Intensive Behavioral Therapy for Obesity

A proposal for Intensive Behavioral Therapy that excludes behavioral health providers. Does that make sense? Obesity is the perfect condition to show how medical and behavioral health professionals can work together to improve outcomes for Medicare beneficiaries.

Obviously medical professionals are necessary for the medical assessment and treatment of obesity. Behavioral Health providers are necessary for the assessment of and intervention in the behavioral and environmental components of obesity.

While medical professionals may be able to provide some behavioral interventions they are not trained to the same degree as Behavioral Health specialists to identify specific psychopathology that can be a barrier to successful outcomes. Behavioral Health specialists have training and experience in working with the normal (but sometimes frustrating) phenomenon of psychological resistance. Behavioral Health specialists are trained in techniques such as motivational interviewing to assist patients in taking ownership of their condition, and therefore to have responsibility for the behaviors under their control. Behavioral Health providers have time to devote to specific interventions for the factors involved with obesity.

Obesity is not just a medical problem. Eating disorders are often associated with obesity. How many primary care providers have the expertise to recognize the psychiatric elements of obesity in addition to the medical complexity?

Please consider some of the non-medical contributors to obesity that I have observed in my practice:
Obesity as a response to sexual molestation; obesity as a result of addiction; obesity caused by medication side-effect; obesity related to environmental pressures to overeat; obesity related to disorder of appetite awareness caused by brain injury.

Will primary care practices be able to afford the intensity of services that would be appropriate for a patient with multi-determined obesity?

I fear that this proposal represents the dark days of bias against the value of behavioral health services. This proposal, on its face, suggests ignorance of the role of behavioral health, and the bias that primary care providers have greater expertise than allied professionals.

This proposal is flawed because it restricts patients choices regarding access to any qualified sevice provider.

This proposal must be modified to remove the bias against allied health professionals, and to promote the highest quality of care for Medicare beneficiaries.

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September 30, 2011

To Whom It May Concern:

On behalf of the 1,500 members of the American Society of Bariatric Physicians (ASBP), a national non-profit comprised of physicians dedicated to the medical management of overweight and obesity, I am pleased to provide the following comments regarding the Proposed Decision Memo for Intensive Behavioral Therapy for Obesity. ASBP agrees with the need for intensive counseling as part of a comprehensive obesity treatment program and commends the Centers for Medicare & Medicaid Services (CMS) for addressing this epidemic.

Physician Definition
The CMS proposes to cover costs for Medicare beneficiaries who seek counseling for obesity. Services furnished by qualified primary care physicians or other primary care practitioners in a primary care setting will be covered in the CMS proposal. The CMS defines primary care physicians as general practitioners, family practice practitioners, general internists, obstetricians or gynecologists. While these physicians should certainly be included in coverage, the proposed list is too restrictive. Obesity is a complex medical problem that requires training and knowledge that goes beyond that of primary care physicians^1-3. Studies have shown that weight management is not adequately addressed in a primary care setting.^4-6 In many patients, the common solutions for obesity given by primary care physicians, such as diet and exercise, are ineffective³, and advanced bariatric care is required. For example, cardiac patients are referred to cardiologists and diabetic patients are referred to endocrinologists when their needs go beyond the ability of primary care physicians. Similarly, obese patients should be referred to bariatric medicine specialists when their needs go beyond the ability of primary care physicians.

Therefore, the physician definition should be expanded to include bariatric medicine specialists and preventive medicine specialists who might not necessarily practice primary care. As specialists in the medical treatment of obesity, bariatric medicine specialists deliver a comprehensive treatment program which addresses medical complications, lifestyle changes, medical therapy when indicated, dietary and exercise recommendations, as well as behavioral counseling. Given the complexity of the obesity epidemic, proper treatment requires physicians who possess the extensive relevant training and experience which primary care physicians may not have the time, interest, experience or training to employ^2-4.

Primary Care Setting Definition
The proposed guidelines limit coverage to primary care settings. Many bariatric physicians and obesity specialists practice with a team comprised of registered dieticians, nurse practitioners, physician assistants, psychiatrists, nurses, and exercise physiologists. Services provided at these settings should also be covered.

Eligibility Criteria
The proposed guidelines currently require a body mass index (BMI) = 30kg/m2. However, patients who fall in the overweight category (BMI 25-30) could also benefit from intensive behavioral therapy and potentially avoid becoming obese. ASBP proposes including patients who have a BMI =27 with co-morbidities.

Covered Services
The exclusion of the coverage of pharmacotherapy will limit the effectiveness of the obesity treatment. Appetite suppressant therapy and insulin resistance medications can be critical components to obesity treatment in some patients^7,8, and the cost of these medications should be covered.

If the CMS would like to discuss any of the above information in further detail, please do not hesitate to contact the ASBP.

Regards,

Laurie Traetow, Executive Director

References

1.Kushner, R.F. Barriers to providing nutrition counseling by physicians: a survey of primary care practitioners. Prev Med 24, 546-52 (1995).
2.Pratt, C.A., Nosiri, U.I. & Pratt, C.B. Michigan physicians' perceptions of their role in managing obesity. Percept Mot Skills 84, 848-50 (1997).
3.Block, J.P., DeSalvo, K.B. & Fisher, W.P. Are physicians equipped to address the obesity epidemic? Knowledge and attitudes of internal medicine residents. Prev Med 36, 669-75 (2003).
4.Tsai, A.G., Abbo, E.D. & Ogden, L.G. The time burden of overweight and obesity in primary care. BMC Health Serv Res 11, 191 (2011).
5.Ferrante, J.M., Piasecki, A.K., Ohman-Strickland, P.A. & Crabtree, B.F. Family physicians' practices and attitudes regarding care of extremely obese patients. Obesity (Silver Spring) 17, 1710-6 (2009).
6.Wadden, T.A. et al. Obese women's perceptions of their physicians' weight management attitudes and practices. Arch Fam Med 9, 854-60 (2000).
7.Vetter, M.L., Faulconbridge, L.F., Webb, V.L. & Wadden, T.A. Behavioral and pharmacologic therapies for obesity. Nat Rev Endocrinol 6, 578-88.
8.Norris, S.L. et al. Efficacy of pharmacotherapy for weight loss in adults with type 2 diabetes mellitus: a meta-analysis. Arch Intern Med 164, 1395-404 (2004).

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September 30, 2011

Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00423N

Dear Sir/Madam:

On behalf of the MEND Foundation, we appreciate the opportunity to submit our comments in response to the Centers for Medicare and Medicaid Services (CMS) proposed coverage decision for intensive behavioral therapy for obesity.

According to the proposed decision memo, CMS plans to add intensive behavioral therapy for obesity as a covered benefit under the Medicare program. The benefit would include obesity screening in adults, dietary/nutritional counseling, and intensive behavioral counseling and therapy to promote sustained weight loss through diet and exercise. MEND strongly supports this proposal.

As the Agency is aware, obesity is a significant public health problem. It is a major risk factor for cardiovascular disease, cancer, diabetes, and early death. It also leads to increased health care costs. Fortunately, obesity is a modifiable risk factor. By lowering the prevalence of overweight and obesity, we can substantially reduce Americans’ risk of chronic disease, as well as improve overall health. We are therefore very pleased that CMS has proposed this new benefit to fight obesity in the Medicare population. Intensive behavioral therapy that includes both nutrition and physical activity interventions can help Medicare beneficiaries lose weight.

To further increase the effectiveness of the new benefit, however, we recommend that CMS consider:

• Adding dieticians, exercise physiologists, and peer health educators / other culturally competent lay people with specialized training and expertise in obesity treatment to the list of eligible providers
• Including other suitable venues for counseling services, such as appropriate community based locations with adequate facilities
• Including evidence-based group-based counseling for coverage
• Extending the initial high frequency period for counseling to 10-12 weeks
• Expanding the duration of the benefit beyond the one-year mark to allow for continued weight loss and visits focused on weight maintenance
• Taking into consideration the 2003 USPSTF recommendations that advise referral to high-intensity weight loss counseling programs and note that trained leader or multi-disciplinary models deliver counseling in the most effective programs. Specifically USPSTF also advise a higher initial frequency of contact
• Deferring a coverage decision until the updated 2010 USPSTF recommendations are published to ensure congruency and alignment between two such important policy guidelines
• Ideally, using waist circumference measurement, in addition to body mass index (BMI), as the recommended screening test
• Seeking to extend similar coverage recommendations for children and families under Medicaid as soon as possible.

In closing, we applaud CMS for its efforts to address the obesity epidemic and we reiterate our strong support for the proposed benefit. We look forward to seeing intensive behavioral therapy for obesity added to the Medicare and Medicaid programs as soon as possible. To maximize the effectiveness of this benefit we recommend that the Agency takes the suggestions above into account.

If you have any questions or need any additional information, please do not hesitate to contact me at 310 993 1183 or harry.macmillan@mendcentral.org

Thank you for consideration of our comments.

Sincerely,

Harry MacMillan
President
MEND Foundation

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On behalf of the International Health Racquet & Sportsclub Association - the trade association for commercial fitness centers - we are grateful for the opportunity to submit comments regarding the CMS proposed coverage decision for intensive behavioral therapy for obesity.

The proposed decision memo would require intensive behavioral therapy for obesity to occur in a primary care setting and be provided by primary care physicians or primary care practitioners.

We are concerned that these limitations would unnecessarily prevent Medicare beneficiaries from accessing vital obesity therapy resources, including expertise and equipment, available in fitness centers across the country.

Accordingly, we request that CMS include fitness centers as allowable settings, and expand the range of practitioners to include exercise physiologists, appropriately certified personal trainers, and nutritionists.

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The Colorado Department of Public Health and Environment (CDPHE) 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 as recommended by the U.S. Preventive Services Task Force (USPSTF).

Colorado has the lowest adult obesity prevalence in the nation, but we have not escaped the obesity epidemic. In fact, we are confronting a very critical and worsening public health problem. In 2010, Colorado’s obesity prevalence was 21.4 percent – more than double the 10.1 percent of Coloradans who were obese 15 years ago. The obesity prevalence among adults aged 65 years and older increased from 10.1 to 18.2 percent over the same period. Currently, obesity related healthcare costs Coloradans more than $1.5 billion each year. The increasing prevalence of obesity in Colorado is of particular concern to the Colorado Department of Public Health and Environment, and we have set our 2011–2012 priorities to improve access to preventive screenings, interventions, and services that can reduce the increasing prevalence of obesity in Colorado.

The causes of obesity are complex and require effective strategies and interventions that have a multipronged approach. We all play a part in stopping obesity. The Centers for Medicare and Medicaid Services’ proposed coverage for Intensive Behavioral Therapy for Obesity complements the work currently underway in Colorado of building stronger capacity within communities to address health, social, economic and environmental conditions. We recommend the following to the proposed changes:

• Establishing specific codes - Specific International Classification of Diseases Tenth Revision, Clinical Modification (ICD-10-CM) and Current Procedural Terminology Code (CPT) that is specific to obesity screening (as opposed to generic preventive codes). This will ensure uniformity in services provided and provide reliable nationwide data.
• Increase counseling sessions - Intensive behavioral counseling should be available to Medicare beneficiaries a minimum of 6 times within 12 months (as recommended by the USPSTF and the National Business Group on Health). ,
• Lift restrictions - Behavioral counseling should be available without restriction for any Medicare beneficiary (such as an obesity-related co-morbidity). Having this type of preventive service available will help maintain health, prevent or delay the onset of disease, and reduce health care costs.
• Expand providers available to counsel - All provider types (including registered dietitians, clinical psychologists, nurses, physicians, cardiologists, and exercise scientists) should be eligible for reimbursement for obesity screening as long as they have received specific obesity or weight management training and follow evidence-based protocols, guidelines, and approaches.

We believe that this benefit will have great impact for Medicare beneficiaries, such as preventing diabetes; lowering blood pressure, cholesterol, and triglyceride levels; improving sleep apnea and overall improvement in their quality of life. We look forward to working with Centers for Medicare and Medicaid Services during the implementation phase. Thank you for the opportunity to comment on this important issue.

Colorado Department of Public Health and Environment

References
Trogdon JG, Finkelstein EA, Cohen JW. State- and Payer-Specific Estimates of annual medical expenditures attributable to obesity. Obesity 2011; Jun 16. doi: 10.1038/oby.2011.169. [Epub ahead of print]
McTigue, Kathleen, Harris, Russell, et al. (2003). Screening and interventions for obesity in adults: Summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 139(11):933-949. Retrieved from www.preventiveservices.ahrq.gov.
National Business Group on Health. (2011). Obesity in Adults (Screening and Counseling). Retrieved from http://www.businessgrouphealth.org/preventive/topics/obesity.cfm

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As the Director of the Doernbecher Children's Hospital Healthy Lifestyles clinic, I provide the recommended services to children, and by extension, their families. I work with a multidisciplinary team that includes a nutritionist, physical therapist and child psychologist. Each member is a key component of the intensive behavioral treatment we perform. I am also a primary care pediatrician who struggles to provide a truncated version during office visits.

I strongly feel that services rendered by psychologists, as the primary experts in motivational interviewing techniques, be included as providers of this care. I am also a firm believer that nutritionists be included as providers of intensive behavioral treatment as the need is so great that most PCPs would struggle to see every motivated obese adult and child in their practices on a weekly basis.

I urge you to consider reimbursing these highly qualified members of the medical home, as the numbers of potential beneficiaries are so great they may prove overwhelming to the primary care provider alone.

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Sept. 30, 2011

RE: CAG-00423N

To Whom It May Concern:

The National Athletic Trainers’ Association (NATA) welcomes the opportunity to provide comment regarding the Centers for Medicare and Medicaid Services (CMS) proposed coverage decision for intensive behavioral therapy for obesity. By way of background, NATA is a professional not-for-profit membership association for certified athletic trainers and others who support the athletic training profession. Founded in 1950, NATA has grown to more than 34,000 members worldwide. Athletic trainers are health care professionals who are trained in injury prevention, diagnosis, treatment and rehabilitation. Licensed or regulated in 47 states, athletic trainers provide these services under the direction of physicians to people of all ages and physical abilities. Athletic trainers work in hospitals, clinics, physician offices, military medical units and many sports settings, including youth, secondary school, collegiate and professional sports. Because athletic trainers work with a focus on health and wellness, the profession is uniquely qualified to serve on the health care team that will positively affect intensive behavioral therapy for obesity.

According to the proposed decision memo, CMS plans to add intensive behavioral therapy for obesity as a covered benefit under the Medicare program. The benefit would include obesity screening in adults, dietary/nutritional counseling, and intensive behavioral counseling and therapy to promote sustained weight loss through diet and exercise. NATA strongly supports this proposal but offers some additional insight based on its medical and public health expertise.

As CMS is aware, obesity is a significant public health problem. It is a major risk factor for impaired physical activity, musculoskeletal disorders, exacerbation of certain types of arthritis, cardiovascular disease, cancer, diabetes, and early death. Obesity many times is the root cause for increased health care costs. The average annual medical claims diabetic employee is $22,512 vs. $1,721, according to a study by ACAP Health Consulting. Fortunately, obesity is a modifiable risk factor. By lowering the prevalence of overweight and obesity through medically and safety supervised physical activity programs, we can substantially improve overall health. NATA is very pleased that CMS has proposed this new benefit to fight obesity through intensive behavioral therapy that includes both physical activity and nutrition.

• Consider adding athletic trainers and other academically prepared professionals with specialized expertise in obesity treatment, including exercise therapy, strength and conditioning training, injury prevention, biomechanics to the list of eligible providers. Dietitians would be also be important to the effectively delivery of therapy.
• Expand the duration of the benefit beyond the one-year mark to allow for continued weight loss and visits focused on weight maintenance.
• Use waist circumference measurement, in addition to body mass index (BMI), as the recommended screening tests. Other measurements may include glucose risk scores, blood pressure and cholesterol testing.

As proposed, only primary care physicians and primary care practitioners (i.e., nurse practitioners, clinical nurse specialists, and physician assistants) would be allowed to provide intensive behavioral therapy for obesity. The benefit must also be provided in the primary care setting. NATA disagrees with this narrow focus on primary care, and encourages the Agency to include sports medicine physician practices as authorized to provide intensive behavioral therapy for obesity. Primary care and orthopedic sports medicine physicians and their athletic trainers, who serve in physician extender roles, are well qualified and have the capacity on a local level to assist in delivery of this wide spread public health issue. NATA is deeply concerned that the already overwhelmed primary care practices will be unable to effectively service this large beneficiary population. Additionally, the sports medicine professional community has the knowledge, skills and abilities to deliver safe and effective programs that include both physical activity and nutrition prescriptions. In general, primary care physicians and non-physician practitioners lack the much of the musculoskeletal knowledge that is provided by athletic trainers and their “team” physicians. This team approach and need for collaboration is emphasized by a recommendation by the National Institutes of Health (NIH) Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults, providers may wish to “avail themselves of the various disciplines that offer expertise in dietary counseling, physical activity, and behavior change.”

Conclusion
In closing, NATA and its members applaud CMS for its efforts to address the obesity epidemic and we reiterate our strong support for the proposed benefit. We look forward to seeing intensive behavioral therapy for obesity added to the Medicare program as soon as possible. To maximize the effectiveness of this benefit, reduce cost and human resource burdens and make powerful improvements in this concerning health issues, we recommended that the Agency add athletic trainers and sports medicine physicians as first-line care providers intensive behavioral therapy for obesity from the beginning of the benefit, if implemented.

If you have any questions or need additional information, please contact Cate Brennan, MBA, CAE, Associate Executive Director of Policy and Advocacy, 972.532.8848 or cate@nata.org .

Thank you for consideration of our comments.

Sincerely,

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September 30, 2011

Louis Jacques, MD
Director
Coverage and Analysis Group

Sarah McClain, MHS
Lead Health Policy Analyst
Division of Medical and Surgical Services
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Jacques and Ms. McClain:

The Campaign to End Obesity Action Fund (CEOAF) is pleased to submit comments to the Centers for Medicare and Medicaid Services on the National Coverage Analysis for Intensive Behavioral Therapy for Obesity. The CEOAF supports this effort as a strong step in expanding Medicare coverage for preventive services to include effective interventions for obesity. In its work, the Campaign to End Obesity Action Fund convenes leaders from across industry, academia, patient and public health communities to speak with one voice for measures to reverse the obesity epidemic and promote healthy weight in children and adults.

The Time is Now
The Campaign to End Obesity Action Fund is dedicated to reversing one of America’s costliest diseases. Today, two-thirds of U.S. adults and nearly one in three children struggle because they are overweight or have obesity. The effects of the nation’s obesity epidemic are immense: taxpayers, businesses, communities and individuals spend hundreds of billions of dollars each year due to obesity, including an estimated $168 billion in medical costs alone. In fact, because of the skyrocketing rates of obesity, the current generation of U.S. children are—for the first time ever—projected to have a shorter life expectancy than their parents.

The costs associated with treating obesity and its related conditions are unsustainable. Given the rising rates of obesity, nearly one out of every five dollars spent on healthcare in the United States will be attributable to obesity and obesity-related conditions within the next decade. Without serious efforts to reverse this epidemic, American taxpayers will incur ever-increasing costs, as obesity is linked to more than 60 other chronic conditions, including diabetes, heart disease, hypertension, cancer and others. Currently, Medicare is projected to pay out nearly $75 billion for diabetes care alone by 2019.

Proposed Determination is a Positive Step Forward to Combating the Obesity Epidemic
The Patient Protection and Affordable Care Act (PPACA) made several strides in ensuring coverage for badly needed preventive services for persons with obesity. According to the United States Preventive Services Task Force (USPSTF), intensive behavioral therapy for obesity consists of the following:

• Screening for obesity in adults (using BMI measurements);
• Dietary assessment; and
• Intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high intensity interventions on diet and exercise.

However, there is currently little, if any, incentive for primary care physicians to conduct interventions with patients with obesity; indeed, these consultations are not covered under most insurance plans. The Campaign to End Obesity Action Fund believes that the proposed coverage analysis provides important incentives for physicians, often for the first time ever, to treat individuals with obesity in the primary care setting.

Because of the complex nature of obesity, there is no single weight loss approach that is proven to be successful across the population. In recognition of this, the proposed coverage analysis provides payment for physicians to have multiple consultations with patients with obesity in order to monitor progress as well as discuss alternative treatment options. This is a needed step in effectively treating persons with obesity.

Work to be Done
While the proposed coverage analysis provides critical steps to treat obesity and prevent chronic conditions, more can be done to properly care for patients with obesity.

The proposed coverage analysis provides payment for services provided in the primary care setting which—while a vital first step—is not the only area in which obesity treatment services are provided. Primary care physicians often lack the essential training in nutrition and exercise therapy to provide comprehensive treatment services for their patients. These patients may be better served by seeing not only a primary care physician, but also a specialist in an area relevant to their clinical needs – i.e., a nutritionist, exercise therapist or an obesity medicine specialist. As such, the Campaign to End Obesity Action Fund would urge coverage for these and other appropriate clinical visits for patients with obesity to ensure that they receive appropriate, high-quality treatment.

On behalf of the Campaign to End Obesity Action Fund, I want to thank you for the opportunity to share our thoughts and express our support for the proposed coverage analysis.

Sincerely,

Lee M. Kaplan, MD, PhD
Chairman emeritus

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September 30, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Dear Dr. Jacques:

On behalf of the American Society for Metabolic and Bariatric Surgery (ASMBS), the largest surgical society in the United States dedicated to the treatment of obesity and related diseases, I am pleased to submit the following comments regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Decision (NCD) memorandum regarding intensive behavioral counseling for obesity. We appreciate the opportunity to provide the Medicare program with feedback regarding this important coverage issue.

The ASMBS believes that Medicare should provide coverage for obese patients beginning at a BMI of 30 and above across the continuum of care including behavioral and nutritional counseling, physician-supervised programs, pharmaceuticals, and surgical treatment. An obese patient should be able to go to their primary physician, have their level of obesity identified and be able to discuss and obtain treatment recommendations and referrals necessary to address obesity. Medicare should pay for this consultation and ongoing intervention. Such an approach would be consistent with diagnosis and treatment coverage policy for other chronic diseases.

We applaud CMS for proposing a comprehensive schedule of counseling intervention for Medicare patients affected by obesity. Intensive behavioral counseling services have been demonstrated to be a critical component of successful outcomes for the bariatric surgery patient. For these reasons, intensive behavioral counseling for obesity as it relates to nutrition is compulsory both for patients working with an intensive medical weight loss program as well as preceding and following bariatric surgery.

The role of nutrition is extremely important during all phases of obesity management including the pre-surgical screening to evaluate weight history, efforts to lose weight, food preferences and food-related behaviors (i.e. binge eating) to assist the beneficiary in achieving weight loss. Counseling as well as frequent monitoring for accountability of recommended therapy has been shown to have the maximum benefit for within an intensive medical weight loss program as well as an adjunct to any surgical therapy.

As the Medicare program moves forward in expanding its coverage of obesity treatment services, ASMBS suggests that CMS strongly consider expanding the providers eligible to deliver such services to include dietitians, nutritionists, mental health professionals, Certified Obesity Medical Physicians (COMP) and bariatric surgeons. These health care professionals make up the multi-disciplinary treatment team so critical for the care surrounding either intensive medical treatment or surgical intervention for those affected by obesity. CMS might also consider evaluating coverage of these services, provided that they are delivered in facilities that are Medicare certified by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence, or recognized by the American College of Surgeons as a Level 1 Bariatric Surgery Center.

Finally, ASMBS recommends that CMS include in the NCD a reference to alternative treatments including drug therapy and surgery for those Medicare beneficiaries who do not medically respond to intensive behavioral therapy. 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 cannot stress strongly enough the importance of Medicare’s leadership role in expanding the treatment avenues available to those affected by obesity. For these reasons, the ASMBS is pleased to endorse the guidelines outlined in the August 30, 2011 proposed NCD as a critical first step toward eventually securing Medicare beneficiary access to, and coverage of, intensive obesity behavioral counseling services provided by all health care professionals that make up the obesity care continuum.

Sincerely,

Robin Blackstone, MD, FASMBS, FACS
President
American Society for Metabolic and Bariatric Surgery

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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: Proposed National Coverage Determination (NCD) 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 propose NCD 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.

CMS’s Proposed Decision Is An Important Step To Fight Obesity, But More Is Needed

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 the proposed NCD, CMS proposes to cover intensive behavioral intervention for obesity when it is provided by a qualified primary care physician or other primary care practitioner in a primary care setting. We support the proposed decision to provide Medicare coverage for intensive behavioral therapy for obesity, defined as a body mass index (BMI) = 30 kg/m2.

As CMS notes, the Centers for Disease Control and Prevention deems the rates of obesity in the US to be of epidemic proportions, directly leading to the increasing prevalence of chronic diseases such as heart disease, type 2 diabetes, certain cancers, and stroke. One recent article estimates Medicare could save from $7 to $15 billion over the lifetimes of a single wave of eligible participants in expanded coverage for weight loss programs. It is in the best interest of the health of the Medicare population, and the overall financial stability of the Medicare program, that CMS offer coverage to Medicare beneficiaries for proven programs to help combat the obesity epidemic.

Therefore, we believe CMS should take this opportunity to fully consider the potential benefits that web-based digital health programs such as those developed by HealthMedia can offer to enhance the effectiveness of primary care physicians and their clinical staffs. Digital health coaching (DHC) is a different category of intervention that is intended to augment “live”, face-to-face services for weight management. For some patients, DHC may also be an alternative to live coaching, but that subject is beyond the scope of this proposed NCD. Currently, HealthMedia has fourteen DHC programs addressing weight management, nutrition, physical activity, stress, depressive symptoms, diabetes, binge eating, hypertension, and a number of other topics. HealthMedia also has a digital health risk appraisal, which is often used as a triage engine to refer patients to the appropriate condition-based interventions.

