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Organization: American Diabetes Association
Date: 04/10/2011
The American Diabetes Association is pleased to submit comments to the Centers for Medicare and Medicaid Services on the National Coverage Analysis for Intensive Behavioral Therapy for Obesity. We support this effort to expand Medicare coverage for preventive services to include effective interventions for obesity, a recognized risk factor for diabetes, stroke, heart disease and many other conditions. In the United States, nearly 26 million Americans have diabetes and 79 million adults have prediabetes. We are truly in the midst of a diabetes epidemic. Because obesity increases the risk for prediabetes and diabetes, it is important we simultaneously address the widespread prevalence of obesity as we work to stem the rising tide of diabetes. The causes of obesity are complex and multifactoral and thus a comprehensive approach in communities and nationwide is required, including increasing access to evidence-based interventions to address obesity and diabetes. Behavioral interventions are one of several effective ways to assist people with weight management.
Behavioral interventions promoting weight loss have been shown to prevent or delay the development of type 2 diabetes. There is significant evidence that the onset of type 2 diabetes can often be prevented or delayed by counseling and support for modest weight loss and physical activity, as shown in the Diabetes Prevention Program (1,2). The evidence base for lifestyle intervention is strong for people with prediabetes, an asymptomatic condition that requires screening to detect. Physical activity and behavior modification are important components of weight loss programs and are most helpful in maintenance of weight loss (3).
Due to the effects of obesity on insulin resistance, weight loss is an important therapeutic objective for overweight or obese individuals with prediabetes or diabetes (3). In overweight and obese insulin-resistant individuals, modest weight loss has been shown to reduce insulin resistance. Behavioral interventions promoting weight loss can improve glycemic control and reduce cardiovascular risk factors in those with diagnosed diabetes (3). The Look AHEAD (Action for Health in Diabetes), a large clinical trial to determine whether long term weight loss improves glycemia and prevents cardiovascular events in people with type 2 diabetes, showed an intensive lifestyle intervention resulted in weight loss, significant reduction in blood glucose levels, and reduction in several cardiovascular risk factors (3,4). Notably, benefits endured after 4 years (5).
Thank you for the opportunity to submit comments.
References
1. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM, Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. NEJM 2002;346:393-403.
2. Ackermann RT, Finch EA, Brizendine E, Zhou H, Marrero DG. Translating the Diabetes Prevention Program into the community: the DEPLOY Pilot Study. Am J Prev Med 2008;35:357-363.
3. American Diabetes Association. Standards of Medical Care in Diabetes – 2011. Diabetes Care 2011;34(S1):S11-S61.
4. Look AHEAD Research Group, Pi-Sunyer X, et al. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care 2007;30:1374-1383.
5. Look AHEAD Research Group. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four year results of the Look AHEAD trial. Arch Intern Med 2010;170:1566-1575.
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Title: Clinical Health Psychologist
Date: 03/24/2011
In the United States, increased obesity rates are seen among minorities and those of lower income. As commercial carriers tend to follow Medicare guidelines in regards to coverage, our current reimbursement system places the burden of the cost of obesity treatment DIRECTLY UPON THOSE WHO CAN LEAST AFFORD IT.
Or, to state my opinion more accurately, our current reimbursement system essentially blocks access to obesity treatment for the vast majority of individuals in need of treatment -- this despite the well-established adverse consequences of obesity on health and quality of life and associated increases in health care costs.
Current recommendations from the Agency for Healthcare Research and Quality (AHRQ) has pointed out that are that the most effective intervention for promoting healthy dietary and physical activity changes are those combine nutrition education, dietary & activity counseling AND behavioral (i.e., psychological) strategies – with high frequency contact with the patient for AT LEAST 3 months and subsequent follow-up over a longer term.
The importance of the inclusion of behavioral/psychological strategies is also included in the USPSTF’s recommendations for children and adolescents.
I would also suggest that individuals who are overweight (e.g., BMI between 25 – 29.9) be targeted and covered for treatment before they become obese. Individuals in the overweight category are already at increase risk of comorbidities and tend to incur increased healthcare costs. Simply preventing overweight individuals from becoming obese individuals is a worthy goal of treatment.
Who Should Provide Intensive Behavioral Treatment:
Due to the extremely complex interplay between multiple factors (e.g., body image, self-esteem, degree of social support, home & work environment, physiology, disordered eating, etc etc etc), I recommend that intensive behavioral therapy be provided by those who have completed graduate training in psychology or a closely related field.
Preferably, services would be provided by a licensed mental health care provider (psychologist, psychiatrist, licensed psychiatric nurse practitioner, master's level health coach, licensed professional counselor) who can demonstrate professional training and experience in this area.
What Should Intensive Behavioral Treatment Consist Of:
A 2008 update to the Cochrane Systematic Review “Psychological interventions for overweight or obesity” (Shaw et al) concludes that “people who are overweight or obese benefit from psychological interventions, particularly behavioural and cognitive-behavioural strategies, to enhance weight reduction. They are predominantly useful when combined with dietary and exercise strategies. The bulk of the evidence supports the use of behavioural and cognitive-behavioural strategies.”
Motivational Interviewing has repeatedly demonstrated to be an effective approach for promoting behavior change.
Mindfulness-based approaches are extremely useful as well.
My read of the literature, combined with almost 20 years of clinical experience in this field, has led me to firmly believe that no one approach is right for every patient -- thus, the need for a well-trained clinician.
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Title: Vice President, Policy Initiatives and Advocacy
Organization: American Dietetic Association
Date: 04/10/2011
April 10, 2011
Sarah McClain, MHS
Joseph Chin, MD, MS
Centers for Medicare and Medicaid Services
Centers for Medicare and Medicaid Management
7500 Security Blvd.
Baltimore, MD 21244
Dear Ms. McClain & Dr. Chin:
The American Dietetic Association (“ADA”), representing over 71,000 registered dietitians (“RDs”), provides the following comments in response to the internally generated national coverage analysis (“NCA”) regarding intensive behavioral counseling for obesity. ADA propones such coverage as it supports the government’s role in improving the nation’s nutrition and in promoting comprehensive health care. While ADA understands intensive behavioral counseling for obesity stretches over multiple disciplines and is pertinent to various providers, this letter will solely focus on the benefits of RD-provided nutrition counseling that is a component of this NCA topic. Of significant note, however, is the effective interplay between the various providers and a cross-disciplinary approach with regard to intensive behavioral counseling for obese patients. Consequently, ADA asserts that this NCA should address nutrition services, MNT provided by RDs to individuals who are pursuing weight loss and also weight loss programs or bariatric surgery programs that include a multi-disciplinary team to address weight loss.
I. Frequency and Effectiveness of Medical Nutrition Therapy (“MNT”) for Intensive Behavioral Counseling for Obesity
An essential component of comprehensive health care is to have RDs provide intensive behavioral counseling for obesity through MNT. Beneficiaries with a variety of conditions and illnesses, including obesity, can improve their health and quality of life by receiving MNT. An MNT intervention includes counseling on behavioral and lifestyle changes required to impact long-term eating habits and health. As part of an MNT intervention, RDs perform the following steps: (i) a comprehensive nutrition assessment determining the nutrition diagnosis; (ii) a plan and implementation of a nutrition intervention using evidence-based nutrition practice guidelines tailored to meet the patient’s needs and interests; and (iii) an evaluation and on-going monitoring of a beneficiary’s progress over subsequent visits with the provider.
Beneficiaries who receive RD-provided nutrition counseling and interventions exhibit significant improvements in weight and re-structured behaviors that impact long-term weight management. Studies show MNT provided by an RD to overweight and obese adults for less than six months yields significant weight losses of approximately one to two pounds per week. MNT provided from six to twelve months yields significant mean weight losses of up to 10% of body weight with maintenance of this weight loss beyond one year.
Overweight/obese individuals who received MNT provided by RDs (an average of 2.6 visits) in addition to an obesity-related health management program that included physician visits, nursing support, education materials and tools, were more likely to achieve clinically significant weight loss than individuals who did not receive MNT. This study demonstrates the health benefits associated with the addition of MNT to a health management program.
The Adult Weight Management Guidelines provide that the optimal length of weight management therapy, i.e., MNT for weight loss, should last at least six months or until weight loss goals are achieved, with implementation of a weight maintenance program after that time. A greater frequency of contacts between the patient and practitioner may lead to more successful weight loss and maintenance. Further studies of the frequency of MNT that include individuals from the Medicare age population are detailed below.
a. Effectiveness of Medical Nutrition Therapy (MNT) for Six Months to One Year
In a positive-quality cohort study by Eilat-Adar et al, 2005, in Israel, 1,669 overweight subjects, aged 50 to 75 years, received nutrition counseling from a RD to support the medical recommendation to lose weight. Nutritional supervision lasted at least 10 weeks and included two to five meetings during the first three months and at least one visit every three months, up to 24 months for all participants. Diets for overweight subjects were based on the National Cholesterol Education Program, American Diabetes Association and American Dietetic Association guidelines and considered the person's lifestyle. Outcomes were documented over four years by repeated weight measurements and by medical record verification. Mean weight loss after six months on the diet was 5.0±4.3kg. As seen from this study, there is a significant association between MNT intervention and eventual weight loss for obese individuals.
Additionally, in a neutral-quality nonrandomized clinical trial in Israel by Feigenbaum et al, 2005, 225 obese subjects were divided into three groups according to their preference. Patients in Group A received individualized reduced-energy diets and orlistat (120mg three times daily) and met with a family practitioner and an RD every two weeks. Patients in Group B received a general reduced-energy diet and orlistat (120mg three times daily), and met with only the family practitioner every four weeks. Patients in Group C received individualized reduced-energy diets and met with the RD once per month. 204 subjects completed the trial. Weight loss was 5.12kg in group A, 7.8kg in group B, and 3.12kg in group C. The percentage of patients who attained their weight reduction goals was higher in group A than in groups B and C (51%, 13% and 9%, respectively, P<0.001). This study exemplifies the positive effect when various providers practice as a team as opposed to an individualized approach.
b. Effectiveness of Medical Nutrition Therapy (MNT) for One Year and Beyond
In a positive-quality randomized clinical trial in the United States by Sacks et al, 2009, 811 overweight and obese subjects were randomized to one of four diets: Low-fat, average-protein (20% fat, 15% protein, 65% carbohydrate), low-fat, high-protein (20% fat, 25% protein, 55% carbohydrate), high-fat, average-protein (40% fat, 15% protein, 45% carbohydrate) or high-fat, high-protein (40% fat, 25% protein, 35% carbohydrate). RDs and behavioral psychologists provided group and individual sessions for a period of two years. 645 subjects completed the trial (80%), and mean weight loss was 4.0kg. Approximately 15% of the participants had a reduction of at least 10% of their body weight and there were no significant differences in weight loss among groups.
As noted by the data from these studies, intensive behavioral counseling for obesity, including MNT provided by RDs as part of a team-based approach, over six months to one year and beyond has a significant positive impact on obese individuals. Additionally, in accordance with the Adult Weight Management Guidelines, the nutrition counseling should last at least six months or until the weight loss goals are achieved.
c. Bariatric Surgery Beneficiaries
There are those beneficiaries who suffer from such a severe level of disease and who have failed in other less invasive interventions that require surgery. These beneficiaries are at high risk for obesity-related morbidity and mortality and therefore, must seek alternative methods. From 1983 to 2000, this group of people has increased 400%. All data indicate that for the morbidly obese, bariatric surgery is the most effective therapy available for weight management and can result in improvement or resolution of the obesity-related comorbidities and improved quality of life. Although surgery may be imperative when the beneficiary has reached a certain stage and met specific requirements, intensive behavioral counseling for obesity as it relates to nutrition is compulsory both prior to and following the surgical procedure(s).
The role of nutrition is extremely important during the pre-surgical screening to evaluate weight history, efforts to lose weight, food preferences and food-related behaviors (i.e., binge eating) to assist in electing the optimal procedure for the beneficiary. The beneficiary must be informed of lifestyle changes needed to decrease postoperative complications and maintain weight loss. Weight loss surgery is most effective when accompanied by pre-and postoperative comprehensive therapy to alter behaviors such as eating, smoking and exercise. Post-surgery, intensive behavioral counseling for obesity with regards to nutrition is vital in promoting lasting behavioral changes in dietary and supplementary requirements. This therapy augments the probability of long-term success and is a standard component of surgical weight management. Of note, all procedures require lifelong medical follow-up and monitoring to avoid and manage possible complications leading to more severe damage to the beneficiary’s health.
II. Qualified Providers
It is imperative to recognize the integral part nutrition plays in the prevention and treatment of chronic diseases. The role of nutrition in health promotion, disease prevention and disease management has become a progressively more significant public health issue. Overweight and morbid obesity runs rampant in the United States. In fact, it is considered to be one of the leading causes of deaths of adults. In preventing chronic diseases, nutrition and diet must be incorporated into a daily regimen.
a. The Role of Nutrition and RDs
Intensive behavioral counseling for obesity that focuses directly on the beneficiaries’ nutritional assessment and requirements should be provided by an RD. RDs have expertise in delivering nutrition counseling, cognitive behavioral strategies and MNT services for prevention, wellness and disease management. The type of nutrition care services RDs provide requires advanced skills beyond those of other professionals. RDs have the education background, training and skill to provide individualized nutrition education, counseling and services based on a comprehensive nutrition assessment to prevent and manage chronic diseases. As part of their services, RDs provide specific, focused and unique prevention and treatment plans for beneficiaries. RDs use anthromopometric, biochemical, clinical and dietary intake data to assess individual status. It is the integration of these key factors and clinical judgment that sets the RDs apart from other providers. This individualized treatment results in better health outcomes for patients.
