05-13196. 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 [phone].

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 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 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.