Digital Health Coaching Programs For Obesity: Enhancing Face-to-Face Services to Meet Individual Patient’s Needs

HealthMedia submitted comments to CMS when the national coverage analysis was opened in March. That letter included background on HealthMedia and our programs, and we will not repeat that information in this letter. Instead, we will focus on the role of DHC programs relative to face-to-face therapy by a qualified physician or other provider.

In numerous health care settings across the US, DHC programs have been fully integrated into the system of care and the workflow in primary care. This enables the provider to “prescribe” use of the DHC program to the patient , and conversely, allows providers to have access to information gathered from the patient by DHC programs. The mechanics of referring patients into DHC programs, and integrating the programs with care systems are discussed in a subsequent section.

DHC programs can help to inform and improve the effectiveness of care, by providing information to the provider that he or she might not have the time or the opportunity to obtain. For example, the “counselor assist” function in DHC programs allows providers direct access to the patient’s assessment data, and the tailored plan generated for the patient as a result of those data. Data gathered from DHC programs can be shared with providers through password protected summaries, in e-mails, or where applicable, in direct feeds into the patient’s medical electronic record, so they are available for immediate access by the provider. Moreover, situations that require more urgent attention (e.g., significant depression) trigger immediate “alerts” to providers, who can follow up with phone outreach to the patient. We know from anecdotal reports that such alerts have resulted in rapid identification and interventions with suicidal patients, thereby preventing self-harm. As will be explained later, DHC can enhance care even in health systems with limited technology resources (i.e., no electronic medical records), as long as providers can access the Internet. Similarly, there are alternative ways to access DHC programs available for patients who do not have Internet service in their homes.

The etiology of obesity can be complex, particularly if disordered eating and other comorbid conditions are part of the problem. Many obese patients have a history of failed weight loss attempts, which undermines their motivation and self-confidence to change. These elements complicate treatment, and addressing them effectively can be time-consuming. Primary care physicians are already in short supply, and they are being stretched thin by an ever-increasing burden of clinical demands. Although providers may receive reimbursement for obesity treatment, the heavy workload in primary care will continue to put a ceiling on the amount of time that they can give to each patient. When used under the coordination of a provider, DHC programs can serve as “physician extenders”, augmenting weight management services offered in primary care, thereby enabling providers to make the most expeditious use of the limited time they have available to spend with each patient. Some examples of how DHC can augment care include the following:

• DHC programs can aid in tracking progress and help patients develop specific self-management skills between visits to the health care provider. The NCD for obesity covers a year-long program, in which the frequency of patient contact with the provider tapers progressively from weekly during the first month down to monthly for the last six months. The DHC programs can provide support to the patient during these ever-widening intervals between visits, while keep the patient engaged in modifying behavior and tracking progress. Moreover, as described below, patient data collected digitally can be made available to the provider through a variety of means, thereby enhancing patient tracking and treatment planning.
• DHC can help the provider and the patient address significant comorbidities that are often associated with obesity, and may complicate weight management efforts. For example, a DHC program may help a patient develop skills in managing depression, which in turn will improve the chances that patient will stay motivated to lose weight. Specific DHC programs for additional conditions can be included to help the patients manage the full scope of their obesity without requiring additional office visits.
• DHC can help to increase motivation and self-confidence to change, by assessing and addressing the perceived barriers that interfere with obesity management.
• DHC can help to reach some typically hard-to-reach populations. In the case of rural and geographically isolated patients, they may receive additional support from DHC programs after an initial visit with a physician. Similarly, patients with mobility problems that restrict travel outside the home represent another group of patients that may benefit from DHC following an initial office visit. DHC may help patients begin to address critical components of obesity they may be reluctant to discuss with their providers, particularly those associated with social stigma. For example, binge eating is very common among obese patients, and will sabotage weight loss efforts if not addressed. DHC may help patients start to acknowledge and modify disordered eating patterns that they may not be ready to address in face-to-face treatment. This may be particularly true for males, who may view disordered eating as a “female” problem. HealthMedia’s binge eating DHC program illustrates these points: Out of 24,000 participants to date, over 87% had not sought any treatment for their eating problems. Moreover, while studies of binge eating disorders often include only females because of difficulties recruiting males, over 30% of the participants in the DHC program are male.

DHC For Obesity Meets The CMS Coverage Criteria, Except For The Face-To-Face Requirement

The proposed NCD relies on CMS’ authority to add coverage of "additional preventive services" if certain statutory requirements are made. For example, CMS’ is allowed 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 United States Preventive Services Task Force (USPSTF).

According to the NCD, intensive behavioral therapy for obesity consists of the following:

1. Screening for obesity in adults using measurement of BMI calculated by dividing weight in kilograms by the square of height in meters (expressed in kg/m2);
2. Dietary (nutritional) assessment; and
3. Intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high intensity interventions on diet and exercise.

Further, under the NCD, the intensive behavioral intervention for obesity should be consistent with the 5-A framework that has been highlighted by the USPSTF:

1. Assess: Ask about/assess behavioral health risk(s) and factors affecting choice of behavior change goals/methods.
2. Advise: Give clear, specific, and personalized behavior change advice, including information about personal health harms and benefits.
3. Agree: Collaboratively select appropriate treatment goals and methods based on the patient’s interest in and willingness to change the behavior.
4. Assist: Using behavior change techniques (self-help and/or counseling), aid the patient in achieving agreed-upon goals by acquiring the skills, confidence, and social/environmental supports for behavior change, supplemented with adjunctive medical treatments when appropriate.
5. Arrange: Schedule follow-up contacts (in person or by telephone) to provide ongoing assistance/support and to adjust the treatment plan as needed, including referral to more intensive or specialized treatment.

Patients typically access digital health coaching programs through three avenues: 1. Primary care physician referrals; 2. Referrals based on their health risk appraisal results; 3. Self-referrals, typically because the programs are available through the websites of their health plans. The following diagram illustrates how DHC can be integrated into primary care services, and how the interventions follow the 5-A framework recommended by the USPSTF.

1. Assess: After enrolling in a DHC program, the patient participates in a “consultation”, an interactive questionnaire which emulates an intake session, establishing an emotional connection with the participant and offering tailored feedback as the process unfolds. The assessment focuses on health risks, comorbid conditions, behavior patterns, current coping strategies, and most importantly, the participant’s motivation and self-confidence to pursue behavior change goals. While use of the DHC programs typically requires Internet access, there are print versions of some programs available. Moreover, patients without home Internet service can access the programs in other locations (e.g., medical facilities or public libraries).
2. Advise: Upon completing the consultation, the patient receives a highly tailored behavior change plan, that includes recommended behavior change goals and strategies. The plan focuses strongly on barriers to change and motivational issues, as well as action steps that promote change. DHC program can be used to inform care in various ways:
   1. Information for providers. The provider can see all the patient’s questionnaire responses and tailored plan by logging into “counselor assist” applications. These applications can also show longitudinal data from patient self-monitoring tools, so that the provider can see how patients are progressing between visits. In the case of obesity, this type of tracking function may be critical for monitoring patient progress, especially during the latter stages of treatment (i.e., after six months), when “live’ visits may only be occurring on a monthly basis. Moreover, this functionality could also enable providers to determine at a glance whether patients have achieved the requisite weight reduction, entitling them to coverage for care during the last six months of treatment.
   2. Alerts to the care system. Information can also be “pushed” to providers, alerting them to high risk symptoms or changes in the patient’s status that require follow-up. This can be accomplished by generating automatic e-mails to providers, or where applicable, transmitting information into the patient’s electronic medical record.
3. Agree: Goals in the plan are generated by algorithms which factor in medical need and clinical guidelines, readiness to change, as well personal values, barriers, and challenges. The resulting plan lays out a path that begins where the participant currently stands in the change process.
4. Assist: The DHC program typically encourages patients to use evidence-based behavior change strategies to increase motivation and confidence, and improve self-management skills. Programs contain a variety of interactive tools and trackers that can be used longitudinally to practice new behaviors and assess progress. Programs encourage use of social supports and promote greater collaboration with one’s health care providers.
5. Arrange: The DHC programs send out a series of e-mail communications to keep the participant longitudinally engaged. Automated follow-up evaluations occur at 30, 90, and 180 days. The patient may opt to take additional DHC programs targeting other areas of concern, either in concert with the initial program or after its completion.

Proven Clinical Results

Expanding the scope of covered services could give Medicare an important opportunity to take advantage of the proven clinical benefits of DHC. A growing body of research demonstrates the efficacy of automated, technology-based programs for managing obesity and a wide range of related conditions (e.g., depression, diabetes, and so on). These studies indicate that not only does DHC result in positive medical outcomes (e.g., weight loss, reduction in depression symptoms, and so on), but it can also lead to reduced utilization of health care services and reduced health care costs. A partial list of such research is included in an appendix to this document.

A landmark randomized controlled trial of DHC for weight management was conducted by Kaiser Permanente health plan, as described in a peer-reviewed publication. Kaiser Permanente conducted a one year trial comparing HealthMedia® Balance™ to other non-tailored web solutions. Results showed that participants used 1.1 fewer outpatient visits than the control group, lost twice the weight and had significantly higher plan satisfaction. Weight loss among the participants in Balance™ compared very favorably with those reported by a number of popular “high touch” weight loss solutions. 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 (A detailed description of the study was published in a peer reviewed journal: Rothert, K., Strecher, et al. Web-based weight management programs in an integrated health care setting: A randomized, controlled trial. Obesity, 14, 266-272).

The research regarding self-help resources, both text- and computer-based, has long shown that outcomes are enhanced when participants receive some guidance in using them, even when the guidance is provided by peers or paraprofessionals. Consequently, Medicare can expect that the effectiveness of DHC will be enhanced when it is integrated into “live” treatment, with a practitioner guiding its use.

Conclusion

Thank you for the opportunity to comment on the NCD for Intensive Behavioral Therapy for Obesity. In our comments, we have described how HDC programs provide an important supplement to make face-to-face visits more effective. We have also included evidence that HDC programs improve health outcomes and reduce health care expenditures. 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 would welcome the opportunity to meet with you in person at any time to demonstrate how our HDC 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

References: Effectiveness of Digital Health Coaching for Weight Loss and Comorbid Conditions

1. Berino-Harvey, J., Pintauro, S., Buzzell, P., Gold, E.C. Effect of internet support on the long-term maintenance of weight loss. Obesity Research, 12, 320-329.
2. Celio, A., et.al. (2000). Reducing risk factors for eating disorders: Comparison of an Internet- and a classroom-delivered psychoeducational program. Journal of Consulting & Clinical Psychology, 68, 650-657
3. Christensen, H., et al. (2004). Delivering interventions for depression by using the internet: Randomised controlled trial. British Medical Journal, 328, 265-269.
4. Gega, L., et al. (2004). Computer-Aided CBT Self-Help tor Anxiety and Depressive Disorders: Experience of a London Clinic and Future Directions. Journal of Clinical Psychology. 60, 147-157.
5. Helwig, A., et al. (1999). An office-based Internet patient education system: A pilot study. Journal of Family Practice, 48, 123-127.
6. Liss, H. et al. (2002). Research on telehealth and chronic medical conditions: Critical review, key issues, and future directions. Rehabilitation Psychology, 47, 8-30.
7. Luce, K., Winzelberg, A., & Zabinski, M. (2003). Internet-delivered psychological interventions for body image dissatisfaction and disordered eating. Psychotherapy: Theory, Research, Practice, Training, 40, 148-154.
8. Napolitano, M., et al. (2003). Evaluation of an Internet-based physical activity intervention: A preliminary investigation. Annals of Behavioral Medicine, 25, 92-99.
9. Proudfoot, J., et al. (2003) Computerised, interactive, multimedia CBT reduced anxiety and depression in general practice: a RCT. Psychological Medicine, 33, 217-227.
10. Rothert, K., Strecher, V.J., Doyle, L.A., et al. Web-based weight management programs in an integrated health care setting: A randomized, controlled trial. Obesity, 14, 266-272.
11. Schwartz SM, Ireland C, Strecher V, Nakao D, Wang C, Juarez DT. (2010).The economic value of a wellness and disease prevention program. Population Health Management. 13(6):309-3167, 2010.
12. Schwartz SM, Day B, Wildenhaus K, Silberman A, et al. (2010). The Impact of an Online Disease Management Program on Medical Costs Among Health Plan Members. American Journal of Health Promotion: November/December 2010, Vol. 25, No. 2, pp. 126-133.
13. Strecher VJ, McClure JB, Alexander GL et al. Web-based smoking-cessation programs: results of a randomized trial. Am J Prev Med. 2008;34:373-381.
14. Strecher VJ, Wang C, Derry H, Wildenhaus K, Johnson C. (2002). Tailored interventions for multiple risk behaviors. Health Educ Res, 19: 619-626.
15. Tate, D.F., Jackvony, E.H., Wing, R.R. Effects of internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: A randomized trial. Journal of the American Medical Association, 289, 1833-1836.
16. Tate, D.F., Wing, R.R., Winett, R.A. Using internet technology to deliver a behavioral weight loss program. Journal of the American Medical Association, 285, 1172-1177.
17. Weight Loss Improved By Computer Automated E-counseling. Retrieved on November 21, 2007, from http://www.medicalnewstoday.com/articles/49662.php.
18. Weinstein, P.K. (2006). A review of weight loss programs delivered via the internet. Journal of Cardiovascular Nursing, 21, 251-258.
19. Williams LC, Day BT. (2011). Medical cost savings for web-based wellness program participants from employers engaged in health promotion activities. Am J Health Promot. 2011 Mar-Apr;25(4):272-80.
20. Winzelberg, A., et al. (2000). Effectiveness of an Internet-based program for reducing risk factors for eating disorders. Journal of Consulting & Clinical Psychology, 68, 346-350.
21. Womble, L.G., Wadden, T.A., McGuckin, B.G., Sargent, S.L., Rothman, R.A., Krauthamer-Ewing, S. A randomized controlled trial of a commercial internet weight loss program. Obesity Research, 12, 1011-1018.
22. Wright, J.H., et al. (2005). Computer-Assisted Cognitive Therapy for Depression: Maintaining Efficacy While Reducing Therapist Time. American Journal of Psychiatry. 162, 1158-1164.
23. Zabinski, M., et al. (2001). Reducing risk factors for eating disorders: Targeting at-risk women with a computerized psychoeducational program. International Journal of Eating Disorders, 29, 410-408.

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September 30, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Dear Dr. Jacques:

On behalf of The Obesity Society (TOS), the leading scientific society dedicated to the study of obesity, I am pleased to submit the following comments regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Decision (NCD) memorandum regarding intensive behavioral counseling for obesity. We appreciate the opportunity to provide the Medicare program with feedback regarding this important coverage issue.

TOS applauds CMS for proposing a comprehensive schedule of counseling intervention for Medicare patients affected by obesity. As you know, intensive behavioral counseling services are a critical component of fostering quality and successful weight loss outcomes. Intensive behavioral counseling can be used as a stand-alone treatment, or in conjunction with pharmacotherapy or bariatric surgery.

As the Medicare program moves forward in expanding its coverage of obesity treatment services, TOS suggests that CMS strongly consider expanding the providers eligible to deliver such services to include dietitians, nutritionists, mental health professionals, and Certified Obesity Medical Physicians (COMP). These health care professionals make up the multi-disciplinary treatment team, which is so critical in the continuum of care for those affected by obesity. Therefore, CMS might also consider evaluating coverage of these services.

Finally, TOS recommends that CMS consider including in the NCD a reference to alternative treatments including drug therapy and surgery for those Medicare beneficiaries who do not medically respond to intensive behavioral therapy. 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.

TOS cannot stress strongly enough the importance of Medicare’s leadership role in expanding the treatment avenues available to those affected by obesity. For these reasons, TOS is pleased to endorse the guidelines outlined in the August 30, 2011 proposed NCD as a critical first step toward eventually securing Medicare beneficiary access to, and coverage of, intensive obesity behavioral counseling services provided by all health care professionals that make up the obesity care continuum.

Sincerely,

Jennifer Lovejoy, PhD
President
The Obesity Society

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Louis B. Jacques, MD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services

Comments Submitted Electronically Via CMS Web Site

Re: Proposed National Coverage Determination (NCD) for Intensive Behavioral Therapy for Obesity (CAG-00423N)

Dear Dr. Jacques:

On behalf of Johnson & Johnson’s Operating Companies, I am pleased to submit these comments and recommendations in response to the proposed decision memo for intensive behavioral therapy (IBT) for obesity. This decision memo was issued by the Centers for Medicare & Medicaid Services (CMS) on August 31, 2011.

Johnson & Johnson (J&J) is the world’s most comprehensive and broadly-based manufacturer of health care products for the consumer, pharmaceutical and medical devices and diagnostics markets. For 125 years, J&J Companies have supplied doctors, nurses and patients with a broad range of products and has led the way in innovation, beginning with the first antiseptic bandages and sutures.

J&J enthusiastically endorses the proposed decision memo to cover intensive behavioral intervention for obesity for those Medicare beneficiaries with obesity, who are competent and alert at the time that counseling is provided and whose counseling is furnished by a qualified primary care physician or other primary care practitioner and in a primary care setting.

The coverage decision will go a long way to decelerate the obesity epidemic and the costs associated with treating obesity-related co-morbidities among Medicare beneficiaries. The coverage decision also may encourage commercial health plans to consider expanding their coverage policy to include IBT for obesity.

Going forward, J&J suggests that CMS consider expanding the providers eligible to deliver such services to include dietitians, bariatricians and surgeons. These health care professionals typically provide basic clinical services and counseling to overweight and obese patients. Expanding coverage to include these primary caregivers and specialists will extend the reach of the coverage decision to a broader Medicare population. And these providers have the training and experience to be a valuable partner/resource to primary care physicians; especially among those PCPs who currently do not have the training or resources to manage the obese Medicare beneficiary.

Additionally, we recommend that Medicare include coverage of digital health coaching (DHC) programs for obesity in the final NCD. HealthMedia, Inc., a Johnson & Johnson company, has submitted separate comments that describe how DHC programs provide an important supplement to make face-to-face visits more effective. Those comments also include evidence that DHC programs improve health outcomes and reduce health care expenditures.

We also suggest that the agency include in the coverage decision a reference to alternative obesity treatments including drug therapy and bariatric surgery for those Medicare beneficiaries whose weight loss under intensive behavioral therapy fails, or is inadequate or unsatisfactory. Medicare covers bariatric surgery for beneficiaries whose body mass index (BMI) is greater than 40, as well as beneficiaries with a BMI>35 and with a major comorbidity such as type 2 diabetes. Bariatric surgery has been shown to be an effective and longer-lasting treatment to weight loss compared to other treatments.

Finally, we recommend that IBT should not be a pre-requisite for Medicare beneficiaries seeking bariatric surgery. There are no Class 1 studies or evidence-base reports that document the benefits of, or the need for, a 6 or 12 month pre-operative dietary weight loss program before bariatric surgery. There is some lower level evidence supporting physician supervised weight loss to improve a patient’s surgical risk or to evaluate patient compliance to diet and exercise following surgery.

We greatly appreciate the opportunity to submit these comments and recommendations to CMS. The proposed coverage decision for IBT for obesity is a groundbreaking initiative that addresses in a direct and cost-effective manner the obesity epidemic.

Sincerely,
Steve Phillips
Director, Health Policy
Worldwide Government Affairs & Policy
Johnson & Johnson Services, Inc.

Publication 100-03, Chapter 1, Part 2, Section 100.1 Bariatric Surgery for Morbid Obesity, February 21, 2006. www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=57&ncdver=3&bc=AAAAgAAABAAA&

American Society for Metabolic and Bariatric Surgery Position Statement on Preoperative Supervised Weight Loss Requirements. http://s3.amazonaws.com/publicASMBS/GuidelinesStatements/PositionStatement/ASMBS%20Position%20Statement%20on%20Preoperative%20Supervised%20Weight%20Loss%20Requirements.pdf

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September 30, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Dear Dr. Jacques:

On behalf of the 27,000 members of the Obesity Action Coalition (OAC), I am pleased to submit the following comments regarding the Centers for Medicare & Medicaid Services (CMS) proposed National Coverage Decision regarding intensive behavioral counseling for the disease of obesity. We appreciate the opportunity to provide the Medicare program with feedback regarding this important coverage issue.

Treating or addressing obesity among those already affected by obesity 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.

Therefore, we applaud CMS for proposing such a comprehensive schedule for intensive behavioral counseling services for those Medicare beneficiaries affected by obesity who are competent and alert at the time that counseling is provided and whose counseling is furnished by a qualified primary care physician or other primary care practitioner and in a primary care setting.

This coverage decision will have a tremendous effect on addressing our country’s obesity epidemic and the costs associated with treating obesity-related co-morbidities among Medicare beneficiaries. Medicare’s catalytic efforts on this issue will also hopefully encourage commercial health plans to consider expanding their coverage policy to include intensive behavioral intervention for obesity.

As the Medicare program moves forward in expanding its coverage of obesity treatment services, the OAC suggests that CMS strongly consider expanding the providers eligible to deliver such services to include dietitians, nutritionists, mental health professionals and Certified Obesity Medical Physicians (COMP). These healthcare professionals represent the front line of the multi-disciplinary treatment team for those affected by obesity.

The OAC cannot stress strongly enough the importance of Medicare’s leadership role in expanding the treatment avenues available to those affected by obesity. For these reasons, the OAC is pleased to endorse the guidelines outlined in the August 30, 2011 proposed NCD as a critical first step toward eventually securing Medicare beneficiary access to, and coverage of, intensive obesity behavioral counseling services provided by all healthcare professionals that make up the obesity care continuum.

Sincerely,

Joe Nadglowski
President & CEO
Obesity Action Coalition
Tampa, Florida

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September 30, 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 on Proposed Coverage Decision Memorandum for Intensive Behavioral Therapy for Obesity (CAG-00423N)

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 has moved forward with a proposed decision memorandum for Medicare coverage of intensive behavioral therapy for obesity (IBTO).

As we noted in our April 2011 comments to you on the initial Medicare National Coverage Analysis (NCA) for IBTO, the obesity epidemic continues to have serious implications for American’s health and related health care spending. In July 2011 we released our eighth annual F as in Fat report in conjunction with the Robert Wood Johnson Foundation. The report found that obesity rates increased in 16 states and did not decrease in any over the past year and noted that the epidemic has grown at a staggering pace over the past several decades.

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. Furthermore, obesity is associated with more than 20 major chronic diseases and obesity-related costs account for almost a tenth of all annual medical expenditures.

Now is the time to deploy and develop evidence-based approaches to addressing the obesity epidemic. IBTO, based on a review and recommendation from the U.S. Preventive Services Task Force, in conjunction with other studies and findings, is one critical opportunity for the Medicare program to address obesity and related co-morbidities among its beneficiary population.

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 and further analysis has confirmed that such programs are effective in older adults, a finding important to the Medicare program. We likewise support the initial findings of the proposed coverage decision memorandum that the IBTO coverage is “reasonable and necessary for prevention and early detection of illness or disability.”

We urge CMS however, to reconsider the scope of eligible IBTO practitioners. As the proposed coverage determination memorandum is currently drafted, only a qualified primary care physician or other primary care practitioner operating in a primary care setting would be eligible to receive reimbursement for providing IBTO services.

As we mentioned in our previous comments to the NCA, IBTO services are not solely provided in the physician setting. In fact, 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.

In some instances, IBTO may be even more effective when provided outside the physician setting. A recent study found that patients that were referred to the Weight Watchers program, a commercial service that provides IBTO services to beneficiaries, lost twice as much weight on average as those that were referred to traditional clinical IBTO programs.

We would also note limiting coverage to physicians and the primary care setting is inconsistent with the original U.S. Preventive Services Task Force (USPSTF) recommendation on this topic. Among the 11 randomized clinical trials that the USPSTF reviewed in arriving at their recommendation, only three explicitly stated the location of the interventions – and only one of these three locations was a primary care physician’s office. The USPSTF recommendation is instead based on intervention itself, which was delivered by not only physicians but dietitians, behavioral therapists, exercise instructors, and multidisciplinary teams.

We thus recommend that the coverage decision memorandum should be expanded to ensure that Medicare patients can receive access to IBTO services when they are provided by a physician or other qualified nonclinical counselor, regardless of the setting where services are provided.

Trained lay providers, or non-physicians or primary care practitioners, have shown to be effective at achieving weight loss results for patients in many settings. As we have commented previously, 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 proposed Coverage Decision Memorandum. If you have any questions, please feel free to contact Becky Salay, Director of Government Relations, at 202-223-9870 x 15 or at bsalay@tfah.org.

Sincerely,

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I am excited that CMS is proposing a mechanism for healthcare providers receive reimbursement for treating obesity in primary care, however, I have significant issues with psychologists not being included as eligible providers. As the movement towards integrated care continues, more and more psychologists are working in primary care to address medical, behavioral, and psychological issues of patients. Obesity is one particular health issue that specifically can benefit from a biopsychosocial treatment model that psychologists are uniquely qualified to provide. Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity. Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity. Psychologists provide the vast majority of health and behavior assessmen t and intervention services to assist patients with a variety of acute and chronic conditions. Additionally, behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

I believe that it is important to include psychologist as one of the categories under the definition as physician. Psychologists have been prominent in designing and researching obesity treatment approaches that have strong research support for evidence based practice, for example, see:

http://www.div12.org/PsychologicalTreatments/treatments/obesity_behavioral.html

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There are a group of provider who have been left out of the categories of those identified as being able to provide behavioral therapy for obesity: Psychologists. Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.

In relation to behavioral health, Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions. Often this occurs outside of a medical physician's primary care setting. Behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity. Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.