By using RD-expertise and extensive training, both academically and clinically, RDs deliver care that is coordinated and cost-effective in a variety of chronic diseases, such as obesity, hypertension, diabetes, disorders of lipid metabolism, HIV infection, unintended weight loss in older adults and chronic kidney disease. As evidenced, nutrition education, nutrition assessment, nutrition counseling and nutrition interventions are examples of the unique knowledge, training and skills RDs possess and prove to provide unmatched value to beneficiaries. By utilizing RDs knowledge and education, beneficiaries can understand daily dietary needs and ultimately, decrease weight in obese individuals.
b. Registered Dietitians as Cost-Effective Providers
Further, RDs are the most cost-effective, qualified healthcare professional to provide MNT and nutrition services. Evidence has shown that involvement by RDs in beneficiary care prove to have a substantial effect on both the health of the beneficiary as well as cost savings. For example, the Massachusetts General Hospital reported that participants receiving group MNT in a 6-month randomized study had a 6% decrease in total and LDL-cholesterol levels, compared with the group not receiving MNT. The non-MNT group had no reduction in total cholesterol or LDL levels. The study additionally identified a savings of $4.28 for each dollar spent on MNT, demonstrating that MNT costs much less than the cost of other therapeutic methods.
Additionally, according to Wolf, et. al, for every dollar an employer invests in the lifestyle modification program for employees with diabetes, the employer would see a return of $2.67 in productivity. Dietary counseling and nutrition care process services provided by RDs also impact productivity; the study indicated the RD led lifestyle intervention provided to patients with diabetes and obesity reduced the risk of having lost work days by 64.3% and disability days by 87.2%, compared with those receiving usual medical care. These studies demonstrate cost-savings and benefits of RD-provided dietary and nutrition counseling.
III. ¬ Conclusion
In sum, intensive behavioral counseling for obesity as related to nutrition has a significant impact on individuals suffering from this chronic disease. RDs are experts in providing such focused nutrition counseling both individually as well as part of a cross-disciplinary team.
We encourage CMS to consider intensive behavioral counseling for obesity with regards to nutrition and RDs as providers of such services. Please do not hesitate to contact Jeanne Blankenship (202-775-8277 ext. 6004 or email: jblankenship@eatright.org) or Prashanthi Rao Raman (312.899.4734 or email: dcconsultant2@eatright.org) with any questions or requests for additional information.
Sincerely,
Jeanne Blankenship, MS, RD, CLE
Vice President, Policy Initiatives & Advocacy
American Dietetic Association
Prashanthi Rao Ramen, MPH, Esq.
Regulatory & Legal Consultant
American Dietetic Association
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Title: EVP, Clinical Affairs and Strategic Planning
Organization: America's Health Insurance Plans (AHIP)
Date: 04/07/2011
Sarah McClain, MHS
Lead Analyst
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850
Dear Ms. McClain:
Thank you for the opportunity to
comment on the Centers for Medicare and Medicaid Services’ (CMS’s) national
coverage analysis (NCA) tracking sheet for
intensive behavioral therapy for obesity (IBTO) (CAG-00423N). America’s Health
Insurance Plans (AHIP) is the national association representing nearly 1,300
health insurance plans providing coverage to more than 200 million Americans.
We are pleased to submit these comments on behalf of our members.
General Comments
AHIP and our member plans support CMS’s efforts to ensure
that Medicare beneficiaries receive access to safe and effective preventive
health services, procedures, and treatments that can improve health outcomes,
as determined by current and robust clinical evidence. Health insurance plans
have a long-standing commitment to preventive services and provide coverage for
services recommended by the U.S. Preventive Services Task Force (USPSTF). While
health plans have been implementing the USPSTF recommendation on screening and
behavioral interventions around obesity, there are several issues that CMS
should address prior to determining coverage for IBTO.
Because the USPSTF aims to update its recommendations every
five years[1]
and the recommendation prompting this NCA was last published in 2003, CMS
should confer with AHRQ and the Task Force regarding the next evidence review
for this topic and possible date when the recommendation will be reconsidered.
This recommendation is currently listed as a topic in the review process[2] on
the USPSTF web site. It is important that CMS coverage policy align with the
updated USPSTF recommendation.
The 2003 USPSTF recommendation was based on reviews that
included programs that used non-licensed providers, including health educators
and case managers, as well as dietitians, psychologists, nurses and physicians.
The durations of the programs were varied, ranging from 12 weeks to 12 months, while
some extended beyond a year. While the IBTO approach may benefit some patients,
there are no data regarding the benefit of IBTO from a population
standpoint.
If implemented, our members believe that this intervention
must be considered utilizing medical necessity guidelines based on scientific
evidence with established thresholds for appropriate patients, including visit
frequency and defined goals over a defined time frame, and criteria specifying
the appropriate licensed professionals to provide IBTO. CMS should consider developing
a certification program to identify providers whose IBTO programs offer the
elements described by the USPSTF in the forthcoming evidence review and
recommendation.
AHIP’s member health insurance plans have implemented and
operationalized the USPSTF 2003 recommendation on screening and behavioral
interventions for obesity. However, given the number of unresolved issues
referenced above and the need for clarification on these issues prior to
implementation of IBTO nationally, additional information is needed for our
industry to comment further on this proposed NCA. We urge CMS to work with AHRQ
and the USPSTF to ensure the evidence reviewed and recommendations align.
Thank you for the opportunity to
comment on this important issue.
Sincerely,
/s/
Carmella Bocchino
Executive Vice President
Clinical Affairs and Strategic
Planning
[1] U.S. Preventive Services Task
Force Procedure Manual. AHRQ
Publication No. 08-05118-EF, July 2008. http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanual2.htm
[2] Topics in
Progress. U.S. Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/uspstf/topicsprog.htm
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Title: President
Organization: TOPS Club Inc.
Date: 04/07/2011
TOPS Club, Inc. supports the recommendation of the USPSTF that intensive behavioral counseling for obesity be given a “B” rating. This recommendation underscores the panel’s confidence in the effectiveness of behavioral counseling, and agreement that the frequency of behavioral counseling needed to be effective is once per week for a minimum of 12 weeks. This is defined as high intensity. Reduction in either frequency or duration of counseling is associated with reduced efficacy.
We further agree that evidence-based community group counseling by trained lay providers is an effective and economical way to provide highly rated intensive behavioral counseling for obesity.
We base our support of these recommendations on over sixty-two years of the results of providing tools and training to volunteer lay leaders of tens of thousands of support groups of hundreds of thousands of members. In addition, we offer for consideration a report in the September 2010 Obesity Magazine by Dr. Nia Mitchell et al of the University of Colorado on the effectiveness of the TOPS Club, Inc. lay leader approach compared to commercial organizations .
In addition, we acknowledge that the obesity epidemic and associated weight-related chronic diseases are creating a looming health care crisis, which requires that all health stakeholders deploy the full range of effective, scalable, and scientifically proven obesity tools.
Sincerely,
Barbara Cady, President
Nia S. Mitchell, L. Miriam Dickinson, Allison Kempe, Adam G. Tsai. Determining the Effectiveness of Take Off Pounds Sensibly (TOPS), a Nationally Available Nonprofit Weight Loss Program. Obesity, 2010; DOI: 10.1038/oby.2010.202
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Title: Executive Director
Organization: The Obesity Society
Date: 04/10/2011
April 10, 2011
Sarah McClain, MHS
Joseph Chin, MD, MS
Centers for Medicare and Medicaid Services
Centers for Medicare and Medicaid Management
7500 Security Blvd.
Baltimore, MD 21244
Dear Ms. McClain & Dr. Chin:
These comments are submitted on behalf of The Obesity Society (TOS), a multi-disciplinary scientific organization representing basic and clinical scientists, physicians and nurses, registered dietitians, psychologists, as well as individuals with policy expertise (economists, public health professionals, and others). TOS has long advocated for improved access to obesity treatment within settings of routine clinical care. TOS believes intensive behavioral therapy for obesity is an intervention that has been documented to produce sufficient weight loss to improve a number of weight-related health conditions. We welcome coverage of this important intervention as a crucial preventive service that should improve health and, over the long term, reduce subsequent health care expenses.
We interpret “intensive behavioral therapy for obesity” (as used in the National Coverage Analysis call for comments) as being synonymous with “intensive counseling and behavioral interventions to promote sustained weight loss” (as used in the USPSTF 2003 recommendations). In that latter document, this was further described as “high-intensity counseling—about diet, exercise, or both—together with behavioral interventions aimed at skill development, motivation, and support strategies.”
Frequency of Counseling
The 2003 guidelines from the U.S. Preventive Services Task Force specify that weight loss counseling should be provided at least twice monthly for the first three months.1 The USPSTF guidelines do not specify an upper limit of treatment intensity. Data from multi-center clinical trials of obesity treatment indicate that patients undertaking weight loss with lifestyle modification (i.e., the combination of diet, exercise, and behavioral treatment) can lose weight continuously for at least 6 months before a natural plateau occurs.1-7 In most of these trials, treatment occurred on a weekly or every other week schedule. TOS supports the 2003 USPSTF guidelines and additionally suggests that intensive weight loss counseling should include up to a maximum of weekly or every other week treatment for up to 6 months.
Types of Providers
Obesity is a medical condition with a multiplicity of causes and a multiplicity of effects, which often requires interventions in a number of areas including diet, exercise, and behavior modification. Effective treatments have been developed with input from specialists in these areas and in medicine. Accordingly, individuals qualified to provide intensive counseling for obesity may come from a variety of backgrounds, so long as they are properly trained in obesity and its management. TOS believes that individuals from a number of disciplines (including registered dietitians, clinical psychologists, nurses, physicians, exercise scientists) are all potentially qualified to provide intensive behavioral weight loss counseling, so long as they have received specific obesity or weight management training and follow evidence-based protocols, guidelines and approaches. We suggest that Medicare should reimburse these qualified providers for intensive treatment of obesity.
Definition and documentation of adequate training in obesity management may vary by provider group. Registered dietitians (RDs) that treat obesity8 can obtain an adult weight management certification program offered by the American Dietetic Association to its members. A coming physician certification, the “Certified Medical Obesity Physician”, or COMP, will allow providers to gain comprehensive expertise in the treatment of obesity. This certification program is being developed by 14 medical and scientific professional societies, including TOS, the American Heart Association, and the American Diabetes Association. In all fields it will be necessary to develop means of designating approved specialty training.
As noted above, the USPSTF recommendations properly describe the focus and content of intensive counseling and behavioral interventions as including a number of areas (e.g., diet, exercise, behavior modification). With providers who are properly trained in obesity and weight management, it is not necessary that a given provider’s services be limited to his/her professional discipline. For example, although clinical psychologists have pioneered the development and evaluation of rigorous behavior modification for treatment of obesity, they can also learn the elements of nutrition recommendations that are appropriate for weight management. Similarly, dietitians, physicians and others can learn to deliver the basic behavior modification strategies that form the backbone of proven weight loss interventions. Thus, so long as trained providers are working within a proven treatment approach and not practicing outside the bounds of their licenses, they should be able to deliver all of the basic elements of a comprehensive behaviorally based weight loss intervention. This approach has been shown to be effective in multi-center trials of structured, protocol-driven behavioral programs such as the Look AHEAD Trial,4, 9 where group leaders and lifestyle counselors included dietitians, psychologists, diabetes nurse educators, and social workers.
Types of Patients
At least three types of patients could potentially undergo treatment in an “obesity practice” (e.g., a practice with a certified physician, dietitian, and/or co-practicing psychologist). One group includes patients undertaking weight loss for the purpose of treating co-morbid conditions, such as diabetes, hypertension, dyslipidemia, obstructive sleep apnea, and osteoarthritis. A second group of patients includes individuals required by their insurance plan to undertake 6 months of medically supervised weight loss before having bariatric surgery. [Patients undergoing bariatric surgery, in particular gastric bypass, should ideally be followed on a routine long-term basis for the development of nutritional deficiencies. These individuals would ideally be followed in such an “obesity practice.”] A third group includes patients being treated with medically supervised low-calorie or very-low-calorie diets, as well as patients treated with pharmacotherapy for weight loss (e.g., phentermine, orlistat).
Obesity Treatment in the Elderly
In the past, there has been controversy about the risks and benefits of weight loss in an elderly age group (65 and older). However, a just published study supports the view that moderate weight loss among obese persons aged 65 and older improves physical function and overall health.10 Two large multi-center trials, the Diabetes Prevention Program and the Look AHEAD Trial, included substantial numbers of participants over the age of 65, with similar health benefits of weight loss accruing to elderly participants and younger participants.
Summary
TOS supports intensive treatment for obesity, delivered on a frequency up to once per one or two weeks for at least six months, and provided by appropriately trained clinicians who have received specific obesity or weight management education and follow evidence-based protocols, guidelines and approaches. Please do not hesitate to contact our leadership (Jennifer Lovejoy, PhD, president of TOS; jennifer.lovejoy@freeclear.com; or Ted Kyle, RPh, MBA, chair of the TOS Advocacy Task Force; ted.kyle@conscienhealth.org) for additional information.
