Intensive Behavioral Therapy for Cardiovascular Disease

Louis B. Jacques, MD Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C 1-09-06
7500 Security Blvd
Baltimore MD 21244

Re: National Coverage Analysis (NCA) for Intensive Behavioral Therapy for Cardiovascular Disease (CAG-00424N)

Dear Dr. Jacques:

HCA is a major hospital provider in numerous states. We maintain a focus on patients and are engaged in many quality initiatives. These initiatives focus on the delivery of high quality patient care, including providing appropriate medical options and education to our patients.

We note that the Centers for Medicare and Medicaid Services (CMS) has posted a proposed National Coverage Determination (NCD) Decision Memo for Intensive Behavioral Therapy for Cardiovascular Disease. We believe this to be a positive step toward the prevention of cardiovascular disease, but would like to submit the following questions and comments.

-Who is eligible for intensive behavioral therapy for cardiovascular disease? The U.S. Preventive Services Task Force (USPSTF) recommendations appear to be for patients not yet diagnosed with cardiovascular disease. The proposed therapy lists aspirin use for specific age groups, and screening for high blood pressure, which implies the patient does not have a diagnosis of hypertension. However, the counseling to promote a healthy diet is for adults with “hyperlipidemia, hypertension, advancing age and other known risk factors…” Therefore, will there be age restrictions, defined risk factors and/or prerequisite conditions to qualify for this service?

-We would also like coverage to be considered for Congestive Heart Failure patients as we feel this patient population could benefit greatly from a behavioral modification standpoint. These patients need intensive teaching on dietary modifications, sodium restrictions, exercise, etc.

-How will “intensive” behavioral counseling be defined? What differentiates this service from the counseling and blood pressure measurement that currently occurs as part of Evaluation and Management (E/M) services?

-The proposal is to cover one face-to-face cardiovascular disease risk reduction visit every two years. The proposed decision memo states that the behavioral counseling for aspirin use and healthy diet should be consistent with the USPSTF Five As approach of Assess, Advise, Agree, Assist, and Arrange. While assessing the patient’s needs, advising the patient, and agreeing on goals may be accomplished in one visit, assisting the patient with meeting goals and arranging follow up to provide ongoing assistance and support will require future visits. We recommend allowing coverage for subsequent visits specific to follow up for this service and adjustment of the patient’s treatment plan if needed.

-We recommend expanding coverage for this service outside of the primary care environment to include the specialty of cardiology in coordination with primary care, and outpatient hospital services provided by dietitians or nutritionists employed by hospitals. Some patients depend on the cardiologist to manage their disease process related to cardiovascular disease. The proposed decision memo references dietitians and nutritionists for providing dietary counseling. If these practitioners are not available in the primary care setting, the patient may be referred to a dietitian or nutritionist in the outpatient hospital setting for this service.

We appreciate the opportunity to comment and your consideration of our request. If you have any questions, please do not hesitate to contact me.

Sincerely,

Anthony Roberts RN, MBA, MSN, CCRN | AVP Cardiovascular Services
Clinical Services Group | HCA |
(615) 344-5498

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

RE: Proposed Decision Memo for Intensive Behavioral Therapy for Cardiovascular Disease (CAG-00424N)

Dear Dr. Jacques:

The American College of Cardiology (ACC) is pleased to submit comments on the proposed decision memo on Intensive Behavioral Therapy for Cardiovascular Disease (IBT CVD). The College is a 39,000-member nonprofit medical society composed of physicians, nurses, nurse practitioners, physician assistants, pharmacists, and practice managers, and bestows credentials upon cardiovascular specialists who meet its stringent qualifications. The ACC is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC strongly supports efforts to prevent cardiovascular disease and is pleased to see CMS take strides into this important area of patient care for Medicare beneficiaries by providing coverage for preventive service that are identified with a grade of A or B by the United States Preventive Services Task Force (USPSTF). The ACC supports coverage for the encouragement of aspirin use, screening for high blood pressure, and healthy diet counseling.

Unfortunately, the ACC does not believe the proposed coverage policy will result in significant improvements in the number of Medicare beneficiaries receiving services that will help them avert the onset of cardiovascular disease. This coverage may be reasonable as a minimum threshold at the primary care level, but in our opinion, lacks the intensity needed for true prevention. We have two specific concerns with the proposed coverage. First, while Dr. Lin and colleagues limited their systematic evidence review to “primary care-relevant behavioral counseling interventions,” it would be incorrect to limit coverage for IBT CVD to services provided by primary care physicians/providers. This counseling can be appropriately provided by specialists. Bell and colleagues found that cardiologists were more likely than primary care physicians to counsel their patients about the benefits of controlling blood pressure. We respectfully request that coverage be amended to remove the primary care restriction in the proposed decision memo.

Second, one face-to-face cardiovascular disease risk reduction visit biannually does not constitute the caliber of behavioral counseling recommended by the USPSTF. In its Grade B recommendation of intensive behavioral dietary counseling for patients with hyperlipidemia and other known risks for cardiovascular and diet-related chronic disease, the USPSTF found, “Medium- to high-intensity dietary behavioral counseling resulted in small but statistically significant changes…” Medium-intensity interventions were defined to include 31 to 360 minutes and high-intensity interventions include more than 360 minutes. We respectfully request that coverage be defined in a manner that more closely aligns with the USPSTF recommendations in terms of frequency/duration of intervention.

More generally, the ACC appreciates that CMS is undertaking new initiatives since the passage of the Affordable Care Act. Each of the three areas addressed in the proposed decision memo—aspirin use, high blood pressure screening, and healthy diet counseling—are important tools in the prevention of cardiovascular disease. However, the USPSTF did not make recommendations on IBT CVD. It made three separate recommendations on the items above. The decision to place services for these three recommendations together under one category makes logical sense, but also poses some problems.

• The recommended intervals for the individual recommendations do not align. The decision to cover the services every other year reduces—and likely eliminates—the demonstrated utility of healthy diet counseling. We suggest that CMS consider offering healthy diet counseling as an independent service.
• We are uncertain what will be required of individual practices in terms of documentation and coding. Will new G code(s) be created? What documentation will be required? How will one practice know if another already provided this service in the prescribed time window? Can IBT CVD as defined be provided as an incident-to service? We would like to see CMS devise reporting and payment mechanisms that will avoid the frustrations experienced by practices providing initial preventive physical examinations and now annual wellness visits.

The ACC knows the CMS will consider these issues and questions carefully. We appreciate this opportunity to comment on the proposed decision memorandum and look forward to future collaboration. Please contact James Vavricek at 202-375-6421 or jvavricek@acc.org with any questions or concerns.