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September 30, 2011

Donald Berwick, MD, MPP
Administrator
Centers for Medicare and Medicaid Services
Hubert H. Humphrey Building
200 Independence Avenue SW, Room 445-G
Washington, DC 20201

Dear Dr. Berwick:

The Diabetes Advocacy Alliance™ (DAA), a diverse group of organizations who have come together with the purpose of changing how the nation perceives and approaches the problem of diabetes, is pleased to submit comments to the Centers for Medicare and Medicaid Services (CMS) on the Proposed Coverage Decision Memorandum for Intensive Behavioral Therapy for Obesity, released August 31, 2011.

We commend the Centers for Medicare and Medicaid Services (CMS) for expanding Medicare coverage for preventive services to include proven, evidence-based interventions for obesity.

• Expand the definition of providers eligible for reimbursement to include credentialed diabetes educators, registered dietitians, pharmacists and organizations that employ trained lay providers with a documented track record of successfully helping participants lose weight, or reducing the incidence of obesity-related complications such as type 2 diabetes; and
• Expand the location of where reimbursement may occur, from only in clinical settings to also include community-based settings.

Obesity is a recognized risk factor for type 2 diabetes, as well as cardiovascular disease, chronic kidney disease and many other chronic conditions. In fact, over 80% of adults with type 2 diabetes are overweight or obese.¹

Both diabetes and obesity have already reached epidemic levels in the US. Nearly 26 million Americans have diabetes and another 79 million have prediabetes and are at high risk for developing the disease if nothing is done.² More than 75% of adults aged 65 and older have either diabetes or prediabetes. Obesity and overweight now affect over two-thirds of US adults.³ Among the Medicare age group, obesity doubled from 17.5% in 1980 to 36.8% in 2008.⁴ Thus, it behooves us as a nation to take immediate steps to address both obesity and diabetes.

A Proven, Evidence-Based Community-Based Program

Fortunately, there already is a proven, evidence-based lifestyle intervention—the Diabetes Prevention Program (DPP)—which although designed to be specific for people with prediabetes, also positively impacts other conditions like overweight and obesity, other disease states, and other outcomes. This community-based lifestyle intervention:

• Promotes weight loss;
• Encourages an increase in physical activity levels;
• Facilitates healthier eating habits;
• Improves the risk factors for cardiovascular disease; and
• Improves health-related quality of life.

The original DPP study, a $200 million clinical trial funded by the National Institutes of Health through the National Institute of Diabetes and Digestive and Kidney Diseases, found that individuals diagnosed with prediabetes who lost a moderate amount of weight (5 to 7%) and engaged in regular physical activity reduced their chances of developing type 2 diabetes by 58%. Adults age 60 and over reduced their risk for developing type 2 diabetes by 71%.⁵ The Diabetes Prevention Program Outcomes Study (DPPOS), a 10-year follow-up of the DPP, shows that prevention or delay of diabetes and its complications persisted through the decade.⁶

Further research sponsored by the Center for Disease Control and Prevention’s (CDC) Division of Diabetes Translation showed that similar results could be achieved in community-based YMCA settings for approximately $300 per person.⁷

The Y is currently offering programs in 43 communities in 23 states and the District of Columbia; and working with the CDC and the Diabetes Prevention and Control Alliance to expand this program nationally under the umbrella of the National Diabetes Prevention Program, authorized under the Patient Protection and Affordable Care Act (PPACA).

In a classroom setting, a trained lifestyle coach helps participants to change their lifestyle by learning about healthy eating, physical activity and other behavior changes. After the initial 16 core sessions, participants meet monthly for added support to help them maintain their progress. The goals of the program are to reduce body weight by 7% and achieve participation in 150 minutes of physical activity per week.

The private sector, led by UnitedHealth Group, is reimbursing YMCAs offering the program on a performance basis through the Diabetes Prevention and Control Alliance. This partnership marks the first time health service companies are reimbursing a community-based organization for delivering a prevention program such as this.

Additional Research Supports Community-Based Programs

A new study published in the September issue of Health Affairs affirms that if this program were scaled up and provided to just one demographic, adults aged 60 to 64 with prediabetes, it would result in net savings to Medicare of over $2 billion in the first 10 years, and lifetime savings just over $9 billion.⁸ If the program were also extended to adults in this age group who are overweight and have high blood pressure, the net lifetime savings to Medicare could reach as high as $15 billion.⁹

Furthermore, if this program were brought to scale nationally, and offered in thousands of communities across the country to overweight and obese adults at risk for diabetes, the Urban Institute estimates that the savings could be as high as $191 billion over 10 years—with Medicare and Medicaid seeing 75% of this savings.¹⁰

Another just-released global study published in Lancet further corroborates the effectiveness of community-based programs focused on weight reduction that are taught in group settings by a lay instructor. The study shows that participants in the community-based program lost more than twice as much weight as overweight and obese individuals who received care and counseling from primary care providers.¹¹

These findings—and those from the DPP and DPPOS—demonstrate that referral to a community-based intervention can successfully help people who are overweight or obese achieve medically significant health benefits from losing weight.

Based on these data, we urge CMS to tap into the existing pool of proven programs to ensure adequate access to intensive behavioral therapy for Medicare enrollees and reimburse community-based programs that are led by appropriately-trained lay providers that have both an evidence base and a track record of participant weight loss, and avoidance or delay of obesity-related complications such as type 2 diabetes. With funding from the National Diabetes Prevention Program and the Prevention and Public Health Fund, both established by PPACA, these programs could be brought to scale nationally, and could be available to far more of the Medicare population and at a lower cost than if these services were provided only by primary care practitioners.

Other Providers Should also be Reimbursed for Obesity Counseling

In addition, we urge CMS to provide reimbursement to providers beyond physicians and other primary care practitioners. Certified diabetes educators (CDEs) and registered dietitians (RDs) have the appropriate training and qualifications and are already offering behavioral weight loss counseling, nutrition services, medical nutrition therapy and other intensive counseling services to individuals who are overweight or obese and/or have diabetes and prediabetes. ^12,13 CDEs and RDs can provide all of the basic elements of a comprehensive behaviorally-based weight loss intervention. Pharmacists are also functioning as members of multi-disciplinary teams that are providing behavioral change counseling.¹⁴

Conclusion
Given the size and scope of the obesity and diabetes epidemic, primary care physicians and other primary providers simply cannot meet the needs of the Medicare population without assistance from community-based lifestyle interventions like the YMCA’S Diabetes Prevention Program and other providers such as CDEs, RDs, and pharmacists who can augment care that is provided in the primary care setting—and add capacity and value.

We appreciate the opportunity to comment on this Memorandum and hope you will consider our recommendations.

Sincerely,

American Association of Diabetes Educators

American Dietetic Association

Healthcare Leadership Council

National Community Pharmacists Association

National Kidney Foundation

Novo Nordisk Inc.

VSP Vision Care

YMCA of the USA

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Our Recommendation—RDs should be included a qualified providers BECAUSE the best interpretation of the USPSTF recommendation that “clinicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults” is one that interprets “clinicians” as including not only Primary Care Physicians (“PCPs”) as defined by Social Security Act §1833(u)(6), §1833(x)(2)(A)(i)(I) and §1833(x)(2)(A)(i)(II), but also Registered Dietitians and Nutrition Professionals (collectively “RDs”) as defined by Social Security Act §1861(vv)(2) and §1861(vv)(3).

**** Our recommendation is based on 4 grounds—(1) Providing Intensive Behavioral Therapy For Obesity consists of the same services performed in providing Intensive Nutrition Counseling For Obese Patients, (2) The USPSTF recommends that RDs as well as PCPs should provide Intensive Nutrition Counseling, (3) The IOM recommends that RDs as well as PCPs should provide Intensive Nutrition Counseling, and further that RDs are typically superior providers of Intensive Nutrition Counseling, and (4) As a practical matter, if RDs do not provide Obesity Therapy it will be provided by so few PCPs that the benefit will be relatively useless.

**** (1) PROVIDING INTENSIVE BEHAVIORAL THERAPY FOR OBESITY CONSISTS OF THE SAME SERVICES PERFORMED IN PROVIDING INTENSIVE NUTRITION COUNSELING FOR OBESE PATIENTS—Intensive Nutrition Counseling (Medical Nutrition Therapy, or “MNT”) is defined by Social Security Act §1861(vv)(1) as “nutritional diagnostic, therapy and counseling services for the purpose of disease management which are furnished by a registered dietitian or nutrition professional pursuant to a referral by a physician.” As the proposed decision memorandum states, the services performed in providing Intensive Behavioral Therapy For Obesity include “measurement of BMI, dietary (nutritional) assessment, and intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high intensity interventions on diet and exercise.” These services are precisely what an RD performs when providing MNT for an obese patient (see Practice Standards for Adult Weight Management at www.adaevidencelibrary.com). An RD can also complete an adult weight management certification program offered by the American Dietetic Association, BUT such certification is not necessary to enable an RD to provide the service, as the Foundation Knowledge and Competencies required to become an RD include all the knowledge and skills required to provide Intensive Behavioral Therapy For Obesity, including knowledge of exercise physiology (see Commission on Accreditation for Dietetics Education Foundation Knowledge and Competencies—Dietetic Education at www.eatright.org/CADE). And the Nutrition Care Process (http://www.eatright.org/HealthProfessionals/content.aspx?id=7077), which is followed by the RD, includes making a nutrition prescription for energy intake, foods, nutrients AND physical activity.

**** (2) THE USPSTF RECOMMENDS THAT RDs SHOULD PROVIDE INTENSIVE NUTRITION COUNSELING—Although the USPSTF is an independent panel of experts composed of PCPs, its recommendations are often not limited to services that may be provided by PCPs only. For its Obesity recommendation, the USPSTF recommends “clinicians” provide the service. “Clinicians” is not defined in this USPSTF recommendation. However, in its recommendation, Intensive Behavioral Dietary Counseling, the USPSTF states “intensive counseling can de delivered by primary care physicians or by referral to other specialists, such as nutritionists or dietitians.”

**** And in the second bullet point under Clinical Considerations the USPSTF states: “or refer to more intensive behavioral nutritional counseling (e.g., medical nutrition therapy) if needed.” So “clinicians” as used in the Obesity recommendation must include at least PCPs, and RDs to whom PCPs make a referral. (In this context RDs are considered part of the Primary Care Setting, even if not located in the physician’s office, just as NPs located in a remote office may be considered part of the Primary Care Setting). “Clinicians” might also include other specialists, such as psychologists, but unless or until the USPSTF specifies other specialists, as they have RDs, Medicare providers for Obesity Therapy should be limited to PCPs, and RDs to whom PCPs make a referral.

**** (3) THE IOM RECOMMENDS THAT RDs SHOULD PROVIDE INTENSIVE NUTRITION COUNSELING, AND FURTHER THAT RDs ARE TYPICALLY SUPERIOR PROVIDERS OF INTENSIVE NUTRITION COUNSELING—On January 1, 2000 the Institute of Medicine published “The Role of Nutrition in Maintaining Health in the Nation’s Elderly”. The genesis of this report is stated at page 2: “In addition to the recent coverage for diabetes education, the Balanced Budget Act of 1997 also required that the Department of Health and Human Services contract with the National Academy of Sciences, Institute of Medicine, to examine the benefits and costs associated with extending Medicare coverage for certain preventive and other services. The services specifically targeted for examination included screening for skin cancer; medically necessary dental services; elimination of time restrictions on coverage for immunosuppressant drugs after transplants; routine patient care for beneficiaries enrolled in clinical trials; and nutrition therapy, including services of a registered dietitian. This [Institute of Medicine] report addresses the benefits and costs associated with extending Medicare coverage specifically for nutrition therapy.”

**** Page 267 of the Institute of Medicine report found that the delivery of Intensive Nutrition Counseling is most clinically effective when delivered by an RD (parenthetical references omitted): “Patients generally consider their physician to be a highly credible source of health and dietary information; however, the debate over whether physicians have the time or skills to provide nutrition counseling has been a long one….In 1985, a report by the National Research Council described inadequacies in the curricula of medical schools and in physicians' knowledge, attitudes, and health care practices related to nutrition. Others have since described a modest growth in physicians’ training in applied nutrition, but continue to acknowledge discrepancies between knowledge and actual practice….In 1995, the U.S. Preventive Services Task Force found that ‘although physicians can often provide general guidelines on proper nutrition, many lack the time and skills to obtain a thorough dietary history, to address potential barriers to changes in eating habits, and to offer specific guidance on food selection.’ In addition, the Task Force rated the quality and strength of evidence regarding the effectiveness of both primary care clinicians and specially trained educators in counseling to change dietary habits….Hence this [Institute of Medicine] report rates dietary counseling performed by a trained educator such as a dietitian as more effective than by a primary care clinician.”

**** And at page 271: “The dietitian has strong academic and clinical training in nutrition science, food science, nutrient composition of foods, and behavior change. This health professional is also the most knowledgeable about strengths and limitations of methods used to determine nutrient composition of foods and dietary intake....The registered dietitian is currently the single identifiable group of health care professionals with the standardized education, clinical training, continuing education, and national credentialing requirements necessary to provide nutrition therapy.”

**** (4) PRACTICAL REALITY—Analyses have found that very few physicians provide obesity counseling, but instead refer their patients to RDs. This is also our experience over the past 17 years that our practice has been in existence, in which we have counseled over 25,000 patients, over half of whom had obesity, either as a sole morbidity or a co-morbidity. So if RDs, upon physician referral, are not added as providers, there will be few if any providers to actually provide the benefit.

**** As to cost, Social Security Act §1861(ddd)(2) states “the Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such service and may take into account the results of such assessment….” So it should be noted that under Social Security Act §1861(a)(1)(T) RDs are paid less than physicians: Like the NP, CNS and PA, the RD is paid 85% of what a physician would be paid, but even further, the RD reports services under CPT 97802 and 97803 (Medical Nutrition Therapy, assessment and intervention, face-to-face with the patient), while the Physician, the NP, CNS and PA report their services under higher paying Evaluation and Management codes, in accordance with the parenthetical instruction in the CPT codebook following the MNT codes. Therefore including the RD as a provider would be not only clinically appropriate, but also cost effective, as Congress intended. **** Thank you for your consideration of this important issue.

**** Sincerely, Robert Howard, RD, LCDN, Managing Partner, Midtown Nutrition Care, 119 West 57th Street, Suite 1414, New York, NY 10019, (212) 333-4243, midtown.nutrition@verizon.net, www.midtownnutrition.com.

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As a clinical researcher who has been treating patients and doing obesity research for over 25 years, I am grateful that CMS is proposing coverage for treating obesity. I do have some concerns about the effectiveness, cost-effectiveness and outcomes of your proposal.

Effectiveness: First, the recognized provider (MD, NP, PA) in your proposal is not the same type of clinicians who delivered the interventions in the studies that the US Preventive Task Force reviewed (and which your proposal is based on). Registered dietitians, licensed psychologists and exercise specialists delivered most of the interventions, and these are the clinicians who should be included as providers. Not only will it be less expensive but also it will be more effective because most of these providers have advanced training in weight management and behavior change. For instance, American Dietetic Association not only requires RDs to have collegiate training in science, communication and behavioral science but also have two advanced level CME courses in weight management and a specialized dietary practice group for dietitians who concentrate on weight management. While there are many MDs, PA, NP that have specialized in obesity and are competent to treat this population, most others tend to refer to the RDs and psychologists for direct and effective treatment. Perhaps, a more cost and effective program would have the primary care provider oversee the treatment program but include these other licensed and credentialed health professionals as providers.

Cost Effectiveness: There are no cost effectiveness studies that indicate MD/PA/NP intensive behavioral therapy for obesity is cost effective. The best research about the cost effectiveness of lifestyle modification for obesity is from the Diabetes Prevention Program which indicated that intense behavioral treatment from clinicians such as registered dietitians, psychologists and other master-level health professionals, was more cost effective for preventing type 2 diabetes than metformin. In 2007, the American Dietetic Association’s Evidence Analysis Library reviewed the literature to evaluate whether outpatient Medical Nutrition Therapy (MNT) was cost effective. Ten studies met the selection criteria and made the following conclusion: “the studies affirm that MNT resulted in improved clinical outcomes and reduced costs related to physician time, medication use and/or hospital admissions for people with obesity, diabetes and disorders of lipid metabolism, as well as other chronic diseases” (Grade I was assigned). More recent studies are suggesting that combining group classes with one-on-one counseling (in replacement for some of the one-on-one counseling) and using using web and telephonic approaches to counseling and group classes are viable and cost effective options to providing treatment.

Outcomes: Please use outcomes that are feasible, parsimonious and relevant to obesity (vs age). Measuring a variety of outcomes (ex. behavioral, anthropometric, quality of life and relevant clinical outcomes) will give you a much better picture of actual changes than weight alone.

Putting it all together: A weight management program that demands effectiveness, use of cost-conscious practice and outcome evaluation is possible. Out of concern for their obese employees, our local county government partnered with their insurance company, a local gym, and myself (a registered dietitian) and we co-created an evidence-based, intense lifestyle weight management program. We screen, intervene and evaluate our program; 50% of participants have hypertension, 47% have hypercholesterolemia, 30% have diabetes or pre-diabetes, 30% have sleep apnea. We provide individual and group sessions that are consciously spread out over 6 months; we use web and in-person group classes and in-person and telephonic individual sessions in order to provide accessibility. We created a partnership where health insurance, employer and employee pay into the program (70% paid by insurance, 15% employer, 15% employee), we created incentives and disincentives for staying in the program and we measure our behavioral, anthropometric and laboratory outcomes. We have a 94% retention rate and a 7% average weight loss (35% lose > 10% of their initial weight). Our results are excellent because we provide support, access and accountability. There are many such programs across the country that should be looked at before final determination is made. Using evidence as well as experience will help CMS to craft an effective and cost-effective program that will meet your goals of reducing the burden of obesity in America. Thank you. Anne Wolf, MS, RD

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As a recipient of a doctoral degree in clinical psychology with an interest in treatment for obesity I am concerned about the lack of language in the current policy proposal that allows clinical psychologist and behavioral specialist to be included among the list of covered providers for treatment of obesity. Clinical psychologist are well trained in the treatment of obesity and have been the primary driving force behind finding treatment techniques and concepts that work in weight mgmt. By not naming psychologist as one of the covered providers, the CMS is shutting out a number of well qualified and newly well qualified professionals such as myself. Furthermore, treatment of obesity should not only be restricted to primary care settings as they do not always allow the space or time for the intense behavioral management (i.e., multiple sessions, group sessions) that are needed for successful treatment of obesity. Please consider adding clinical psychologist and behavioral specialist to your policy as they are the ones who have the training, theh behavioral training, that is needed in combination with medications or maybe surgery to help initiate and maintain weight loss.

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September 30, 2011

Donald Berwick, MD
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-1503-P
P.O. Box 8013
Baltimore, MD 21244-8013

Dear Dr. Berwick,

On behalf of the American College of Preventive Medicine (ACPM) and the American College of Lifestyle Medicine (ACLM), we welcome the recent Centers for Medicare and Medicaid Services (CMS) proposal to provide eligible Medicare recipients with intensive behavioral therapy for obesity. The U.S. Preventive Services Task Force (USPSTF) recommends that “clinicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults.”¹ Providing this screening and counseling for Medicare beneficiaries with a BMI ≥ 30 kg/m² is central to efforts aimed at reducing chronic disease and improving public health.

Obesity is a significant epidemic in the United States as the prevalence has increased from “13% to 27% in the adult population over the last 40 years.”^1,2 Nearly one in three Americans are not just overweight but are clinically obese. Obesity is a condition associated with increased risk for life-threatening diseases such as coronary heart disease, hypertension, stroke, type 2 diabetes and several types of cancer.^1,3,4 Obesity is also associated with conditions that interfere with daily living; including sleep apnea, osteoarthritis, decreased quality of life, and social stigmatization.⁴

Opponents may argue that a lack of direct evidence exists to support behavioral interventions lowering mortality or morbidity from obesity. However, studies have shown that “counseling interventions led to weight changes from 4% to 8% of body weight.”⁵ Furthermore, the USPSTF notes that “the changes in intermediate outcomes, such as improved glucose metabolism, lipid levels, and blood pressure, from modest weight loss provide indirect evidence of health benefits.” Improving these aspects of personal health and lowering the risk for diabetes and other obesity related complications is a worthy goal.

ACPM and ACLM have long recommended periodic BMI measurement of all adults with diet and exercise counseling for all adults regardless of BMI.⁶ “The BMI is easy to measure, highly reliable, and highly correlated with percentage of body fat and body fat mass.”¹ Providing Medicare recipients with intensive behavioral therapy for obesity is another step towards re-directing our focus from disease treatment to disease prevention.

Should you have any questions or wish to discuss this further, please contact Paul Bonta, Associate Executive Director, Policy and Government Affairs, at, pbonta@acpm.org or 202-466-2044 X110.

Sincerely,

Miriam Alexander, MD, MPH, FACPM
President
American College of Preventive Medicine

Wayne S. Dysinger, MD, MPH, FACPM, FAAFP
President
American College of Lifestyle Medicine

[1] U.S. Preventive Services Task Force. Screeningn for Obesity in Adults: Recommendations and Rationale. Available at: http://www.uspreventiveservicestaskforce.org/3rduspstf/obesity/obesrr.htm.

[4] Centers for Disease Control and Prevention. Overweight and Obesity: Health Consequences. Available at: http://www.cdc.gov/obesity/causes/health.html

[5] NHLBI Obesity Education Initiative. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: the Evidence Report. NIH Publication No. 98-4083. Bethesda, MD: U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, National Heart, Lung, and Blood Institute; 1998.

[6] Nawaz H, Katz D. American College of Preventive Medicine Medical Practice Policy Statement: Weight Management Counseling for Overweight Adults. Am J Prev Med. 2001;21:73–78. Available at: http://www.acpm.org/polstmt_weight.pdf.

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September 30, 2011

Donald Berwick, M.D.
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attn: CMS-1524-P
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Intensive Behavioral Therapy for Obesity (CAG-00432N)

Dear Dr. Berwick:

I am writing on behalf of the American Psychological Association (APA), the largest scientific and professional organization representing psychology in the United States and comprised of 154,000 researchers, educators, clinicians, consultants, and students. Psychologists provide Medicare beneficiaries with criticalmcntal and behavioral health services, including psychotherapy, testing, and health and behavior assessment and intervention. i\PA wishes to share with you our comments on the proposed decision memo for intensive behavioral therapy for obesity.

We strongly support the intent of the Centers for Medicare and Medicaid Services (CMS) to provide beneficiaries with intensive behavioral counseling and behavioral therapy (hereafter referred to as behavioral services) for obesity to modify such critical health factors as diet and exercise. As discussed in the proposed decision memo, obesity in the U.S. has increased significantly in the past three decades and is associated with a number of serious, chronic diseases, including diabetes and cardiovascular disease. Behavioral interventions for the treatment of obesity arc elTective and much less costly than surgical procedures. (We would be pleased to provide citations to research studies that provide empirical support for this finding.)

We vehemently object, however, to the severe limitations CMS is proposing on how these services can be furnished. By failing to include psychologists as providers of behavioral services, CMS will prevent Medicare beneficiaries from accessing psychological services that have been proven effective in treating obesity. [n addition, we see no purpose in limiting the benefit to services provided in primary care settings wben bendiciaries suffering from obesity could readily be treated in other community settings. Furthermore, a given primary care setting may not have qualified health care providers on staff with the requisite training, skill. and experience to offer behavioral services for obesity.

Our specitic recommendations to address these two critical concerns are as follows:

1. Psychologists must be recoguized as providers of behavioral services for obesity

CMS is proposing to allow only physicians, nurse practitioners, clinical nurse specialists. and physician assistants in primary care settings to furnish behavioral services to Medicare beneficiaries with obesity. There is no mention of psychologists, who have the most extcnsi ve training in behavioral interventions of all health care professionals. In fact. most of the evidence base supporting behavioral interventions for obesity and diabetes consists of work by psychologists and behavioral scientists, such as the multi-site study by the National Institutes of Health on the effectiveuess of behavioral change in preventing diabetes. ¹

Omitting psychologists from the proposed decision memo was an oversight that must be cOlTected. Psychologists have significant expertise in developing and applying behavioral interventions to address physical health problems. Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acutc and chronic conditions. Medicare beneficiaries struggling with obesity will benefit from the knowledge and skills that psychologists have in providing behavioral services.

2. Behavioral services for obesity should not be limited to primary care settings

We see no reason why behavioral services for obesity should be limited to primary care settings. Many other locations, such as the office of a specialty provider or a clinic that focuses on conditions related to obesity (e.g., diabetes and cardiovascular disease) could also serve Medicare beneficiaries who suffer from obesity. Making access to behavioral services more convenient and available will encourage beneticiaries with obesity to utilize these services resulting in a potentially greater impact on public health.

Conclusion

Thank you in advance for your attention to our concerns. We look forward to hearing that eMS will adopt our recommendations to add psychologists as providers of behavioral services for obesity and to allew these services to be provided in settings beyond primary care. If you have any questions or would appreciate additional information, please contact Diane Pedulla, J.D., Director of Regulatory Affairs with our APA Practice Directorate, at (202) 336-5889 or dpedulla@apa.org.

Sincerely,

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September 30, 2011

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1577-P
P.O. Box 8010
Baltimore, MD 21244-8010

RE: Proposed Coverage Decision Memorandum for Intensive Behavioral Therapy for Obesity

Dear Dr. Berwick:

The American Dietetic Association (ADA) appreciates the opportunity to submit comments to the Centers for Medicare and Medicaid Services (CMS) at the United States Department of Health and Human Services (HHS) related to its 31 August 2011 Proposed Coverage Decision Memorandum for Intensive Behavioral Therapy for Obesity (the "Memorandum"). With over 72,000 members, ADA is the largest association of food and nutrition professionals in the United States and is committed to improving the nation's health through food and nutrition across the lifecycle. ADA's member registered dietitians and nutrition professionals (collectively "RDs") already independently provide professional services under Medicare Part B, specifically medical nutrition therapy (MNT) for beneficiaries with diabetes, chronic renal insufficiency/end state renal disease (non dialysis renal disease) and post kidney transplant. ADA respectfully provides comments that reiterate and expand upon our 10 April 2011 comments on intensive behavioral therapy for obesity made during the initial thirty-day comment period.