References
1. U.S. Preventive Services Task Force. Screening for obesity in adults: recommendations and rationale. Ann Intern Med. 2003;139(11):930-932.
2. Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393-403.
3. Knowler WC, Fowler SE, Hamman RF, et al. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009;374(9702):1677-1686.
4. Look AHEAD Research Group. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010;170(17):1566-1575.
5. Foster GD, Wyatt HR, Hill JO, et al. Weight and metabolic outcomes after 2 years on a low-carbohydrate versus low-fat diet: a randomized trial. Ann Intern Med. 2010;153(3):147-157.
6. Sacks FM, Bray GA, Carey VJ, et al. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med. Feb 26 2009;360(9):859-873.
7. Svetkey LP, Stevens VJ, Brantley PJ, et al. Comparison of strategies for sustaining weight loss: the weight loss maintenance randomized controlled trial. JAMA. 2008;299(10):1139-1148.
8. Ashley JM, St Jeor ST, Schrage JP, et al. Weight control in the physician's office. Arch Intern Med. 2001;161(13):1599-1604.
9. Pi-Sunyer X, Blackburn G, Brancati FL, et al. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care. 2007;30(6):1374-1383.
10. Villareal DT, Chode S, Parimi N, et al. Weight loss, exercise, or both and physical function in obese older adults. N Engl J Med. 2011;364(13):1218-1229.
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Date: 03/15/2011
I am medical director of the Vanderbilt center for Integrative Health.
I strongly support this innitiative to provide behavioral counselling for the obese. Initial contact should be for 1 hour.I believe there should be weekly contact for 4 weeks and then every 2 weeks for 4 weeks then every month for 12 months.
Health Coaches would be the ideal professional for this service.
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Title: Health Scientist
Organization: CDC
Date: 03/14/2011
Given the importance of physical activity as it relates to obesity, and given the difficulty of extracting the effects of counseling on increasing physical activity as opposed to changing nutritional behavior, it would seem important to provide counseling for these behaviors separately.
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Title: Director of Psychological Services
Organization: Vanderbilt center for Integrative health
Date: 03/15/2011
Intensive behavior Therapy is most effective when paired with family systems work so the person is supported by community, mindfulness work so the person is more aware of the emotional issues that may reinforce the unhealthy habits and emotional suffering that impedes health, and a group aspect so each person can have support as well as a place to learn new skills and habits in a safe environment with a skilled facilitator. Once weekly one on one, with group weekly that would include mindfulness skills, sharing, body image issues and some movement so the person can start to exercise with a cohort and a check in via phoen or email for about 6 months with then monthly follow-up for another year to maintain changes is the minimum required. The obstacles to make these changes are huge and the recidivism rate is too high when not intensive up front with more than a year follow-up.
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Title: Executive Director, Government Affairs & Public Po
Organization: Eisai Inc.
Date: 04/08/2011
April 08, 2011
Centers for Medicare & Medicaid Services
Coverage and Analysis Group
Office of Clinical Standards and Quality
ATTN.: Louis Jacques, MD
CC: Joseph Chin, MD, MS, and Sarah McClain, MHS
Re: Intensive Behavioral Therapy for Obesity - National Coverage Analysis and Determination Request (CAG-00423N)
Dear Dr. Chin and Ms. McClain,
Eisai is pleased to submit comments to the Centers for Medicare & Medicaid Services (CMS) on the National Coverage Analysis for Intensive Behavioral Therapy for Obesity (IBTO). We applaud CMS's efforts to examine coverage for obesity preventive services in a timely and cohesive manner. Specifically, our comments will address key issues and evidence related to the effectiveness of counseling and behavioral interventions, as well as pharmacotherapy as an adjunct to behavioral interventions.
Since the release of the 2003 USPSTF B recommendation for screening and intensive behavioral interventions for obese adults, new evidence has emerged further supporting the effectiveness of intensive behavioral interventions for the obese, as well as interventions for overweight adults, and pharmacotherapy as an adjunct to behavioral interventions for the obese. We believe there is sufficient evidence to support the coverage of screening, and intensive behavioral interventions for obese and overweight adults in the Medicare population, and that obese individuals benefit from access to a full spectrum of proven weight loss interventions. Additionally, we believe this is an opportu nity for CMS and the U.S. Preventive Services Task Force (USPSTF) to coordinate the conduct of an evidence review to aid both coverage policy and USPSTF recommendations. Accordingly, we recommend a thorough evidence review on obesity interventions be conducted to inform a coverage policy and to update the 2003 USPSTF recommendations on screening and interventions for obeSity.
Eisai is a research-based human healthcare company which strives to meet the diverse healthcare needs of patients and their families and caregivers, and believe in primary and secondary preventive health measures as critical to advance population health.
Obesity in Adults is Contributing to the Growth of Comorbid Conditions and Healthcare Costs
The Health Burden of Obesity
We believe there is an urgent need to address the obesity epidemic in the U.S. due to the high proportion of the population that is obese and the comorbidities often associated with being obese.1,2 Data from 2007 to 2008, as part of the Center for Disease Control's (CDC) National Health and Nutrition Examination Survey (NHANES), demonstrated that obesity rates, defined by a body mass index (8MI) of 30 or greater, are rising and that 32.2 percent of adult men and 35.5 percent of adult woman are obese.3 Furthermore, a 2009 Congressional Research Service Report for Congress, indicated that if the growth in obesity continues, nearly half of the elderly population will be obese in 2030.4
Obesity has been linked to a variety of chronic conditions, including cancer, cardiovascular disease, stroke and diabetes.5 In the elderly, obesity can worsen many conditions associated with aging, such as type 2 diabetes, hypertension, heart disease, and cancer.6 For example, obesity in the elderly has been associated with functional limitations, including reducing activities of daily living and instrumental activities of daily living, as well as a 25 percent increased risk for osteoarthritis (cA) in hip joints, and an over 300 percent increased risk of OA in knee joints.7, 8 Additionally, recent studies demonstrate that, in older adults, the decline in insulin sensitivity often correlated with type 2 diabetes, is associated with abdominal obesity and physical inactivity.9
The Economic Burden of Obesity
Nearly half of obesity related costs in the U.S are covered by public programs such as Medicare and Medicaid, and data consistently demonstrate that obese patients contribute more to healthcare costs than normal weight patients.10 For populations over the age of 55, AHRQ's Medical Expenditure Panel Survey data demonstrated that, in 2002, mean total expenditures for obese patients was $7,235, which was significantly higher than normal weight or overweight individuals whose mean total expenditures were $5,390 and $5,478, respectively.11
Due to the harmful health effects of obesity, as well as obesity's contribution to rising healthcare costs, we feel strongly that there is a critical need to provide services to prevent and care for overweight individuals, especially Medicare beneficiaries.
Weight Loss Leads to Significant Improvement in Clinical Outcomes
While the detrimental health effects of obesity are significant, fortunately many obesity-related disorders are reversible as weight loss in obese individuals, including the elderly, has been proven to produce favorable clinical outcomes.12,13,14 A 2006 systematic review of studies assessing obesity, in adult populations with an average age greater than 60 years, demonstrated that a weight loss of 3 to 4 kg over 1 to 3.3 years was correlated with improved clinical outcomes such as reductions in diabetes and hypertension, and increases in glucose tolerance and physical functioning.15 Furthermore, a 2011 study showed that adults who maintained weight loss for one year, as compared to individuals who did not lose weight, had more favorable total cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and diastolic blood pressure.16
These studies indicate that achieving and maintaining weight loss in obese adults can improve clinical outcomes for the patient. Additionally, weight loss not only improves clinical outcomes but also reduces costs. In 2008 the CDC estimated that if an overweight individual maintained a 10 percent weight loss, that person's lifetime medical costs would be reduced by $2,200-$5,300 due to decreases in hypertension, type 2 diabetes, heart disease, stroke, and high cholesterol.17
USPSTF 2003 Recommendations for Screening and Intensive Behavioral Interventions for Obese Adults Was Favorable but Recommendations Need Updating to Incorporate New Evidence
Counseling and Behaviora/lnterventions Are Effective Methods to Support Weight Loss in the Obese Elderly Population
For the last decade there has been a growing body of evidence supporting behavioral interventions as a method to achieve weight loss, but more recently new data has emerged focusing specifically on the success of interventions in the elderly population. A systematic review of obesity studies published between 1980 and 2005 on individuals age 60 years or older, indicated that intensive behavioral interventions can be successful for the elderly population.18 The systematic review demonstrated that behavioral, dietary, and exercise interventions helped to achieve a weight loss of 3 to 4 kg over 1 to 3.3 years which was associated with reductions in diabetes and hypertension, and increases in glucose tolerance and physical functioning.
New data also indicate that exercise interventions in older obese individuals can help to achieve improvement in health outcomes.19 A 2007 study indicated that obese individuals who were physically fit and walked 30 minutes or more most days of the week, had a lower risk of allcause mortality than healthy weight individuals, which highlights the need to provide exercise interventions for older adults.
We believe obese patients should have access to covered high intensity behavioral interventions. The 2003 USPSTF recommendations define high intensity behavioral interventions as more than one person-to-person (individual or group) session per month for at the first three months of intervention. We agree that the data supports the need for interventions to occur more than once a month.
Counseling and Behavioral Interventions Are Effective Methods to Support Weight Loss in the Overweight Population
New data has also emerged on the effectiveness of interventions in the overweight population, defined by a 8MI of 25-29.9. A meta-analysis published in 2005, including 36 studies and 3495 older adult participants, showed that behavioral and cognitive-behavioral weight reduction strategies are effective methods to support weight loss in both obese and overweight populations.20 The average frequency of intervention was once every two weeks for an average of 12 weeks. Additionally, the meta-analysis indicated that more frequent interventions produced greater weight loss among both populations, and that behavioral therapy combined with diet and exercise also increased weight loss as compared to behavioral or cognitive interventions used alone.
We recommend that intensive behavioral interventions be covered by Medicare for overweight populations, and that these interventions be more frequent than once a month sessions, as the data indicates that more frequent interventions increase the likelihood of greater weight loss.
Obese Patients Benefit from Access to a Spectrum of Proven Weight Loss Interventions
A variety of weight loss interventions exist and recent data indicate that obese patients benefit from access to more than one type of weight loss intervention.21 A meta-analysis covering 24 studies and 13,326 adults showed that three-component interventions achieved greater weight reductions than one or two component interventions.22 Interventions included individual sessions, family involvement and problem solving strategies that emphasized life style changes. Further supporting the need for multi-intervention strategies, The Counterweight Programme, an evidence-based weight management model, employed a successful mUlti-intervention strategy for adults age 18-75. A variety of evidence-based approaches were utilized including patientcentered goal setting, prescribed eating plans, group sessions, physical activity, weight maintenance strategies and anti-obesity medication. The results of the program indicated 43 percent of fully compliant patients achieved a weight loss of 5 percent or more at 12 months.23
Obese Patients Benefit from Medica/Interventions that Include Pharmacotherapy as an Adjunct to Behaviora/lnterventions
The 2003 USPSTF recommendations on screening for obesity discussed pharmacotherapy, and the associated adverse effects of pharmacotherapy, but specific recommendations on pharmacotherapy were not included in the published guidance. However, since the release of those recommendations, additional published data exists on the clinical success and cost effectiveness of weight lost drugs, in particular as an adjunct to behavioral interventions.24
Several anti-obesity drugs are FDA approved for obese individuals or are under investigation. Many of these drugs have been proven not only to be effective for weight loss, but also for reducing cardiovascular risk factors.25 As an example, data published in 2005 indicated that Orlistat, an inhibitor of gastrointestinallipases. reduced weight loss, improved metabolic risk factors and reduced the risk of developing type 2 diabetes when used in addition to dietary intervention.26
In addition to the demonstrated clinical effectiveness of weight loss drugs, many weight loss drugs have also been proven to be cost effective. A review of 14 published studies on the costeffectiveness obesity drugs indicated that these medications are within the range of what is typically regarded to be cost-effective.27
Collectively, this data indicates that the use of pharmacotherapy is not only an effective clinical intervention, but also a cost-effective one for the adult obese population. We recommend that obese individuals have access to the full spectrum of weight loss interventions, including access to pharmacotherapy interventions as an adjunct to behavioral interventions. Medicare beneficiaries and providers need a complete armamentarium to fight against obesity.
Evidence Exists to Support Coverage of Screening and Intensive Behavioral Interventions for the Obese and Overweight Medicare Patient Population
Eisai believes there is sufficient evidence to support the coverage of screening, and high intensity counseling and behavioral interventions for obese and overweight adults, and that these patient populations benefit from access to more than one intervention a month. Additionally, obese populations would benefit from access to the full spectrum of proven interventions, including pharmacotherapy as an adjunct to behavioral interventions. In light of new evidence generated since the publication of the 2003 USPSTF recommendations on screening for obesity in adults, we believe a thorough updated evidence review is needed to inform an appropriate coverage policy and to support an update the 2003 USPSTF obesity screening recommendations.
Eisai appreciates this opportunity to offer feedback to CMS on this important coverage decision, and we look forward to continuing to collaborate with CMS. We appreciate your consideration and are happy to provide further information or assist with any additional questions. We would welcome the opportunity to meet with eMS to answer any questions you may have about the evidence and how Eisai can support a more formal evidence review. Please feel free to contact Steve McMillan, Director, Federal Public Policy at stephen mcmillan@eisai.com should you have any questions or wish to discuss our comments in further detail.
