40506 Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Notices

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.

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
Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Notices 40507

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 reevaluations 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 reevaluations. 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

DEPARTMENT OF DEFENSE

Office of the Secretary

Privacy and Security on Publicly

Accessible DoD Internet Services

AGENCY: Department of Defense, Office

of the Secretary of Defense (Public

Affairs).

ACTION: Notice.

SUMMARY: This is a voluntary notice by

the Department of Defense to inform

those who use publicly accessible

defense information on the Internet

what measures are being taken to gather

information about visits and to protect

the integrity of Department of Defense

Internet systems. Effective immediately,

the DoD changing its notice to users to

notify them of what we are doing and

why.

FOR FURTHER INFORMATION CONTACT: Mr.

Richard Silva, OASD(PA), Room 2E791,

1400 Defense Pentagon, Washington, DC

20301–1400 or on-line via the

DefenseLINK message form at http://

www.dtic.mil/defenselink/faq/

comment.html.

SUPPLEMENTARY INFORMATION: In its

ongoing efforts to provide open, honest

and accurate information to the public,

the Department is hereby notifying

those who use publicly accessible

defense information on the Internet

what measures are being taken to gather

information about visits and to protect

the integrity of Department of Defense

Internet systems and why it is necessary

to do so.

First, most World Wide Web services

record information about web site visits

for site management purposes. DoD uses

industry-standard software to gather

basic data about web site visits. This

data is used for site management

purposes, such as assessing what

information is of most and least interest

to users, determining technical design

specifications, and identifying system

performance or problem areas.

Second, computer vandalism has

become an ever increasing problem over

the past few years. These attacks can

lead to the alteration of information that

is used and trusted by millions of

people. It is becoming more and more

important for the Department to take a

more proactive role in protecting its

computer systems from these attacks.

Therefore, to insure that the DoD public

web services remain available to all

users and to protect them from

fraudulent, unlawful or abusive use, the

Department is employing industrystandard methods to monitor network

traffic to identify unauthorized attempts

to upload or change information, or

otherwise cause damage.

No other attempts are made to

identify individual users or their usage

habits. Raw data logs are used for no

other purposes and are scheduled for

regular destruction in accordance with

National Archives and Records

Administration General Schedule 20.

Third, the Department is publishing

the attached ‘‘privacy and security

notice’’ on its publicly accessible

Internet systems to inform users what

we are doing and why.

DefenseLINK (http://www.dtic.mil/

defenselink/) is the official World-Wide

Web Information Service from the

Department of Defense and is the

starting point for locating U.S. defense

information around the world. The

purpose of DefenseLINK is to provide

the public with a single, unified starting

point for information about the

Department of Defense, its organization

and its functions. DefenseLINK provides

direct access to the Information Services

established by each military service.

These Defense World Wide Web

services contain many Defense

publications, answers to frequently

asked questions about the department,

news releases and photographs.

Information within these public access

services may be distributed or copied.

Use of appropriate byline/photo/image

credits is requested.

Below is the new privacy and security

notice being implemented on all DoD

publicly accessible Internet systems.

Link from Index.html pages—‘‘Please

read this privacy and security notice.’’

( )—indicates sections to be tailored

at the installation level.

[ ]—indicates hyperlinks.

*—indicates information located at

the hyperlink destination indicated.

Privacy and Security Notice

1. (DefenseLINK) is provided as a

public service by the ([Office of the

Assistant Secretary of Defense-Public