Sincerely,

David R. Holmes, Jr., MD, FACC
President

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September 9, 2011, 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 Cardiovascular Disease

Dear Dr. Berwick:

The American Dietetic Association (ADA) appreciates the opportunity to submit comments limited to the third component to the Centers for Medicare and Medicaid Services (CMS) at the United States Department of Health and Human Services (HHS) related to its 10 August 2011 Proposed Coverage Decision Memorandum for Intensive Behavioral Therapy for Cardiovascular Disease (the “Memorandum”).^[1] 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 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 applauds the ongoing efforts at CMS to shift the nation’s health care paradigm towards a more cost-efficient and healthier model focusing on prevention and early treatment of chronic diseases. Although ADA has long advocated covering intensive behavioral dietary counseling that has been proven effective in promoting a healthy diet for adults at risk of cardiovascular disease (CVD), it has serious concerns about ambiguities in the Memorandum.ADA requests that CMS clarify whether it proposes only “to cover one face-to-face CVD risk reduction visit every two years for Medicare beneficiaries,” or whether it proposes to additionally cover any subsequent referral for reasonable medium or high-intensity dietary interventions . In addition, ADA asks CMS to clarify ambiguity whether the proposed coverage substantively conforms to the United States Preventive Services Task Force’s (USPSTF’s) (a) explicit recommendation that dietitians, nutritionists, and other specialists are eligible for reimbursement as qualified providers and (b) implicit requirement that coverage include the types of effective medium and high-intensity interventions underlying its recommendation.

I. USPSTF: Recommendations and Reviews

CMS’s statutory authority to add coverage for specified preventive services is conditional upon the USPSTF having formally recommended coverage of the same specified preventive services with a Grade of A or B.^[2] In 2003, the USPSTF recommended “intensive behavioral dietary counseling for adult patients with hyperlipidemia and other known risk factors for cardiovascular and diet-related chronic disease. Intensive counseling can be delivered by primary care clinicians or by referral to other specialists, such as nutritionists or dietitians” with a Grade B recommendation.^[3] Since 1996, the USPSTF and affiliated researchers have undertaken a series of evidence reviews and systematic evidence updates analyzing available studies related to dietary interventions and counseling to promote a healthy diet. These reviews identify intensity of intervention (minutes in a session; frequency of sessions) as the most significant factor; the largest changes in diet come after medium to high intensity interventions conducted by a dietitian or other specially trained practitioner.^[4]

According to the USPSTF, “[e]ffective interventions combine nutrition education with behaviorally-oriented counseling to help patients acquire the skills, motivation, and support needed to alter their daily eating patterns and food preparation practices. Examples of behaviorally-oriented counseling interventions include teaching self monitoring, training to overcome common barriers to selecting a healthy diet, helping patients to set their own goals, providing guidance in shopping and food preparation, role playing, and arranging for intra treatment social support.” ^[5]Evidence reviews consistently identify several factors as significant barometers of effectiveness, and should be present in dietary interventions covered as components of intensive behavioral dietary counseling.

A. Intensity of Intervention
The USPSTF consistently identifies the intensity of intervention (number of minutes; frequency of sessions) as the most significant factor in explaining differences in effects from dietary intervention trials:

The largest effect of dietary counseling in asymptomatic adults has been observed with more intensive interventions (multiple sessions lasting 30 minutes or longer) among patients with hyperlipidemia or hypertension and among others at increased risk of diet-related chronic disease.^[6]

Medium- to high-intensity behavioral interventions appear to produce consistent, sustained, and clinically important changes in dietary intake of total fat, saturated fat, fruit and vegetables, and fiber. However, these trials were generally either conducted with patients with known risk factors for diet-related chronic disease, or performed in special clinics with highly selected patients and specially trained providers. More intensive interventions, and those of longer duration, are associated with larger magnitude of benefit and more sustained changes in diet.^[7]

In our review, virtually all studies achieving large effect sizes fell into the high-intensity category. . . . Low intensity counseling interventions, such as those typically used in primary care settings, also achieved only small to medium effects on dietary behavior.^[8]

ADA is concerned with a reference in the Memorandum that could easily be misinterpreted to indicate that CMS’ process for determining the intensity/frequency for covered intensive behavioral dietary counseling was unscientific and essentially random. ^[9] If misinterpreted, the reference could raise substantial questions about the author’s understanding of the role of the USPSTF, the ease with which sufficient frequency or intensity could be gleaned from USPSTF evidence reviews, and what appears to be a fundamental misunderstanding of intensive behavioral counseling. ADA respectfully suggests that the final memorandum revise the reference to avoid the misinterpretation and ADA asks CMS to clarify the process and the factors influencing CMS’s determination of frequency and intensity for the covered biennial visit. If (asked discussed below) CMS intends for the biennial visit to be the entire additional covered service for the third component, ADA strongly objects to CMS’s determination that this one visit every two years could reasonably be termed “intensive” and questions whether this biennial provision of services could be of adequate intensity and duration to realistically lead to lifestyle change. Providing services that are incompletd or inadequate is not consistent with CMS’s report focus on improved quality and innovative care that is cost-efficient.

B. Provider Type/Expertise
After intensity, the specialized skills or type of practitioner conducting interventions is the second most significant factor in producing statistically significant improvements in dietary change or physiological results in most trials. The most recent evidence review concluded that “[a]lmost all of the effective medium- to high-intensity interventions were delivered by specially trained health educators or nurses, counselors or psychologists, dietitians or nutritionists, or exercise instructors or physiologists. Very few of these interventions involved the primary care physician at all.”^[10] According to the Institute of Medicine, “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.”^[11]

ADA believes primary providers play a critical role in the screening and referral of patients with risk factors for cardiovascular disease, and expanded coverage for one biennial CVD visit is an important first step in preventing or minimizing the progression of chronic disease. Primary care providers are limited in their time, training, and skills to conduct the medium or high-intensity interventions that are scientifically proved to be the most effective in producing the largest, most lasting results. It is both cost-effective and efficient to have primary care provider-driven referrals of patients with risk factors for CVD to practitioners skilled in conducting dietary interventions who practice both inside and outside of primary care settings. Thus, ADA asks CMS to confirm that it proposes to expand coverage in its memorandum for the referral from the primary care provider to a dietitian or other specialist and visits for appropriate dietary intervention.