Sincerely,
/s/
Raymond Frost
Executive Director, Government Affairs & Public Policy
1 Karlsson J, Sullivan M, Sjostrom L Swedish Obese Subjects (SOS): An Intervention study of obesity. Four year follow-up of weight loss and quality of life. International Joumal of Obesity 1997;21 :s122-23.
2 Narbro K. et et a1.Sick·leave and disability pension before and after treatment of obesity. Intemational Joumal of Obesity 1997;21 :s24.
3 Flegal et al., ·Prevalence and Trends in Obesity Among US Adults, 1999-2008: JAMA 2010;303(3):235-241 .
4 Sommers A., "2009 Congressional Research Service Report for Congress: Obesity in Elderty Americans, ~ accessed at hltp:llaging.senate.gov/crslaging3.pdf.
5 Sommers A., "2009 Congressional Research Service Report for Congress: Obesity in Elderly Americans: accessed at hltp:llaging.senate.gov/crslaging3.pdf.
6 Sommers A., "2009 Congressional Research Service Report for Congress: Obesity in Elderly Americans," accessed at hltp:llaging.senate.gov/crslaging3.pdf.
7 Houston OK et aI., ~Role of Weight History on Functional limitations and Disability in Late Adulthood: The ARIC study," Obesity Research, 2005; 13:1793-1802
8 Baumgartner R.N. et ai., ·Sarcopenic Obesity Predicts Instrumental Activities of Daily living Disability in the Elderly," Obesity Research, 2004 12(12): 1995-2004.
9 Haffner S.M., ~Abdom i na l Obesity, Insulin Resistance, and Cardiovascular Risk in Pre-diabetes and Type 2 Diabetes,M European Joumal of Cardiology, vol. 8, suppt. B (2006), pp, 620-625.
10 Sommers A., "2009 Congressional Research Service Report lor Congress: Obesity in Elderly Americans,accessed at http://aging.senate.gov/crslaging3.pdf.
11 Agency for Heatthcare Research and Quality Medical Expenditure Panel Survey, "Overweight and Obese Elderly and Near Elderly in the United States, 2002: Estimates for the Noninstitutionalized Population Age 55 and Older: 2005. accessed at http://www.meps.ahrq.gov/mepsweb/dataJileslpublicationslst681staISS.pdf.
12 Garrow J. Obesity and related diseases. 1s1 Edition. Edinburgh:Churchili Livingstone, 1988.
13 Wilding J. Obesity treatment. British Medical Jouma11997;315 (7114):997.
14 McTigue, K. M., et aI., "Obesity in older adults: a systematic review of the evidence for diagnosis and treatment,Obesity 2006; 14(9):1485-1497.
15 McTigue, K. M., et al., ·Obesity in older adults: a systematic review of the evidence for diagnosis and treatment,Obesity2006; 14(9):148501497.
16 Truesdale K.P. et at, ·Oifferences in Cardiovascular Disease Risk Factors by Weight History: The Aerobics Center Longitudinal Study,· Obesity March 10, 2011 : advance online publication.
17 CDC, · Preventing Chronic Diseases: Investing Wisely in Health Preventing Obesity and Chronic Diseases Through Good Nutrition and Physical Activity,~ Accessed at http://www.cdc.gov/nccdphplpublicationslfactsheetsiPreventionlpdflobesity.pdf.
18 McTigue, K. M., et aI., ·Obesity in older adults: a systematic review of the evidence for diagnosis and treatment,Obesity 2006; 14(9):1485·1497.
19 Sui X et aI., ~Cardiorespiratory Fitness and Adiposity as Mortality Predictors in Older Adults,· JAMA, 2007 298 (21):2507·2516.
20 Shaw, K., P. O'Rourke, et aI., ' Psychological interventions for overweight or obesity." Cochrane Database Syst Rev 2005(2): CD003818.
21 McTigue, K. M. , et aI., 'Obesity in older adults: a systematic review of the evidence for diagnosis and treatment, Obesity 2006; 14(9): 1485-1497.
22 Seo, D. C. and Sa J., 'A meta-analysis of psycho-behavioral obesity interventions among US multiethnic and minority adults." Prev Med2008; 47(6): 573-582.
23 laws, R. "A new evidence-based model for weight management in primary care: the Counterweight Programme.' JHum NutrDiet 2004; 17(3): 191-208.
24 Arbeeny C.M., "Addressing the Unmet Medical Need for Safe and Effective Weight loss Therapies.Obesity Research, 2004; 12(8): 1191-1196.
25 Fujioka K., "Management of Obesity as a Chronic Disease: Nonphannacologic, Phannacologic, and Surgical Options." Obesity Research, 2002; 1 O(Suppl 2): 116S-123S.
26 Curran M.P. and Scott l.J., "Spotlight on Orlisatat in the Management of Patients with Obesity," Treat Endocrinol 2005; 4(2):147-149.
27 Neovius M. and Narbro K., "Cost-effectiveness of pharmacological anti-obesity treatments: a systematic review," Intemational Joumal of Obesity 2008; 32, 1752-1763.
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Title: President
Organization: American Society for Metabolic and Bariatric Surgery
Date: 04/10/2011
April 10, 2011
Sarah McClain, MHS
Joseph Chin, MD, MS
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244
Dear Ms. McClain & Dr. Chin:
On Behalf of the American Society for Metabolic and Bariatric Surgery (ASMBS), the largest surgical society in the world specifically treating the severest form of obesity and related diseases, I am pleased to submit the following comments regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Analysis (NCA) regarding intensive behavioral counseling for obesity. We appreciate the opportunity to provide the Medicare program with feedback regarding this important coverage issue.
Treating or addressing obesity among those already obese is difficult. This is clearly demonstrated by the more than 34 percent of Americans who are currently affected by obesity. However challenging though, efforts must be made to both prevent and treat obesity at all stages and in all age groups. Patients and their healthcare providers need an arsenal of treatments -- as any one treatment may not work for every individual.
The ASMBS believes that Medicare should provide coverage for the continuum of care for the overweight or obese patient – including behavioral and nutritional counseling, physician-supervised programs, pharmaceuticals, and surgical treatment. Such an approach would be consistent with diagnosis and treatment coverage policy for other chronic diseases.
We are pleased that CMS will be examining the merits of providing Medicare coverage for intensive behavioral counseling services for those Medicare beneficiaries affected by obesity as currently Medicare only covers surgical intervention for this population under very strict guidelines.
As an organization dedicated to providing the best and most comprehensive care for the bariatric surgical patient, ASMBS strongly believes in the critical importance of the multi-disciplinary treatment approach for those affected by obesity. As such, the ASMBS endorses the comments of both the American Dietetic Association and the Obesity Society in connection with the agency’s NCA on intensive behavioral counseling for obesity.
In particular, ASMBS echoes the ADA’s comments regarding Medicare beneficiaries undergoing bariatric surgery:
“There are those beneficiaries who suffer from such a severe level of disease and who have failed in other less invasive interventions who require surgery. These beneficiaries are at high risk for obesity related morbidity and mortality and therefore, must seek alternative methods. From 1983 to 2000, this group of people has increased 400%. All data indicate that for the morbidly obese, bariatric surgery is the most effective therapy available for weight management and can result in improvement or resolution of the obesity-related comorbidities and improved quality of life. Although surgery may be imperative when the beneficiary has reached a certain stage and met specific requirements, intensive behavioral counseling for obesity as it relates to nutrition is compulsory both prior to and following the surgical procedure(s).
The role of nutrition is extremely important during the pre-surgical screening to evaluate weight history, efforts to lose weight, food preferences and food-related behaviors (i.e. binge eating) to assist in electing the optimal procedure for the beneficiary. The beneficiary must be informed of lifestyle changes needed to decrease postoperative complications and maintain weight loss. Weight loss surgery is most effective when accompanied by pre-and postoperative comprehensive therapy to alter behaviors such as eating, smoking and exercise. Post-surgery, intensive behavioral counseling for obesity with regards to nutrition is vital in promoting lasting behavioral changes in dietary and supplementary requirements. This therapy augments the probability of long-term success and be a standard component of surgical weight management. Of note, all procedures require lifelong medical follow-up and monitoring to avoid and manage possible complications leading to more severe damage to the beneficiary’s health. “
ASMBS can not stress strongly enough the importance that Medicare take a leadership role in expanding the treatment avenues available to those affected by obesity especially given the positive impact that coverage of these critical services will have on the private health insurance market.
Sincerely,
Bruce M. Wolfe, MD, FASMBS, FACS
President
American Society for Metabolic and Bariatric Surgery
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Date: 03/15/2011
Weekly group or individual visits have been identified in the literature as most beneficial. Many patients can lose 5-10% of their body weight through behavioral interventions, which translates into positive improvements in health outcomes. The additional support provided by behavioral providers can help patients sustain motivation to make lasting health behavior change. Programs like the LEARN program developed by Dr. Kelly Brownell include evidence-based behavioral intervention techniques for obesity. Psychological providers with Masters or PhD degrees should be covered for providing this much needed service to Medicare patients. Studies published by Drs. Brownell and Thomas Wadden provide evidence base for behavioral intervention for weight management. Thank you for considering.
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Title: Clinical Nutritionist/Diabetes Educator
Organization: Open Door Family Medical Centers, Inc
Date: 04/01/2011
Intensive behavioral and nutrition therapy to treat and or prevent obesity provided at least monthly by Registered Dietitian individually or jointly with a behavioural therapist will result in an healthier population and greatly reduce health care costs as the incidence of diabetes, cancer, hypertension, heart disease and cancer will be much lower.
As a reistered dietitian I see first hand the dramatic health improvements achieved with medical nutrition therapy weight loss, diabetes and other health problems that can be improved with healthful eating.
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Date: 03/14/2011
1) Will it be a requirement that all the people involved must have a BMI between 18 and 22 (except of course the patient)?????
2) Are you going to lock them in their room until they lose weight? Or follow them around and slap their hands every time they reach for too much food?
3) This should be a good source of jobs: with 8 hour shifts, with extra on weekends, you can employ at least 5 workers per fat person, PLUS all of the ancillary staff and supervisors. AND all of the benefits. They will undoubtedly make more income and perks than the fat person, and since none of it will work, the jobs are guaranteed for life.
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Title: Associate Professor
Organization: Department of Health Policy, The George Washington University
Date: 04/10/2011
The George Washington University, Department of Health Policy, School of Public Health and Health Services, academic home of the STOP Obesity Alliance, is pleased to respond to the request from the Centers for Medicare and Medicaid Services (CMS) 1 for relevant studies related to the issues of frequency of service and provider qualifications for the delivery of intensive behavioral counseling for the treatment of adult obesity, a Grade B recommendation of the United States Preventive Services Task Force (USPSTF).2
Dedicated to health policy education and research, the Department of Health Policy is home to more than $45 million in funded research and programs. Its core and adjunct faculty include some of the nation’s best known health policy experts as well as leaders from across the public and private health policy sector. The Department’s training includes both stimulating classroom offerings, as well as hands-on experience with the major health policy issues of the day. Our graduates can be found in Congressional offices, federal health agencies, and Washington D.C.’s most prominent professional health societies, trade associations, and health policy consultancies.
The STOP (Strategies to Overcome and Prevent) Obesity Alliance is composed of nearly 50 consumer, provider, government, labor and business organizations united to encourage innovation and practical strategies to combat obesity. The goal of the STOP Obesity Alliance is to go beyond awareness and consumer education efforts to identify and address systemic and cultural barriers that are failing to adequately support individual successes. Its Executive Director Christine Ferguson, J.D., is a Professor in the Department of Health Policy at the School of Public Health and Health Services of The George Washington University. Professor Ferguson is joined in this comment by Jennifer Leonard, J.D., Associate Professor, and Morgan Downey, J.D., Policy Director of the Alliance. The Alliance’s Health and Wellness Chair is Richard H. Carmona, M.D., M.P.H., FACS, 17th U.S. Surgeon General (2002-2006), President of Canyon Ranch Institute, and Distinguished Professor at the Mel and Enid Zuckerman College of Public Health at the University of Arizona.
The Alliance. The Alliance focuses on four key areas where the private and public sectors can impact the nation's ongoing struggle to change how our nation perceives and approaches the problem of obesity, overweight, and weight-related health risks, including heart disease and diabetes. The four key areas are:
• Identifying and breaking down cultural and systemic biases around obesity;
• Re-defining success as sustained weight loss based on health rather than social norms;
• Highlighting and promoting research-based initiatives and technologies to improve prevention and treatment, and;
• Identifying, recommending and promoting innovations in community, employer and healthcare delivery and financing systems.
