[Federal Register: July 6, 2005 (Volume 70, Number 128)]
[Notices]
[Page 38888-38890]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jy05-60]
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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.
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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
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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
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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