C. Selected/Unselected Population
ADA believes both the general, unselected population and a selected population with risk factors for CVD could benefit from dietary interventions, but the nature of interventions may well differ. The USPSTF in 2003 identified “two approaches [that] appear promising for the general population of adult patients in primary care settings: (1) medium-intensity face-to-face dietary counseling (two to three group or individual sessions) delivered by a dietitian or nutritionist or by a specially trained primary care physician or nurse practitioner and (2) lower-intensity interventions that involve 5 minutes or less of primary care–provider counseling supplemented by patient self-help materials, telephone counseling, or other interactive health communications. However, more research is needed to assess the long-term efficacy of these treatments and the balance of benefits and harms.”^[12] Thus, for unselected patients, it may be sufficient to cover the single biennial CVD visit. CMS should confirm that selected patients with risk factors for or with CVD will have additional coverage for the kind of intensive behavioral dietary counseling the USPSTF evidence reviews demonstrate is most likely to attenuate disease progression .^[13]

II. ADA’s Concern with a Possible Reading of CMS Decision

“The USPSTF found good evidence that medium- to high-intensity counseling interventions can produce medium-to-large changes in average daily intake of core components of a healthy diet (including saturated fat, fiber, fruit, and vegetables) among adult patients at increased risk for diet-related chronic disease. Intensive counseling interventions that have been examined in controlled trials among at-risk adult patients have combined nutrition education with behavioral dietary counseling provided by a nutritionist, dietitian, or specially trained primary care clinician (e.g., physician, nurse, or nurse practitioner).”^[14]

CMS also wrote that “[w]e believe that the above discussion regarding primary care settings and practitioners appropriately applies to all three services that comprise intensive behavioral counseling for cardiovascular disease. Since aspirin counseling is for the prevention of CVD and blood pressure screening is to ensure that high blood pressure is caught very early, we believe both of these services are appropriately delivered in the primary care setting. The USPSTF specifically identifies primary care in the recommendation for healthy diet counseling in addition to the service being provided (through referral) by a nutritionist or dietician.”

ADA supports an emphasis on primary care and its role as the link from the patient to the greater medical community, recognizes the need for CMS to consider the implementation on primary care settings of any coverage determination, and takes no issue with the proposed coverage expansion as written above. However, ADA is deeply concerned that one could reasonably read the Memorandum to limit the proposed expansion of coverage (a) only to low-intensity interventions, (b) only in primary care settings, and (c) only if provided by primary care practitioners. If that reading does describe the extent of CMS’s intent in the Memorandum, it would be an evisceration of the purpose and effectiveness of this preventive care initiative. That reading would mean CMS’s solution to one of the nation’s worst chronic diseases would be an approach lacking all of the USPSTF’s hallmarks of effective intervention. It would cover only the least intensive and least effective intervention approach, and would preclude the qualitative benefits and cost-effectiveness of RD-provided nutrition counseling that is a component of effective intensive behavioral therapy. It would be a far cry from the intensive behavioral counseling envisioned by the USPSTF or shown effective in any of the evidence CMS references in the Memorandum.

ADA notes that the only specific mention of referral to dietitians or other specialized providers in the Memorandum is when CMS references the USPSTF’s recommendations. Although CMS reference to the last “A”^[15] of the Five As approach (adopted by the USPSTF to describe behavioral counseling services) implies coverage for a referral to a specialist such as a dietitian, the Memorandum never makes clear that coverage is expanded to include it. In fact, the only clear statement of any additional coverage for the third component is that “CMS proposes to cover one face-to-face CVD risk reduction visit every two years for Medicare beneficiaries: 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.”

ADA remains convinced this reading must be incorrect and CMS could not possibly have intended to expand coverage merely by one biennial visit however, because CMS would have no legal authority under the Social Security Act to propose additional coverage inconsistent with the USPSTF recommendation forming the basis of its coverage determination. The USPSTF clearly chose not to recommend a limited approach in 2003 (even though the studies being reviewed involved more intensive, qualitative superior primary care interventions than just a routine biennial CVD visit with a primary care provider), and expanding coverage as suggested by a (mis)reading of the Memorandum for a low-intensity, ineffective approach that excludes specialists bears no substantive resemblance to the coverage the USPSTF recommended that year.^[16] Thus, ADA asks that CMS clarify its intent to expand coverage for medium and high-intensity dietary interventions conducted by dietitians, nutritionists, or other specialists after referral from the primary care provider.

III. Medical Nutrition Therapy for Risk Factors of Cardiovascular Diseases

ADA requests that CMS include dietary modification through MNT as a component of intensive behavioral dietary counseling for adults with risk factors for CVD. In so doing, CMS will help bridge the gap in good clinical practice between what respected health care organizations and government agencies believe is medically indicated to treat CVD risk factors and by what is presently covered by CMS. The National Heart, Lung, and Blood Institute guidelines indicate therapeutic lifestyle changes when LDL is above goal and intensification of weight management and hypertension treatment as treatment for metabolic syndrome.^[17] The Endocrine Society Guidelines for CVD recommends “that lifestyle management be considered first-line therapy for patients at increased metabolic risk.”^[18] The American Heart Association states:

• The guidelines continue to prioritize lifestyle approaches to the prevention of CVD, likely the most cost-effective strategy.
• The preponderance of evidence suggests that unidimensional interventions such as brief initial patient education and traditional patient reminders are generally ineffective. The most robust interventions are multifaceted, are interactive, and incorporate decision systems and feedback.
• Providing successful patient education is challenging for clinicians because of many factors, including limited time for healthcare visits, patients with complex comorbidities, lack of staff for teaching and follow-up, lack of training in counseling patients about behavior change, and lack of reimbursement for prevention in general and patient education in particular.
• These guidelines call for a renewed focus on health education, including systematic follow-up to assess effectiveness of medical and lifestyle therapies.
• Thirty percent to 70% of all hospital admissions for medication-related illness are attributed to poor adherence, resulting in billions of dollars in additional healthcare costs annually. Addressing adherence to recommendations in guidelines is of utmost importance. Effective implementation of national guidelines for the primary prevention of CVD will require a team-based approach to education that includes the patient, the family, and key healthcare professionals.^[19]

Including MNT as a component of intensive behavioral therapy when indicated is a cost-effective strategy to enhance quality of life by enhancing the quality of care. CMS already determined in 2004 that there may be a benefit resulting from dietary modification using MNT for patients/clients with cardiovascular disease, including dyslipidemia and hypertension. In 2005, 78.1% of beneficiaries presented with some form of heart disease, including 9.2 % with congestive heart failure. Cardiovascular diseases kill more than 800,000 adults each year. Of these deaths, 650,000 are 65 years or older.

A. Dyslipidemia

RD-provided MNT for beneficiaries suffering from dyslipidemia is necessary and should be covered under Medicare. Dyslipidemia is the medical term for high LDL-cholesterol, low HDL-cholesterol, and/or high triglycerides and is an established risk factor for heart disease as indicated by the Lipid Disorder Screening protocol of the USPTSF.^[20] A lipid disorder increases the risk for atherosclerosis, and thus for heart disease, stroke, high blood pressure (hypertension), and associated medical problems. Dyslipidemia disproportionately affects older adults, with a prevalence of 60.3 % in adults age 65 or over.^[21] The causes of this disorder include poor dietary choices and diet-related conditions such as obesity and diabetes,^[22] thus this condition can be effectively treated and prevented through dietary interventions.