The high prevalence of obesity, with its multiple, adverse health effects on mortality, morbidity and disability, pose a profound challenge to Medicare. Many papers have analyzed the high economic impact of the rising rates of obesity among the incoming Medicare beneficiaries, both those qualifying by age and by disability status. 3
Effectiveness of Counseling
Since the 2003 publication of the USPSTF recommendation referenced above, several additional studies have been published regarding the effectiveness of intensive behavioral counseling to achieve weight loss with improvements in related metabolic metrics. For example, in the Look AHEAD trial, after four years, the intensive lifestyle intervention group had a greater percentage of weight loss, greater improvement in treadmill fitness, hemoglobin A1c level, systolic and diastolic blood pressure and higher levels of HDL cholesterol and reduction in LDL cholesterol. 4 In the Diabetes Prevention Program, an intensive lifestyle intervention was compared to drug therapy (metformin) to examine a reduction in risk for development of Type type 2 diabetes. The lifestyle intervention significantly reduced the incidence of diabetes by 58% compared to 31% in the metformin group, as compared with placebo.5 At one year, intensive lifestyle participants lost 8.6% of initial weight loss compared to controls. Interestingly, the study’s oldest participants (65-74 years of age at baseline) lost a significantly greater percentage of initial weight than those in the younger age group. 6 The 10- year results of the DPP showed significant reduction of type 2 diabetes in the lifestyle group. Of particular relevance is the observation that, “The lifestyle effect was greatest in participants aged 60-85 years at randomization (49% reduction rate) in whom metformin had no significant effect. 7
Evidence exists that intentional weight loss, even as little as between 5-10%, may be of benefit in controlling cardiovascular risk factors, reducing medication and amelioratingion of pulmonary disease and osteoarthitis.8
Meta-analyses have also confirmed the effectiveness of counseling. Dansinger et al state, “On average, dietary counseling for weight loss can result in a net loss of approximately 2 BMI units at 12 months or 6%”. 9 Greaves, et al, concluded, “High quality causal evidence (grade1+++) from eight meta-analyses of randomized clinical trials (RCTs) from four reviews showed that interventions to promote changes in diet (or both diet and physical activity) produced moderate and clinically meaningful effects on weight loss (typically 3-5kg at 12 months, 2-3 kg at 36months.). 10
Frequency for Intensive Counseling
The USPSTF recommendation states that “A high-intensity intervention is more than one person-to-person (individual or group) session per month for at least the first three months of the intervention.” It is important to note that lower intensity counseling received an “I” recommendation as did counseling of any intensity for overweight adults. Subsequent studies have provided more support for high intensity counseling. The Look AHEAD trial (referenced above), a multi-center, NIH-funded randomized controlled trial designed to determine whether intentional weight loss reduces cardiovascular morbidity and mortality in overweight individuals with type 2 diabetes, includes over 5,000 participants with a mean age of 60 assigned to either intensity care or usual care. The intervention group attended one individual and three group sessions per month for 6 months. For months 7-12, they attend one individual and two group meetings per month. Starting at month 7, more intensive behavioral interventions are available. In years 2-4, treatment includes at least one on-site visit per month and a second contact by telephone, mail or email. After year 4, participants are offered monthly individual visits, as well as one refresher group. 11
The DPP, ( also referenced above), provided 16 individual counseling sessions plus individual counseling and a maintenance program with further individual and group counseling. 12 The optimal frequency of a period of intensive counseling of weekly sessions for 6 months for a least a year and provision of continuation of counseling during the maintenance phase of weight management appear to be appropriate. Given the numerous factors that might affect the course of counseling, flexibility should be provided.
Provider Qualifications
There are few studies comparing outcomes by the profession of the provider. Greaves, et al, concluded, “There was a lack of high quality evidence in (evaluating the intervention provider) ... However, strong evidence from individual RCTs (based on data in the evidence tables of the included reviews) showed that a wide range of providers (with appropriate training) including doctors, nurses, dieticians/nutritionists, exercise specialists and lay people, can deliver effective interventions for changing diet and/or physical activity.” 10
While many types of providers can provide and/or support behavioral counseling, it is important that primary care providers be both better educated and covered for such services. They are on the frontline, seeing patients either for treatment of their obesity and/or co-morbid conditions. Their advice and recommendations can be of enormous value to the patients.
The STOP Obesity Alliance is committed to addressing the role of primary care in the management of obesity. In August of 2009, a roundtable was held to outline the role and challenges of the primary care community.13 This roundtable was followed by a white paper summarizing the literature to date on the topic.14 In addition, the Alliance conducted a two-pronged survey of primary care physicians and patients which showed that a most primary care physicians believe that it is their responsibility to counsel and educate patients on obesity and overweight. This survey is in peer review for publication.
It has been recommended that older persons engaging in weight loss do so in medically supervised programs in combination with physical exercise to help maintain muscle mass, and an evaluation of vitamin D and calcium status to help maintain bone health. It is also important that providers be aware that weight loss may be involuntary and an indicator of a more serious disease state. Training should include identification of spontaneous, unintentional weight loss.8
Footnotes
1 http://www.cms.gov/medicare-coverage-database/details/nca- tracking-sheet.aspx NCAId=253&ver=1&NcaName=Intensive+Intensive+Behavioral+Therapy+for+Obesity&bc=BEAAAAAAEAAA, accessed March 20, 2011.
2. http://www.uspreventiveservicestaskforce.org/uspstf/uspsobes.htm, accessed March 20, 2011.
3. Bell JF et al, Health-Care Expenditures of Overweight and Obese Males and Females in the Medical Expenditures Panel Survey by Age Cohort, Obesity, 2011:19:228-232.Tsai AG, et al. Direct medical cost of overweight and obesity in the USA: a quantitative systematic review Obesity Reviews 2010 Jan 6. Lakdawalla DN et al. The Health and Cost Consequences of Obesity among the Future Elderly. Health Affairs 2005; 24(Supp2):R30-R41)
4. Look Ahead Research Group, Long-term Effects of a Lifestyle Intervention on Weight and Cardiovascular Risk Factors in Individuals with Type 2 Diabetes Mellitus. Arch Intern Med 2010;170(17):1566-1575.
5. Diabetes Prevention Program Research Group, Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin, NEJM 2002. 334(6):393-403.
6. Wadden et al, One-Year Weight Losses in the Look AHEAD Study: Factors Associated with Success. Obesity (2009) 17: 713-722.
7. Diabetes Prevention Program Research Group, 10 Year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study, Lancet, 2009, Nov. 14; 374(9702): 1677-86.
8. Zamboni M, Health consequences of obesity in the elderly: a review of four unresolved questions. Int J Obes 2005 Sep; 29(9):1011-29.
9. Dansiger ML, et al. Meta-analysis: The Effect of Dietary Counseling for Weight Loss, Ann Intern Med 2007;147:41-50.
10. Greaves, CJ et al. Systematic review of reviews of intervention components associated with increased effectiveness in dietary and physical activity interventions. BMC Public Health 2011,1 1:119
11. Look AHEAD Research Group, The Look AHEAD Study: A Description of the Lifestyle Intervention and the Evidence Support it Obesity, 2006 May;14(5):737-752)
12. Diabetes Prevention Program Research Grp. The Diabetes Prevention Program Description of lifestyle intervention, Diabetes Care, 2002 25;12:2165-2171.
13. http://www.stopobesityalliance.org/wp-content/assets/2009/08/Primary-Care-Roundtable-Transcript-Summary-FINAL1.pdf, accessed March 20, 2011
14. http://www.stopobesityalliance.org/wp-content/assets/2010/03/STOP-Obesity-Alliance-Primary-Care-Paper-FINAL.pdf, accessed March 20, 2011
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Title: Executive Director
Organization: Trust for America's Health
Date: 04/08/2011
Sarah McClain, MHS
Lead Analyst
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850
Comments re: National Coverage Analyses (NCA) Tracking Sheet for Intensive Behavioral Therapy for Obesity
Dear Ms. McClain:
As a nonprofit, nonpartisan public health advocacy organization dedicated to making disease prevention a national priority, Trust for America’s Health is pleased to see that CMS is considering adding Intensive Behavioral Therapy for Obesity as a preventive service in the Medicare program. Given the profound impact of the obesity epidemic on Americans’ health, and the evidence of such programs’ effectiveness, we believe that including coverage for this intervention will be a crucial tool for improving the health of Medicare beneficiaries.
Over two-thirds of adults in the United States are overweight or obese. In 1980, 15 percent of American adults were obese; by 2008, that figure had reached 34 percent. From 2009 to 2010, adult obesity rates rose in 28 states, and fell in only one. There are striking racial and ethnic disparities in obesity rates: in 40 states, adult obesity rates are higher among Blacks and Latinos than among Whites.
Obesity is associated with more than 20 major chronic diseases. These diseases are among the most prevalent and deadly in the United States: one in three adults has a form of heart disease, and over 80 million Americans have type 2 diabetes or are pre-diabetic. Obesity-related costs account for almost a tenth of all annual medical expenditures.
As the U.S. Preventive Services Task Force found in its 2003 review of available data, intensive counseling led to modest sustained weight loss in obese adults. High-intensity programs – defined as those offered more than once per month – were more effective than lower-intensity.
A more recent analysis has confirmed that such programs are effective in older adults, a finding important to the Medicare program. A 2006 data review focused on studies of adults with an average age of 60 found that intensive counseling programs that addressed overall behavior, diet and exercise led to weight loss of 3-4 kg sustained over measured periods of 1-3.3 years. This modest weight loss was associated with improved glucose tolerance, better physical functioning, and lower incidence of diabetes and a combined hypertension and cardiovascular endpoint.
Other recent research has confirmed that such high-intensity interventions can be effective when offered by trained lay providers. In 2002, the NIH- and CDC-funded Diabetes Prevention Program (DPP) study found that intensive lifestyle interventions, including promotion of physical activity and weight loss, could lead to modest weight loss and reduce the development of diabetes in adults with prediabetes. A 2008 study reported that the DPP program could be conducted by trained lay providers in a community setting at YMCAs and still result in modest weight loss sustained over 12 months.
We believe that based on this data, it is important that Medicare coverage for intensive behavioral therapy for diabetes include coverage for programs offered by appropriately trained lay providers, if the programs or similar program have been shown to be effective when offered by such providers. The availability of these programs in community settings will render them available to far more beneficiaries, allowing this coverage change to make a meaningful impact on the health and lives of the Medicare population. Leveraging the expertise of non-clinicians produces additional benefits to the Medicare program; they can deliver effective services to Medicare beneficiaries without affecting physician and other clinician caseloads and at a lower cost. Community-based lay providers also have opportunities to direct behavioral interventions that are lacking in the clinical setting. The sustained improved outcomes that have been demonstrated by these types of interventions can lead to lower prevalence of obesity and associated co-morbidities within the Medicare program – which ultimately means lower Medicare expenditures for related health care services and savings for the program overall.
Thank you for the opportunity to comment on this important Coverage Analysis. If you have any questions, please feel free to contact Jack Rayburn, Government Relations Representative, at 202-223-9870 x 28 or at jrayburn@tfah.org.
Sincerely,
/s/
Jeffrey Levi, PhD
Executive Director
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M
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Title: President
Organization: The Certification Board for Obesity Educators
Date: 04/10/2011
I appreciate the opportunity to offer my views on intensive behavioral therapy for obesity. I limit my remarks to the issues of professional qualification and frequency of treatment.
The question of professional qualification is difficult because physicians, nurses, dietitians, diabetes educators, psychologists, exercise scientists and other health professionals advise obese patients, yet there exists no model for obesity treatment that is generally accepted.
The USPSTF is silent on the question of professional qualifications. Under the circumstances this is reasonable. Each professional discipline has something to contribute and all are necessary as there are presently too few boots on the ground to combat the U.S. obesity epidemic.
What is missing is a science-based standard of care that qualified health professionals share and to which they may be certified. Such a standard would promote the measurement and tracking of outcomes, informing research and accelerating translation into effective treatment. This, in turn, would improve the science and further elevate the standard of evidence-based care.
As we work to establish a shared standard of care for obese persons, the primary care provider should be encouraged to fill this role and proactively coordinate care utilizing other health professionals as may be appropriate. Be reminded however, that the economic impact of this activity on the primary care provider must be addressed as a matter of urgency.
The question of frequency of treatment seems less difficult. The goal should be to select a frequency that is likely to be embraced by the participating health professions, to collect outcomes data, and to learn. The outcomes data will suggest whether the frequency of treatment should be adjusted to improve outcomes.
Keith P. McGuinness, FACHE
President
The Certification Board for Obesity Educators
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Title: MD, bariatrician
Organization: Fairview Southdale Weight Loss Clinic
Date: 03/31/2011
There is evidence that weekly behavioral modification works very well for weight loss and weight maintenence. In the study by John P. Foreyt and G. Ken Goodick,Ann Inter Med. 1993, patients lost an average of 9.9 kg over 18 weeks with behavorial modification. Moderately obese patients lost 10% of their body weight.66% of patients maintained their weight loss at 52 weeks. These results are comparable to pharmachological treatments for obesity or even better. I believe coverage for these services is critical as behavioral therapy for weight loss inproves the chances of sustaining weight loss (after any weight loss method).
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Title: Chief Science Officer
Organization: Weight Watchers
Date: 04/08/2011
April 8, 2011
The
Honorable Donald Berwick, MD
Administrator,
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human
Services
200 Independence Avenue, SW
Washington, DC
Subject: CAG-00423N National Coverage Analysis
Comments
Attention: Dr.
Joseph Chin and Ms. Sarah McClain
Dear Dr.
Berwick:
Transformation
of our nation’s health care system from an illness-treatment system to a value-based,
quality health and wellness system is a vital and achievable goal. It can be accomplished
through integration of strong primary care and preventive care services with
acute and community-based care. Recent estimates of skyrocketing
rates of obesity and weight-related chronic disease only increase the
importance of Medicare coverage policy on this topic.