ADA continues to applaud the ongoing efforts at CMS to shift the nation's health care paradigm towards a more cost'fficient and healthier model focusing on prevention and early treatment of chronic diseases. CMS's efforts to expand coverage for intensive behavioral therapy ("IBT") for obesity are certainly a step in the right direction, and ADA supports CMS's recognition that intensive behavioral counseling for obesity requires frequent services and patient/provider contact over an extended period of time. However, despite the fact that leading authorities and the literature recognize RDs as the most qualified, cost effective providers of nutrition assessments and nutrition interventions (including intake and physical activity), the Memorandum proposes to exclude RDs as qualified clinicians. ADA urges CMS to revise its proposed coverage determination to mirror the United States Preventive Services Task Force (USPSTF) recommendations and define qualified providers of intensive behavioral therapy to include not only primary care practitioners ("PCPs") as defined by Social Security Act -§1833(u)(6), -§1833(x)(2)(A)(i)(I) and -§1833(x)(2)(A)(i)(II), but also RDs as defined by Social Security Act -§1861(vv)(2) and -§1861(vv)(3). We believe this revision will better achieve the Institute of Healthcare Improvement's Triple Aim, which is supported by CMS.

I. CLINICAL AND COST EFFECTIVENESS OF RDPROVIDED IBT FOR OBESITY

RDs are recognized as uniquely skilled, clinically effective, and cost'ffective providers of nutrition assessments and interventions that comprise intensive behavioral therapy for obesity. Through expertise applying the four-step nutrition care process ("NCP"),¹ RDs help beneficiaries best understand their daily dietary and energy expenditure needs and ultimately develop skills and motivation to decrease weight and produce significant outcomes.

A. RDs' Specialized Skills and Training to Provide IBT for Obesity
Modifying dietary and exercise habits is a complex undertaking requiring particular expertise.² Unlike smoking cessation, healthcare professionals cannot ask patients to simply cease eating. Food is not just necessary for the delivery of essential nutrients that sustain life; it also helps define a person's culture, social interactions, and religious life. The comprehensive nutrition assessments and dietary interventions shown to be effective in weight loss and in preventing and managing chronic diseases related to obesity require advanced skills beyond those possessed by most primary care practitioners.

RDs are specifically trained to develop individualized patient-centered dietary and physical activity interventions that meet the patient's physiological parameters, while addressing behavioral, emotional, psychological, and cultural needs of the patient. In accordance with the definition of the nutrition intervention step of the NCP, the RD "develops a nutrition prescription that states his or her individualized recommendations for energy intake, food, nutrients, and physical activity."³ Yet even the most appropriately designed intervention will fail if not adopted by the patient. A patient's ability to make a successful lifestyle change can be enhanced though applications of behavior and cognitive modification techniques RDs are trained to use. RDs help patients progress through the stages of change using a variety of techniques, including motivational interviewing and patient-centered counseling. A RD can determine a patients' readiness for change; assess and evaluate the patient's total social environment; assist the patient in identifying the behaviors that patient wants to change; and can examine and elucidate the conditions and events surrounding the behavior to better assist the patient in making desired changes. Services provided by RDs have been proven to improve a consumer's health and increase productivity and satisfaction levels through decreased doctor visits, hospitalizations and reduced prescription drug coverage.⁴

RDs use the nutrition care process, a systematic problem-solving method, to critically think and make decisions to address nutrition related problems and provide safe and effective quality nutrition care. The nutrition care process consists of four distinct, but interrelated and connected steps: (a) nutrition assessment, (b) nutrition diagnosis, (c) nutrition intervention, and d) nutrition monitoring and evaluation. The nutritional assessment and nutritional intervention NCP steps match the assessment and intensive behavioral counseling components of IBT. In Appendix A, ADA offers CMS detail about each step of the NCP showing that effective nutrition assessment and intensive behavioral dietary counseling requires a more thorough and in depth process than that outlined in the Memorandum.

B. RDs Are Clinically Effective Providers of IBT for Obesity
Intensive nutrition counseling (medical nutrition therapy, or "MNT") is defined by Social Security Act -§1861(vv)(1) as "nutritional diagnostic, therapy and counseling services for the purpose of disease management which are furnished by a registered dietitian or nutrition professional pursuant to a referral by a physician." As the Memorandum states, the services performed in providing intensive behavioral therapy for obesity include "measurement of BMI, dietary [nutritional] assessment, and intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high intensity interventions on diet and exercise." These are precisely the services a RD performs when providing MNT for an obese patient (see Practice Standards for Adult Weight Management at www.adaevidencelibrary.com⁵); they are two areas in which RDs are recognized experts worthy of reimbursement.⁶

Beneficiaries who receive RD-provided nutrition counseling and interventions exhibit significant improvements in weight and re-structured behaviors that impact long-term weight management.⁷ Both the USPSTF's recommendations for IBT for obesity and the Memorandum itself are predicated upon studies and trials in which RDs play a significant role in providing services. The 2003 Systematic Evidence Review by McTigue, et al "serve[s] as the foundation for the recommendations of the USPSTF" and includes review and analysis of numerous studies in which registered dietitians and nutrition professionals were explicitly part of the multidisciplinary intervention team or were the sole providers of intensive behavioral therapy: ⁸

• Tuomilehto J, Lindstrom J, Eriksson JG, et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001;344:1343-50.
• Stevens VJ, Obarzanek E, Cook NR, et al. Long-term weight loss and changes in blood pressure: results of the Trials of Hypertension Prevention, phase II. Ann Intern Med 2001;134:1-11.
• Fogelholm M, Kukkonen-Harjula K, Nenonen A, Pasanen M. Effects of walking training on weight maintenance after a very-low'nergy diet in premenopausal obese women: a randomized controlled trial. Arch Intern Med 2000;160:2177-84.
• Wing RR, Anglin K. Effectiveness of a behavioral weight control program for blacks and whites with NIDDM. Diabetes Care 1996;19:409-13.
• 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;346:393-403.
• Ashley JM, St Jeor ST, Schrage JP, et al. Weight control in the physician's office. Arch Intern Med 2001;161:1599-604.
• Jones DW, Miller ME, Wofford MR, et al. The effect of weight loss intervention on antihypertensive medication requirements in the Hypertension Optimal Treatment (HOT) study. Am J Hypertens. 1999;12:1175-1180.
• Jakicic JM, Winters C, Lang W, Wing RR. Effects of intermittent exercise and use of home exercise equipment on adherence, weight loss, and fitness in overweight women: a randomized trial. JAMA. 1999;282:1554-1560.
• Kuller LH, Simkin-Silverman LR, Wing RR, Meilahn EN, Ives DG. Women's Healthy Lifestyle Project: A randomized clinical trial: results at 54 months. Circ. 2001;103:32-37.
• Van Gaal LF, Broom JI, Enzi G, Toplak H. Efficacy and tolerability of orlistat in the treatment of obesity: a 6-month dose-ranging study. Orlistat Dose- Ranging Study Group. Eur J Clin Pharmacol. 1998;54:125-132.

Additional studies show MNT provided by a 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.⁹ 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.

ADA's Adult Weight Management Guidelines¹⁰ show 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 RD may lead to more successful weight loss and maintenance.¹¹ The additional studies detailed in Appendix B demonstrate the health benefits associated with the addition of RD-provided MNT to an obesity-related health management program.

C. RDs Are the Most CostEffective Providers of IBT for Obesity
Based on the literature, RDs are the most cost'ffective, qualified professional to provide MNT and nutrition services. The Social Security Act -§1861(ddd)(2) states, "the Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such service and may take into account the results of such assessment. . . ." The Social Security Act -§1861(a)(1)(T) provides that RDs are paid less than physicians. Like the NP, CNS, and PA, the RD is paid 85% of what a physician would be paid, but even further, the RD reports services under CPT 97802 and 97803 (medical nutrition therapy, assessment and intervention, face-to-face with the patient), while the physician, the NP, CNS, and PA report their services under higher paying Evaluation and Management codes, in accordance with the parenthetical instruction in the CPT codebook following the MNT codes. In addition, CMS should consider the overall cost of other more expensive, more intensive obesity interventions (such as bariatric surgery) that can be expected if populations continue to be underserved due to the lack of PCP's providing effective nutrition interventions. Studies bear out the cost-savings and benefits of RDprovided dietary and nutrition counseling.^12,13,14 Therefore, including the RD as a qualified provider would be not only clinically appropriate, but also maximally cost effective, as Congress intended.

II. CMS SHOULD EXPAND COVERAGE TO PROMOTE EFFECTIVE COORDINATED CARE

A. Authorities Recognize Need for RDProvided Nutrition Therapy
Both the United States Preventive Services Task Force (USPSTF) and the Institute of Medicine (IOM) recommend that RDs as well as PCPs should provide intensive nutrition counseling. ADA notes the disconnect between (1) the Memorandum's limited definition of the "primary care setting" as only including services provided by primary care practitioners and (2) the broader interpretation of the USPSTF, IOM, and AHRQ that includes referrals to RDs. Many of the clinical guidelines and screening tools cited in the "Memorandum" also recognize RDs as necessary and appropriate referral sources for patient/clients at nutritional risk and/or with comorbidities and complex needs. CMS should revise its Memorandum to conform with the USPSTF's and IOM's interpretations of the evidence purportedly underlying CMS's coverage determination to expand coverage for RD-provided IBT.

1. USPSTF Recognition
Although the USPSTF is an independent panel of experts composed of PCPs, it often makes recommendations for the provision of services in the primary care setting not limited to PCPs. The Systematic Evidence Review (SER) at issue here asserts it is "reviewing evidence in the primary care setting," and then proceeds to review evidence of RDs providing assessments and interventions after referral and outside of the primary care clinic. ¹⁵ When making its obesity recommendation in 2003, the USPSTF recommended that "clinicians" provide the service without fully defining the variety of appropriate clinicians. However, in its recommendation for intensive behavioral dietary therapy for cardiovascular disease, the USPSTF states that the same kind of intensive counseling can be delivered by primary care practitioners "or by referral to other specialists, such as nutritionists or dietitians."¹⁶

Thus, "clinicians" as used in the USPSTF's obesity recommendation includes at least PCPs and the RDs to whom PCPs make a referral. (In this context RDs are considered part of the primary care setting, even if not located in the physician's office, just as NPs located in a remote office may be considered part of the primary care setting.) Although 'clinicians' might conceivably include other specialists, such as exercise physiologists or psychologists, unless and until the USPSTF recommends other specialists as qualified to provide intensive diet and physical activity counseling.as they have RDs, CMS should limit qualified providers for IBT for obesity to PCPs and the RDs to whom PCPs choose to refer their patients.

2. IOM Recognition
In its 2000 report, The Role of Nutrition in Maintaining Health in the Nation's Elderly, "examin[ing] the benefits and costs associated with extending Medicare [nutrition therapy] coverage for certain preventive and other services," the IOM found that intensive nutrition counseling is most clinically effective when delivered by an RD:

At the end of its report the IOM concluded, "the registered dietitian is currently the single identifiable group of health-care professionals with standardized education, clinical training, continuing education and national credentialing requirements necessary to be directly reimbursed as a provider of nutrition therapy."¹⁸

B. Primary Care Limitations
Primary care providers are limited in their time, training, and skills to conduct by themselves the medium or high-intensity interventions that are scientifically proven to be most effective in producing the largest, most lasting results.¹⁹ "Specific interventions to address obesity are infrequent in visits to US physicians. Obesity is underreported and interventions are only moderately likely among patients identified as obese, even for those with serious obesity-related comorbidities."²⁰ Unfortunately, "only around 16 percent of the overweight individuals and 40 percent of the obese individuals indicated receiving a physician's advice to lose weight."²¹ Research shows reasons could include PCPs' lack of knowledge about nutrition, lack of skills needed to talk about weight loss, and not seeing obesity as an important medical issue."²²

Screening for nutrition risk, the first stage of CMS's proposed IBT, is an important supportive step to identify patients/clients who would benefit from intensive behavioral counseling in the form of MNT. ADA supports the critical role primary providers play generally in coordinating care of the patient and specifically in screening and referral of obese patients/clients. PCPs are at the center of the coordinated care model, appropriately making patient care decisions and leading intervention teams. Due to the complexities associated with treatment and management of obesity and its related co-morbidities, the PCP-centered referral process to RDs should be the next step after screening. No single health discipline can solve the growing obesity-chronic disease problem, so care must be coordinated through multidisciplinary team approaches to care such as Wagner's Chronic Care Model.²³ RDs skilled in conducting nutrition interventions fit into this model working in coordination with the primary care team. Clearly from a perspective of cost, time, and expertise, expanding coverage for PCP-driven referrals to RDs is the right decision.

RDs are integral to the patient-centered medical home as they work hand-in hand with referring providers to deliver care that is patient-centered, coordinated and cost'ffective. To achieve the desired results of improved health and cost-savings, CMS policy must support effective treatment. RD intensive counseling should therefore be viewed as part of the services delivered through the primary care setting. ADA urges CMS to revise its proposed coverage determination to include language specifically allowing referral to RDs and clearly articulating the coordination of care necessary for effective intensive behavioral therapy for obesity.

C. Memorandum's 5As Approach Requires RD Role and Coverage
The Memorandum requires that "the intensive behavioral intervention for obesity should be consistent with the 5-A framework that has been highlighted by the USPSTF."²⁴ The USPSTF recommended the 5-As approach as "a useful tool to help clinicians guide interventions for weight loss." Each of the 5-As comport with elements of the nutrition care process and strongly imply the role of specialists such as RDs in intensive behavioral interventions. Yet even though CMS insists that the 5-As approach is mandatory, the Memorandum appears to reject the purpose and intent of two particular components of the approach by excluding registered dietitians from coverage:

• Assess: Ask about/assess behavioral health risk(s) and factors affecting choice of behavior change goals/methods; and
• Arrange: Schedule follow-up contacts (in person or by telephone) to provide ongoing assistance/support and to adjust the treatment plan as needed, including referral to more intensive or specialized treatment.

Nutrition assessments are another one of three covered elements of intensive behavioral therapy for obesity, envisioned as the intermediate step between screening for BMI and intensive behavioral counseling through dietary interventions:

A screening identifies red flags that may warrant a more in-depth assessment.²⁶ Here, however CMS defines the screening merely as BMI measurement and defines the nutrition assessments to more closely resemble simple risk screening tools designed to identify potential malnutrition. Most of the putative assessments referenced in the Memorandum are not designed to provide the depth and breadth of information needed to assess nutritional status for the purposes of developing an individualized, patient-centered care plan for the effective treatment of obesity.

As Appendix A shows, RD-provided assessments.such as those in the effective clinical trials relied upon by the USPSTF.go far beyond the simplistic binary questions asked in the kinds of "brief screening instruments . . . developed to assess nutritional status in the elderly" described in the Memorandum²⁷ Even though the Memorandum quotes a researcher's admonition to have more thorough nutrition assessments, CMS fails to extend coverage to RDs with the specialty training and skills to provide them:

By narrowly redefining the Assess component to be a mere simplified risk screening, the Memorandum negates or severely diminishes its value. In addition, by denying coverage to RDs when a PCP deems it appropriate, CMS disregards the essence of the Arrange component: "referral to more intensive or specialized treatment." In eliminating the referral process, CMS precludes the patient and PCP from making a decision to seek the services the PCP believes is necessary. If CMS is going to use the 5-As approach as a requirement, it should not handicap the approach's demonstrated effectiveness by eliminating the Arrange component entirely and stripping the Assess component of its intended purpose. CMS should clearly support the Arrange and Assess elements of the 5-As approach by revising its memorandum to expand coverage for referral to a registered dietitian.

D. Bariatric Surgery for Beneficiaries
Bariatric surgery is a prime example of "more intensive or specialized treatment" envisioned by the "Arrange"component of the Five As approach adopted by the USPSTF and the Memorandum. Beneficiaries who suffer from such a severe level of disease are at high risk for obesity-related morbidity and mortality will have failed in other less invasive interventions and may thus require the specialized treatment of bariatric surgery. From 1983 to 2000, this group of people has increased 400%.²⁹ 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.³⁰ The safety and efficacy of Bariatric surgery is well documented and a primary reason why so many federal health plans provide coverage for surgical intervention for those with morbid obesity, including Medicare, the Federal Employees Health Benefit Plan and Tricare.

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).³¹ RD services are a critical component of this treatment, and so CMS should specifically expand coverage for RDs who provide them.

Comprehensive nutrition assessments are paramount 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 motivated to make 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.³² 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.

III. SUMMARY

ADA strongly urges CMS to reconsider its proposed coverage determination to include RDs as qualified clinicians pursuant to a referral by a primary care provider. RDs are demonstrated to be cost effective and clinically effective individually and as members of coordinated intervention teams, and are recognized by leading authorities as having skills and training in nutrition interventions superior to other health care professionals. The same intensive behavioral therapy studies leading the USPSTF to recommend and CMS to propose coverage include RDs as effective providers. If CMS decides to exclude them it would undoubtedly lessen the efficacy of this important preventive care initiative and fail to achieve the maximum potential cost-savings.

ADA appreciates the opportunity to comment on this important initiative; please contact either Jeanne Blankenship at 202-775-8277 ext. 6004 or by email at jblankenship@eatright.org or Pepin Tuma at 202-775-8277 ext. 6001 or by email at ptuma@eatright.org with any questions or requests for additional information.

Sincerely,

1. Nutrition Assessment
Nutrition assessment is a systematic method for obtaining, verifying, and interpreting data needed to identify nutrition-related problems, their causes, and their significance. It is an ongoing, nonlinear, dynamic process that involves initial data collection, but also continual reassessment and analysis of the patient's/client's status compared to specified criteria. From the nutrition assessment data, a RD is able to determine whether a nutrition diagnosis/problem exists.

RDs use biochemical,³⁴ anthropometric,³⁵ clinical,³⁶ dietary intake, ³⁷ and energy expenditure³⁸ data to assess individual status for obese and overweight patients/clients. Beyond intake, RDs evaluate a number of factors, including social, cultural, and economic factors that may enhance or challenge interventions; economic and time limitations related to the purchase, selection, or preparation of food; cues for eating (locations, emotions, activities, other people); dieting history (including what worked and what did not and why); weight history and patterns of weight gain and loss; physical activity (including the types, frequency, duration, and intensity of physical activity); sedentary time (including television and computer time); and daily routines. RDs investigate and evaluate the types of social and family support available to clients and address the patient's/client's social isolation or connections that are critical to success.

In completing the nutrition assessment, the RD performs the following functions:

• Uses critical thinking skills to determine the appropriate data to collect (i.e., relevant vs nonrelevant data);
• Validates collected data;
• Organizes data in a meaningful way to make nutrition diagnoses;
• Analyzes and interprets data, using evidence-based standards and norms for comparison (e.g., the Dietary Reference Intakes or ADA's Evidence-Based Adult Weight Management Nutrition Practice Guidelines);
• Identifies nutrient requirements and gaps in needs using reference standards and evidence-based recommendations and guidelines; and
• Identifies groups or clusters of abnormal or discrepant data that requires attention.

The above information collected, analyzed, and integrated by RDs clearly goes far beyond the simplified 'yes/no' data collection process detailed in the Nutritional Assessment section of the Memorandum. It is the integration of these key factors and clinical judgment that sets the RDs apart from other providers. RD-provided individualized treatment results in better health outcomes for patients.³⁹

2. Nutrition Diagnosis
In the second step of the NCP, the RD identifies and labels specific nutrition problems based on the results of the nutrition assessment, the RD's clinical judgment, and the likelihood that RD interventions can resolve the nutrition diagnosis or improve its signs and symptoms. Nutrition diagnosis is a critical step between nutrition assessment and nutrition intervention.

3. Nutrition Intervention
Nutrition intervention is the third step in the Nutrition Care Process. The nutrition intervention is directed at eliminating the etiology of the nutrition diagnosis. The RD also drills down to the "root cause" etiology by identifying the most specific cause that the RD can address with a nutrition intervention. Nutrition intervention strategies are purposefully selected to change nutritional intake, nutrition-related knowledge or behavior, environmental conditions, or access to supportive care and services. Nutrition intervention goals provide the basis for monitoring progress and measuring outcomes.

The RD develops a nutrition prescription that states his or her individualized recommendations for energy intake, foods, nutrients, and physical activity. When setting the nutrition prescription, the RD uses critical thinking skills together with current reference standards and dietary guidelines, the client's health condition, and nutrition diagnoses. The RD links the comparative standards that were defined in the nutrition assessment step with the client's goals, via the nutrition prescription.

Nutrition intervention entails two distinct and interrelated components.planning and implementing. Planning the nutrition intervention involves (a) prioritizing nutrition diagnoses, (b) consulting ADA's Evidence-Based Nutrition Practice Guidelines and other practice guides, (c) determining patient'ocused expected outcomes for each nutrition diagnosis, (d) conferring with patient/client/resident and caregivers, (e) defining a nutrition intervention plan and strategies, (f) defining time and frequency of care, and (g) identifying resources needed. Planning also involves working with the client to set short-term (next appointment) and longterm (entire course of nutrition intervention) goals and strategies apprpriate to needs and abilities. Examples of goals are weight loss, reduction in energy intake, behavior change, increased physical activity, and improvement in knowledge. Implementing the nutrition intervention is the action phase, which includes carrying out and communicating the plan of care, continuing the data collection, and revising the nutrition intervention, as warranted, based on the patient/client response. This step cannot be completed unless both components are in place to support the nutrition intervention.

4. Nutrition Monitoring and Evaluation
The purpose of nutrition monitoring and evaluation is to quantify progress made by the patient/client in meeting nutrition care goals. During the monitoring and evaluation process, nutrition care outcomes.the desired results of nutrition care. have been defined, and specific indicators that can be measured and compared to established criteria have been identified. Nutrition monitoring and evaluation tracks patient/client outcomes relevant to the nutrition diagnosis and intervention plans and goals.

During this step, RDs monitor the patient's/client's progress by determining whether the nutrition intervention is being implemented and by providing evidence that the nutrition intervention is or is not changing the patient's/client's behavior or nutritional/health status. Food and nutrition professionals measure outcomes by selecting the appropriate nutrition care indicator(s) and comparing the findings with nutrition prescription/intervention goals, and/or reference standards. The use of standardized indicators and criteria increases the validity and reliability of the outcome data and facilitates electronic charting, coding, and outcomes measurement.

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Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Jacques:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed decision memo for intensive behavioral therapy for obesity (IBTO) (CAG-00423N). America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.

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 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 proposed decision memo was last published in 2003, CMS should confer with AHRQ and the Task Force regarding the next evidence review 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 any updated USPSTF recommendations once finalized.

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. Our members are concerned with the specifications outlined by CMS in regards to the frequency of counseling sessions:

• One face to face visit every week for the first month;
• One face to face visit every other week for months 2-6;
• One face to face visit every month for months 7-12 (contingent on beneficiaries achieving 3 kg weight loss in the prior 6 months).

The USPSTF defines high intensity interventions as, “more than 1 person-to-person (individual or group) session per month for at least the first 3 months of the intervention.” We are not aware of evidence that supports the proposed intervention schedule in the primary care setting resulting in sustained weight loss and weight maintenance goals. We urge CMS to cover IBTO that is evidence-based for this population.

Our members recommend that CMS define what primary care clinicians are qualified to provide IBTO, based on the updated recommendation of the USPSTF, as well as more specific information on what setting is considered a primary care setting. For example, it is unclear if specialists such as endocrinologists are considered by CMS to be qualified to provide IBTO if the endocrinologist is serving as a primary care physician; or if a registered dietitian is qualified to provide IBTO outside of the primary care setting when ordered by a primary care physician.

Since 2003, the literature has changed substantially and if the USPSTF finds evidence supporting newer interventions such as web-based programs, CMS should consider such evidence as well. Further, we recommend that CMS 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. 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,

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Sarah McClain, MHS
Joseph Chin, MD, MS
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

September 30, 2011

Dear Ms. McClain and Dr. Chin:

The American Cancer Society Cancer Action Network is pleased that the Centers for Medicare and Medicaid Services (CMS) has initiated a National Coverage Analysis (NCA) on Intensive Behavioral Therapy for Obesity (CAG-00423N). We support CMS' proposed coverage decision with some modifications and appreciate the opportunity to provide comment. The American Cancer Society Cancer Action NetworkSM (ACS CAN) is the nonprofit, nonpartisan advocacy affiliate organization of the American Cancer Society dedicated to eliminating cancer as a major health problem. ACS CAN supports legislative, regulatory, and policy efforts that will make cancer a top national priority.