1. Effectiveness of Nutrition-Related Interventions in Adults with Dyslipidemia
The USPTSF’s Grade B recommendation of intensive dietary behavioral counseling supports nutrition services for hyperlipidemia and other known risk factors for cardiovascular and diet-related diseases, which includes other forms of dyslipidemia in addition to hyperlipidemia, namely lowered HDL-cholesterol.^[23] RD-provided MNT produces beneficial changes in adiposity and lipids, as well as improvements in self-reported behavioral outcomes.^[24]

In studies and reports, health experts and advocacy organizations cite the importance of having physicians refer patients/clients with dyslipidemia to RDs or other qualified nutritionists for MNT intervention.^[25] As the various presentations of dyslipidemia respond to differing dietary interventions,^[26][27][28] the importance of utilizing the services of a health professional specifically trained to individualize treatment is of paramount importance.

2. RD-Provided MNT for Dyslipidemia
A multitude of studies have demonstrated that MNT provided by an RD has a positive impact on dyslipidemia and other cardiovascular risk factors in both individualized and RD-led group settings. Additional research demonstrates improved treatment outcomes if the intervention includes an RD as part of the intervention team versus interventions which do not include an RD (Holmes et al, 2005; Henkin et al, 2000). Of these studies, those which conducted a cost-benefit analysis of RD services found a savings in health care dollars spent due to decreased use of medications (Delahanty et al, 2001; Sikand et al, 2000; Sikand et al, 1998).^[29]

Shai et al, 2008 investigated the effects of three dietary interventions utilized over the course of 2 years on BMI, blood lipid levels, and other cardiovascular risk factors. RDs conducted 90-minute dietary intervention group sessions for each intervention group and conducted 10-15 minute motivational telephone calls for participants having trouble with adherence. Statistically significant improvements were seen in HDL-cholesterol and triglycerides in all groups, along with reductions in blood pressure and BMI.

Holmes et al, 2005 examined the effectiveness of having RD-led education and counseling compared to general education provided by cardiac rehabilitation. Education from a registered dietitian was associated with improvements in total cholesterol, LDL cholesterol and triglycerides, along with reduced BMI. The general education intervention did not result in significant improvements in cardiac-related biomarkers.

In Delahanty et al, 2001, patients with high cholesterol received either MNT from an RD or usual care from a physician. RD-led MNT achieved a greater decrease in total and LDL cholesterol levels, as well as greater weight loss, when compared with usual care.

In Henkin et al, 2000, researchers examined the differences between patients with high cholesterol who received dietary counseling from both an RD and a physician as compared to usual care from a physician only. The researchers determined that an intervention that includes an RD is more effective at lowering LDL-cholesterol levels in the short term than a physician-only intervention.

In Sikand et al, 2000, researchers conducted a chart review on male patients with hyperlipidemia who had two to four individualized RD visits over an eight-week period. Statistically significant improvements were seen in total cholesterol, LDL cholesterol, triglycerides, and BMI compared to baseline for patients who completed two to four MNT sessions with an RD. As a result of MNT, 50% of eligible patients did not need cholesterol-lowering medication therapy.

In Sikand et al, 1998, researchers conducted a chart review of patients who met criteria for initiating lipid-lowering drug therapy. For patients who completed two to four MNT sessions with an RD, total cholesterol, LDL-cholesterol, and triglycerides decreased. LDL-cholesterol decreased more with four RD visits compared with two RD visits.

3. Cost-effective data for RD-provided MNT for dyslipidemia
With the rising costs of healthcare, it is important to acknowledge the cost-effectiveness of MNT. Cost-effectiveness analyses affirm that MNT results in improved clinical outcomes and reduced costs related to physician time, medication use and/or hospital admissions for adults with disorders of lipid metabolism.

In Troyer et al, 2010, the cost-effectiveness of MNTand therapeutic meals for older adults with cardiovascular disease was assessed. The intervention groups all demonstrated higher quality-of-life-years scores compared to the control group. The findings of this study suggest that MNT for individuals with dyslipidemia can be delivered at a low cost and can result in significant improvement in quality of life for older adults.

In Delahanty et al, 2001, researchers evaluated the cost effectiveness of MNT versus usual care. Although the cost of usual care versus MNT could not be compared directly in this study, the costs and potential benefits of ongoing MNT were examined. The cost-effectiveness ratio of MNT compared to usual care was estimated to be 36% per 1% decrease in total and LDL-cholesterol levels.

In Sikand et al, 2000, researchers found that, as a result of MNT, an annual cost-savings of $638.35 per patient was realized by avoiding the use of lipid-lowering medications. A cost saving of $3.03 in medication therapy was realized for each $1 spent on MNT.

In Sikand et al, 1998, lipid drug eligibility was obviated in 51% of patients who received two to four MNT sessions with an RD, with savings of $60,561.68 from not using medications. A cost-savings of $4.28 in statin therapy was realized for each $1 spent on MNT. Authors concluded that two to four individualized RD visits of 50 minutes each over seven weeks was associated with significant serum cholesterol decrease and a savings of healthcare dollars in avoiding the use of medications.

4. MNT as Reasonable and Necessary for Dyslipidemia: Satisfying the Standard
In addressing the needs of the increasing number of adults that have high LDL cholesterol and forms of dyslipidemia, MNT proves to be an effective intervention. As evidenced above, ADA asserts that MNT for dyslipidemia is a reasonable and necessary service that will positively impact the health of individuals enrolled in Medicare Part B. Not only does MNT result in positive health outcomes, but also yields direct and necessary health cost-savings. Therefore, ADA believes that due to the prevalence of this condition, the improved health outcomes of RD-provided MNT, and the associated cost-savings of MNT therapy, the NCD requirement of reasonable and necessary for dyslipidemia has been fulfilled.

B. Hypertension

1. Background
Lifestyle and nutrition modifications, such as those included in MNT sessions, play a crucial role in both preventing and controlling hypertension. Hypertension, or high blood pressure, is a chronic medical condition in which the systemic arterial blood pressure is elevated. According to the World Health Organization, elevated blood pressure is responsible for 62% of cerebrovascular disease and 49% of ischemic heart disease, making it the number one attributable risk factor for death throughout the world.^[30] Persistent hypertension is also a leading cause of chronic kidney failure.^[31] More than half of the US population age 65 or older has hypertension, with prevalence increasing with increased age.^[32] Nutrition and lifestyle changes can improve blood pressure control and decrease the risk of associated health complications.^[33]

2.Effectiveness of General Nutrition-Related Interventions in Adults with Hypertension
MNT interventions have shown to be beneficial for treating hypertension. Obesity and hypertension are strongly correlated. People with obesity are prone to hypertension, and those who have hypertension are prone to weight gain.^[34] Interventions that lead to a moderate weight loss of 5 to 10 kg can have a significant beneficial effect on hypertension in obese patients.^[35] Furthermore, lifestyle modifications, including dietary changes, can have additional beneficial effects on hypertension beyond that of weight loss.^[36] The Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure asserts that patients benefit from clinicians collaborating with other healthcare professionals, such as RDs, in the treatment of hypertension, including referring selected patients for more intensive counseling, which can result in improved patient lifestyle change and blood pressure control.^[37] Lifestyle modification is best initiated and sustained through an educational partnership between the patient and a multidisciplinary healthcare team. While team members may vary by clinical setting, behavior change strategies should include nutrition, exercise, and smoking cessation services, and should be reviewed and re-emphasized at least annually.^[38]