The
evidence is clear:even small changes such as a sustained weight loss of just 10%,
reduce the likelihood of type II diabetes by 50%[1]
and decreases lifetime medical costs by
$2200[2].
The
Medicare National Coverage Analysis on Intensive Behavioral Counseling for
Obesity wisely identified the two components essential to effective, quality
service to assist individual patients, improve population health, and lower
health costs – the appropriate frequency and provider of service. Weight Watchers is pleased to offer comments based
on our 50-year history of delivering effective, community-based care to HOW
MANY? MILLIONS OF PEOPLE and conducting decades of research. Our work, coupled
with other extensive clinical and research evidence, shows that:
- Intensive Behavioral Counseling for Weight Loss should be delivered for one hour per week for a minimum of 12 weeks.
- Trained lay leaders for group counseling on healthy lifestyles provide consistent and evidence-based results that are either as good as, or better than, standard of care (physician office based counseling).
If carefully
crafted, the March 10th Medicare National Coverage Analysis on
Intensive Behavioral Counseling for Obesity can align Medicare coverage to
deliver better quality care, improve population health, and lower health
costs. Below, please find the irrefutable
evidence to support these comments.
Frequency of
Service Needed for Quality Outcomes
The
evidence supports weekly one hour sessions for a minimum of 12 weeks
Based on an
extensive evidence review, the 2003 USPSTF recommended a B rating for intensive
behavioral counseling for obesity.According to the Evidence Review,
what proved effective was either behavioral counseling in weekly, one-hour
sessions OR four hours of behavioral
counseling sessions monthly (group or individual) over at least 12 weeks. (Some
programs were longer.) This evidence
review also found that reduction in either frequency or duration of
counseling reduced efficacy and did not earn the B rating. Bottom line:
anything less than high-intensity behavioral counseling should not be
considered. [McTigue K,
Harris R, Hemphil B, Lux L, Sutton S, Bunton AJ, Lohr KN. Screening and Interventions for
Obesity in Adults. Summary of the Evidence for the U.S. Preventive Services Task Force. Ann
Intern Med 2003;139(11):933-49.]
Since the
2003 USPSTF Evidence Review, new research continues to demonstrate that
regular, weekly behavioral counseling over at least 12 weeks leads to sustained,
clinically significant weight loss for more than half of the enrollees.
-
Attendance at Weight Watchers
meetings for a 24-week period was tracked among 40 individuals participating in
a randomized clinical trial. Significant
correlations were found between attendance and decreases in body weight, BMI,
and waist circumference. These findings
show that regular attendance at behavioral counseling sessions plays a
significant role in weight-loss success. [L
Zuckley, J Lowndes, V Nguyen, T
Angelpoulos, J Rippe, Diabetes 2006; 55(Suppl 1):A518.]
-
Among 29,326 participants referred to Weight
Watchers by the National Health Service in the UK, 33% lost 5% or more of their
initial body weight after 12 weeks. Among those who attended at least 10 of the
12 sessions, 55% lost at least 5%. [AL Ahern et al. Obesity Reviews 2010;
11(Suppl 1):S242.]
-
In a one- year trial comparing Weight Watchers to
physician-based standard care, 61% of participants randomized to Weight
Watchers lost at least 5% of initial body weight at the end of the study
compared with 32% in the physician care group. [SA Jebb et al. Obesity
Reviews 2010; 11 (Suppl 1):S240.]
-
Weight-loss maintenance after successful completion
of a program was assessed in 699 lifetime members of the Weight Watchers
program. One, two and five years after successful completion of the program,
79.8%, 71.0% and 50% of participants maintained at least 5% of their weight
loss. [MR Lowe, TVE Kral, K Miller Kovach. British Journal of Nutrition
2007; 28:1-6.]
Appropriate
Provider to Achieve Quality, Scalable Outcomes
Those
who attend group counseling by trained lay leaders achieve clinically
significant, sustained weight loss.
Since
publication of the 2003 USPSTF Evidence Review and B-rated Recommendation for
Intensive Behavioral Counseling for Obesity, extensive clinical research has examined
the effectiveness of trained, lay educators to deliver lifestyle, behavioral
counseling. These studies find uniformly that trained, lay educators providing
community-based group counseling are as effective or more effective than
primary-care based counseling. The
following identifies a few, key studies, in chronological order:
2003:
A multi-center, randomized, parallel-group, 2- year trial found
community- based, trained lay-education intensive behavioral counseling was
correlated with both weight loss and weight-loss maintenance. [Heshka S et al. JAMA 289:1792-1798, 2003.]
2007:
A NIH funded pilot found weight loss results were comparable when
behavioral interventions were provided by trained lay-people or health care
professionals. [Pinto AM, Kearns
M and Wing RR. Effectiveness of a Novel Weight Loss
Approach that Combines Brief Standard Treatment and a Commercial Program. Annals of Behav Med 33 (Suppl):S140,
2007]
2008:
The DEPLOY study demonstrated significant reductions in risk factors
(i.e. weight loss) among subjects with pre-diabetes with intensive group
behavioral counseling by trained lifestyle coaches. [Ackerman, RT et al. Am J Prev Med 35: 357-363, 2008.]
2010:
Increased attendance at weight-loss program meetings facilitated by
trained role models was associated with significant improvement in weight,
waist circumference, fasting insulin and glucose, and HOMA among overweight and
obese adults. [Melanson
J and Lowndes J. Am J
Lifestyle Med 4: 275-281, 2010.]
2010: A study evaluating usual source of care versus referral to community- based, trained, lay educators found statistically significant weight loss with the community-based, intensive behavioral counseling interventions. [DB Wilson, RD Johnson, RM Jones, AH Krist, SH Woolf, SK Flores. Patient Educ Counseling 2010; 79(3):338-343.]
2010:
A recently released trial found that one-thirdof those referred to
intensive diet counseling by non-healthcare providers sustained
weight loss of 5% of initial body weight for one year . These results
were substantially better compared to
standard care provided in a primary care setting. [Jebb S et al. Obesity Reviews 2010; 11 (Suppl 1):S240.]
2011:
Attendance at a weight-loss program using dietary and behavioral
intensive counseling by trained-role models found reduction in cardiovascular
risk factors.[Milsom
V et al. Changes in Cardiovascular Risk Factors with Participation in a 12-Week
Weight Loss Trial Using a Commercial Format. (publication pending).]
Trained lay leaders of group counseling provide a scalable
and consistent delivery model to achieve sustained weight loss.
The
prevalence of obesity and the looming crisis it poses for our health care
system will require a full-range of effective, scalable, scientifically proven,
and consistent (similar outcomes across all sites of service) providers of
weight loss solutions for those struggling with obesity. Given the size, scope and time needed to
address obesity effectively, traditional office-based physicians simply cannot meet
the need without assistance from community-based, trained, lay counselors who
can add capacity, value, and
consistency.
-
Evidence,
including extensive European studies of lay-trained group behavioral counseling
programs, demonstrates consistent, high levels of performance across sites of
care. In Spain, performance was measured in
2003 and then again in 2008. Average participation was 12 to 14 weeks with an
average total weight loss of 3.3Kg in both 2003 and 2008, even with a doubling
of participation between 2003 and 2008. [Z Hellman, K Miller-Kovach. Obesity Reviews 2010; 11 (Suppl
1):S249.]
-
Among 29,326 participants referred to Weight
Watchers by the National Health Service in the UK, 33% lost 5% or more of their
initial body weight after 12 weeks. Among those who attended at least 10 of the
12 sessions, 55% lost at least 5%. [AL Ahern et al. Obesity Reviews 2010;
11(Suppl 1):S242.]
Trained, lay group counselors provide a cost-effective and efficient model
of care delivery that is essential to the public health crisis that obesity
poses.
With about one-third of the US population obese and another
quarter overweight and at risk of obesity, it is essential to use a consistent,
effective and efficient model to deliver intensive behavioral counseling on
healthy diet and lifestyle. Group
counseling delivered by trained lay leaders shows substantial evidence-based success and its lower cost of service offers
value essential to address the public health crises our nation faces.
-
Using
the economic formula from the UK’s NICE Guidance on Obesity, the cost-effectiveness of the Weight Watchers
program (a trained lay, lead group counseling model that is among one of the
NHS covered obesity service providers), it was found that Weight Watchers has similar
cost-efficacy as counseling or school-based interventions and offers a
cost-effective means of providing weight management services. [P Trueman, S
Flack. (Abstract). Clinical Excellence, Birmingham,
December 2006.]
-
A computer modeling methodology was used to predict
future health and economic impacts of a 12-week Weight Watchers intervention in
the UK.
The findings suggested that the large scale application this methodology can
translate into considerable savings to the Government and improvements in
health outcomes for individuals. [M Brown and K McPherson. Obesity Facts
2009; 2(Suppl 2):115.]
Figure A below lays out average costs for the US and makes the case quite clearly.
Figure A: Cost for One Hour Group Session per Person
|
Medicare –
Medical Nutrition Therapy [97804]
|
Medicare-
Diabetes Self Management [G0109]
|
Trained
Lay Lead
Behavioral
Counseling
[Published
Price]
|
|
$28[3] |
$37.38[4] |
$9.99[5]
|
Conclusion:
The
Medicare National Coverage Analysis on Intensive Behavioral Counseling for
Obesity wisely identified the two components essential to effective, quality
service to assist individual patients, improve population health, and lower
health costs – the appropriate frequency and provider of service. The clinical and research evidence is well developed
and extensive:
-
Intensive
Behavioral Counseling for Weight Loss should be delivered for one hour per week
for a minimum of 12 weeks.
-
Trained
lay leaders for group counseling on healthy lifestyles provide consistent and
evidence-based results that are either as good as, or better than, standard of
care (physician office based counseling).
If you have
any questions regarding the evidence cited in this letter or that is part of
the publication record, I would be happy to speak with you in person of by
phone. Please do not hesitate to contact
me at Karen.kovach@weightwatchers.com
Sincerely,
Karen Miller-Kovach, MBA, MS,RD
Chief Science Officer
[1] Hamman et al., Effect of Weight
Loss with Lifestyle Intervention on Risk of Diabetes, Diabetes Care, September 2006, 29(9): 2102-2107, 2105.
[2] Oster et al., Lifetime Health and
Economic Benefits of Weight Loss Among Obese Persons, Am J Public Health, October 1999, vol. 89 No. 10, 1536-1542, 1536.
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Title: President and CEO
Organization: Shape Up America!
Date: 04/10/2011
April 10,
2011
To Whom It
May Concern:
Obesity is
one of the most challenging health crises this country has ever faced. In the
U.S., two-thirds of adults and nearly one third of children and teens are
currently obese or overweight, putting them at increased risk for more than 20
major diseases, including Type 2 diabetes and heart disease. According to a
2009 economic analysis by Health Affairs,
obesity-related health costs a total of $147 billion annually. Medicare and
Medicaid pay for an estimated $61.8 billion of these obesity-related health
costs. We must find new solutions to
control these costs.
Both the U.S.
Preventive Services Task Force and the Medicare National Coverage Analysis on
Intensive Behavioral Counseling for Obesity are moving in the right direction
to help solve our nation’s obesity crisis. A number of studies now show that
trained lay counselors can provide effective obesity behavioral counseling,
provided that it is done weekly for at least 12 weeks of treatment. The fact
that the U.S. Preventive Services Task Force has now given this research a B
rating opens the door to an important, scientifically proven way to help
millions of overweight and obese Americans conquer their added pounds and reduce
their risk of chronic diseases. Relying on trained lay professionals to deliver
this counseling provides an important new opportunity to help reduce weight and
with it, obesity-related health care costs.
2003:
The USPSTF comprehensive evidence review of literature found randomized
clinical trial evidence showing intensive behavioral counseling, defined as
weekly engagement for three months, produced modest and sustained weight loss. [McTigue K, Harris R, Hemphil B, Lux L,
Sutton S, Bunton AJ, Lohr KN. Screening
and Interventions for Obesity in Adults. Summary of the Evidence
for the U.S. Preventive Services Task Force. Ann
Intern Med 2003;139(11):933-49.]
2003:
A multi-center, randomized,
parallel-group, two-year trial found community based trained lay-education
intensive behavioral counseling was correlated with both weight loss and
weight-loss maintenance. [Heshka S et
al. Weight Loss With Self-help Compared
With a Structured Commercial Program: A Randomized Trial. JAMA 289:1792-1798,
2003.]
2007: A
NIH-funded pilot showed that weight loss results were comparable whether
behavioral interventions were provided by trained lay-people or health care
professionals. [Pinto AM, Kearns
M and Wing RR. Effectiveness of a Novel Weight Loss Approach that Combines
Brief Standard Treatment and a Commercial Program. Annals of Behav Med 33 (Suppl):S140, 2007]
2008: The
DEPLOY study demonstrated significant reductions in risk factors (i.e. weight
loss) among subjects with pre-diabetes with intensive group behavioral
counseling by trained lifestyle coaches. [Ackerman, RT et al. Translating the Diabetes
Prevention Program into the Community: The DEPLOY Pilot Study. Am J Prev Med 35 : 357-363, 2008.]