In general, ACS CAN supports CMS' proposed decision to provide coverage of intensive behavioral therapy for weight management. Overweight and obesity increase the risk for several types of cancer, while, conversely, weight 1055 among individuals who are overweight and obese likely reduces cancer risk. We believe that intensive behavioral therapy for weight management meets CMS' criteria for coverage under Medicare Part B because it is reasonable and necessary to prevent cancer incidence and mortality, recommended by the U.S. Preventive Services Task Force with a grade B, and appropriate for the Medicare population, given that nearly two in three Medicare beneficiaries (64.7%) are overweight or obese, including 28.3 percent that are obese. We agree that intensive behavioral therapy for obesity should include BMI screening, dietary/nutrition assessment, and intensive behavioral counseling and behavioral therapy to promote weight 1055 through diet and exercise. We also have a number of recommendations for strengthening CMS' proposal:

• Expand the goals of intensive behavioral therapy to include weight maintenance and prevention of weight gain, in addition to weight 1055;
• Expand access to intensive behavioral therapy to individuals within the overweight category (25≤BMI< 30) and the healthy weight category (18≤BMI< 25) who have experienced gradual weight gain throughout adulthood, in addition to those in the obese category (BMI≥30);
• Add an assessment for physical activity to the assessment phase of the intensive behavioral therapy intervention;
• Maintain access to intensive behavior therapy for all eligible individuals for a minimum of one year through eliminating the requirement that individuals must lose a set amount of weight in the first six months to maintain eligibility for continued treatment;
• Expand the list of eligible treatment providers to include, at minimum, registered dietitians;
• Expand the list of eligible treatment locations to include other locations in which eligible providers typically work and where patients receive other types of ongoing treatment, including outpatient hospital settings, skilled nursing facilities, inpatient rehabilitation facilities, and other independent and community-based facilities.
• Periodically review and update the final coverage decision, as needed, with new research developments.

The remainder of our comments provides more detailed comments and recommendations regarding specific components of CMS' proposed coverage decision.

ACS CAN is pleased that CMS has generated a NCA on intensive behavioral therapy for obesity and issued a proposed decision memo indicating an intent to provide coverage for the service under Medicare. Overweight and obesity contribute to 14 to 20 percent of all cancer-related deaths and are clearly associated with increased risk for cancer of the breast (postmenopausal), colon, endometrium, esophagus and kidney.¹ There is also highly suggestive evidence of a link between overweight and obesity and cancers of the pancreas, gallbladder, thyroid, ovary, and cervix, and for multiple myeloma, Hodgkin's lymphoma, and aggressive prostate cancer.²

Although there has been less research on the relationship between cancer and weight loss than on cancer and excess weight, observational cohort studies and randomized controlled trials of both dietary interventions and bariatric surgery indicate fairly immediate reductions in cancer incidence following intentional weight loss.³ Because both cancer incidence and levels of circulating cancer biomarkers drop fairly rapidly following weight loss, intentional weight loss may well lead to meaningful reductions in cancer risk in a relatively short time period.⁴ Recent studies suggest that losing weight may reduce the risk specifically of breast cancer and colon cancer.^5,6 Other studies examining risk reduction resulting from weight loss following bariatric surgery found that the reduction in cancer risk was largely concentrated in obesity-related cancers (Le., esophageal adenocarcinoma, colorectal cancer, pancreatic cancer, postmenopausal breast cancer, corpus and uterus cancers, kidney cancer, non-Hodgkin's lymphoma,leukemia, multiple myeloma, liver cancer, and gallbladder cancer).^7,8 Given that overweight and obesity clearly increase the risk for several types of cancer, healthy weight, overweight, and obese patients should be advised to avoid weight gain through the cancer treatment process.⁹

In addition to potentially reducing cancer risk, weight loss produces other health benefits. Studies have shown that even a modest weight loss, such as 5 to 10 percent of one's total body weight, is likely to lead to other health benefits, including improvements in blood pressure, blood cholesterol, and blood sugars.^10,11 As a result of the relationship between overweight and obesity and certain types of cancer, ACS CAN supports multi-faceted population-based policy, environmental, and regulatory approaches to improving nutrition, physical activity, and weight status by removing barriers, changing social norms, increasing awareness, and increasing access to evidence-based treatment.

ACS CAN supports CMS' conclusions that intensive behavioral treatment for obesity meets all three of the agency's criteria for coverage under Medicare Part 8 as a preventive service:

1. Reasonable and necessary for the prevention or early detection of illness or disability;
2. Recommended with a grade A or 8 by the U.S. Preventive Services Task Force (USPSTF); and
3. Appropriate for individuals entitled to benefits under Medicare Part A or enrolled under Part B.

Given the strong relationship between overweight and obesity and the risk for cancer and other chronic diseases, we believe that coverage of obesity treatment services is both reasonable and necessary for reducing incidence of and mortality from cancer and other diseases that are leading causes of death in the United States.

Screening and behavioral treatment for obesity is recommended by the USPSTF with a 8 recommendation. In 2003, USPSTF recommended "that clinicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults."¹² We believe that the definition of "intensive behavioral therapy for obesity" in the proposed decision memo is largely consistent with USPSTF's definition of intensive counseling and behavioral interventions to promote sustained weight loss for obese adults. According to the USPSTF, there is fair to good evidence that high-intensity nutrition and/or physical activity counseling together with behavioral interventions aimed at skill development, motivation, and support strategies produces modest, sustained weight loss in obese adults.¹³

Intensive behavioral therapy for obesity is appropriate for the Medicare population. Currently, nearly two in three individuals covered by Medicare are overweight or obese (64.7%), including 28.3 percent that are obese.¹⁴ In addition, older individuals have a particularly high cancer incidence rate. According to the American Cancer Society, about 78 percent of all cancers are diagnosed in individuals ages 55 years and older.¹⁵ Research has shown that it's never too late for individuals to lose weight and reduce their disease risk. Changes in weight status at any age can result in positive changes in indicators of disease risk, such as reduced insulin and estrogen levels, which suggests that weight loss is good for overall health and reduces cancer risk.¹⁶

ACS CAN supports CMS' proposed definition of intensive behavioral therapy for obesity as consisting of:

1. Screening for obesity in adults using Body Mass Index (BMI)
2. Dietary/nutritional assessment
3. Intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high-intensity diet and exercise interventions

The World Health Organization defines BMI as a simple index of weight-for-height that is commonly used to classify underweight, overweight, and obesity in adults.¹⁷ According to the Centers for Disease Control and Prevention and other organizations^18,19 BMI provides a reliable indicator of body fatness for most people and is used to screen for weight categories that may lead to health problems.²⁰ The USPSTF also noted in its clinical considerations that 8MI is a reliable, valid, and practical tool for assessing weight status.²¹ We support the use of BMI to screen for overweight and obesity in adults and recommend that 8MI be assessed in adult patients at each routine health care visit.

We also support the inclusion of a dietary/nutritional assessment and recommend that a physical activity assessment also be included as part of the assessment phase. Given that both diet and physical activity contribute to weight status, it is important to assess both individuals' dietary patterns and intake as well as their physical activity patterns and time spent being active, consistent with recommendations of the American Dietetic Association and the American College of Sports Medicine.²² We are pleased that CMS has proposed that the intensive behavioral counseling and behavioral therapy to promote sustained weight loss must focus on both diet and exercise, with a particular emphasis on diet. A diet that is individually planned and creates a deficit of 500 to 1,000 kcal per day should be an integral part of a weight loss program for overweight and obese adults.^23,24 Physical activity also contributes to weight loss and weight maintenance.^25,26 The National Heart, Lung, and Blood Institute ofthe National Institutes of Health concluded based on a review ofthe evidence in its Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity that a combination of a reduced calorie diet and increased physical activity produces greater weight loss than either diet or physical activity alone.²⁷ The American Dietetic Association's Adult Weight Management Evidence-Based Nutrition Practice Guideline also concluded that weight loss and weight maintenance therapy should be based on a comprehensive weight management program including diet, physical activity, and behavior therapy, with the combination of these three components more successful than using anyone intervention alone.²⁸

We also agree that the intensive behavioral intervention for obesity should be consistent with the "S-A" Framework recommended by the USPSTF.

ACS CAN recommends that goals of intensive behavioral therapy be expanded beyond weight loss for obese individuals to also include weight loss for overweight individuals (25≤BMI< 30) and weight maintenance and prevention of weight gain for individuals who are obese or overweight. Because the risk of developing some cancers increases as weight increases even within the 'healthy weight range',²⁹ we also recommend that goals be expanded to include those individuals whose BMI falls within the healthy weight range (18≤BMI< 25) but who have experienced gradual weight gain throughout adulthood. Research has shown that the risk of several types of cancer occurs with overweight as well as obesity (BMI≥~30)³⁰ with greater BMI associated with greater risk.³¹ ln addition, once individuals are obese, few are able to achieve sustained weight loss through changes in diet and exercise.^32,33 In the absence of a continued behavioral intervention, the large majority of patients return to close to their baseline weight.³⁴ Therefore, it is prudent to include preventing healthy weight and overweight individuals from becoming obese and preventing overweight and obese individuals from gaining additional weight³⁵ as supplemental goals of behavioral therapy for obesity. We recommend that instead of labeling the service "intensive behavioral therapy for obesity" it should be called "intensive behavioral therapy for weight management" to clarify that weight loss, weight maintenance, and prevention of weight gain are all important goals. In order to prevent individuals from becoming obese in the first place, people who are overweight (25≤BMI< 30) and who are of healthy weight (18≤BMI< 25) whose weight has increased over time must be eligible for intensive behavioral therapy covered by Medicare.

It is indisputable that prevention saves lives. Preventing people from getting cancer, heart disease, or other chroniC diseases in the first place is more effective in reducing morbidity and mortality from these diseases than even the best treatments. Obesity currently costs the United States $147 billion per year in direct medical expenses.³⁶ Reducing the number of people who are overweight or obese should help to decrease that staggering estimate, or at least prevent it from increasing in the near future.

The proposed decision memo also considered whether coverage of intensive behavioral therapy should be confined to only a subpopulation of Medicare beneficiaries, given that obesity is more prevalent in certain raCial/ethnic groups. Currently, there is a higher rates of obesity among African-American Medicare beneficiaries (40.2% ), than Hispanic (32.8%) or white beneficiaries (27.1%) and a higher rate among Hispanic beneficiaries than white beneficiaries.^37,38 We support CMS' decision to "encourage all individuals with obesity to take advantage of this important proposed benefit", rather than restrict the benefit to only particular subgroup(s) of beneficiaries. While disparities in obesity need to be addressed, obesity prevalence is high among Medicare beneficiaries of all racial/ethnic groups, and all individuals who are obese, overweight, or increasing in weight deserve access to treatment.

ACS CAN supports the intensity and duration of coverage for intensive behavioral therapy for obesity proposed by CMS in the proposed decision memo. According to the USPSTF, high-intensity interventions, defined as person-to-person meetings of more than once a month for at least the first three months, promoted greater weight loss than lower-intensity interventions.³⁹ Recommendations for an ideal initial weight loss goal are about 1-2 pounds per week for a period of 6 months, with the subsequent strategy based on the amount of weight lost and weight status.^40,41 Implementation of a weight maintenance program should follow the initial weight loss period.^42,43 A greater frequency of contacts between the patient and practitioner may lead to more successful weight loss and maintenance."

ACS CAN supports these evidence-based recommendations, and recommends that CMS make behavioral therapy available to eligible individuals for a minimum of one year, with greater intensity for the first six months. For individuals whose goal is weight loss, the initial period of intense treatment should be focused on weight loss, followed by a minimum of six months of behavioral therapy focused on maintenance of weight loss and prevention of weight gain. For individuals whose goal is weight maintenance, the entire duration of treatment should be focused on weight maintenance and prevention of weight gain. An individual should not be denied access to treatment during months seven through 12 due to their weight status or whether or not they experience a change in weight during the first six months of therapy.

ACS CAN strongly disagrees with the proposed requirement that individuals receiving intensive behavioral therapy for obesity be required to lose a minimum of 3 kg within the first six months of treatment and have this weight loss documented in the patient's record in order to continue to be eligible for an additional six months of treatment. Individuals who fail to lose a minimum amount of weight during the initial intervention period still have the potential to receive health benefits from weight management or future weight loss and may need more, rather than less, support than individuals who meet their weight loss target during the first six months of therapy. All patients in need of support losing or maintaining weight should have access to therapy, and patients should be supported in achieving their individual weight management goals, regardless of whether they are for weight loss or weight maintenance.

Weight loss must be sustained in order to provide a long-term health benefit.⁴⁵ Maintaining a moderate weight loss over a prolonged period is more beneficial than regaining weight after a marked weight loss.⁴⁶ According to the NHLBI Clinical Guidelines, the likelihood of weight loss maintenance following successful weight loss increases if dietary therapy, physical activity, and behavior therapy are continued indefinitely.⁴⁷ In individuals do not have access to the treatment and support they need to maintain weight loss, all benefit of the initial weight loss treatment may be lost.

If CMS chooses to maintain a weight loss minimum despite a lack of evidence that such a requirement is benefiCial, weight loss of 3 kg may not be an appropriate goal for all individuals. Weight loss treatment should be individualized for each patient, based on medical, psychological, and nutritional factors,⁴⁸ and the amount of weight a patient should and can be expected to lose should also be tailored to the individual's needs, motivations, and willingness to change behavior.⁴⁹

In addition, according to the USPSTF, high intensity counseling together with behavioral interventions aimed at skill development, motivation, and support strategies produces modest, sustained weight loss of 3-5 kg or more in one year,⁵⁰ rather than in six months. While many individuals may be able to safely lose much more than this amount in a year, it should not be a requirement that limits access to continued treatment. In addition, a percentage of body weight may be a more appropriate weight loss target than an absolute amount of weight for all Medicare beneficiaries. The NHLBI Clinical Guidelines and the American Dietetic Association's evidence-based clinical guidelines recommend 10 percent of body weight as an appropriate initial weight loss target.5152 For a 5'2" woman with a BMI of 30, this would be 7.Skg (16.Slbs), whereas for a 6'0" man with a BMI of 32.5, this would be llkg (24 Ibs). While 10 percent of body weight may be an appropriate individual target for many people, we still do not recommend that it be used as a benchmark for limiting access to care.

ACS CAN strongly recommends that the list of providers eligible to provide treatment be expanded to include registered dietitians (RDs), and potentially other providers such as behavior therapists and exercise physiologists working in conjunction with a RD. A range of providers currently provide treatment for weight loss, and a multidisciplinary team approach may be the most effective.⁵³ However, USPSTF found limited data on the ideal composition of the multidisciplinary team that should deliver the intervention.⁵⁴ Given the lack of evidence in this area, CMS should not limit treatment providers to only primary care physicians and primary care practitioners, as these terms are defined in the proposed decision memo, because other providers, including registered dietitians, may be better suited to provide intensive behavioral weight management therapy. According to the American Dietetic Association, a RD is a food and nutrition expert who has met the minimum academic and professional requirements to qualify for the credential "RD".⁵⁵ The majority of RDs work in the treatment and prevention of disease administering medical nutrition therapy (MNT) as part of medical teams.⁵⁶ MNT involves counseling clients on behavioral and lifestyle changes required to impact long-term eating habits and health, including performing a comprehensive nutrition assessment, planning and implementing an evidencebased nutrition intervention, and evaluating progress over time.⁵⁷ Based on their training and experience, RDs are qualified to provide intensive behavioral therapy for weight management, and many are already providing the service.

While we do not object to allowing primary care physicians and primary care practitioners to provide intensive behavioral therapy to eligible patients, we acknowledge that their time and training on the topic may be limited. The majority of primary care providers do not provide their patients with any exercise or dietary counseling, even during well visits.⁵⁸ less than half of obese patients receive any weight loss advice during routine medical checkups.⁵⁹ Primary care physicians and practitioners often see a large number of patients and provide treatment for a wide variety of conditions each day, and they may not have the time, expertise, or resources to provide patients with a high-intensity therapeutic intervention on an ongoing basis⁶⁰ and may prefer to refer eligible patients elsewhere for treatment. A likely scenario may be that a primary care physician or practitioner conducts the initial BMI screening, and then refers eligible patients for intensive treatment with a trained specialist, such as an RD, in a different location. Research has shown that patients are more likely to receive referral to behavior change counseling when there are established linkages between primary care practices and resources for behavior change in the community:'such as access to a registered dietitian or other specialist in intensive behavioral therapy for weight management.

ACS CAN also recommends that eligible treatment locations be expanded to include additional venues in which it would make sense for intensive behavioral therapy for weight loss to be provided and the venues in which eligible providers typically practice. If treatment is to be provided by providers other than primary care physicians and practitioners, it only makes sense that treatment should be offered outside of a primary care setting. We recommend allowing services to be provided at additional venues, including outpatient hospital settings, skilled nursing facilities, inpatient rehabilitation facilities, and other independent or community-based facilities, which the proposed decision memo specifically excludes. It is important for patients to be able to receive care both where the provider typically works and where the patient may receive other types of ongoing treatment or services. For example, if a patient is receiving cardiac rehabilitation in a cardiac rehabilitation facility and intensive behavioral therapy for weight management is provided in the same location, the patient should be able to take advantage of the therapy without having to go to a different venue specifically for the weight management behavior therapy. Similarly, a patient living in a skilled nursing facility should be able to take advantage of the therapy in the location in which they live. We agree that acute treatment settings, such as hospital emergency rooms, are not appropriate venues for intensive behavioral therapy for weight management.

ACS CAN supports the statement in the proposed decision memo that physicians should consider adjunct therapy for morbid obesity to maximize individual weight loss when medically necessary and indicated. Surgery provides the greatest chance of long-term weight loss for morbidly obese individuals, and may also reduce the excess cancer risk caused by the obesity.^62,63

Following implementation of a final coverage decision, we also recommend that CMS periodically review the research and update their coverage decision accordingly. A review will be particularly warranted following the publication of NHLBI's updated clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults that are currently under development.

Thank you for the opportunity to provide input on this important issue. If we can provide any additional information or if you have any questions, please contact Melissa Maitin-Shepard at melissa.maitinshepard@cancer.org or 202-S85-3205.

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Statement in Response to Centers for Medicaid and Medicare Services Proposed Coverage Decision Memorandum for Intensive Behavioral Therapy for Obesity from the Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School

Dear:

Louis Jacques, MD
Director, Coverage and Analysis Group

Tamara Syrek Jensen, JD
Deputy Director, Coverage and Analysis Group

Jyme Schafer, MD, MPH
Director, Division of Medical and Surgical Services

Sarah McClain, MHS
Lead Health Policy Analyst, Division of Medical and Surgical Services

Joseph Chin, MD
Medical Officer, Division of Medical and Surgical Services

This comment is submitted on behalf of the Division of Preventive and Behavioral Medicine at the University of Massachusetts Medical School. Our Division is a multi-disciplinary academic entity with a faculty representing the behavioral sciences, psychology, nutrition, public health, epidemiology, biostatistics and medicine. Our mission is to improve clinical and public health practice and policy through innovative and sustainable education, research, and service in preventive, behavioral and mind-body medicine. The faculty is involved in research on behavioral therapies for obesity as well as the clinical delivery of these therapies. We are very excited about the prospect of CMS coverage for intensive behavioral treatment for obesity.

A concern with the current proposal is the limited focus on primary care providers. We strongly recommend that the definition of provider be expanded. Specifically, werecommend that the definition of “provider” be expanded to include allied health professionals, including psychologists, dietitians, social workers, diabetes nurse educators, and exercise specialists. This recommendation is strongly supported by the scientific literature.

There are important arguments against limiting the CMS proposal to only reimburse primary care providers (PCPs): There are documented barriers to intervening for weight loss in the primary care setting, including: 1) PCPs are not trained in behavioral weight loss treatment protocols and have well-documented lack of confidence and expertise to deliver such treatments; 2) The PCP setting is characterized by short appointment times, lack of space for treatment groups; and 3) There is a well-recognized shortage of PCPs nationally. As indicated by the CMS proposal, the scientific evidence supports that substantial training and intense treatment over repeated visits are required for weight loss therapies to be effective. The primary care environment is not conducive for implementing behavioral weight loss therapies. In contrast to PCPs, allied health professionals are trained to implement weight loss treatments and have the ability to implement intensive treatment protocols over extended periods of time. The optimal role of the PCP is as referral source to treatment programs implemented by allied health professionals.

There are important arguments for expanding the CMS proposal to reimburse allied health professionals: The efficacy of allied health professionals is supported by clinical trials. The majority of randomized trials demonstrating the effectiveness of behavioral weight loss treatment were developed by clinical psychologists and delivered by allied health professionals. Thus, the efficacy of behavioral weight loss treatments delivered by allied health professionals is strongly supported by scientific data. Delivery of weight loss interventions by allied professionals will result in substantial cost savings because they are reimbursed at a lower rate than PCPs.

A second concern with the current proposal is the lack of description of the types of intensive behavioral treatments that will be covered. We strongly recommend that treatment criteria be defined based on the current scientific evidence-base. Evidence-based behavioral weight loss treatments include the following components: dietary self-monitoring, stimulus control, problem solving, understanding social cues, stress management, dealing with negative thinking, nutrition education, portion control training, physical activity education with instruction, relapse prevention, and weight maintenance strategies. Evidence-based weight loss programs include detailed protocols that must be adhered to with fidelity to be effective. These protocols are intensive, require training and cannot be delivered in the context of routine primary care visits. Consistent with our first concern (the limited focus on primary care providers), the capacity to deliver evidence-based behavioral weight loss treatment is not feasible with PCP training and time availability. While we commend the inclusion of the 5A’s in the CMS proposal, we strongly caution that the 5A’s is not an intervention per se, but rather an effective clinical tool to assist PCPs with triaging and making referrals. We strongly recommend that the CMS proposal be revised to specifically state that the 5A’s are recommended as a screening tool for PCPs to use in making referrals to evidence-based weight loss programs delivered by allied health professionals.

In summary, the Division of Preventive and Behavioral Medicine enthusiastically supports the CMS proposal to cover behavioral weight loss treatment. However, we strongly recommend that the definition of “provider” be expanded to include delivery of evidence-based behavioral weight loss treatment protocols by allied health care professionals. We also recommend that that PCPs be reimbursed for screening and referral to evidence-based treatments using the 5A’s approach, and that the proposal specify that evidence-based behavioral weight loss treatments be covered. Evidence-based interventions are intensive and delivered over extended periods of time, thus consideration of intensity and time are important criteria for ultimately considering reimbursement schedules.

References

1. DPP Research Group, Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med, 2002. 346(6): p. 393-403.

Wadden, T., et al., One-year weight losses in the Look AHEAD study: Factors associated with success. Obesity, 2009. 17: p. 713-722.

3. U.S. Preventive Services Task Force, Screening and interventions for overweight and obesity in adults. 2003, Agency for Healthcare Research and Quality: Rockville, MD.

4. Wadden, T.A., et al., Four-year weight losses in the Look AHEAD study: Factors associated with long-term success. Obesity, 2011. epub ahead of print.

5. Herman, W., et al., The cost-effectiveness of lifestyle modification or metformin in prevention type 2 diabetes in adults with impaired glucose tolerance. Annals of Internal Medicine, 2005. 142: p. 323-332.

6. Brownell, K., The Learn Program for Weight Management. 10th ed. 2004, Euless, TX: American Health Publishing Company.

7. DPP Research Group, The Diabetes Prevention Program (DPP): Description of lifestyle intervention. Diabetes Care, 2002. 25(12): p. 2165-71.

8. Wadden, T.A., et al., The Look AHEAD study: A description of the lifestyle intervention and the evidence supporting it. Obesity (Silver Spring), 2006. 14(5): p. 737-52.

9. Schwartz, M., et al., Changes in medical students' views of internal medicine careers from 1990 to 2007. Archives of Internal Medicine, 2011. 171(8): p. 744-749.

10. Bodenheimer, T., Primary care will it survive? New England Journal of Medicine, 2006. 355(9): p. 861-864.

11. Wing, R.R. and J.O. Hill, Successful weight loss maintenance. Annual Reviews in Nutrition, 2001. 21: p. 323-341.

12. Wing, R.R., et al., A self-regulation program for maintenance of weight loss. New England Journal of Medicine, 2006. 355(15): p. 1563-1571.

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September 30, 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

TRANSMITTED BY EMAIL

RE: Proposed Decision Memo for Intensive Behavioral Therapy for Obesity (CAG-00423N)

Dear Dr. Berwick:

With skyrocketing rates of obesity and weight-related chronic diseases like diabetes and cardiovascular disease (CVD), there is no room for error or in-effective Medicare coverage policy on obesity. Ensuring that Medicare coverage is aligned with evidence based effective obesity reduction is essential for the future health and health costs of our nation. For the treatment of obesity, clinical evidence and research demonstrate that integration of community based role model led care through primary care patient evaluation and referrals is the lynchpin to effective treatment.

While wisely identifying the need for medical care providers to reduce obesity, the proposed coverage for Intensive Behavioral Therapy for Obesity is misguided, costly, and likely to be ineffective. The coverage decision disregards published clinical research showing the most effective approaches to obesity reduction as well as the USPSTF 2003 recommendation and its update process.

We recommend that CMS defer a coverage decision on obesity until FULL REVIEW of an updated USPSTF recommendation, clinical evidence, AND effective private plan/employer coverage policy is completed. Delay of this coverage decision is essential to align Medicare coverage to reduce obesity with the upcoming USPSTF recommendation, clinical evidence and best practices. Further, it is vital that CMS take into account and review private insurance approaches (employer wellness programs for example) as well as the impact of Medicare coverage policy upon primary care practices [and effective weight loss programs operating throughout the US]. The proposed Medicare coverage policy significantly differs with the approach recommended by USPSTF, the models supported by clinical evidence, and the coverage provided by effective, outcomes oriented private plans.

The following provides more detail and citations regarding the divergence between the proposed coverage and published clinical evidence, the 2003 USPSTF recommendation, and effective private plan approaches to provide intensive behavioral counseling for obesity.

The Published Clinical Evidence: Partnership between primary care doctors and role model led group weight loss programs results in greater weight loss in obese adults.