3. RD-Provided MNT for Hypertension
Research demonstrates that MNT provided by a RD that is targeted specifically to sodium reduction can effectively reduce dietary sodium intake and lower blood pressure in older adults with hypertension (Appel et al, 2001; Applegate et al, 1992). In further studies, MNT provided by an RD resulted in lifestyle changes contributing to reduced blood pressure (Pritchard et al, 1999).^[39]

In Appel et al, 2001, older adults with hypertension received RD-led group education in dietary sodium reduction. The reduced dietary sodium groups achieved and maintained a substantial reduction in dietary sodium, resulting in a reduction in systolic and diastolic blood pressure when compared to the usual lifestyle group.

In Applegate et al, 1992, researchers investigated the effectiveness of non-pharmacologic interventions in older adults with hypertension. Intervention sessions were led by an RD and combined weight reduction, sodium restriction and increased physical activity. The intervention group experienced greater reductions in systolic and diastolic blood pressure than did the control group.

Pritchard et al, 1999: This study investigated the effects of a physician-RD team versus an RD-alone intervention on weight loss and hypertension. Both intervention groups reduced weight and blood pressure compared to the control group, although the RD intervention was able to achieve results at a lower cost.

3. Cost-effective Data for RD-Provided MNT for Hypertension
While RD-provided MNT results in positive health outcomes for patients/clients, the cost-savings are also worth noting. Research affirms that MNT provided by RDs results in improved clinical outcomes and reduced costs related to medication use and physician time for adults with hypertension (Eriksson et al, 2010; Troyer et al, 2010; Pritchard et al, 1999).

Eriksson et al, 2010 examined the effects of a lifestyle intervention program, including diet counseling provided by RDs combined with standard care versus standard care alone. Significant improvements in quality of life and savings in healthcare were found for the lifestyle intervention group. This study demonstrates that a lifestyle intervention program that includes the services of an RD can improve quality of life and be highly cost-effective in relation to standard care.

In Troyer et al, 2010, researchers assessed the cost-effectiveness of MNTand therapeutic meals for older adults with cardiovascular disease. The intervention groups all demonstrated higher quality-of-life-years scores compared to the control group. The findings of this study suggest that MNT for individuals with hypertension can be delivered at a low cost and can result in significant improvement in quality of life for older adults.

Pritchard et al, 1999 investigated the effects of a physician-RD team versus an RD-alone intervention on weight loss and hypertension. Weight loss in both intervention groups was achieved at a lower cost when compared with commercial weight reduction programs, although the cost was lower in the dietitian alone group. Associated reductions in blood pressure were attained with no further cost and without the use of increased anti-hypertensive medications.

4. MNT as Reasonable and Necessary for Hypertension: Satisfying the Standard
As demonstrated by the research findings above, expanded MNT coverage is highly beneficial and cost effective for Medicare beneficiaries suffering from hypertension. Studies reveal that there is a direct correlation between dietary behavioral modification and improved health outcomes. Additionally, MNT is cost-effective by providing interventions that dramatically increase quality of life. As MNT is an appropriate and effective intervention for people with hypertension and is needed to reduce the prevalence and negative health outcomes of this chronic condition. Consequently, ADA contends that the reasonable and necessary requirement has been complied with for the chronic condition, hypertension.

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,

/s/
Jeanne Blankenship, MS RD
Vice President, Policy Initiatives and Advocacy
American Dietetic Association

/s/
Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
American Dietetic Association

Appendix A.

MNT for Treatment of Hyperlipidemia: References

Delahanty LM, Sonnenberg LM, Hayden D, Nathan DM. Clinical and cost outcomes of medical nutrition therapy for hypercholesterolemia: a controlled trial. J Am Diet Assoc. 2001 Sep;101(9):1012-23.

In this randomized clinical trial (class A) of 6 months duration, 90 participants (mean age, 49 years ± 9.5) were assigned to either of two arms, usual care by physician or 2-3 MNT visits in 2-3 months and additional 2-3 visits over the next 3 months if lipids were not at goal. The average time spent on MNT was 90 minutes at 3 months and 30 minutes during the second 3 months. At 6 months, statistically significant differences were seen in percentages of energy from dietary fat (-21.9% vs -6.5%, P<0.01) saturated fat (- 36.4% vs -9.1%, P<0.001) and dietary cholesterol (-29.8% vs -1.2%, P<0.05) in the MNT group as compared to the control group. Futhermore, decreases were seen in total cholesterol (-6.8% vs -2.1%, P<0.05) and LDL-cholesterol (-7.2% vs ↓-2.6%, NS) in the MNT group as compared to the control group. Increased time with RD at 3 months correlated with decreases in total cholesterol (r=−0.47, P=0.001) and LDL-cholesterol (r=−0.39, P=0.008).

Henkin Y, Shai I, Zuk R, Brickner D, Zuilli I, Neumann L, Shany S. Dietary treatment of hypercholesterolemia: do dietitians do it better? A randomized, controlled trial. Am J Med. 2000 Nov;109(7):549-55.

In this 3-month, randomized clinical trial (class A), 136 participants (mean age 50 years ± 11) were assigned to either usual care by a physician or 2-4 nutrition counseling sessions with an RD. At 3 months, total cholesterol had decreased by 9% in the MNT group as compared to 5% in the control group (P<0.05). LDL-cholesterol had decreased by 12% in the MNT group as compared to 7% in the control group (P<0.05).

Holmes AL, Sanderson B, Maisiak R, Brown A, Bittner V. Dietitian services are associated with improved patient outcomes and the MEDFICTS dietary assessment questionnaire is a suitable outcome measure in cardiac rehabilitation. J Am Diet Assoc 2005;105(10):1533-1540.

In this retrospective cohort study (class B) in the United States, Holmes et al, 2005 examined the effectiveness of having a registered dietitian educating and counseling on diet-related patient outcomes compared with general education provided by the cardiac rehabilitation staff. Patients were encouraged to attend weekly small-group education classes, which were led by registered dietitians and focused on heart-healthy nutrition and label reading. Individual counseling was recommended to supplement the group education classes and general cardiac rehabilitation education when indicated. In this analysis, patients receiving any education and/or counseling from a registered dietitian were grouped together. Data on 426 patients (mean age 62 ± 11 years) with coronary heart disease who completed cardiac rehabilitation were abstracted from a Cardiac Rehabilitation Program outcomes database. At baseline, the subjects in the registered dietitian group (n=359) had significantly more dyslipidemia (88% versus 76%), more obesity (47% versus 27%), a higher waist circumference (40± 6 versus 37± 5 inches), a higher body mass index (30± 6 versus 27± 5 kg/m²), a higher diet score (32± 28 versus 19± 19), and lower self-reported physical activity (7 ± 12 versus 13 ± 18 metabolic equivalent hours) than the subjects in the general education group (n=67, all P <0.05). Education from a registered dietitian was associated with improved LDL cholesterol (r=0.13, P = 0.04) and triglycerides (r=0.48, P= 0.01).