2010:
Increased attendance at weight-loss program meetings led by trained
role models was associated with significant improvement in body weight, waist
circumference, fasting insulin and glucose blood levels, and HOMA among
overweight and obese adults. [Melanson J and Lowndes J. Type 2 Diabetes Risk Reduction in Overweight
and Obese Adults Through Multidisciplinary Group Sessions: Effects of Meeting
Attendance. Am J Lifestyle Med 4: 275-281, 2010.]
2010:
A study evaluating usual source of care versus referral to
community-based, trained lay educators found statistically significant weight
loss with the community-based intensive behavioral counseling
interventions. [DB Wilson, RD
Johnson, RM Jones, AH Krist, SH Woolf, SK Flores. Patient weight counseling choices and outcomes
following a primary care and community collaborative intervention. Patient Educ Counseling 2010;
79(3):338-343.]
2010:
A recently released trial found that 1/3 of those referred to intensive
diet counseling by non-healthcare providers sustained weight loss of 5% of
initial body weight for two years and results were substantially better when
compared to standard care provided in primary care setting. [Jebb S et al. Referral to a commercial
weight management programme enhances weight loss achieved in primary care. Int J Obes 11: Suppl 1, 2010.]
* * * * *
In closing, the
Medicare National Coverage Analysis on Intensive Behavioral Counseling for
Obesity wisely identified two components essential to effective, quality
service to assist individual patients in their weight loss efforts, improve
population health, and lower health care costs.
Those factors are the appropriate frequency of service and the provider
of service. The clinical and research
evidence is well developed and extensive:
- Intensive Behavioral Counseling for Weight Loss should be delivered for one hour per week for a minimum of 12 weeks.
- Trained lay leaders for group counseling on healthy lifestyles provide consistent and evidence-based results that are either as good as, or better than, standard of care (i.e., physician office based counseling).
Should you
have any questions regarding the evidence cited in this letter or that is part
of the publication record, I would be happy to speak with you in person of by
phone. Please do not hesitate to contact
me at barbara.moore@att.net or by
phone at 406-686-4844.
Sincerely,
Barbara J.
Moore, PhD
President and
CEO
Shape Up
America!
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Title: President and CEO
Organization: Care Continuum Alliance
Date: 04/08/2011
April 8, 2011
Ms. Sarah McClain
Lead Analyst
Centers for Medicare and Medicaid Services
[CAG-00423N]
Dear Ms. McClain,
On behalf of the more than 200 members of the Care Continuum Alliance, I respectfully offer the following comments in strong support of including Intensive Behavioral Therapy for Obesity (IBTO) in the original Medicare program.
Care Continuum Alliance (CCA) members provide services across the entire continuum of care, from wellness and prevention to complex care management. CCA members include wellness and population health management organizations, health plans, physician groups, hospitals and hospital systems, labor unions, employer organizations, pharmaceutical manufacturers, pharmacy benefit managers, HIT service and device suppliers, academicians and others. These diverse organizations share the vision of aligning all stakeholders toward improving the health of populations. Our members seek to improve health care quality and contain health care costs at a population level by providing targeted interventions and services to individuals who are well, at-risk for or managing one or more chronic conditions.
Obesity plays a key role as an indicator for and co-morbidity to other chronic conditions such as diabetes and heart disease. As a result, the Alliance has prioritized obesity as a key research issue for the last five years. The culmination of these efforts has been the development and release of an obesity toolkit designed to meet the needs of providers addressing obesity within their patient populations. CCA members believe CMS’s National Coverage Analysis (NCA) offer a unique opportunity for CMS to highlight the important role of intensive behavioral therapy for obesity as a key preventive service under Medicare for improving wellness and broader population health.
The Care Continuum Alliance (CCA) is pleased to provide peer-reviewed literature and case studies to inform the NCA process and in support of coverage for intensive behavioral therapy for obesity coverage. A compelling body of clinical research demonstrates that behavioral counseling in health promotion and wellness programs can effectively increase weight loss and reduce risk factors for obesity patients. We are encouraged by CMS’s consideration for interventions that motivate, support and educate individuals as a part of this intensive behavioral therapy. Behavioral counseling has been demonstrated to increase patient engagement, leading to greater self-care management and accountability for treatment adherence. Wellness programs incorporate behavioral counseling within a supportive framework to foster patient engagement and accountability for personal health status. Further, patients benefit from the shared decision-making aspect of counseling and the collaborative interaction with their clinicians. This process facilitates greater patient understanding of the potential risks and benefits of particular treatments as well as taking into account patient preferences. Access to educational information in behavioral counseling can also positively reinforce the importance of healthy eating and physical activity that can motivate patients to consider lifestyle changes.
We encourage CMS to give further consideration for preventive services in the general Medicare population by assessing behavioral therapy for obesity that incorporates new developments in health information technology and a role for physician extenders. Telehealth, mobile health tools and remote monitoring systems offer increased patient access to preventive services and greater opportunities for shared-decision making between patients and care providers beyond traditional person-to-person encounters. Also, health coaches, nurse practitioners and peer mentors are ideally situated to provide ongoing support, motivation and encouragement during behavioral therapy for obesity interventions.
We appreciate the opportunity to provide these comments and would be pleased to provide additional information.
Sincerely,
Tracey Moorhead
President and CEO
Olson, R., W.K. Anger, D.L. Elliott et al., A New Promotion Model for Lone Workers: Results of the Safety & Health Involvement For Truckers (SHIFT) Pilot Study, 51 J. Occ. Env. Med. (2009): 1233 – 46; Gemson, D.H., R. Commisso, J. Fuente et al., Promoting Weight Loss and Blood Pressure Control at Work: Impact of an Education and Intervention Program, 50 J. Occ. Env. Med. (2008): 272 – 81; Loppke, R., S. Nicholson, M. Taitel et al., The Impact of an Integrated Population Health Enhancement and Disease Management Program on Employee Health Risk, Health Conditions, and Productivity, 11 Pop. Health Mangm’t. (2008): 287 – 96; Nilsson, P.M., E.B. Klasson and P. Nyberg, Life-Style Intervention at the Worksite – Reduction of Cardiovascular Risk Factors in a Randomized Study, 27 Scandanavian J. of Work, Env. And Health (2001): 57-62; Proper, K.I., V.H. Hildebrandt, A.J. Van Der Beek et al., Effect of Individual Counseling on Physical Activity Fitness and Health: A Randomized Controlled Trial in a Workplace Setting, Am. J. Prev. Med. (2003): 218 – 226; Wadden, T.A., D.S. West, R. Neiberg et al., One-Year Weight Losses in the Look AHEAD Study: Factors Associated with Success, 17 Obesity (2009): 713 -22; Greaves, C.J., K.E. Sheppard, C. Abraham et al., Systematic Review of Reviews of Intervention Components Associated with Increased Effectiveness in Dietary and Physical Activity Interventions, 11 BMC Public Health (2011): 119; J. Unick, J.M. Jakicic, B.H. Marcus, Contribution of Behavior Intervention Components to 24-Month Weight Loss, 42 Medicine & Science in Sports & Exercise (2010): 745 – 53.
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Date: 03/14/2011
[PHI Redacted] Now that I am a beneficiary of Medicare and Disability , I welcome this change. Any service that will help each of us will hopefully improve our lives and the lives of our family and friends. [PHI Redacted] Thanks to those who see this need and are responding to it.
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Title: President
Organization: Obesity Action Coalition
Date: 04/10/2011
April 10, 2011
Sarah McClain, MHS
Joseph Chin, MD, MS
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244
Dear Ms. McClain & Dr. Chin:
On behalf of the 25,000 members of the Obesity Action Coalition (OAC), a national non-profit organization dedicated to helping those affected by obesity, I am pleased to submit the following comments regarding the Centers for Medicare & Medicaid Services (CMS) Nationa Coverage Analysis (NCA) regarding intensive behavioral counseling for obesity. We appreciate the opportunity to provide the Medicare program with feedback regarding this important coverage issue.
Treating or addressing obesity among those already obese is difficult. This is clearly demonstrated by the more than 34 percent of Americans who are currently affected by obesity. However challenging though, efforts must be made to both prevent and treat obesity at all stages and in all age groups. Patients and their healthcare providers need an arsenal of treatments -- as any one treatment may not work for every individual.
The OAC believes that Medicare should provide coverage for the continuum of care for the overweight or obese patient – including behavioral and nutritional counseling, physician-supervised programs, pharmaceuticals, and surgical treatment. Such an approach would be consistent with diagnosis and treatment coverage policy for other chronic diseases.
We are pleased that CMS will be examining the merits of providing Medicare coverage for intensive behavioral counseling services for those Medicare beneficiaries affected by obesity as currently Medicare only covers surgical intervention for this population under very strict guidelines.
Though OAC’s membership is comprised of mostly individuals affected by obesity, we do closely partner with a number of scientific and healthcare organizations whose members are involved in treating those affected by this chronic disease. These groups include The Obesity Society, American Dietetic Association, and the American Society for Metabolic and Bariatric Surgery. As such, OAC endorses the comments that each of the above groups are making in connection with the agency’s NCA on intensive behavioral counseling for obesity.
We can not stress strongly enough the importance that Medicare take a leadership role in expanding the treatment avenues available to those affected by obesity especially given the positive impact that coverage of these critical services will have on the private health insurance market.
Sincerely
Joseph Nadglowski, Jr
President
Obesity Action Coalition
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Organization: National Association of Social Workers
Date: 04/08/2011
NASW'S COMMENTS FOR NATIONAL COVERAGE ANALYSIS FOR INTENSIVE BEHAVIORAL THERAPY FOR OBESITY
The National Association of Social Workers(NASW), the largest professional organization of social workers with a membership of 150,000, appreciates the opportunity to comment on the national coverage analysis for intensive behavioral therapy for obesity. NASW is supportive of the Centers for Medicare and Medicaid Services decision to consider intensive behavioral therapy for obesity as a preventive service.
Clinical social workers are Medicare providers who diagnose and treat mental illness. They frequently treat obesity patients who have psychological or behavioral factors that contribute to obesity. When not resolved, these factors precipitate or exacerbate obesity health risks for medical conditions such as diabetes, coronary artery disease, and renal disease. Clinical social workers have the training, expertise and skills in cognitive, behavioral, supportive therapy to help obesity patients problem solve emotional and behavioral problems contributing to their obesity. In 2006, the National Institute of Mental Health linked obesity to mental disorders such as mood and anxiety. As one of the largest providers of mental health services in the nation, NASW recommends clinical social workers as one of the providers to be approved to perform intensive behavioral therapy for obesity patients. Clinical social workers treat patients from a holistic perspective, and thus also have expertise in working with obesity patients who have psychosocial problems related to health and medical disability.
Although treatment for persons suffering from obesity should be individualized, a standard one hour a week therapy session is recommended unless the patient has a severe behavioral problem requiring additional weekly therapy sessions.
Thank you for your consideration of clinical social workers as providers of behavioral health therapy for obesity.
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P
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Title: Director, Health Policy
Organization: Johnson & Johnson
Date: 04/07/2011
Louis B. Jacques, MD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C 1-09-06
7500 Security Blvd Baltimore MD 21244
Re: National Coverage Analysis (NCA) for Intensive Behavioral Therapy for Obesity (CAG-00423N)
Dear Dr. Jacques:
On behalf of HealthMedia, Inc. (HMI), a Johnson & Johnson company, I am pleased to submit comments on the National Coverage Analysis (NCA) for Intensive Behavioral Therapy for Obesity (CAG-00423N).
HealthMedia is a leading Wellness and Prevention innovator that combines advanced proprietary technology, behavioral science and national clinical guidelines to effectively deliver Digital Health coaching programs via the web. These programs have been proven to improve health outcomes and reduce health care expenditures. We recommend they be included as covered Medicare services under an affirmative National Coverage Determination (NCD) for Intensive Behavioral Therapy for Obesity.
Background and Introduction
CMS announced on March 11, 2011 its decision to initiate this NCA for Intensive Behavioral Therapy for Obesity, which is recommended with a grade B by the United States Preventive Services Task Force (USPSTF). CMS indicated it would be interested in receiving any recommendations on the appropriate frequency of this therapy and those qualified to provide it, based on documentation from the medical literature, current clinical practice guidelines, or the USPSTF recommendations.
In our comments which follow, we will: (1) describe HMI’s programs and summarize the evidence that these programs improve health outcomes and reduce health care costs; and, (2) summarize recent legislation and regulations that provide the opportunity for coverage of HMI’s programs.
HMI Programs: Description and Summary of Evidence of Improved Outcomes
HealthMedia, Inc. provides a comprehensive, integrated suite of web-based digital health coaching programs that combine advanced proprietary technology and behavioral science to emulate the experience of a confidential live health coaching or counseling session. It can be cost-effectively implemented across any size population and across the care continuum. HealthMedia’s sophisticated digital health coaching programs deliver highly customized individual action plans and advice that address each person’s needs, motivations, and barriers to success, with the convenience of 24/7 access and cost-effectiveness that web-based coaching provides.
HealthMedia has been delivering approaches that have demonstrated positive behavior outcomes for over 13 years. HealthMedia’s digital coaching is a web-based solution that blends behavior change science theories combined with nationally recognized guidelines for health and wellness to address prioritized risks based on need, want (motivation) and can (self-confidence). The product suite incorporates a Health Risk Assessment (HRA) integrated into lifestyle issues, behavioral health and chronic medical conditions. Among our health plan and employer customers, the HRA results are typically utilized to recruit participants into the appropriate condition-based programs (see below for a description of the programs relevant to obesity). Healthcare providers also refer their patients directly into our programs.
