program (DVHIP) Protocol II Traumatic Brain Injury (TBI) 
Rehabilitation: A Controlled, Randomized Multicenter Study of Two 
Interdisciplinary Programs with Adjuvant Pharmacotheraphy. Under the 
demonstration, DoD will participate in a controlled trail of cognitive 
therapy for TBI at four participating Department of Veterans Affairs 
medical facilities. Participation in these clinical trails will provide 
access to cognitive rehabilitation for TRICARE/CHAMPUS beneficiaries 
when their conditions meet the study protocol edibility criteria. DoD 
financing of these procedures will assist in meeting clinical trail 
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, 1997.

FOR FURTHER INFORMATION CONTACT:
Mr. Tariq Shahid, Health Care Program Development Branch, Office of 
Civilian Health and Medical Program of the Uniform Services (OCHAMPUS), 
Aurora, CO, 80045-6900, telephone (303) 361-1401 or Ms. Ann Fazzini, 
Health Care Policy Analyst, Program Development Branch, OCHAMPUS, 
Aurora, CO 80045-6900, telephone (303) 361-1403.

SUPPLEMENTARY INFORMATION: 

A. Background

    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 scrunity 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 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 
standardized patient outcome data that will allow the DVHIP to compare 
the relative efficacy and cost of various TBI treatment and 
rehabilitations 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 can currently 
provide services at its DVA facilities only for those patients who are 
eligible for care within the DVA system. At present this excludes a 
significant number of TRICARE/CHAMPUS patients from participation in 
the DVHIP.
    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 
trail 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 of 364 patients. 
In addition, patients randomized into either the cognitive or the 
traditional rehabilitation program will be further randomized to 
receive pharmacotherapy or placebo. The pharmacotherapy will consist of 
methylphenidate if the patient is determined to be non-depressed and 
apathetic, and sertraline for all others.
    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. 
DoD financing of these procedures will assist in meeting clinical trial 
goals and arrival at conclusions regarding the safety and efficacy of 
cognitive rehabilitation in the treatment of TBI.

B. TRICARE/CHAMPUS Experience

    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 investigational under TRICARE/
CHAMPUS.
    TRICARE/CHAMPUS, by regulation, does not approve payment for 
experimental or investigational procedures. Any change in the 
experimental 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.
    Among TRICARE/CHAMPUS beneficiaries of all ages (5.4 million) 
approximately 5,000 have head injuries each year with 1,300-1,400 
requiring hospitalization.
    Overall CHAMPUS billed charges for 1,360 TBI admissions in Fiscal 
Year (FY) 1992 were approximately $31.1 million (or $1,908 per day), 
and the total allowed amount (i.e., the government payments and 
beneficiary cost shares) was almost $21.4 million (or $1,309 per day). 
This included acute and rehabilitation hospitalizations and skilled 
nursing home costs.
    CHAMPUS billed charges for 78 admissions in FY 1992 for services in 
rehabilitation hospitals were approximately $5.8 million (or $1,343 per 
day), and the total allowed amount was $5.46 million (or $1,247 per 
day). This represented about 4,378 rehabilitation hospital bed days.
    CHAMPUS billed charges for 31 admissions in FY 1992 for services in 
skilled nursing homes were approximately $2.2 million (or $930 per 
day), and the total allowed amount was approximately $2.15 million (or 
$902 per day). This represented about 2387 skilled nursing home bed 
days.
    Together, the total CHAMPUS cost for services in rehabilitation 
hospitals and in skilled nursing homes for beneficiaries with TBI in FY 
1992 was

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approximately $7.6 million for 109 admission requiring 6,765 bed days. 
The average length of stay was 62 days with an average per diem of 
$1,125 in FY 1992. Based on increases in the Consumer Price Index 
(Urban) for medical care, the average per diem for 1996 under CHAMPUS 
is estimated to be $1,320. This contrasts with a current estimated 
average cost of about $600 per day in participating VAMCs.

C. Caseload, Costs

    The design of the rehabilitation protocol is limited to patients 
between the ages of 17-55 years. CHAMPUS population projections for 
fiscal year (FY) 1996 included approximately 2.1 million beneficiaries 
between 17 and 55 years of age.
    This Demonstration Project is conservatively projected to provide 
inpatient rehabilitation services for approximately 100 TRICARE/CHAMPUS 
patients with TBI each year.
    The Demonstration Project involves the costs for the inpatient bed 
days required for the initial evaluation, rehabilitation and subsequent 
re-evaluations at the participating DVA facilities. The beneficiary 
cost-shares applicable under TRICARE/CHAMPUS shall apply under the 
Demonstration Project.
    On average, each TRICARE/CHAMPUS beneficiary participating in the 
clinical trials would require about three bed days for evaluation for 
the protocol, sixty bed days for the rehabilitation services, and five 
bed days each for the post-discharge evaluation and three follow-on re-
evaluations. Over the entire Demonstration Project each participant 
would require about eighty-three bed days.
    The current annual CHAMPUS costs for 100 admissions in 
rehabilitation hospitals and skilled nursing facilities for the 
beneficiaries with TBI are estimated to be $8.18 million. This 
contrasts with the estimated cost of $4.38 million for 100 admissions 
during the first year of the demonstration. This represents a projected 
cost avoidance of approximately $3.8 million to DoD during the first 
year of the demonstration while providing access to rehabilitation 
services for the beneficiaries.

D. Operation of the Demonstration

    The Demonstration is projected to last for three years. The 
Assistant Secretary of Defense (Health Affairs) will designate a 
Project Officer in the Office of the Deputy Assistant Secretary of 
Defense (DASD) for Clinical Services. The DASD (Clinical Services) 
provides oversight for the DVHIP operations.
    Office of CHAMPUS will provide for demonstration claim processing 
via specific contractual arrangement with a claims processor. The 
contractor would not be involved in clinical issues but will direct 
patients to the nearest participating DVA facility for evaluation.

    Dated: July 21, 1997.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 97-19829 Filed 7-28-97; 8:45 am]
BILLING CODE 5000-04-M