Shai I, Schwarzfuchs D, Henkin Y, Shahar DR, et al; Dietary Intervention Randomized Controlled Trial (DIRECT) Group. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. N Engl J Med. 2008 Jul 17;359(3):229-41. Erratum in: N Engl J Med. 2009 Dec 31;361(27):2681.

In a randomized, controlled 2 year trial (class A) with 322 participants (mean age 52 years), Shai et al, 2008 investigated the effects of three dietary interventions on BMI, blood lipid levels, and other cardiovascular risk factors. Participants were randomized to 1 of 3 diets: a VLC diet with no calorie restrictions; a calorie-restricted Mediterranean diet (MED); or a calorie-restricted LF diet. RDs conducted 90-minute dietary intervention group sessions for each intervention group once every two weeks for 8 weeks, then once every 6 weeks after that . During 2 year intervention, RDs also conducted 10-15 minute motivational telephone calls for participants having trouble with adherence approximately six times during the 2 year intervention. Statistically significant improvements were seen in HDL-cholesterol and triglycerides in all groups, along with reductions in blood pressure and BMI. The mean weight change was −4.7 kg for the VLC group, −4.4 kg for the MED group, and −2.9 kg for the LF group. The ratio of serum total cholesterol to HDL-C decreased in all groups, with the LC group showing the greatest improvement with a relative decrease of 20% compared with the LF group with a decrease of 12%.

Sikand G, Kashyap ML, Wong ND, Hsu JC.Dietitian intervention improves lipid values and saves medication costs in men with combined hyperlipidemia and a history of niacin noncompliance. J Am Diet Assoc. 2000; 100: 218-224.

In a positive-quality retrospective chart review (class B) in the United States, Sikand et al, 2000 conducted a cost-benefit analysis for 43 hyperlipidemic male patients (mean age 60.7 years) that were classified as niacin failures. Niacin failures were subjects that were non-compliant to taking niacin due to its side effects and were placed on a trial of MNT for eight weeks prior to beginning statin therapy (if needed). Patients had two to four individualized RD visits over eight-week period and subjects were following Step I NCEP diet. Average RD intervention time was three MNT sessions and 169 minutes during seven weeks of MNT. As a result, TC decreased -11% (P<0.001), LDL-C decreased 9% (P<0.001), TG decreased 22% (P<0.0001). HDL-C increased 4% however this was not statistically significant and BMI decreased 2% (P<0.0001) compared to baseline. As a result of MNT, 15 of 30 eligible patients did not need medication therapy which resulted in an annual cost savings of $638.35 per patient by avoiding the use of statins. A cost saving of $3.03 in statin therapy was realized for each $1 spent on MNT. Although given a high-quality rating, complete information was only available for 43 of 73 patients. Authors concluded that three visits of one hour each over an eight-week period had a significantly beneficial effect in treating patients with combined hyperlipidemia (high LDL-C and high triglyceride).

Sikand G, Kashyap ML, Yang I. Medical nutrition therapy lowers serum cholesterol and saves medication costs in men with hypercholesterolemia. J Am Diet Assoc. 1998; 98: 889-894.

In a positive-quality retrospective chart review (class B) in the United States, Sikand et al, 1998 completed a cost-benefit analysis based on 95 male VA patients with hyperlipidemia (high LDL) who participated in an eight-week nutrition intervention program. Subjects met criteria for initiating drug therapy (LDL-C 4.1mmol/L), were not on lipid-lowering medications, were 21-75 years of age (mean age 60.8 years), and had two to four RD visits over six to eight-week period. The initial visit was 60 minutes, the first follow-up visit four weeks later was 60 minutes and the remaining two follow-up visits were 30 minutes each. Complete medical records available for 74 of the 95 subjects were used for analysis. As a result of MNT, TC decreased -13.4% (P<0.0001), LDL-C decreased -14.2% (P<0.0001), TG decreased 10.8% (P<0.05), and­ HDL-C decreased -4.4% (P<0.05) compared to baseline. Average RD time was 144±21 minutes, 2.8±0.7 sessions, 6.8±0.7 weeks. LDL-C decreased more with four RD visits compared to two RD visits (-21.9% vs. -12.1%; P<0.027). Lipid drug eligibility was obviated in 34 of 67 (51%) of subjects with savings of $60,561.68 from not using the medications. A cost savings of $4.28 in statin therapy was realized for each $1 spent on MNT. Authors concluded that two to four individualized RD visits of 50 minutes each over seven weeks was associated with significant cholesterol decrease and a savings of health care dollars in avoiding the use of medications.

Troyer JL, McAuley WJ, McCutcheon ME. Cost-effectiveness of medical nutrition therapy and therapeutically designed meals for older adults with cardiovascular disease. J Am Diet Assoc 2010;110:1840-1851.

In a positive-quality cost-effectiveness study (class M) in the United States, Troyer et al, 2010 assessed the cost-effectiveness of MNTand therapeutic meals for older adults with cardiovascular disease. A total of 321 subjects (aged 60 years and older who were medically diagnosed with either hypertension or hyperlipidemia) were randomized to one of four arms for one year: a literature control group, a therapeutic meal group that received seven therapeutic meals per week, an MNT group, and an MNT plus therapeutic meal group. MNT sessions took place in participants' homes and occurred over three sessions, with each participant receiving individualized counseling and education based on the MNT protocol for hyperlipidemia. The primary outcome measure was quality-adjusted life years (QALYs). All three intervention groups had higher QALYs than the literature control group. The meals and MNT were found to be cost-effective, however, the combination of MNT and therapeutic meals did not have an independent significant effect on QALYs; home-delivered therapeutic meal design, production and delivery costs were <$1,600 per year for 364 meals, and the provision of three MNT sessions in the home by a registered dietitian cost <$300 per person.

Appendix B.