HealthMedia’s digital coaching programs can help improve health, aid in reducing healthcare utilization and support existing treatments which can result in lower costs. HealthMedia’s scalability enables enterprise organizations the ability to implement digital coaching programs as a risk management triage option providing alignment with the appropriate level of support. HealthMedia also provides robust reporting and data analytic capabilities. Lastly, just as an ATM machine does not eliminate the services offered inside a bank, HealthMedia’s programs are not intended to take the place of face-to-face health services, or telephonic health coaching. However, they provide an additional channel through which services can be delivered to patients. For example, our programs can be delivered to large patient groups to promote the development and maintenance of new self-management skills, while their healthcare providers focus on more pressing medical issues.
As the figure below indicates, obese patients often present with a range of multiple comorbid conditions, and as such, may require help in many areas. In Succeed we identify participants with multiple conditions comorbid with obesity, e.g., elevated blood pressure, dyslipidemia, increased waist circumference, and elevated blood glucose, glucose, diabetes, binge eating, and depression. Because our HRA assesses motivation and confidence to change, as well as the presence of health risks, we are able to triage patients into programs on the basis of their personal preferences, as well as their clinical needs, thereby increasing the likelihood of effective engagement.
HealthMedia currently has in excess of 39 million covered lives with over 250 different customers including national health plans, regional health plans, and self-insured employers along with multiple partners that interface with Medicaid, Medicare and the U.S. Government Federal Employee Program (FEP).
The programs described below are those that align with your therapeutic focus. Each one addresses a different set of modifiable risk factors that are associated with obesity. For example, binge eating, physical inactivity, and poor nutrition are primary contributors to the development of obesity. As individuals get more exercise, lose weight, and adhere to prescribed medications, risks and complications associated with obesity can be reduced.
HealthMedia offers powerful, scientific and affordable programs which specifically address the co-morbidities and co-behaviors involved with obesity syndrome.
• Losing Weight: HealthMedia® Balance™ provides a tailored action plan, based on a comprehensive assessment of the critical elements of successful weight loss and maintenance. The program design facilitates stage progression toward the achievement and maintenance of healthy Body Mass Index (BMI) levels by incorporating awareness and self-monitoring activities with cognitive-behavioral techniques for making healthier food choices.
• Increasing Physical Activity: HealthMedia® Move ™ is a physical activity program for people with sedentary to moderately active lifestyles. Move is much more than a walking program. Move guides people through the process of overcoming barriers, setting goals, and incorporating physical activity into his or her lifestyle. It helps people incorporate physical activity as part of their lifestyle, advancing them to their next level of activity. Move ™ incorporates Step by Step, a robust activity tracker. Move is up to date with CDC 2008 physical activity guidelines.
• Improving Mood: HealthMedia® Overcoming™ Depression: Depression, which is highly prevalent among obese patients, is both a cause and a result of obesity. It results in significantly higher medical costs due to lack of self-care, non-compliance with medication and treatment, and high-risk behaviors such as smoking and substance abuse. The program is based on sound clinical evidence and helps users to monitor symptoms and measure progress, gain confidential, 24/7 access to coping strategies and tools, and learn relapse prevention strategies.
• Managing Binge Eating: HealthMedia® Overcoming™ Binge Eating. Binge eating is a major cause of obesity, and highly prevalent among obese and severely obese, particularly those who participate in weight loss interventions or seek weight reduction surgery. Through a series of interactive exercises, participants establish a pattern of regular meals and snacks, while learning strategies to curb urges to overeat.
• Improving Nutrition: HealthMedia® Nourish™ simplifies the complex task of making healthy eating decisions and helps modify unhealthy eating behaviors which can increase diabetes risks. Nourish provides participants with smart and creative strategies to improve eating habits over time, both in terms of food selection and methods for handling challenging situations.
• HealthMedia® Care For Your Health™ is an exceptional chronic illness self-management program. The program is longitudinal, individually tailored (in print and web form), and focused on developing self-management skills that are important regardless of which chronic condition(s) the participant has. Care for Your Health comprehensively addresses three critical elements of successful self-management: medical management; lifestyle management; and emotional management. The program is based on the belief that everyone has to self-manage his or her health. One cannot "not" do it. The issue is whether one does it well or does it poorly. The Care for Your Health program provides the knowledge, skills, and support to learn to do it well.
• HealthMedia’s Succeed™ HRA provides participants with tailored individualized results variables specific to the individual member including age and gender. Succeed™ goes beyond other basic health assessments by determining the “need/want/can” of the participant’s lifestyle risks. The program identifies the participant’s need to change a behavior, motivation to change, and the participant’s self-confidence to change. In total we use nine different behavior change models to assess the individual and solicit change. A proprietary scoring algorithm is applied to provide recommendations for all key lifestyle behaviors, and detailed recommendations for the top four risks. These risks are prioritized according to the participant’s “need/want/can” results. The assessment questions in Succeed are derived from validated research measures, including the Behavioral Risk Factor Surveillance Survey, USDHHS, CES-D, Cohen’s Stress Scale, Fagerstrom Nicotine Index, WPAI and USPSTF.
• Diabetes Management: HealthMedia Care for Diabetes® is a complete diabetes management plan. It works to effectively change behaviors across all acuity levels by improving lifestyle issues, medication adherence, doctor-patient relationships, and diabetes education. The HealthMedia Care® for Diabetes program combines what is known from research about living with and managing diabetes and personalizes it—so individuals can accept the responsibility of day-to-day management of their condition.
• Blood Pressure Control: HealthMedia® Control™ is designed to bring participants into recommended blood pressure ranges by helping them to improve medication adherence, work more effectively with their health care team, lose weight, improve nutrition habits, and increase physical activity levels.
• Blood Pressure Control: HealthMedia® Achieve™ is designed to bring participants into recommended cholesterol ranges by helping them to improve medication adherence, work more effectively with their health care team, lose weight, improve nutrition habits, and increase physical activity levels.
Sample weight loss management protocols
HealthMedia® Balance™ is an ideal program for adults who want to lose weight, maintain a recent weight loss, or prevent the weight gain patterns frequently found with aging. Balance™ addresses three critical elements of successful weight loss and maintenance: nutritional habits (food); physical activity patterns (body); and the psychological, emotional, and behavioral patterns (mind) that influence them. This three-pronged methodology is significantly more comprehensive than traditional weight management interventions and support programs.
Balance™ assesses and then incorporates the following components into each tailored program:
• Health and medical history;
• Prior weight loss efforts and weight patterns;
• Intrinsic and extrinsic motivators for managing weight;
• Perceived barriers to change;
• Attitudes and stereotypes about overweight people and weight loss;
• Social support systems;
• Body image;
• Nutritional habits; and
• Physical activity patterns.
As mentioned, HealthMedia won the C. Everett Koop National Health Award for the positive results realized by the participants in a randomized clinical trial with the Balance™ program. The results of this trial were published in the February 2006 issue of Obesity.
Like other HealthMedia scalable interventions, Balance™ emulates a nurse counseling session to deliver an individually-tailored weight loss and maintenance plan that address each participant’s specific needs, taking into account their motivation, confidence and barriers to change.
This action plan is a blend of health behavior theory and counseling methodologies based on the individual’s unique situation utilizing the food, body and mind foundation. What’s more, because obesity is co-morbid and co-behavioral with so many other conditions such as stress, heart disease, hypertension, hyperlipidemia, depression, diabetes, etc., Balance™ assesses the whole person, not just a single problem.
Proven Clinical Results
Kaiser Permanente conducted a 1 year randomized control trial using HealthMedia® Balance™ vs. other non-tailored web solutions. Results showed that participants used 1.1 fewer outpatient visits than the control group, lost 2 times more weight and had significantly higher plan satisfaction. As a result of this study, Kaiser Permanente and HealthMedia, Inc, jointly won the prestigious C. Everett Koop Honorable Mention in the 2004 for Balance.
Predictive algorithms: What evidence base research was used to identify the at-risk populations?
From our work with health plan customers who have provided us access to claims data we have developed and validated 3 proprietary risk stratification algorithms using Succeed HRA data matched to 1) current healthcare costs, 2) Quality of Health, and 3) Morbidity Risk (Johns Hopkins scale). As such, we can use these algorithms to help you identify who is costing you the most money now, who is likely to cost you the most money in the future, or who has the highest risk for future health events. In the event that we move forward with an agreement, we will be happy to share the details of the results and the subsequent models that we use for prediction.
The Succeed HRA combines the latest practice guidelines from the U.S. Preventive Services Task Force, established constructs drawn from the evidence-based health and behavioral science literature and validated instruments (e.g. CES-D, WPAI) into a single, comprehensive measure of physical and behavioral health (strong construct validity) that not only allows for valid assessment of a population’s health status but also, unlike most other HRAs on the market, provides the individual with tailored feedback and an action plan that has been proven to change behavioral and biometric risks. In addition, through our strong collaborative relationship with our customers we have also established concurrent and predictive validity of the Succeed constructs with verified biometric values and costs/claims respectively.
HealthMedia is committed to bringing the best in psychometrics to its assessment and outcomes evaluations. With that in mind we continue through our ongoing research and development process to validate Succeed and the constructs that compose its contents in real world settings by leveraging our extensive database composed of hundred of thousands of respondents and our strong data analytical skills. Current work includes developing a predictive model for Productivity complete with odds ratios and confidence intervals for individual predictors of productivity impairment (stress, depression, obesity, etc.) and risk stratification that will allow customers to segment their population relative to costs, claims, morbidity and/or quality of health. Finally, we can provide customer specific validation upon request as part of our Data Analytics and Reporting service offerings.
All HealthMedia programs utilize evidence based guidelines (see partial listing below):
• National Heart Lung and Blood Institute. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: National Institutes of Health. 1998.
• ATP III and subsequent guidelines on identification and treatment of metabolic syndrome:
• National Cholesterol Education Program. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). National Heart, Lung, and Blood Institute. NIH Pub. No. 02-5125; 2002.
• Grundy SM, Cleeman JI, Merz CN, Brewer HB, Jr., et al. Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation 2004; 110:227-239.
• Grundy SM, Cleeman JI, Daniels SR, Donato KA, et al. Diagnosis and Management of the Metabolic Syndrome. An American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation 2005.
Legislation and Regulations Supporting the Use of HMI’s Web-Based Digital Health Coaching Programs
The tracking sheet for this NCA identifies the Medicare benefit category for Intensive Behavioral Therapy for Obesity as “Additional Preventive Services.” This new benefit category was established by Section 101(a) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. Law 110-275). Effective January 1, 2009, CMS is allowed to add coverage of "additional preventive services" if certain statutory requirements are made. Regulations for the coverage of "additional preventive services" were issued by CMS in the final rule for the 2009 Medicare Physician Fee Schedule under 42 CFR 410.64. Consistent with the statute, the regulations allow CMS to cover "additional preventive services", if it determines through the NCD process that the service is recommended with a grade A (strongly recommends) or grade B (recommends) rating by the USPSTF.
The statute and the regulations also indicate that “[t]he Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such services and may take into account the results of such an assessment in making such national coverage determinations.” In light of this provision and the evidence showing that HMI’s Digital Coaching programs reduce health care costs, we ask that CMS consider these cost savings as a specific component of this NCA.
The statute and the regulations do not require that coverage of “additional preventive services” be limited to services that are provided during a “face-to-face” encounter. In addition, Section 4102 of the Patient Protection and Affordable Care Act (ACA) “Medicare Coverage of Annual Wellness Visit Providing a Personalized Prevention Plan” includes the following in the definition of personalized prevention plan:
• a health risk assessment that may be furnished through an interactive telephonic or web-based program that meets certain standards, and
• The furnishing of personalized health advice and a referral, as appropriate, to health education or preventive counseling services or programs aimed at reducing identified risk factors and improving self-management, or community-based lifestyle interventions to reduce health risks and promote self-management and wellness, including weight loss, physical activity, smoking cessation, fall prevention, and nutrition.
We believe these provisions in ACA provide clear evidence of Congressional intent to expand the scope of preventive services beyond those provided during a traditional face-to-face encounter to include any programs that have been proven to improve health outcomes and reduce health care expenditures. We believe HMI’s Digital Coaching programs meet these outcome standards and offer the kind of intensive behavioral therapy that allows patients to develop and maintain skills to self-manage their obesity.
Conclusion
Thank you for the opportunity to comment on the NCA for Intensive Behavioral Therapy for Obesity. In our comments, we have provided evidence that HMI’s Digital Coaching programs improve health outcomes and reduce health care expenditures and that recent legislation and regulations support the use of interactive web-based programs to provide clinically important preventive services. Therefore, we recommend they be included as covered Medicare services under an affirmative NCD for Intensive Behavioral Therapy for Obesity.
If you have any questions, please call me at 774-275-0848 or send me an e-mail at rbedrosian@HealthMedia.com. We look forward to working with you through the entire NCA process. We would welcome the opportunity to meet with you in person at any time to demonstrate how our Digital Coaching programs work and to provide you any additional information that would facilitate your review of our programs and how they meet the requirements for Medicare coverage as outlined above.
Sincerely,
Richard C. Bedrosian, Ph.D.
Director, Behavioral Health and Solution Development
130 S. First Street
Ann Arbor, MI 48104
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