Simply, clinical evidence, including random clinical trial evidence, shows that partnership between primary care doctors and role-model led group weight loss programs result in greater weight loss in overweight and obese adults compared to medical practice delivered care. In a landmark study published in The Lancet, those patients randomized to community based role model led intensive behavioral counseling for healthy diet had significantly better clinical results (weight loss AND biometric measures) than those who received healthy diet counseling from a primary care team. [S Jebb, A Ahern, A Olson, L Aston, C Holzapfe, J Stoll, U Amann-Gassner, A Simpson, N Fuller, S Pearson, N Lau, A Mander, H Hauner, I Caterson. The Lancet, Early Online Publication, 8 September 2011doi:10.1016/S0140-6736(11)61344-5]

The editorial published with this landmark study spells out what this means for coverage policy, “We can conclude that free commercial programmes provided for 6 months or a year lead to weight loss that would be associated with health benefits, particularly in those who complete the programme…… Primary care weight management programmes need to learn lessons from more effective interventions.” [K Jolly, P Aveyard. The Lancet, Early Online Publication, 8 September 2011doi:10.1016/S0140-6736(11)61186-0 ]

These recent clinical trial results simply bolster the transformative and extensive clinical research conducted over the last decade in which effective intensive behavioral counseling for weight loss is provided by trained group leaders, including role models and lay persons (see Weight Watchers Comment letters of September 8, 2011 and April 10, 2011 that outline the compendium of relevant research of the last decade.) Unfortunately, the proposed decision memo on Intensive Behavioral Counseling for Obesity lays out a coverage policy that would set back progress in addressing obesity AND undermine private sector progress in developing scalable, evidence based programs to support primary care practitioners.

USPSTF 2003 Recommendation and 2010 Evidence Review: Advises referral to high-intensity weight loss counseling programs and notes that trained leader¹ or multi-disciplinary models deliver counseling in the most effective programs.

“It is advisable to refer obese patients to programs that offer intensive counseling and behavioral interventions for optimal weight loss. ……. There are limited data on the best place for these interventions to occur and on the composition of the multidisciplinary team that should deliver high-intensity interventions.” [http://www.uspreventiveservicestaskforce.org/3rduspstf/obesity/obesrr.htm]

Further, the 2010 published Evidence Review, prepared for the upcoming update of its 2003 recommendation on intensive behavioral counseling for obesity, found that the most effective programs were led by people trained to provide health education not primary care practitioners. [Lin, O’Connor, Whitlock, and Beil: Behavioral Counseling to Promote Physical Activity and a Healthful Diet to Prevent Cardiovascular Disease in Adults: A Systematic Review for the U.S. Preventive Services Task Force, Ann Intern Med. 2010;153:736-750.]

The proposed coverage does not comply with USPSTF 2003 recommendation. Further, the updated, 2010, USPSTF evidence review clearly states that the body of evidence and clinically effective weight loss programs are delivered in group, trained health educator models.

Effective Private Sector Plans: Use of role-model led group counseling for weight loss and healthy diet is one of the key components to successful private payer wellness programs.

Many sources exist that document successful programs to reduce obesity in the workplace. Among the entities analyzing employer and private payer programs are: National Business Group on Health and AHRQ. The common theme for programs successfully reducing obesity is use of role model led group counseling to support those who are working to lose weight. None of the effective programs used coverage policy similar to that proposed by CMS.

Finally, while we fully understand that National Coverage Decisions do not consider costs, we believe it is vital to document the expected treatment costs associated with the proposed coverage compared to the therapy option that clinical trials show is more effective.

In addition to our comments above, the citations contained in Weight Watchers previously submitted comments on the National Coverage Analysis on Intensive Behavioral Counseling for Obesity and the Proposed Decision Memo on Intensive Behavioral Therapy to Reduce CVD Risk, outline the relevant and extensive research on weight loss and obesity for the last decade. We reiterate the vital need to ensure that coverage policy reflect this body of research as it documents the effective path to addressing obesity and scalable approaches to integrate role model led group counseling with primary care to effectively address obesity. Weight Watchers firmly believes that this body of clinical research and evidence should comprise the basis of a USPSTF recommendation as well as CMS coverage policy

Conclusion:

The proposed coverage as written does not follow 2003 USPSTF recommendation or clinical research of the last decade. The proposed coverage is likely to set back progress in addressing the nation’s obesity crisis. It is vital that CMS defer publication of its coverage policy until the updated USPSTF recommendation is published AND full review of clinical research and effective private sector programs is completed.

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,

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September 30, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Coverage Decision Memorandum for Intensive Behavioral Therapy for Obesity (CAG-00423N)

Dear Dr. Jacques:

The American Gastroenterological Association (AGA) is the trusted voice of the GI community, representing 17,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. We appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) National Coverage Analysis and Proposed Decision Memo (NCA) regarding intensive behavioral counseling for obesity.

An estimated 1.6 billion adults worldwide are overweight (body mass index [BMI]>25) and 400 million are obese (BMI>30), and potentially as many 20 million children are overweight - obesity is the most common nutritional problem worldwide. As obesity becomes a global problem, it is harder for government, institutions and individuals to continue to consider obesity as a problem of personal choice that can be controlled and even reversed by deciding to eat less and exercise more. The incidences of diabetes and other debilitating diseases attributable to obesity continue to rise along with the negative impact on health care budgets and various sectors of the economy leading to changing attitudes about the obesity epidemic.

The AGA has long recognized that nutritional deficiencies and obesity are significant risk factors for several gastrointestinal disorders with large economic burdens. The AGA maintains that reducing the risk of obesity should be part of the gastroenterologist's management strategy in the treatment or prevention of these disorders.

The AGA applauds and supports CMS' initiative to expand coverage to include intensive behavioral therapy for beneficiaries who are at risk for or have been diagnosed with obesity. We concur that intensive behavioral therapy for obesity is a reasonable and necessary preventive service for the prevention and/or early detection of obesity, and that sufficient Grade A and B evidence is available to support CMS' proposal. As new research continues into the causes, prevention and treatments for obesity, the role played by the gastrointestinal (GI) tract is becoming more defined.

We encourage CMS to continue its collaborative efforts on the development of proposals that would increase beneficiary access to additional therapies that will detect, prevent and help manage obesity. To that end, we look forward to a finalized proposal from CMS on this issue.

If you need any additional information please do not hesitate to contact Michael Roberts, AGA's Vice President of Public Policy, at mroberts@gastro.org or via telephone at (240) 482-3220.

Sincerely,

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Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.

As a licensed psychologist, I am writing in response to behavioral therapy for obesity, which is consistent with the American Psychological Association's position. The key points are as follows:

• Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.
• Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.
• Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.
• Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.
• Behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

Thank you for your attention to this matter.

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Comment:
Psychologists must be included as treatment providers in treatment of obesity for the following reasons:
* Obesity has serious circular CAUSE-AND-EFFECT relationship with self esteem. Psychotherapists treat self esteem. Medication alone cannot.
* Weight loss and weight loss maintenance, diet and exercise require serious self discipline. More than any other branch of mental health or general medical health, more than psychiatry, psychology is the discipline that has focused on motivation and behavior change. This includes self motivation and working with contingency management, family support, social support structures, prompts, reminders, and self reinforcement and reinforcement from external sources as well.
* or example, the field of Applied Behavior Analysis (aka Behavior Modification) is most researched and developed by psychologists, and psychologists are the professionals of choice to teach this material to other professionals and to use it with patients. The developments, refinements, and research projects, publications, and clinical applications of these methods are extensive, are very well documented to be effective, and are extensively the produced by psychologists, rarely by other mental health disciplines.
* Cognitive Behavioral Therapy is a well known, well researched, proven effective method of treating both anxiety and depression. It is an outgrowth of the applied behavior analytic work, and it is extensively employed by psychologists, as compared to other disciplines. Though CBT is widely known throughout mental health, I will assert that psychology is the discipline most characterized by mastery of these principals and procedures. Further, I will add that many professionals such as educators utilize behavioral techniques. However, in my experience, these professionals are not trained iin sufficient depth to carve out interventions for difficult cases....the typical Behavioral techniques applied by educators and social workers and nurses are useful for those who do not really need them much, ie., for those who are not 'stuck." For more complex problem patients, a more prescriptive more analytic intervention design is often quite useful, but this is generally NOT an obvious maneuver like reward the positive and ignore or punish the negative. It will be an error to rely on professions that are only superficially trained in these techniques. there should be psychologist involvement on a design or supervisory or front line clinical level.
* Psychologists are the developers of psychological assessment instruments and procedures, having based these on psychometric procedures and research, and being well trained to comprehend the development of such instruments and hence the proper uses and proper limitations of these instruments. In situations necessitating assessment of psychological preparedness for surgeries for morbid obesity such as bariatric surgery, psychologists are the proper assessment providers. In fact, other disciplines are not licensed to apply psychometric - ie., psychological testing instruments without the supervision of a psychologist.
*Obesity impacts general health eg., it significantly predisposes the individual to Type II diabetes, cardiovascular problems, hypertension, and even Alzheimers. In all these illnesses care must involve behavioral self management, which in turn require motivation. And, as stated, these are the province of psycholgy more than any of the other fields of practice mentioned in this plan so far.

Thank you.

Mary Hebblewhite, Ph.D.
Clinical Psychologist
Georgia License #1088

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I am a psychologist in private practice, in central Illinois, a rural/small town region. I am quite surprised that the memo regarding proposed services to people with obesity excludes reimbursed service provision by psychologists. It seems very odd that the professionals who typically have the most training and experience with interventions related to health behaviors would be left out of this otherwise laudable proposal. I can only speculate as to why, but the result is certain: people with obesity will be less, rather than more, likely to receive the intensity and quality of services they need to give them a fighting chance. Why not propose collaboration between healthcare professionals, in all settings related to mental and physical healthcare? What is accomplished by excluding psychologists? It is my earnest hope that this will be reconsidered and re-written.

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I have 26 yrs experience as a psychologist in health settings and am distressed with the policy as written on several counts:

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Obesity as it is becoming a worldwide epidemic. The prevention and treatment of obesity must be a health care priority. However, the interventions must be comprehensive and should include all appropriate professionals who treat obesity.

The guidelines address the physical and behavioral aspects and treatment but overlook the important mental health component that is associated with individuals who struggle with obesity in attempting to change behavior.

The World Health Organization has identified a number of noncommunicable diseases which are escalating to epidemic levels. These include cardiovascular disease and diabetes, with cardiovascular disease being the number one chronic disease burden worldwide. It was also the consensus of the United Nations General Assembly Declaration, signed by 193 nations in September 2011, that mental health, is an important risk factor and needs to be addressed in the prevention and control of such chronic diseases. For example, depression is also often co-morbid with cardiovascular disease and chronic disease.

Therefore, the comprehensive management of individuals who are obese and often suffer from cardiovascular disease and diabetes must address the mental health component. The inclusion of licensed psychologists is a necessary component for the treatment of obesity and chronic disease.

Specifically,

• Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.
• Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.
• Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.
• Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.
• Behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

The successful prevention and treatment of obesity will require a multidisciplinary approach which comprehensively addresses the important risk factors.

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I am a licensed psychologist, specializing in the treatment of individuals with eating problems (anorexia, bulimia, compulsive overeating). I am shocked that psychologists are not included in your list of authorized providers. Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity. Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity. Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity. Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions. Behavioral services should not be limited to primary care settings, and should also include wellness centers. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

Thank you for your time,

Sincerely,

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Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.

Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.

Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.

Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.

Behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

Thank you for your consideration of these important points.

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CMS is to be commended for considering how to make evidence-based obesity treatment available to the population in need of it. It is excellent that number of covered sessions matches that needed for the intensive lifestyle interventions found effective by the NHLBI Obesity Guidelines Task Force and by the U.S. Preventive Services Task Force. However, there are a few provisions of the policy under consideration that fail to match the evidence base and that are counterproductive to curtailing the obesity epidemic. Surely CMS intends to have obesity treatment offered by the health professionals best trained to provide it. Expertise in behavior change is the essential skill needed to deliver effective intensive lifestyle intervention for obesity. Behavior change expertise is the core competence of professional psychologists. Hence, it is no accident that the effective intensive lifestyle interventions for obesity that CMS is trying to provide were developed by psychologists (Rena Wing, Leonard Epstein, Tom Wadden, Bob Jeffery, Gary Foster). Therefore, it is critically important that psychologists be covered providers in CMS's efforts to scale obesity treatment. Also covered must be dieticians, kinesiologists, and exercise physiologists - the other health professions whose members actually receive training to offer intensive lifestyle treatment of obesity.

For several reasons, it is also very important for CMS to eliminate the provision that requires intensive lifestyle intervention to be offered in a primary care setting. The evidence does not support that choice of venue for offering intensive obesity treatment. Moreover, the evidence provides some suggestion that offering treatment in a community setting may increase the reach of treatment to disadvantaged subgroups. The high cost, high volume, rapid pace of service delivery, and competitive utilization of primary care clinic space usually mean that workflow is the primary driver of space allocation. It would be very difficult for the business model of most primary care clinics to justify space allocation for the multi-session, time intensive, evidence-based lifestyle intervention that USPSTF finds to be effective for obesity treatment. Hence, obesity treatments offered in the primary care clinic tend to devolve toward briefer, less frequent contacts that are less effective in helping patients achieve weight management.

In sum, I urge CMS to add particularly psychologists, but also nutritionists and exercise specialists to the qualified providers covered by this policy. Additionally, CMS should not restrict service provision to the primary care clinic, but rather scale treatment to be delivered broadly throughought the community. Thank you for consideration.

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Psychologists must be included in the list of providers of these types of behavioral services. Psychologists are the leading experts in the delivery of behavioral health interventions. Psychologists have produced most of the research pertaining to behavioral health and are uniquely qualified in providing efficacious treatments. Additionally, psychologists are experts in the assessment of personality and behavioral factors that can contribute to an individual's medical condition, particularly obesity. Obesity is not a problem that can be solved through medical intervention alone, as it is largely based on psychological factors that need to be addressed. Physicians and nurse practitioners do not have the training and skill set that psychologists do to be able to provide these types of services.

Psychological services have been proven to be effective preventative treatments, leading to decrease in more serious health conditions and subsequently, more money spent on the treatment of medical conditions. It is vital for patients to have access to behavioral health services from psychologists for preventative treatment. c

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I am pleased that CMS sees the value of behavioral intervention for obesity as “reasonable and necessary” for the early detection and prevention of chronic illness and disability. However, as a pediatric psychologist who specializes in treating obesity in children and adolescents, I have several concerns with the proposed decision memo (CAG-00423N).

First, I recommend expanding the definition of obesity to include the standard of practice for children and adolescents of a BMI at or above the 95th percentile. The BMI for age percentiles published by the CDC in 2000 indicate vastly different cutoffs than the adult standard of 30 kg/m2; for example, a 5 year-old girl with a BMI of 18.2 kg/m2 would be obese. Expanding the definition of obesity in the decision memo would allow children and adolescents with Medicaid to receive developmentally appropriate services.

My biggest concern with the proposed decision memo is the omission of psychologists as qualified practitioners. This is a substantial oversight given that psychologists have the most extensive training of all health care providers in behavioral interventions and have contributed the most to the body of literature supporting behavioral treatment for obesity. Psychologists also provide the vast majority of health and behavior assessment and intervention for a variety of acute and chronic health conditions. Including psychologists as qualified practitioners will grant obese patients access to expert care in evidence based treatments for obesity and establish a wider network of providers to address this pressing health concern.

Last, behavioral intervention for obesity must not be limited to primary care settings. Inclusion there is extremely important. However, making access to behavioral services more available and convenient will increase the likelihood that patients will utilize these services. Expansion to other community resources will also allow primary care physicians to refer beneficiaries to other professionals with expertise in behavioral treatment of obesity such as tertiary care obesity clinics and psychologists in private practice and community mental health. The more qualified practitioners and settings involved, the wider impact we can have in treating obesity and improving the health of our nation.

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Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity. Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity. Furthermore, and perhaps most important, psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.

Currently psychologists provide the vast majority of health behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions. Thus, behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services and provide real benefit to those needing services.

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I am concerned about this Policy and its exclusion of psychologists — psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.

Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity. Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.

Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.

In addition, behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services, thereby decreasing morbidity and mortality associated with obesity.

I urge CMS to reconsider this policy and include psychologists as providers who would be eligible to offer behavioral services to Medicare beneficiaries with obesity.

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I feel strongly that psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.

Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.

Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.

In addition, psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.

Furthermore, behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

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Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.

• Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.
• Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.
• Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.
• Behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

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• Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.
• Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.
• Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.
• Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.
• Behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

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In reading the proposed CMS decision for intensive behavioral therapy for obesity, it makes little sense to me why licensed psychologists should not be included in the list of professionals who can provide such treatment.

Not only is obesity as much an emotional and cognitive issue as it is a physical one, the field of counseling psychology has provided the majority of the evidence for the effectiveness of behavioral interventions for obesity. To not include psychologists in the list is not just an affront to the field of counseling psychology, but a disservice to those who experience difficulties with obesity by depriving them of empirically-validated, effective treatment.

Please reconsider your decision to limit the treatment of obesity to primary care settings and exclude psychologists. Not only will opening up the list open up other effective avenues of treatment, it will encourage your beneficiaries with obesity to seek treatment.

Thank you for your consideration on this issue,

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I applaud CMS for its attention to such a crucial public health issue. Obesity is a perfect example of a biopsychosocial issue that requires multidisciplinary treatment. However the exclusion of reimbursing psychologists on this proposed intervention troubles me greatly. Particularly health psychologists, and those that specialize in behavioral medicine, whom are psychologists that are explicitly trained in the brief delivery of health services for weight management and chronic disease prevention. I conduct presurgical psychological evaluations for gastric bypass and lap band procedures, as well as provide behavioral weight loss interventions for outpatients simply wanting to lose weight "the old fashioned way". Typically, I observe 80 to 90% of these individuals needing the servuces you suggest in this intervention for services either for addressing food addictions, lack of knowledge about how to address food triggers, nutrition, how to address co occurring behavior or concerns such as motivation for exercises, how to restrict calorie intake without psychological distress or tendency to relapse, binge eat, or over eat. It is concerning to me that CMS would not recognize the huge volume of psychological literature which states that brief behavioral interventions for obesity as effective, and that this also has traditionally has been conducted with PhDs included. Furthermore, the lack of the ability to bill for these services in an appropriate way, such as via health and behavior codes, which were recently revoked in this area, leaves PhD no adequate reimbursement whatsoever. This is a bizarre and seemingly discriminatory action against the discipline of psychology, PhDs, and/or health psychologists in specific.

I will also note i live in a state that is largely rural, has a nationally recognized obesity problem, and CMS has a huge presence. Limiting this intervention to primary medical providers will severely impact the ability of psychologists, of which there are many, to deliver this much needed services, when the reality is that primary care is completely overwhelmed and in a shortage of being able to provide services. I respectfully suggest that in my area, and perhaps many others as well, this initiative will have the opposite intended effect of denying this service to those most in need, and limiting psychologists ability to participate in disease prevention.

In closing, i urge you to proactively consider APA's stance on this issue, which is articulated below:

Thank you for hearing my concerns.

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In all candor, it is stunning that the CMS decision memo for provision of intensive behavior therapy for obesity in primary care is proposing to exclude clinical psychologists from furnishing this service(CAG-00423N).

Psychologists for decades have closely studied the neurobiologial, environmental, cognitive, behavioral and emotional factors that contribute to obesity and have designed and researched through many clinical trials behavior therapies that effectively change eating behavior to reduce obesity (See the work of Kelly Brownell, Ph.D.).

To only to allow physicians, nurse practitoners, clinical nurse specialists and physician assistants in primary care settings to furnish behavior therapies for obesity for medicare recipients is akin to restricting dental services or eye care services to the above practioners. When, in fact, those trained in these areas, such as dentists and optemitrists can more efficiently provide the services and yeild better outcomes for the ever-shrinking health care dollar.

Psychologists do work in primary care medical settings and have made adaptive changes with practice methods to effeciently procure behavior therapies that improve health outcomes (please see the work of Kirk Strosahl, Ph.D.).

In closing, I ask CMS staff review the policicy outlined in the proposal above and include psychologists as the providers of their craft— intensive behavior therapy for obesity. Thank you for you consideration.

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Psychologists, as scientists that focus in part on behavior change, are ideally suited to work with individuals struggling with obesity. Psychologists should be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.

Psychologists, of all health care professionals, have the most extensive training in behavioral interventions and have contributed most of the evidence supporting behavioral interventions for obesity. As many chronic health conditions have been shown to have significant behavioral factors in etiology, Medicare beneficiaries need to have access to lower cost but effective treatment options. These behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize such services.

The biomedical model for obesity has been shown to have limited long-term benefits and yet these are the only providers currently included in the definition of provider. Inclusion of psychologists to incorporate a biopsychosocial perspective is critical for both the appropriate comprehensive assessment that is needed along with behavioral interventions for long-term efficacy.

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It is CRUCIAL that psychologists be included in the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity. Psychologists have the MOST EXTENSIVE TRAINING in behavioral interventions OF ALL HEALTH CARE PROFESSIONALS and HAVE CONTRIBUTED MOST of the EVIDENCE SUPPORTING behavioral interventions for obesity. I have worked with obese patients during my career and have worked with the bariatric surgery population for 6 years. I have completed an extensive literature review regarding obesity, and surgical interventions. I have also had training in an evidence based treatment (ACT) which has been shown to be successful in a number of conditions (ACT), use this approach individual treatment and I am developing group therapy specifically designed for this population. It is also important to note that a significant percentage of the obese patients I work with suffer from Post Traumatic Stress Disorder (PTSD), which is particularly prevalent in females, based on my clinical experience. Very few, if any of the professionals suggested in the primary care settings have ANY training in treating PTSD and this is especially true as related to eating behavior. Eating as the PRIMARY coping mechanism for many patients often develops early and more work at a deeper level is required to educate patients and teach them other skills. Working with these patients requires advanced knowledge and training in PTSD, as underlying emotional issues MUST be addressed for long-term behavior change. I find a large percentage of individuals who have suffered for years with PTSD, yet it has never been diagnosed. Psychological treatment in conjunction with addressing the behavior changes is key to successful outcomes for many patients.

It should be pointed out that psychologists provide the vast majority of health & behavior assessment and intervention services to address a variety of acute and chronic conditions. Also, behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services. Salient to this point, recently an obese female patient (over 400 lbs) confided that she cancels some of her medical appointments, feeling judged negatively, blamed for her obesity and talked about disparagingly by the administrative staff. She feels extremely self-conscious in settings where there are many patients in the waiting room area. She has delayed or avoided some necessary medical care due to these concerns, something most medical professionals would never consider.

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September 29, 2011

Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00423N

Dear Sir/Madam:

On behalf of the American Heart Association (AHA), including the American Stroke Association (ASA) and over 22.5 million AHA and ASA volunteers and supporters, we appreciate the opportunity to submit our comments in response to the Centers for Medicare and Medicaid Services (CMS) proposed coverage decision for intensive behavioral therapy for obesity.

According to the proposed decision memo, CMS plans to add intensive behavioral therapy for obesity as a covered benefit under the Medicare program. The benefit would include obesity screening in adults, dietary/nutritional counseling, and intensive behavioral counseling and therapy to promote sustained weight loss through diet and exercise. AHA strongly supports this proposal.

As the Agency is aware, obesity is a significant public health problem. It is a major risk factor for cardiovascular disease, cancer, diabetes, and early death. It also leads to increased health care costs. Fortunately, obesity is a modifiable risk factor. By lowering the prevalence of overweight and obesity, we can substantially reduce Americans' risk of chronic disease, as well as improve overall health. We are therefore very pleased that CMS has proposed this new benefit to fight obesity in the Medicare population. Intensive behavioral therapy that includes both nutrition and physical activity interventions can help Medicare beneficiaries lose weight.

• Use waist circumference measurement, in addition to body mass index (BMI), as the recommended screening tests
• Expand the duration of the benefit beyond the one-year mark to allow for continued weight loss and visits focused on weight maintenance
• Consider adding dieticians, exercise physiologists, and others with specialized expertise in obesity treatment to the list of eligible providers

We expand upon these recommendations below.

Waist Circumference as a Screening Test
The proposed decision memo directs providers to screen adults for obesity by calculating the BMI. AHA supports the use of the BMI to assess body weight. Assessing BMI is an important first step in diagnosing and managing obesity; it allows clinicians to classify levels of overweight and obesity and estimate body fat. However, the accuracy of BMI for diagnosing obesity is especially limited for individuals in the intermediate BMI ranges, those with increased muscle mass, and in the elderly, and misses more than half of people with excess fat.ⁱ

In addition, clinical and epidemiological evidence demonstrates that waist circumference is a better indicator than BMI of total body fat and intra-abdominal fat mass (visceral obesity).ⁱⁱ Abdominal adiposity and visceral fat provide a more refined health indicator of the risk for cardiovascular death than BMI.ⁱⁱⁱ For example, one recent study found that individuals with a very large waist circumference had twice the risk of death during the study period. The study also found that risk of death increased in all individuals with a large waist, even if their BMI indicated a normal weight.^iv

Adding waist circumference to the recommended BMI obesity screening could change the way clinicians assess obesity for individual patients, provide a more accurate assessment of overweight and obesity, and identify individuals whose weight and/or body fat place them at increased risk for cardiovascular disease, diabetes, and metabolic syndrome, as well as increased risk of death.

Waist circumference can easily be measured by a primary care provider and can be conducted at the same time as the proposed BMI screening. Research has shown that patients are comfortable with this measurement when the reasons for it are described to them.

We therefore request that CMS include waist circumference, in addition to the BMI, as the recommended screening tests.

Continued Weight Loss and Weight Maintenance
Under the proposed benefit, obese Medicare beneficiaries would be eligible for one face-to-face intensive behavioral counseling and therapy visit every week for the first month, one visit every other week for months two through six, and one visit every month for months seven through twelve. AHA does not have any specific concerns with this proposed visit frequency; however, we recommend that CMS consider including additional visits beyond the one-year mark for beneficiaries that have not yet met their goal weight. Additional visits - perhaps at a less frequent interval - would allow for continued weight loss. To be eligible for additional sessions past the one-year mark, the Agency could require beneficiaries to achieve a preset minimum weight loss during the first twelve months of therapy. This requirement could be structured similarly to the Agency's current proposal that beneficiaries must achieve at least a 3kg weight loss during the first six months in order to continue therapy at that point.

