[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Notices]
[Pages 38888-38890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13196]


-----------------------------------------------------------------------

DEPARTMENT OF DEFENSE

Office of the Secretary


TRICARE; Healthy Choices for Life Initiatives Demonstration 
Projects for TRICARE Prime Beneficiaries

AGENCY: Office of the Secretary, Department of Defense.

ACTION: Notice of Healthy Choices for Life Initiatives Demonstration 
Projects for TRICARE Prime Beneficiaries.

-----------------------------------------------------------------------

SUMMARY: This notice is to advise interested parties of demonstration 
projects that the Department of Defense Military Health System proposes 
to implement and evaluate under the Healthy Choices for Life 
Initiatives: A Tobacco Cessation Quitline Demonstration project and a 
Weight Management Demonstration project. The Tobacco Cessation 
Demonstration project is being done to measure the effectiveness of a 
toll-free telephone Tobacco Quitline alone, or when used in conjunction 
with prescription pharmacotherapy in curtailing or stopping the use of 
tobacco products by demonstration participants. This portion of the 
Demonstration will enable DoD to evaluate these selected interventions 
in a DoD beneficiary population and gather data for health care costs 
and utilization. The Demonstration will occur in four states: Colorado, 
Kansas, Missouri and Minnesota. The Tobacco Cessation Demonstration 
project will provide information that will enable DoD to determine 
whether behavior modification, either alone or with pharmacotherapy, 
should be added to the TRICARE Prime benefit for the treatment of 
patients who use or are dependent upon tobacco.
    The Weight Management Demonstration project will allow the DoD to 
determine the efficacy and acceptability of distance behavioral 
interventions and pharmacotherapy in producing and maintaining 
clinically significant weight loss in at-risk overweight or obese 
individuals. The Weight Management Demonstration project will occur in 
four states: Indiana, Illinois, Michigan, and Ohio. The Weight 
Management Demonstration project will provide information that will 
enable DoD to determine whether to seek a change in statute to 
authorize, as part of the TRICARE benefit, behavior modification either 
alone or with pharmacotherapy for the treatment of patients that are 
overweight or obese.
    Certain preventive care services not normally provided as part of 
basic program benefits under TRICARE are covered benefits when provided 
to TRICARE Prime enrollees. Tobacco cessation and weight loss programs, 
along with pharmacotherapy, are currently not benefits under either the 
TRICARE basic program or under TRICARE Prime. This demonstration will 
evaluate whether these services should be extended to Prime 
beneficiaries as additional preventive care benefits. These 
Demonstration projects are being conducted under the authority of 10 
U.S.C. 1092.

EFFECTIVE DATE: October 1, 2005.

FOR FURTHER INFORMATION CONTACT: LCDR Robert Fry, Office of the Chief 
Medical Officer, TRICARE Management Activity (TMA), 5111 Leesburg Pike, 
Skyline Five, Suite 810, Falls Church, VA 22041-3206, telephone (703) 
681-0064.

SUPPLEMENTARY INFORMATION:

A. Background

    By law, under 10 U.S.C. 1079(a)(13), TRICARE may cost share only 
medically or psychologically necessary care under the Basic Program. 
Under TRICARE Prime, TRICARE may also provide additional preventive 
health care benefits. One of the major priorities of the Assistant 
Secretary of Defense for Health Affairs is the Healthy Choices for Life 
Initiatives for a fit and ready force and healthy beneficiary 
population. Preventive health measures are an integral part of Healthy 
Choices for Life. Currently, uniform tobacco cessation and weight 
management programs for TRICARE Prime enrollees in the Military Health 
System (MHS) have not been established as a preventive benefit.

Tobacco Cessation

    Tobacco use is the leading cause of preventable death in the United 
States. It is responsible for 440,000 deaths annually nationwide, 
including 14,000 in the Department of Defense (DoD). The case for an 
expanded and comprehensive approach to tobacco cessation in the DoD is 
compelling. With estimated medical costs from tobacco use that exceed 
$1.6 billion per year and the observation of an alarming increase in 
smoking prevalence among young active duty service members, the need 
for a global and effective DoD strategy has never been greater. 
Research indicates tobacco use has a negative impact on readiness 
during wartime (for example, 20-50 percent reduction in night vision 
for smokers; deleterious effects of rapid nicotine withdrawal on 
cognitive function and visual acuity; significant decrement in tracking 
ability; and increased reaction times). Tobacco use also (1) puts

