00-22407. 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.

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 [phone].

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 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.