In addition, we recommend that CMS consider extending the benefit to focus on weight loss maintenance once the beneficiary has achieved his/her target weight or the weight loss phase has been completed. As the U.S. Preventive Services Task Force (USPSTF) found in its evidence review, both initial interventions and maintenance interventions can help individuals sustain their weight loss over time. And as a recent study found, the practices that help people lose weight differ from those that help them maintain that weight loss.^v Therefore, it is important that providers periodically meet with their patients to monitor weight loss and counsel them on the specific behaviors that contribute to successful weight loss maintenance. We expect that visits focused on weight loss maintenance could occur less frequently.

Professionals with Expertise in Obesity Treatment
As proposed, only primary care physicians and primary care practitioners (i.e., nurse practitioners, clinical nurse specialists, and physician assistants) would be allowed to provide intensive behavioral therapy for obesity. The benefit must also be provided in the primary care setting.

AHA agrees with CMS that primary care providers should, and do, play an important role in obesity treatment, but we question the Agency's decision to limit the provision of this benefit to the primary care setting. We are concerned that these narrow restrictions will prevent primary care providers from collaborating with or referring patients to other professionals with expertise in weight loss treatment and maintenance. As recommended by the National Institutes of Health (NIH) Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults, providers may wish to "avail themselves of the various disciplines that offer expertise in dietary counseling, physical activity, and behavior change."^vi To facilitate this type of collaboration, CMS should consider allowing nutritionists, exercise physiologists, and other experts to provide these services.

Conclusion
In closing, we applaud CMS for its efforts to address the obesity epidemic and we reiterate our strong support for the proposed benefit. We look forward to seeing intensive behavioral therapy for obesity added to the Medicare program as soon as possible.

To maximize the effectiveness of this benefit we recommended that the Agency add waist circumference measurement to BMI as the recommended screening tests; allow for additional visits beyond the one-year mark for beneficiaries who have not meet their target weight; and include additional visits specifically focused on weight loss maintenance.

In addition, we recommend that CMS consider adding nutritionists, exercise physiologists, and other professionals with expertise in weight loss therapy and maintenance to the list of eligible providers.

Finally, as we noted in our April 2011 letter to the Agency, the NIH is currently in the process of updating its obesity guidelines. The USPSTF is also in the process of updating its recommendation for obesity screening and management. The updated guidelines and recommendations may serve as useful resources for CMS in the future. We recommend that CMS review the updated NIH guidelines and USPSTF recommendations when they are available and determine if any revisions to the benefit design are warranted at that time.

If you have any questions or need any additional information, please do not hesitate to contact Susan Bishop, MA, Regulatory Affairs Manager, at 202-785-7908 or susan.k.bishop@heart.org. Thank you for consideration of our comments.

Sincerely,

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This response to the CMS "Proposed Decision Memo for Intensive Behavioral Therapy for Obesity (CAG-00423N)" is provided by the Interdivisional Healthcare Committee (IHC). The IHC is an independent working group comprised of representatives from seven Divisions and Sections of the American Psychological Association that are dedicated to the practice of psychology in health settings (Clinical Geropsychology, Clinical Neuropsychology, Counseling Psychology, Family Psychology, Health Psychology, Pediatric Psychology, and Rehabilitation Psychology).

As with many chronic conditions, behavioral factors are central to the problem of obesity. In the context of obesity care, psychological evaluation focusing on patients’ current and past adherence to medical intervention, their repertoire of coping skills and extent of psychopathology is a prerequisite for consideration of bariatric surgery at most health science centers across the country. Psychologists also are trained to provide intensive interventions that address impulsive and compulsive behaviors such as those leading to obesity, including the cognitive and emotional patterns that cause people to have difficulty maintaining a healthy weight. In fact, psychologists have contributed most of the evidence supporting behavioral interventions for obesity. We agree that the treatment schedule outlined by CMS would be fairly typical for this type of treatment in a psychological setting.

Given the skill set of psychologists and their long history of involvement in obesity care, the exclusion of psychologist from reimbursement for these services, or restricting where psychologists must work in order to be reimbursed for behavioral health services seems untenable. Therefore, we strongly recommend that CMS include psychologists for eligibility for reimbursement for intensive behavior therapy for obesity, in the settings in which they typically work.

We also recommend that the algorithm for intensive behavioral therapy for obesity in primary care allow providers to refer patients for treatment by psychologists, in a timely manner as needed. For example, patients may need to be referred if their problem with obesity is complicated by emotional, social, adherence or other non-medical factors, or if the primary care provider does not feel it is within his or her skill set to provide direct intervention for that patient. Referrals should be allowed at the point of identifying a complex patient, or lack of appropriate in-house provider, rather than restricted to the 6 or 12 month assessment timeframes.

We emphasize that psychologists currently have no viable means for CMS-based reimbursement for behavioral assessment and treatment of obesity, per se, despite the fact that psychological care has proven integral to successful outcomes for most patients and families with this condition. In the event that there is Axis I psychopathology, treatment for the Axis I problem alone is indicated (i.e. if a patient identifies both obesity and depression as problems, the psychologist may not bill for reimbursement for treatment of obesity if using a CPT code for individual psychotherapy and a diagnosis code for depression). Also, the Health and Behavior code set specifically excludes obesity and smoking as treatment targets. Thus, psychologists do not have alternate means to address this key public health concern.

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I am writing to strongly express the necessity for including Psychologists as a provider class, to provide intensive behavioral treatment of obesity. Psychologists igsts are specifically trained as behavioral scientists and are the MOST qualified to provide these treatment services.

Services should not be limited to primary care settings, which are geared to medical/physical treatment, and NOT to behavioral intervetions. Primary care swettings may be comfortable for some patients, but designating medical settings and personnel as the only providers LIMITS and REDUCES patient options for competent and comprehensive access to behavioral services. Also, psychologists work collaboratively in primary care settings to provide their expertise in behavioral treatmnet to medical patients.

Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.

Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.

Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.

Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.

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I am writing to comment on the importance of including licensed and appropriately trained psychologists in the behavioral treatment of obesity.

Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity. Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity. Failing to do so will deny beneficiaries access to psychological services that have been proven effective in treating obesity. In fact, behavioral services, as provided by psychologists, should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services, preventing the development of more serious and costly health problems.

Respectfully,

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I am a licensed psychologist and Board Certified in Cognitive and Behavioral Psychology. The lack of inclusion of psychologists who have developed these techniques and who are trained for many years in their application is stunning. Please consider that:

I strongly encourage CMS to allow reimbursement for services provided by psychologists to address behavioral health needs of individuals experiencing obesity. Psychologists are the best trained in behavioral health assessment and intervention approaches, have contributed the most to the scientific evidence regarding effective behavioral health approaches to obesity, and are prepared to collaborate effectively with medical and allied health professionals.

Excluding psychologists from coverage severely limits patient access to appropriate providers to address a persistent and treatment-resistant problem.

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I fully support Intensive Behavioral Therapy for Obesity, however, it is imperative that psychologists be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.

Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.

Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.

Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.

Behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

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• Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.
• Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.
• Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.
• Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.
• Behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

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I am writing to argue that the exclusion of clinical/health/pediatric psychologists from this proposed decision memo is unacceptable. Given that psychologists are the only doctoral-level providers with expert training in the techniques of behavioral modification/therapy, the exclusion of them as providers for Intensive BEHAVIORAL THERAPY for obesity is a remarkable oversight. Indeed, the determination that behavioral therapy for obesity is effective has been based largely upon research done by researchers who are psychologists and who have trained their teams (of physicians and nurses) to administer such interventions. I think that exclusion of psychologists from the memo leaves behavioral therapy for obesity vulnerable to failure, because those administering the intervention (i.e., physicians, nurses, physician assistants) are:

1) not explicitly trained in the area rendering their services ineffective/inadequate

2) will not have to access experts (i.e., psychologists) to train/guide them because those experts cannot bill for the time they must spend training these authorized providers

3) patients will essentially receive substandard care because the authorized providers are hardly the most qualified providers of this treatment

4) intervention will be under-utilized because limiting services to the primary care setting essentially results in an environment that is not conducive to the administration of the effective behavioral interventions for obesity (i.e., due to time constraints, space limitations, accessibility, etc)

Psychologists MUST be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity. Additionally, behavioral therapy for obesity should be administered in a variety of settings including (but not limited to) primary care and behavioral health settings.

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There is a noteworthy omission in this document, which is that it leaves out psychologists. Please consider the following points:

Psychologists have the most extensive training in behavioral interventions of all health care professionals. They are trained as scientist-practitioners, which I think is the kind of professional that you want doing these treatments.

As researchers, psychologists have contributed most of the evidence supporting behavioral interventions for obesity.

Because of this, psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity. Failing to do so will deny beneficiaries access to psychological services that have been proven effective in treating obesity.

Additionally, behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

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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,

The proposed coverage of intensive behavioral counseling of adults for obesity is both indicated by its endorsement by the United States Preventive Services Task Force , subsequent literature, and two studies published in the last month.

The Look AHEAD study has focused on the benefits of lifestyle changes to achieve weight loss in overweight/obese participants with type 2 diabetes. The study population which received intensive lifestyle intervention (such as that contained in the proposed decision memorandum) obtained superior results to those receiving usual care (diabetes support and education.) At year 4, there was a 4.7% reduction from initial weight in the intensive lifestyle group compared to 1.1% in the usual care group. 46% of the intensive lifestyle group lost more than 5% of initial weight and 23% lost more than 10%. (The usual care group saw 25% lose more than 5% and 10% lose more than 10%.)

As these results would predict, the intensive lifestyle group had significantly greater improvements in glycemic control and several markers of cardiovascular disease risk.

As with the Diabetes Prevention Program, the study’s oldest participants, 65-74 years of age, lost significantly more weight than younger counterparts at all 4 years, and reported lower daily caloric intake, higher physical activity and overall greater adherence to the behavioral program. (Wadden TA, Neiberg RH, Wing RR, et al, Four-Year Weight Losses in the Look AHEAD Study: Factors Associated with Long-Term Success, Obesity (2011) 19;10: 1987-1996.)

Thus, it appears that Medicare could ‘look ahead’ with some confidence that the proposed benefit can result in immediate health improvements to Medicare beneficiaries.

These health improvements can be economically quantified, although that is not necessary for the purposes of National Coverage Determinations. Recently, Dr. Kenneth Thorpe reported that a 10% reduction in weight in persons with obesity age 60-64 could provide Medicare with savings of $1.8 to $2.3 billion over ten years and even more if overweight pre-diabetic adults were included. (Thorpe KE, Yang Z, Enrolling people with prediabetes ages 60-64 in proven weight loss program could save Medicare $7 billion or more. Health Affairs 2011 Sep; 30(9):1673-9) While the study participants did not achieve the 10% criteria, their remarkable results indicate a significant cost saving to the Medicare program could be achieved.

For these reasons, the Centers for Medicare and Medicaid Services should not only implement the proposed decision memorandum for Medicare beneficiaries but to explore ways in which such intensive behavioral counseling for obesity may be utilized by as many obese beneficiaries as possible. This would include a two-prong educational campaign. The first prong would be directed to the appropriate health care professionals to make them aware of the benefit and how to achieve competency in intensive behavioral counseling. The other prong would be directed at Medicare beneficiaries to make them aware of the new benefit and possibilities of successful weight management.

Sincerely,
Morgan Downey,
Editor & Publisher, Downey Obesity Report
Washington, D.C.

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Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity to ensure access to care that has been proven to be effective in treating obesity. Behavioral services should not be limited to primary care settings for the same reason. Maximizing access to these services will positively impact the costs associated with other health effects associated with obesity.

Psychologists have the most extensive training in behavioral assessment and interventions of health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity as well as a variety of acute and chronic conditions.

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To Whom it May Concern:

I support funding for intensive behavioral treatments for the prevention and treatment of obesity, as backed by a substantial and growing base of scientific research.

My extreme concern about this policy stems from the proposal to restrict psychologists from providing these services. A review of the literature in behavioral treatments for obesity plainly shows that the vast amount of this work has been done by psychologists. This is appropriate given their extensive training in behavioral change theory and techniques. Stated another way, health psychologists have the greatest expertise in supporting behavior change among patients with acute and chronic illnesses. It is therefore absolutely essential that they be included as providers. One could argue that to deny patients access to treatment delivered by a psychologist is not only costly in the short and long term with regard to poorer patient outcomes, but actually unethical due to the complete disregard for existing body of scientific literature demonstrating the superiority of behavioral health specialists in applying these techniques to promote weight loss relative to standard treatment provided by other health providers not specifically trained in behavioral interventions (e.g., many MDs, nurses, physician assistants).

Furthermore, it is imperative that behavioral obesity treatment not be restricted to primary care as this reduces access to those who desperately need the care.

I would strongly encourage you to consider these very serious flaws in the proposed policy changes.

Sincerely,

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Although I am excited that CMS is proposing a mechanism for healthcare providers receive reimbursement for treating obesity in primary care, I have significant issues with psychologists not being included as eligible providers. As the movement towards integrated care continues, more and more psychologists are working in primary care to address medical, behavioral, and psychological issues of patients. Obesity is one particular health issue that specifically can benefit from a biopsychosocial treatment model that psychologists are uniquely qualified to provide.

Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.

Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.

Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.

Additionally, behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

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As a clinician who works directly with children and families who struggle with overweight and obesity, I applaud the CMS’ effort to provide intensive behavioral therapy to Medicare beneficiaries. As noted in the proposal, evidence shows that intensive behavioral therapy for obesity is necessary for the prevention or early detection of illness or disability. I also agree wholeheartedly with the CMS’ definition of intensive behavioral therapy as including:

However, as a pediatric psychologist who already provides intensive behavioral therapy for obesity to children and families, I am troubled by the rule that would limit those who are allowed to provide these services; specifically, that this rule excludes psychologists. This limitation is concerning, and I am writing to urge CMS to reconsider for these reasons:

I am writing to urge CMS to include psychologists on the list of providers who can provide intensive behavioral services to Medicare beneficiaries in need of weight management.

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I am a psychologist with specialization in treating individuals with physical illness and disability. I have also done research in the treatment and management of obesity. I would STRONGLY oppose excluding psychologists from the list of eligible providers to furnish behavioral services to Medicare beneficiaries with obesity.

Psychologists are specifically trained, more than any other discipline, to effect behavior change. Obesity is largely connected to one's mental health, coping strategies (or lack thereof), and unhealthy behavior patterns, and success in treating obesity is highly dependent upon being able to address the psychological and emotional patterns that interfere with making the positive behavior change. While obesity is a medical condition, it is strongly connected with one's emotional functioning, maladaptive behavioral repertiorres, underlying psychological factors that effect both, and the effectiveness (or lack there of) of coping skills and stress management. There is a great deal of literature that shows that the involvment of psychologists and addressing these factors is essential, and that simply "educating" the patient and devising a behavior change plan isn't sufficient. It's actually getting the patient to comply and follow through with it that makes the difference. And this is the realm of psychologists. Physicians, nurses, and physicians assistants are not extensively trained in this, nor in assessing and identifying the psychological and emotional underpinnigs that contribute to their current condition of obesity, and that create barriers to treatment being effective.

I strongly assert that the inclusion of psychologists in the list of providers eligible to provide behavioral services to beneficiaries of Mediare with obesity is essential. Without it, treatment success will be extremely limited.

Sincerely,
Vanessa LoPresti, Ph.D.

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We need to include licensed psychologists as providers of behavioral health services to Medicare beneficiaries with obesity. Psychologists are the ones who developed our empirically supported behavioral interventions for obesity and arguably have the best training and experience in providing behavioral assessment and treatment for obesity and related conditions. Excluding them among the listed providers would be a serious disservice to the public.

Furthermore, limiting obsesity interventions to primary care settings overlooks other key contexts in which behavioral therapy is effectively provided, and seriously restricts Medicare recipients' access to effective behavioral interventions. Recipients must be granted access to such interventions outside of primary care settings, which will save lives and substantially reduce healthcare costs.

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September 28, 2011

Donald Berwick, MD
Administrator
Centers for Medicare & Medicaid Services
Department of Health & Human Services
P.O. Box 8013
Baltimore, MD 21244.8013
Submitted via email to CAGinquiries@cms.hhs.gov

Re: Proposed Decision Memo for Intensive Behavioral Therapy for Obesity (CAG-00423N)

Dear Dr. Berwick:

On behalf of the American Academy of Family Physicians (AAFP), which represents more than 100,300 family physicians and medical students nationwide, I am writing to express our strong support for the Centers for Medicare & Medicaid Services (CMS) proposal to begin coverage for intensive behavioral therapy for obesity, defined as a body mass index (BMI) . 30 kg/m2.

For Medicare beneficiaries with obesity, who are competent and alert at the time that counseling is provided and whose counseling is furnished by a qualified primary care physician or other primary care practitioner and in a primary care setting, CMS proposes to cover:

• One face to face visit every week for the first month;
• One face to face visit every other week for months 2-6; and
• One face to face visit every month for months 7-12.

At the six month visit, a reassessment of obesity and a determination of the amount of weight loss would be performed. To be eligible for additional face to face visits occurring once a month for an additional six months, Medicare beneficiaries must have achieved a reduction in weight of at least 3kg over the course of the first six months of intensive therapy. However, as obesity is a complex condition usually involving co-morbidity, the AAFP is hesitant to support an arbitrary weight loss requirement of 3kg. Several factors can influence weight loss, such as medications, smoking cessation, relapse or other medical conditions. This determination must be documented in the physician office records for applicable beneficiaries consistent with usual practice.

We concur with CMS that the evidence is adequate to conclude that intensive behavioral therapy for obesity is reasonable and necessary for the prevention or early detection of illness or disability and is therefore appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

In this proposed decision memo, CMS initiates a new national coverage analysis (NCA) on intensive behavioral therapy for obesity, which is recommended with a grade B by the U.S. Preventive Services Task Force (USPSTF). This analysis is consistent with AAFP policy on obesity. The AAFP recommends that family physicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults. Intensive counseling involves more than one session per month for at least 3 months. For children and adolescents, the AAFP recommends that clinicians screen children aged 6 years and older for obesity and offer them or refer them to comprehensive, intensive behavioral interventions to promote improvement in weight status.

The AAFP is pleased that CMS continues to utilize its new authority to cover "additional preventive services" if the agency determines through the national coverage determination process that the service is recommended with a grade A (strongly recommends) or grade B (recommends) rating by the USPSTF and meets certain other requirements.

The AAFP looks forward to working further with CMS to assist in the creation of coding and billing rules needed to implement this new policy. We appreciate the opportunity to provide these comments and make ourselves available for any questions you might have or clarifications you might need. Please contact Robert Bennett, Federal Regulatory Manager, at 202-232-9033 or rbennett@aafp.org.

Sincerely,

CC: Louis Jacques, MD
Joseph Chin, MD, MS
Sarah McClain, MHS

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I think it is important for Psychologists to be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.

To fail to do so will deny beneficiaries access to psychological services that have been proven effective in treating obesity.

Are you aware that Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity? In fact Psychologists already provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.

Thank you for considering this request.

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Psychologists should be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity. Psychologists have the most extensive training in behavioral interventions of all health care professionals. They have also conducted the most research and contributed most of the evidence supporting behavioral interventions for obesity.

Also, psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions. Failing to include psychologists will deny beneficiaries access to evidence-based psychological services to treat obesity.

Further, behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services

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I urge you to include psychologists as primary care providers for obesity intervention. Psychologists receive extensive training in behavioral interventions, such as family therapy, motivational interviewing and cognitive behavior therapy to address chronic disease disorders such as diabetes. They should be included in the CMS PHI policy as providers and not be denied as approved providers for treating this epidemic.

Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.

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Limiting the provision of Intensive Behavioral Therapy to the list of CMS approved providers such as you have is not consistent with a policy of providing evidence based services for patients under the care of the most thoroughly trained practioners. Psychologists, as part of their graduate training, get much more exposure to and practice in the methods of Behavior Therapy both prior to graduation and certainly during the course of their subsequent clinical practice than medically trained providers.

Also, the goal of Integrated Primary Care and Patient Centered Medical Home is in it's infancy. To restrict the provision of Obesity care exclusively to that location of practice will restrict access to many patients that,yes, may have a primary care provider but not one with on-site access to a qualified behavioral health clinician.
Patients deserve the freedom to go to a local qualified behavioral health clinician that is not necessarily under the roof of the PCP.

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The proposed rule promotes the worthy interventions of:

1. “Screening for obesity in adults using measurement of BMI calculated by dividing weight in kilograms by the square of height in meters (expressed in kg/m2);
2. Dietary (nutritional) assessment; and
3. Intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high intensity interventions on diet and exercise.”

While #1-2 in the above list are best performed by medical professionals, #3 could be better implemented by professionals highly trained to perform behavioral interventions. Many primary care practices include integrated behavioral health specialists who would be ideal for provided this therapy, often at a reduced reimbursement rate. They are trained in building rapport, motivational interviewing, assessment, developing shared-decision behavioral treatment plans, and community referrals. These match the 5-A framework described in the memo:

“The intensive behavioral intervention for obesity should be consistent with the 5-A framework that has been highlighted by the USPSTF:

1. Assess: Ask about/assess behavioral health risk(s) and factors affecting choice of behavior change goals/methods.
2. Advise: Give clear, specific, and personalized behavior change advice, including information about personal health harms and benefits.
3. Agree: Collaboratively select appropriate treatment goals and methods based on the patient’s interest in and willingness to change the behavior.
4. Assist: Using behavior change techniques (self-help and/or counseling), aid the patient in achieving agreed-upon goals by acquiring the skills, confidence, and social/environmental supports for behavior change, supplemented with adjunctive medical treatments when appropriate.
5. Arrange: Schedule follow-up contacts (in person or by telephone) to provide ongoing assistance/support and to adjust the treatment plan as needed, including referral to more intensive or specialized treatment.”

Unfortunately, the memo lists the following professionals as those who would be reimbursed for these services:
“1833(x)(2)(A)
Primary care practitioner—The term “primary care practitioner” means an individual—
(i) who—
(I) is a physician (as described in section 1861(r)(1)) who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or
(II) is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in section 1861(aa)(5)).”

I strongly encourage CMS to expand the list of professionals who can provide the behavioral services to include all those who could do so within the scope of their licensed practice (psychologists, LCSW, LCPC, for example).

Obesity is a serious health issue that needs to be addressed using the skills of multiple professionals, most desirably in an integrated setting. At the very least, the professionals providing the interventions should be those most skilled to do so. Therefore, using behavioral health specialists to deliver the behavioral health services needed as part of the treatment plan for obesity will assure better patient outcomes.

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Greetings -

I am a master's level psychologist and Board Certified Behavior Analyst and I currently provide behavior therapy and coaching to help others initiate and maintain healthy habits. I recently learned about the new NCA on Intensive Behavior Therapy for Obesity and appreciate this opportunity to comment on the frequency and credentials necessary for effective service.

Frequency: With intensive behavior therapy, BCBAs typically teach clients to track data on their behavior (eating, exercise, weight) daily and then we review graphs of that behavior to review their progress and adapt programming as necessary. Most BCBA's would recommend that graphs be reviewed and (any necessary program adjustments be made) at least once per week especially at the beginning of service. As the client gets more adept at performing healthy habits and maintaining weight loss, sessions may be conducted once every 2 weeks. A client should never go more than 4 weeks without a consultation as this leaves too much room for error and drift in behavior and data collection.

Credentials: Intensive behavioral therapy includes very specific goal-setting, data collection and graphing of progress which requires knowledge of the principles and strategies of Applied Behavior Analysis and/or Cognitive Behavior Therapy. These strategies are not taught in depth during eclectic psychology graduate programs. So, my recommendation is that a Board Certified Behavior Analyst or someone with at least a master's degree in Applied Behavior Analysis or Cognitive Behavior Therapy be providing these intensive services. There are several accredited ABA graduate programs that I would recommend and more information on BCBA credentials can be found at www.bacb.com.

As someone who is dedicated to helping others lead healthy lifestyles and to disseminating behavior therapy techniques and strategies, I appreciate your time and consideration on this important issue. Please feel free to contact me with any further questions. I'm happy to help in any way that I can.

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• Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.
• Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.
• Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.
• Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.
• Behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

I provide these services here in Oklahoma as part of a multidisciplinary team and in an outpatient, individualized setting. I would be happy to talk to anyone at anytime about the importance of psychologists providing these services.

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Dear CMS Leadership,

For a numebr of reasons outlined below, psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity. Psychologists are trained in human behavior and specialize in understading and promoting healthy, lasting behavior change, which is necessary to treat & prevent obesity. Compared to psychology, current biomedical training includes a much more limited focus on behavioral therapy interventions, including those proposed in this CMS policy.

• Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.
• Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.
• Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.
• Behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

Respectfully,

- Jeff Greeson, PhD, Clinical Psychologist

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Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.

• Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.
• Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.
• Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.
• Behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

Please consider these points in your descision making process.

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Psychologists are uniquely qualified to treat obesity. As specialists in human behavior, we have a strong evidence base that documents the success of behaviorally based interventions. Further, it is well documented that engagement in such interventions is a strong predictor of successful outcomes. We have a strong evidence base showing that motivational interviewing (MI) approaches enhance such engagement. Psychologists have the unique combination of clinical and research training that allows for us to provide such evidence in support of our clinical methods.

Speaking from my experience, patients with difficulties managing their weight are greatly appreciative of and welcoming towards the inclusion of a mental health professional in their care. They readily recognize the emotional and behavioral contributors to their problems with weight and are eager to learn tools to help them overcome such roadblocks to success.