Estimated Reductions in Systolic Blood Pressure with Lifestyle Changes

Modifications	Recommendations	Approximate Systolic Blood Pressure Reduction
Weight Reduction	Maintain normal body weight (BMI 18.5-24.9)	5-20 mm Hg for each 10 kg weight loss
Adapt DASH eating plan	Consume diets rich in fruits, vegetables, low fat dairy and low saturated fat	8-14 mm Hg
Dietary sodium reduction	Reduce sodium to no more than 2.4 g/day sodium or 6g/day NaCL	2-8 mm Hg
Increase physical activity	Engage in regular aerobic activity such as walking (30 min/day on most days)	4-9 mm Hg
Moderate alcohol consumption	Limit alcohol to no more than 2 drinks/d for men and 1 drinks/day for women	2-4 mm Hg

Appendix C:

MNT for Treatment of Hypertension: References

Appel LJ, Espeland MA, Easter L, Wilson AC, Folmar S, Lacy CR. Effects of reduced sodium intake on hypertension control in older individuals: results from the Trial of Nonpharmacologic Interventions in the Elderly (TONE). Arch Intern Med. 2001 Mar 12; 161 (5): 685-693.

Applegate WB, Miller ST, Elam JT, Cushman WC, El Derwi D, Brewer A, Graney MJ. Nonpharmacologic intervention to reduce blood pressure in older patients with mild hypertension.Arch Intern Med. 1992; 152: 1162-1166.

In a neutral-quality randomized controlled trial (class A) in the United States, Applegate et al, 1992, determined if nonpharmacologic interventions are effective in 56 older patients with hypertension (mean age 65 years in the intervention group, 64 years in the control group). The experimental arm was a nonpharmacologic intervention combining weight reduction, sodium restriction and increased physical activity, consisting of eight weekly group sessions and two individual sessions during the intensive 10-week phase, followed by four monthly group sessions during the maintenance phase. All intervention sessions were conducted by a registered dietitian who had previous experience with conducting group sessions involving weight management and sodium restriction. 47 completed the trial (84%). The intervention group experienced a greater reduction in systolic (P=0.02) and diastolic (P=0.003) blood pressure than did the control group (mean differences between groups at six months were 4.2 to 4.9mm Hg, respectively).

Eriksson MK, Hagberg L, Lindholm L, Malmgren-Olsson EB, Osterlind J, Eliasson M. Quality of life and cost-effectiveness of a 3-year trial of lifestyle intervention in primary health care. Arch Intern Med 2010;170(16):1470-1479.

In a positive-quality cost-effectiveness study (class M) in Sweden, Eriksson et al, 2010 assessed the quality of life and cost-effectiveness of a 3-year trial of lifestyle intervention in primary healthcare, based on the Swedish Bjorknas Study. A total of 151 men and women, aged 18 - 65 years, at moderate to high risk for cardiovascular disease (diagnosed with hypertension, dyslipidemia, type 2 diabetes, obesity, or any combination of these), were randomly assigned to either lifestyle intervention (71 subjects, mean age 55.7 years) with standard care or standard care alone (74 subjects, mean age 53.1 years). The intervention consisted of supervised exercise sessions and diet counseling for three months, followed by regular group meetings over a three-year period; diet counseling was in accordance with the Nordic nutrition recommendations and was provided by a registered dietitian both verbally and written. There were significant differences between groups in quality of life during the three years, as measured by the EuroQol VAS (P = 0.002), 6-dimensional Short Form 6D (P = 0.01), and the 36-item Short Form Health Survey (P = 0.04). The net savings amounted to $47 per participant, and costs gained per QALY were $1668 to $4813. Probabilities of cost-effectiveness were 89% to 100% when the amount of $50,000 was used as the threshold of willingness to pay for a gained QALY.

Pritchard DA, Hyndman J, Taba F. Nutritional counseling in general practice:A cost effective analysis. J Epidemiol Community Health. 1999; 53: 311-316.

In one positive-quality randomized controlled trial (class A) in Australia by Pritchard et al, 1999, 273 subjects (aged 25 to 65 years, 73% were under age 50) who were overweight or who had hypertension and type 2 diabetes were allocated to one of two intervention groups (doctor/dietitian or dietitian) or a control group. Both intervention groups received six counseling sessions over 12 months from a dietitian; the initial session was 45 minutes long, with 15 minutes for follow-up sessions. 177 subjects completed the study (65%), but the dropout rate of overweight patients in the dietitian group (45%) was significantly greater than the 29% for the doctor/dietitian group. Both intervention groups reduced weight and blood pressure compared to the control group. Compared to the control group, the cost of an extra kilogram of weight loss for the doctor/dietitian group was $9.76 and for the dietitian group was $7.30.

Troyer JL, McAuley WJ, McCutcheon ME. Cost-effectiveness of medical nutrition therapy and therapeutically designed meals for older adults with cardiovascular disease. J Am Diet Assoc 2010;110:1840-1851.

In a positive-quality cost-effectiveness study (class M) in the United States, Troyer et al, 2010 assessed the cost-effectiveness of MNTand therapeutic meals for older adults with cardiovascular disease. A total of 321 subjects (aged 60 years and older who were medically diagnosed with either hypertension or hyperlipidemia) were randomized to one of four arms for one year: a literature control group, a therapeutic meal group that received seven therapeutic meals per week, an MNT group, and an MNT plus therapeutic meal group. MNT sessions took place in participants' homes and occurred over three sessions, with each participant receiving individualized counseling and education based on the MNT protocol for hyperlipidemia. The primary outcome measure was quality-adjusted life years (QALYs). All three intervention groups had higher QALYs than the literature control group. The meals and MNT were found to be cost-effective, however, the combination of MNT and therapeutic meals did not have an independent significant effect on QALYs; home-delivered therapeutic meal design, production and delivery costs were <$1,600 per year for 364 meals, and the provision of three MNT sessions in the home by a registered dietitian cost <$300 per person.

Appendix D.

Class Description of Data

Primary Reports of New Data Collections
A = Randomized, controlled trial
B = Cohort-study
C = Non-randomized trial with concurrent or historical controls; Case-control study; Study of sensitivity and specificity of a diagnostic test; Population-based descriptive study
D = Cross-sectional study; Case series; Case report

Reports that Synthesize or Reflect upon Collections of Primary Reports
M = Meta-analysis; Systematic review; Decision analysis; Cost-effectiveness analysis
R = Consensus statement; Consensus report; Narrative review
X = Medical opinion

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[1] ADA limits its comments on the Memorandum to focus on (a) ADA’s recommendation that dietary modification using MNT be included as a component of intensive behavioral dietary counseling for for adult patients with hyperlipidemia and other known risk factors for cardiovascular and diet-related chronic disease; and (b) concerns with the proposed effectuation of the third component of intensive behavioral therapy proposed for coverage (“intensive behavioral counseling to promote a healthy diet for adults with hyperlipidemia, hypertension, advancing age, and other known risk factors for cardiovascular and diet-related chronic disease”), which implicates concerns at the core of ADA members’ expertise and has potential to substantially negatively impact members and the profession.

[2] 42 U.S.C. 1395(ddd).