[[Page 38889]]

individuals at greater risk for pneumonia, asthma, and lung disease; 
(2) results in more hospitalization and lost work in young active duty; 
(3) degrades performance on physical fitness tests; and (4) increases 
likelihood of sustaining musculoskeletal injuries.
    The purpose of this demonstration is to determine that 
pharmacotherapy, proactive telephone Quitlines, and counseling are 
effective interventions in achieving tobacco cessation for the TRICARE 
eligible population. According to the Centers for Disease Control and 
Prevention (CDC), smokers are more likely to utilize telephone 
counseling than group or individual counseling, and high intensity 
interventions are more effective than lower intensity ones.
    TRICARE does not cover behavioral counseling for tobacco cessation, 
or medications used to facilitate tobacco cessation. Treatment of 
tobacco use/dependence is excluded by 32 CFR 199.4(g). The Tobacco 
Cessation Demonstration project will provide the opportunity to test 
the effectiveness of selected interventions in the DoD population 
before these interventions are considered for inclusion in the TRICARE 
Prime benefit.

Weight Management

    Obesity is a leading cause of preventable death in the United 
States, contributing to more than 112,000 deaths annually. All segments 
of the DoD population demonstrate upward weight trends with 
approximately 13 percent of active duty members, 34 percent of non-
active duty adults, and 19 percent of dependent DoD adolescents 
classified as obese according to National Institutes of Health 
criteria. Many high volume, high cost medical conditions, including 
diabetes, heart disease, back and joint pain, asthma, some cancers, and 
sleep apnea are related to obesity, and costs will increase as the DoD 
population ages.
    In 2004, the Centers for Medicare and Medicaid Services deleted 
policy language indicating that obesity is not a disease. Blue Cross/
Blue Shield of North Carolina recently decided to offer coverage of 
physician visits and nutritional counseling for weight loss. According 
to an America's Health Insurance Plans survey, 76 percent of surveyed 
U.S. health insurers covered nutritional counseling as part of their 
preventive services benefit.
    According to the 1998 National Heart Lung and Blood Institute 
(NHLBI) Guideline for the Identification, Evaluation and Treatment of 
Overweight and Obesity in Adults, a reduction in body weight of 10 
percent is an appropriate initial goal with six months cited as a 
reasonable period of time in which to achieve this goal (weight loss of 
1-2 pounds/week). Weight loss in the 5-10 percent range has been shown 
to produce health benefits for obese patients. Greater weight loss does 
not improve health outcomes and rapid weight loss is more likely to be 
followed by weight gain.
    After six months of successful weight loss the rate of weight loss 
usually declines or plateaus. Successful weight maintenance is defined 
as a regain of weight less than 6.6 pounds (3 kilograms) in 2 years.
    TRICARE does not cover nutritional counseling, behavioral 
counseling, or medication for weight loss. Treatment of obesity as a 
sole medical condition is excluded by statute (10 U.S.C. 1079(a)(11)) 
with the exception of bariatric surgery for morbid obesity when 
conditions for coverage under 32 CFR 199.4(e)(15) are met. Bariatric 
surgical procedures performed in the purchased care network have 
increased from 954 in 2001 to 3,415 in 2004. Facility costs associated 
with bariatric surgery made the top ten list for most expensive DoD 
Diagnosis Related Groups for the first time in fiscal year 2004, with 
$26 million in actual government costs. This does not include 
associated professional fees or the value of approximately 500 
additional procedures performed annually in the direct care system.
    Each military service offers behavioral and educational 
interventions to active duty service members exceeding body fat 
standards. These interventions are sometimes, but not universally, 
available to non-active duty beneficiaries depending on the resources 
of the Military Treatment Facility (MTF) or the local health promotion 
activity.

B. Description of Demonstration Project and Costs

    For the Tobacco Cessation Quitline Demonstration project, based 
upon information from DoD and CDC surveys, of the 101,000 Prime 
enrollees in the four states, we estimate that about 22,000 (or 21.8 
percent) are smokers. Treatment protocol costs are estimated at 
approximately $1.8 million. For the Weight Management Demonstration 
project, based upon information from DoD and CDC surveys in the four 
states, we estimate that about 45,000 Prime enrollees meet the 
definition (Body Mass Index greater than or equal to 25) for overweight 
or obese. Treatment protocol costs are estimated at approximately $3 
million.
    These demonstration projects are anticipated to start in the first 
quarter of fiscal year 2006 and continue for three years.