I strongly suggest that the policy be adjusted to allow for psychologists to provide weight management services in Primary Care and other healthcare settings.

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• Psychologists must be included among the providers eligible to furnish behavioral services to Medicare beneficiaries with obesity.
• Failing to include psychologists will deny beneficiaries access to psychological services that have been proven effective in treating obesity.
• Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity.
• Psychologists provide the vast majority of health and behavior assessment and intervention services to assist patients with a variety of acute and chronic conditions.
• Behavioral services should not be limited to primary care settings. Making access to behavioral services more convenient and available will encourage beneficiaries with obesity to utilize these services.

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I am a psychologist with a multi-disciplinary pediatric obesity program and would like to comment on the exclusion of doctoral level psychologists as providers of behavioral interventions for obesity in this proposed rule.

Psychologists are currently heavily integrated into both primary care and specialty care settings to provide behavioral interventions related to a variety of chronic illnesses, including obesity. Excluding psychologists will limit access to behavioral interventions that have been proven to be effective.

Psychologists have the most extensive training in behavioral interventions of all health care professionals and have contributed most of the evidence supporting behavioral interventions for obesity. Excluding psychologists will prevent patients from receiving care from those best versed in behavioral intervention making it less likely that care will be effective.

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I hope to keep my comment brief and focused related to the breadth of approved providers of behavioral interventions for obese patients. I am a Ph.D psychologist who assesses patients related to many types of medical procedures: readiness for device implants, organ transplants, bariatric surgery and subsequently psychological symptoms that result from those procedures.

The assessment of the obese and bariatric surgery candidate is meant to be contextual and add to the success of change in the behaviors that relate to and promulgate obesity, heart disease, etc. Furthermore, the assessment makes specific interventional recommendations as to how to best work with the particular obese patient, rather than to consider a single treatment template will suffice for all. Those recommendations are addressed to the development of an interdisciplinary team and treatment plan focused on a patient learning to alter those behaviors and sustain the change. The team includes: surgeon, primary care physician, nurse practitioner, registered dietician, exercise physiologist and even the front office staff. Essentially the evaluation provides a means for that team to be the primary managers of the patient's care. If there is a significant psychosocial component noted, recommendations are also made for the appropriate behavioral health specialist to be involved. This can be particularly important because many of the obese patients are prescribed psychotropic medications by a PCP that need to be reassessed by a specialist, such as a psychiatrist before proceeding to the surgery. Such assessment is needed because of the change in the ability to metabolize such medications following surgery. Without thoughtful management of medication and support for the patient, we may trade obesity for a relapse in mental health problems, which could lead back to obesity or other difficulties.

The Contextual Analysis referred to above is a critical part of a thorough behavioral and/or bariatric surgery assessment. It allows the team and patient to highlight various areas of risk that can undermine the compliance to medical recommendations that are so highly needed prior to and long-term following the surgery. If engaging patient compliance were as easy as handing out a health education brochure or other form of patient educative counseling, then there wouldn't be the epidemic proportion of obesity this country is wrestling with. rather patients would already have found success as the result of a physician imploring them to lose weight. In fact, the assessment as conducted by our group finds a significant number of patients suffering from health literacy problems [reading, comprehension, numeracy]. That kind of important data is uncovered in the realm of the biopsychosocial assessment and critical to patient success. If behavioral health specialists are eliminated from or not added to the care paradigm for obese patients, it is unlikely that patients will have an opportunity to have an individualized treatment program that will take into account the best ways for them to learn and for the team to act as teachers/mentors to the patient.

To further explain the Contextual Analysis, one can refer to Narrative Medicine theories. Therein, it is critical to listen to the individual stories of patients, their interpretation of life experiences, and subsequent behaviors based on the beliefs that they derive from that personal history. Examples of the various contextual components that influence patient behavior and beliefs are: family/relationships; occupation; past personal experiences regarding health/providers; economics; education; faith; limits imposed by health insurance; mental health; etc. By building a mosaic picture of who this patient is based on life experiences, beliefs and behavioral patterns the behavioral health specialist [i.e. psychologist] develops an important contributing part to the treatment plan. The more individualized the plan involving the patient investment and continuity of care from providers who agree on strategies of care, the less recidivism one can expect.

I know this epistle is not filled with referencing articles and hard core research. I hoped to provide a small bit of insight as to why I sincerely believe that psychologists are a practical piece of the obese patients care. Without that level of expertise, I truly believe based on my 39 years of experience that surgeries will be done, but there will be a higher rate of weight regain, recurrence of diabetes and hypertension, etc. In turn, risks to the patient in terms of surgical complications or return to former behaviors will occur and the health care dollar will have been needlessly spent on a procedure that will not have lasting effect.

Thank you for your consideration.

Sincerely,

Lee Reichbaum, Ph.D.
Licensed Psychologist

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While all of us applaud the attempt to offer coverage for evidence based treatment for obesity, this proposal flies in the face of enlightened steps taken by ARHQ, HRSA, SAMHSA and even elsewhere in CMS to make behavioral health services (mental health, substance abuse, and health behavior change) available to patients in primary care by supporting the addition of properly trained behavioral health clinicians to the primary care team. The idea that the physician will add these services to their repetoire has been discredited by thirty years of development in Family Medicine in which the training of physicians to provide behavioral health services has been given a substantial trial. (No such training is offered in Medicine or Pediatric residencies as a rule.) It was only after behavioral health clinicians were added to the team that evidence based depression treatment began to be delivered in primary care. A professional trained in health psychology is far more likely to be able to deliver the services that this proposal endorses that a primary care physician. I urge that the regulations either be changed to include psychologists, or that a cross disciplinary training standard be established that could be met by physicians, NPs, PAs, psychologists and clinical social workers who have the required training.

Alexander Blount, EdD
Professor of Family Medicine and Psychiatry University of Massachusetts Medical School

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I am writing about intense behavior therapy for obesity in seniors. This type of treatment should be delivered by a behavior therapist, such as a Board Certified Behavior Analyst or a clinical psychologist trained in cognative behavioral psychology. An inter-disciplinary approach with a nurse, physician and dietician would be best. However, this problem is not just about nutrition, but about behavior and psychology, and that discipline should be highly involved. Behavioral psychology is a data and results driven field, and will the most cost effective in the long-run. Education and tracking alone are not enough to fight obesity, goal setting, feed-back and habit training are also necessary. Please consider including the behavioral sciences in this treatment model.

Sincerely,

Jennifer King, MA, BCBA

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Proposed Decision Memo for the Intensive Behavioral therapy for Obesity by CMS it is wonderful to see Medicare supporting intensive therapy for treatment of obesity which we expect will lower health care costs associated with the multitude of co-morbidities. I have two comments:
1. Why are not registered dietitians with training and experience in motivational change, cultural competency in food and eating habits, and expertise in nutritional content of food included as qualified providers?
2. Why is this not considered for coverage in Medicaid for children and younger individuals who will benefit the most?

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It is bizarre that this proposed policy recommends intensive behavioral therapy for obesity based on substantial evidence provided by studies of interventions implemented primarily by behavioral specialists (e.g., psychologists, dieticians, certified exercise experts) while limiting coverage to primary care providers (physicians, NP, CNS, PA) and not permitting coverage of treatments provided by behavioral specialists. A primary care practitioner must be able to refer to qualified behavioral specialists for covered services for obesity treatment. Primary care providers, by their own report, do not typically have adequate training to do such behavior therapy, nor do they have capacity to add these services to their practice. There are not enough of these providers available to care for the huge segment of the US population that is now obese.

It is also concerning that the criterion for obesity does not take into consideration that a child may be severely obese with a BMI of 20. Including a pediatric criterion is supported by the research literature on behavioral treatment for child obesity.

1) the covered providers of intensive behavioral therapy for obesity include behavioral experts (clinical psychologists, registered dieticians, ACSM certified exercise experts) as well as primary care providers, and that

2) a pediatric obesity criterion such as the 97th percentile is included along with the adult BMI criterion.

I realize this will increase claims cost in the short term and that decreasing cost of complications of obesity and diabetes, along with increased productivity, will more than offset this short-term cost.
I am an obesity researcher and clinical health psychologist (PhD).

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Dear:

Louis Jacques, MD
Director, Coverage and Analysis Group
Tamara Syrek Jensen, JD
Deputy Director, Coverage and Analysis Group
Jyme Schafer, MD, MPH
Director, Division of Medical and Surgical Services
Sarah McClain, MHS
Lead Health Policy Analyst, Division of Medical and Surgical Services
Joseph Chin, MD
Medical Officer, Division of Medical and Surgical Services

These comments are submitted on behalf of The Society of Behavioral Medicine, a multi-disciplinary scientific organization representing social scientists, physicians, nurses, epidemiologists, registered dietitians, exercise scientists, psychologists, and public health professionals. SBM is dedicated to the study of the interactions of behavior with biology and the environment, and the application of that knowledge to improve the health and well-being of individuals, families, communities and populations. We are honored to have among our membership many of the clinician scientists who were involved in the development and evaluation of behavior therapy for obesity, including evidence-based protocols such as those used in the landmark Diabetes Prevention Program [1] and Look AHEAD [2] trials. A substantial proportion of our membership is currently involved in the study and clinical delivery of behavioral treatments for obesity. SBM is in strong support of the CMS proposal to cover behavioral therapy for obesity.

Since the USPSTF assigned a B rating to behavior therapy for obesity in 2003 [3] studies have further strengthened support for the efficacy of behavior therapy, most notably the landmark Look AHEAD trial which enrolled 5,145 individuals with type 2 diabetes and revealed weight loss exceeding that of the Diabetes Prevention Program up to 4 years [2, 4]. SBM would also like to note that since the original USPSTF report, behavior therapy for obesity has been shown to be cost effective [5]. The evidence overwhelmingly supports that behavior therapy for obesity is an effective and cost-effective service.

Recommendation to Expand the Definition of Provider

In this statement, SBM strongly concurs with the recommendations put forth in comments by The Obesity Society, The American Society of Bariatric Surgery, and a host of other commenters that the definition of provider be expanded to include psychologists, dietitians, social workers, diabetes nurse educators, and exercise specialists. Our concerns are captured in the following 5 points.

1. Allied Health Professionals Were Utilized in Clinical Trials. The behavior therapy protocols utilized in the majority of randomized trials for obesity (i.e., LEARN[6], Diabetes Prevention Program[7], and the Look Ahead [8]) were developed by clinical psychologists. In trials, protocols were typically delivered by clinical psychologists, dietitians, social workers, diabetes nurse educators, and exercise specialists, including both the Diabetes Prevention Program and Look Ahead trials. Therefore, we strongly urge CMS to reimburse the types of providers found to be effective in delivering obesity treatment, and encourage primary care providers (PCP) to refer to these clinicians. Fortunately, behavior therapy and health behavior change counseling are a regular part of practice for a variety of professionals that routinely work along with PCPs and to which PCPs routinely refer (e.g., psychologists, dietitians, social workers, diabetes nurse educators, and exercise specialists). Further support for a broader definition of providers comes from the NHLBI Obesity guideline which states that there is no evidence for differential efficacy of obesity treatment across health professionals.

2. Limiting to PCPs May Reduce Access. SBM is very concerned that limiting coverage to PCPs (per the stated definition) will severely limit access to effective obesity treatment given that PCPs have short appointment times, often lack space for group-based programs, lack training in delivering behavior therapy protocols, and are currently in short supply in the US [9, 10]. The allied health care professionals listed typically have longer appointment times and have repeat visits built into their practice structure, which is conducive to intensive counseling.

3. Limiting to PCPs May Lead to Insufficient Treatment Intensity. The availability/access barriers discussed about could result in insufficient treatment intensity (number of visits, time spent), and as a result, insufficient outcome. Studies routinely show that intensity of intervention is a strong predictor of weight loss [2, 11, 12].

4. Limiting to PCPs May Have Insufficient Impact on Minorities. Also a consequence of limited access is the possibility of under serving individuals from ethnic minority groups and those residing in low-income communities, who bear an excess burden of obesity and its comorbidities. Enabling additional qualified providers will increase access to essential treatment for these high-risk individuals/groups, thereby reducing health disparities.

5. Allied Health Professionals May Be More Cost Effective. The allied health professionals listed here have lower hourly rates than PCPs, thus covering these well trained professionals may be less costly than exclusive coverage of PCPs.

For these reasons, we strongly recommend that Medicare reimburse the qualified providers we have listed to do this work in their respective treatment settings.

Summary
In summary, SBM enthusiastically supports the CMS proposal to cover behavior therapy for obesity. We strongly urge that the definition of “primary care provider” be expanded to include the allied health care professionals that routinely deliver these interventions in health care settings as well as in the trials in which efficacy was originally established (e.g., psychologists, dietitians, social workers, diabetes nurse educators, and exercise specialists). We believe that the current definition is too narrow which will limit the availability of this treatment for patients who need it, possibly lead to insufficient treatment intensity, disallow appropriate coverage for practitioners who are able to effectively deliver this treatment, and unnecessarily inflate the expense of coverage. Expanding the definition will reduce cost and increase access, which together will greatly enhance our ability and capacity to impact the obesity epidemic in the US.

References

1. DPP Research Group, Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med, 2002. 346(6): p. 393-403.
2. Wadden, T., et al., One-year weight losses in the Look AHEAD study: Factors associated with success. Obesity, 2009. 17: p. 713-722.
3. U.S. Preventive Services Task Force, Screening and interventions for overweight and obesity in adults. 2003, Agency for Healthcare Research and Quality: Rockville, MD.
4. Wadden, T.A., et al., Four-year weight losses in the Look AHEAD study: Factors associated with long-term success. Obesity, 2011. epub ahead of print.
5. Herman, W., et al., The cost-effectiveness of lifestyle modification or metformin in prevention type 2 diabetes in adults with impaired glucose tolerance. Annals of Internal Medicine, 2005. 142: p. 323-332.
6. Brownell, K., The Learn Program for Weight Management. 10th ed. 2004, Euless, TX: American Health Publishing Company.
7. DPP Research Group, The Diabetes Prevention Program (DPP): Description of lifestyle intervention. Diabetes Care, 2002. 25(12): p. 2165-71.
8. Wadden, T.A., et al., The Look AHEAD study: A description of the lifestyle intervention and the evidence supporting it. Obesity (Silver Spring), 2006. 14(5): p. 737-52.
9. Schwartz, M., et al., Changes in medical students' views of internal medicine careers from 1990 to 2007. Archives of Internal Medicine, 2011. 171(8): p. 744-749.
10. Bodenheimer, T., Primary carewill it survive? New England Journal of Medicine, 2006. 355(9): p. 861-864.
11. Wing, R.R. and J.O. Hill, Successful weight loss maintenance. Annual Reviews in Nutrition, 2001. 21: p. 323-341.
12. Wing, R.R., et al., A self-regulation program for maintenance of weight loss. New England Journal of Medicine, 2006. 355(15): p. 1563-1571.

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While I am in favor of this, particularly so for persons with type 2 diabetes, CMS should also cover such services when the PCP desires to refer the patient to an integrated weight-loss / lifestyle modification program. In the area of central New York where I practice, less than 5% of PCP's are prepared to do this kind of work within their practice and most don't feel competent to do so. As an internist / sports medicine physician deeply involved with the American College of Sports Medicine in the area of policy, I am very confident that this is typical of the nation as a whole. Thus, CMS is more likely to achieve the goals of this initiative if the policy covers specialized centers as extensions of the patient centered medical home.

Requiring the services to be provided within the primary care practice itself is - at this point in medical home evolution - likely to undermine the objective. Simple examination of the CDC's maps on obesity / diabetes prevalence shows that much of the population that needs these kinds of services are in rural and poorer areas of the USA, much of which is served by small- to mid-sized practices. Affordably assembling the human resources capable of providing the multifactoral guidance required to lose weight is well beyond the financial capacity of many if not most of these kinds of small- to mid-sized practices. CMS should be inclusive of specialized centers that are designed to help with lifestyle medicine, including weight loss. Many of these programs are hospital-based departments (like the one where I work), because these are the institutions with sufficiently deep resources to create these kinds of programs.

I strongly encourage CMS to include PCP-allied intensive lifestyle intervention programs, including weight-loss services, as extensions of the medical home, and that CMS not require that the services be provided by the PCP within the practice. America's health care system is not ready for that at this time. I work in Ithaca, New York, which is a very forward-thinking community on such matters, and even Ithaca is not close to being ready for this. This issue is sufficiently important to our nation's economy that we cannot afford to create such options, only to someday find that very few patients could make use of them.

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It is exciting to see that Intensive Behavioral Therapy is being considered as a covered benefit for the treatment of obesity. I have worked in a private practice setting for 20 years treating emotional eating issues, and a significant number of my clients are on SSI disability, with Medicare as their insurance. There is no question that their weight is affecting their immediate health, quality of life, mobility, and long-term morbidity. While I try to make the service affordable to this specific category of clients, there are far more who need the help than there are resources to provide it.

I take issue, however, with the provider categories the proposal outlines. I have participated in the training of medical students, and am aware that their exposure to methods of nutrition assessment, counseling techniques, and comorbid psychiatric diagnosis that affect this patient population is minimal. Physician's Assistants and Nurse Practitioners do slightly better, but rarely specialize in dealing with overweight clients. Registered Dietitians are specifically trained to assess, educate, and counsel clients with a variety of diet-influenced conditions. Including them in the list of acceptable providers (and therefore allowing them to be reimbursed directly) would encourage their integration into the primary care setting, where I agree this client population would receive the most comprehensive care. Having said that, I think it is naive to assume that services provided in a private practice setting occur in isolation. In my practice, I work closely with physicians, therapists, NP's, psychiatrists, personal trainers-any professional that will benefit my client and their long-term success. I would suggest that the medical professional be allowed to refer to an RD with whom they have a working relationship, and again, that the RD be able to be directly reimbursed via Medicare. RD's are already Medicare providers; this would just be an additional category under which they could provide services.

I would also like to see a way that certain individuals who are making excellent progress, yet who still have a long way to go, be able to appeal to have these benefits extended so they can receive the support they need to both continue their progress and maintain it for at least a year before losing their professional support. The literature suggests that this kind of long-term follow-up is crucial to long-term maintenance.

Thank you.

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Please include licensed psychologists in your list of providers for intensive behavioral therapy for obesity. Psychologist have the required knowledge base, clinical skills and professionalism to effectively and efficiently deliver this form of treatment. Their training far exceeds the training that physicians receive in behavioral treatments for obesity.

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Behavior therapy has been created by, researched by, improved by, and best delivered by Clinical Psychologists as the research literature shows. Failure to include clinical psychologists - in fact, perhaps noting they are generally MORE QUALIFIED IN SPECIFIC TRAINING than most physicians - is notable as a systematic methodology to prevent patients from receiving actually QUALIFIED services in favor of wasting taxpayer/patients' money for more billable services from under-qualified healthcare workers.

Please note the use of the term BEHAVIORAL and then do any literature search on the term, examining where nearly the entirety of the published literature is generated from the field of psychology.

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Thank you for the opportunity to make a comment on the proposed coverage of behavioral therapy for obesity. Specifically, this comment is in reference to the “Proposed Decision Memo for Intensive Behavioral Therapy for Obesity” (CAG-00423N). A key part of this decision proposes that only certain health care providers would be eligible to provide this important service with reimbursement. The relevant section defining eligible staff (i.e. the primary care practitioner) reads as follows:
Primary care practitioner—The term “primary care practitioner” means an individual—
(i) who—
(I) is a physician (as described in section 1861(r)(1)) who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or
(II) is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in section 1861(aa)(5)).

The current range of eligible providers does not include Licensed Psychologists who have specialty training and expertise in the behavioral treatment of obesity. This group of professionals is uniquely trained in screening, assessing, and treating weight related conditions. Further, they are more than capable of following the 5-A framework that has been highlighted by the USPSTF (Assess, Advise, Agree, Assist, and Arrange) in their work with obese patients. Licensed Psychologists who have specialty training and expertise in the behavioral treatment of obesity also have experience in motivational interviewing, exercise motivation, and goal setting issues relevant to this patient population. Given this, I encourage you to consider adding Licensed Psychologists who have specialty training and expertise in the behavioral treatment of obesity to the list of eligible providers of this service.

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I cannot urge you enough to include psychologists in this proposal as covered providers of behavior therapy for obesity. Behavior therapy for obesity was developed by psychologists, they receive the most rigorous training in delivering this treatment to obese individuals, and they comprise the largest group of professionals implementing this empirically-based treatment for obesity.

The proposal is for coverage of "intensive behavioral therapy"—this is what psychologists w/ this expertise do on a daily basis. Including psychologists in this proposal not only means that individuals in need of this service will be able to receive it from the most well-qualified health care providers, but also that more individuals will be able to receive treatment. This is imperative given the public health epidemic of obesity. Thank you for the opportunity to comment.

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The Intensive Behavioral Therapy (IBT) that is proposed for Obesity (CAG-00423N) is part of what Registered Dietitians (RDs) are trained for, capable of and are already providing. RDs have more expertise and education in the nutrition field than nurses, doctors, nurse practitioners, physician or assistants. RDs are required to have 15 hours of continuing education yearly all of which could be focused on weight control/obesity if that was the RDs area of interest. I respectfully ask that you include RDs in the list of qualified healthcare providers to implement the IBT for Obesity. RDS screen for obesity in adults using measurement of BMI; we conduct nutrition assessments; and we are trained to provide intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high intensity interventions on diet and exercise ... as described in this policy. The proposed 5A frame-work is part of the way in which we provide nutritional care. Please include RDs as qualified healthcare providers of IBT for Obesity.

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Why is CMS reversing its own policy and saying it always was in favor of this?

You say, "since 2003, the USPSTF has recommended screening for obesity in all adults and then offering intensive counseling and behavioral interventions to promote sustained weight loss.” Go to the USPSTF website (http://www.uspreventiveservicestaskforce.org/uspstf/uspsobes.htm) and read the summary of statements. This is your 2003 statement (which appears to be the most current statement): “The USPSTF concludes that the evidence is insufficient to recommend for or against the use of counseling of any intensity and behavioral interventions to promote sustained weight loss in overweight adults.”

The data do not support intentional weight loss for seniors. The data do support physical activity whether someone changes weight or not, and taxpayer dollars are best utilized by facilitating opportunities for people of all ages and sizes to find the physical activity that suits and refreshes them, for a lifetime. Pairing this effort with weight loss dooms it to failure when weight loss inevitably slows and rebounds. Please investigate the Health at Every Size ® model, an empirically validated , weight neutral approach for health maintenance and improvement. www.sizediversityandhealth.org.

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Medicare coverage for obesity counseling for seniors is NOT good for the health of seniors and not good for the taxpayer.

With the proposed minimum 17 doctor visits at $100 per visit, it would cost $257.57 to $154 per pound for temporary weight loss.

Statistically, seniors who lose weight have WORSE morbidity and mortality. So taxpayers would be paying for worsening the health of seniors.

There is NO currently known method of weight loss that is long term. Weight that is lost will return for the vast majority of people(*). So the claimed 6.6-11 pound weight loss is likely to be temporary, followed by weight cycling with weight GAIN.

This is not good for seniors nor tax payers.
(*) Mann, T., Tomiyama, A.J., Westling, E., Lew, A.M.., Ann-Marie; Samuels, B., Chatman, J., Jason. (2007). Medicare’s search for effective obesity treatments: Diets are not the answer. American Psychologist. Vol 62(3), Apr 2007, 220-233. http://motivatedandfit.com/wp-content/uploads/2010/03/Diets_dont_work.pdf

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Re: Proposed Decision Memo for Intensive Behavioral Therapy for Obesity (CAG-00423N)

Two of the references cited in this decision reference the program which I direct, the MOVE! Weight Management Program for Veterans.

In VA, we have not found that physicians can and do carry out behavioral interventions for weight management. In fact, I would estimate that less than 1% of MOVE! patients have had care primarily provided by the primary care physician.

Rather, we took a mulitdisciplinary approach, and assembled a team consisting of a dietitian, nurse, psychologist, and physical activity expert (when available). In some situations, when multidisciplinary staff support was not available, the following order of professionals provided the counseling: dietitians, nurses, psychologists.

We gave training for dietitians, nurses, physicians and others in methods of providing coaching/counseling, and asked our behavioral health staff (mostly psychologists) to assist others in building these skills.

I have several concerns about this decision:

1) I don't think that primary care physicians are adequately trained to provide behavioral counseling for weight management. While they have a huge role in this process, the successes achieved thru MOVE! have been thru patients changing their dietary, physical activity behavior as well as specific behaviors related to weight (e.g., stress eating, eating out too much at restaurants/fast food, speed of eating, ...). I have not seen great evidence that physicians, not specifically trained in behavioral counseling for for weight managment, can be effective assisting patient in weight management. I doubt that this change, in and of itself will result in substantial weight loss in CMS recipients.

2) Given our success with MOVE! (and we have moderate success), we have found that allied health professionals, working with a team or alone), can provide this care. I am very concerned that other disciplines are not mentioned. If doctors brought in dietititians, psychologists, or nurses who have specialized in weight management, I think this care could be much more effective and that this care could be more cost effective. I have seen prior decisions that allow dietitians to receive reimbursement for weight management care. Thus, I am specifically concerned about others receiving reimbursement for this care.

I am glad to see that CMS is addressing these issues, but I believe that this decision is unlikely to make a difference at a public health level unless there will be an active training program to teach PC providers the skills that should be offered.

I would be happy to discuss these comments.

Kenneth R. Jones, PhD
National Program Director for Weight Management/MOVE!
National Center for Health Promotion and Disease Prevention
Office of Patient Care Services (VA Central Office)
Veterans Health Administration
919-383-7874 ext. 228

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