Tobacco Cessation Demonstration

    Location: The Tobacco Cessation Demonstration project will include 
four states--Colorado, Minnesota, Missouri, and Kansas--which have 
large numbers of Prime beneficiaries who are greater than 40 miles from 
an inpatient MTF within the same TRICARE Region. The Demonstration 
participants will be TRICARE eligible beneficiaries enrolled in TRICARE 
Prime, TRICARE Prime Remote (TPR), or TPR for Active Duty Family 
Members (TPR-ADFM), are between18-64 years of age, who are not entitled 
to Medicare on the basis of age, disability, or end-stage renal-
disease, and reside in the identified zip code areas of the 
demonstration. Beneficiaries enrolled in other special programs (for 
example, Extended Care Health Options (ECHO)) available through TRICARE 
are not eligible for enrollment in this demonstration. Eligible 
beneficiaries in the four state demonstration areas will receive a 
letter from the Tobacco Cessation Demonstration service provider 
explaining program elements, participation criteria, and how to enroll 
in the demonstration.
    Scope: The scope of services available through the program will 
include: (1) The availability of a proactive toll-free telephone 
Quitline; (2) the availability of a web-based tobacco cessation 
information resource; (3) prescription pharmacotherapy and physician 
visits with normal cost-shares; and (4) unlimited numbers of quit 
attempts.
    Key elements of the Tobacco Cessation Demonstration project include 
enrollment of participants and utilization of a Quitline plus access to 
scheduled telephone counseling. Additionally, the website will also 
provide links to DoD, Federal, and State resources for tobacco 
cessation. E-mail support will be available for questions and comments.
    Pharmacotherapy will be made available in all four states only 
through the TRICARE Mail Order Pharmacy (TMOP). Uniform formulary TMOP 
cost-shares will apply. To access pharmacotherapy, Prime enrolled 
beneficiaries in the four-state area must be enrolled in the 
demonstration program, see a provider, and obtain a prescription for 
appropriate tobacco cessation pharmacotherapy, and submit it to the 
TMOP.
    It will be necessary for Quitline personnel to make follow-up 
contact to program participants to evaluate the effectiveness of the 
program and to

[[Page 38890]]

determine tobacco-use status after program participation. This will 
require the Quitline personnel to obtain basic contact information on 
participants to allow for follow-up.
    There will be no limit on the number of times an eligible 
beneficiary will be allowed to participate in the program if they fail 
to stop using tobacco products or obtain a prescription for appropriate 
tobacco cessation pharmacotherapy during the demonstration period.

Weight Management

    Location: The Weight Management Demonstration will include Prime 
enrollees residing in Indiana, Illinois, Michigan and Ohio. These 
states have been selected in part on the basis of high prevalence of 
obesity and overweight in these areas, according to the CDC. The 
Demonstration participants will be TRICARE eligible beneficiaries 
enrolled in TRICARE Prime, TRICARE Prime Remote (TPR), or TPR for 
Active Duty Family Members (TPR-ADFM), are between18-64 years of age, 
who are not entitled to Medicare on the basis of age, disability, or 
end-stage renal-disease, and reside in the identified zip code areas of 
the demonstration. Beneficiaries enrolled in other special programs 
(for example, ECHO) available through TRICARE are not eligible for 
enrollment in this demonstration. Eligible beneficiaries in the four 
state demonstration areas will receive a letter from the Weight 
Management Demonstration service provider explaining program elements, 
participation criteria, and how to enroll in the demonstration.
    Scope: The scope of services available through the program will 
include: (1) Telephone and web-based counseling for weight management, 
and (2) prescription pharmacotherapy and physician visits with normal 
cost-shares. The physician visits are to evaluate the patient to insure 
patients who may be at cardiovascular risk or metabolic risk approve 
patient's participation in diet and exercise changes. Physician visits 
may also be used to manage medication in event titration is needed, or 
there are side effects.
    To access pharmacotherapy, Prime enrolled beneficiaries must see a 
provider, have a Body Mass Index >=30 or >=27 with other risk factors 
or diseases, and obtain a prescription for appropriate weight loss 
pharmacotherapy. Pharmacotherapy will be made available through TMOP 
only. Uniform formulary TMOP cost-shares will apply.

    Dated: June 29, 2005.
Jeanette Owings-Ballard,
OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 05-13196 Filed 7-5-05; 8:45 am]
BILLING CODE 5001-06-P