[3] http://www.uspreventiveservicestaskforce.org/uspstf/uspsabrecs.htm. The USPSTF summarized evidence related to counseling for the promotion of a healthy diet in adults to make the Grade B recommendation.A total of 21 randomized controlled trials were included in the systematic review. Dietary counseling was shown to produce modest changes in self-reported consumption of saturated fat, fruits and vegetables, and possibly dietary fiber. Furthermore, more intensive interventions were more likely to produce important changes than brief interventions. The authors concluded that moderate- or high-intensity counseling interventions, including use of interactive health communication tools, can reduce consumption of saturated fat and increase intake of fruit and vegetables. Pignone MP, Ammerman A, Fernandez L, Orleans CT, Pender N, Woolf S, Lohr KN, Sutton S. Counseling to promote a healthy diet in adults: a summary of the evidence for the U. S. Preventive Services Task Force. Am J Prev Med 2003;24(1):75-92

[4] “The largest effect of dietary counseling in asymptomatic adults has been observed with more intensive interventions (multiple sessions lasting 30 minutes or longer) among patients with hyperlipidemia or hypertension, and among others at increased risk for diet-related chronic disease. Effective interventions include individual or group counseling delivered by nutritionists, dietitians, or specially trained primary care practitioners or health educators in the primary care setting or in other clinical settings by referral.”

[5] “Behavioral Counseling in Primary Care to Promote a Healthy Diet: Recommendations and Rationale,” U.S. Preventive Services Task Force2003, accessed 8 September 2011 http://www.uspreventiveservicestaskforce.org/3rduspstf/diet/dietrr.pdf

[6] “Behavioral Counseling in Primary Care to Promote a Healthy Diet: Recommendations and Rationale.” USPSTF 2003, accessed 8 September 2011 http://www.uspreventiveservicestaskforce.org/3rduspstf/diet/dietrr.pdf

[7]Id.

[8] Lin JS, O’Connor E, Whitlock EP, Beil TL. 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.

[9] “Proposed Coverage Decision Memorandum for Intensive Behavioral Therapy for Cardiovascular Disease,” CMS 10 August 2011, accessed 8 September 2011http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=248&ver=4&NcaName=Intensive+Behavioral+Therapy+for+Cardiovascular+Disease&bc=ACAAAAAAIAAA& (“Frequency of Visit: The JNC7 recommended that blood pressure screening occur “every 2 years with BP <120/80.” The USPSTF has reported for aspirin use that “risk assessment and discussion should probably be held at least every 5 years with middle-aged and older people or when CVD risk factors are detected.” The USPSTF did not make frequency recommendations for blood pressure screening or intensive behavioral dietary counseling for adult patients with hyperlipidemia and other known risk factorsfor cardiovascular and diet-related chronic disease. CMS is proposing coverage of this visit every 2 years.”)

[10] Id.

[11] Committee on Nutrition Services for Medicare Beneficiaries. “The Role of Nutrition in Maintaining Health in the Nation’s Elderly: Evaluating Coverage of Nutrition Services for the Medicare Population.” Washington, DC: Food and Nutrition Board, Institute of Medicine; January 1, 2000 (published).

[12] “Behavioral Counseling in Primary Care to Promote a Healthy Diet: Recommendations and Rationale.” USPSTF 2003, accessed 8 September 2011 http://www.uspreventiveservicestaskforce.org/3rduspstf/diet/dietrr.pdf

[13] See Lin JS, O’Connor E, Whitlock EP, Beil TL. 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.

“Among the healthful diet counseling trials, low-intensity interventions were almost all conducted in general-risk persons, and medium- to high-intensity interventions were mostly conducted among persons selected for poor dietary intake or with elevated risk for CVD.”

[14] “Proposed Coverage Decision Memorandum for Intensive Behavioral Therapy for Cardiovascular Disease,” CMS 10 August 2011, accessed 8 September 2011http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=248&ver=4&NcaName=Intensive+Behavioral+Therapy+for+Cardiovascular+Disease&bc=ACAAAAAAIAAA&

[15] Id. (“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.”)

[16] “Behavioral Counseling in Primary Care to Promote a Healthy Diet,” USPSTF accessed 9 September http://www.uspreventiveservicestaskforce.org/uspstf/uspsabrecs.htm (“The U.S. Preventive Services Task Force (USPSTF) concludes that the evidence is insufficient to recommend for or against routine behavioral counseling to promote a healthy diet in unselected patients in primary care settings.”)

[17] ATP III GuidelinesAt-A-Glance Quick Desk Reference, accessed 8 September 2011 www.nhlbi.nih.gov/guidelines/cholesterol/atglance.pdf

[18] “Primary Prevention of Cardiovascular Disease and Type 2 Diabetes in Patients at Metabolic Risk,” Endocrine Society 2008, accessed 8 September at http://www.endo-society.org/guidelines/upload/Metabolic-Syndrome-Guideline-Standalone.pdf

[19] “Effectiveness-Based Guidelines for the Prevention of Cardiovascular Disease in Women—2011 Update A Guideline From the American Heart Association,” American Heart Association 2011 accessed 8 September 2011 http://circ.ahajournals.org/content/123/11/1243.full.pdf

[20] http://www.uspreventiveservicestaskforce.org/uspstf/uspsabrecs.htm.

[21] McDonald M, Hertz RP, Unger AN, Lustik MB. Prevalence, awareness, and management of hypertension, dyslipidemia, and diabetes among United States adults aged 65 and older. J Gerontol A Biol Sci Med Sci. 2009 Feb;64(2):256-63.

[22] Dorland's Medical Dictionary for Health Consumers. 2007 by Saunders, an imprint of Elsevier; he American Heritage Medical Dictionary. 2007, 2004 by Houghton Mifflin Company.

[23] http://www.uspreventiveservicestaskforce.org/uspstf/uspsabrecs.htm.

[24] Lin JS, O’Connor E, Whitlock EP, Beil TL, Zuber SP, Perdue LA, Plaut D, Lutz K. Behavioral counseling to promote physical activity and a healthful diet to prevent cardiovascular disease inn adults: update of the evidence for the U. S. Preventive Services Task Force. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Dec. Report No. 11-05149-EF-1.

[25] Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation and Treatment of High Cholesterol in Adults (Adult Treatment Panel III)National Cholesterol Education Program, National Heart, Lung, and Blood Institute; National Institutes of Health, NIH Publication No. 02-5215, September 2002; American Heart Association Nutrition Committee, Lichtenstein AH, Appel LJ, Brands M, Carnethon M, Daniels S, Franch HA, Franklin B, Kris-Etherton P, Harris WS, Howard B, Karanja N, Lefevre M, Rudel L, Sacks F, Van Horn L, Winston M, Wylie-Rosett J. Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee. Circulation 2006 Jul 4;114(1):82-96;

[26] Berglund L, Lefevre M, Ginsberg HN, Kris-Etherton PM, Elmer PJ, Stewart PW, Ershow A, Pearson TA, Dennis BH, Roheim PS, Ramakrishnan R, Reed R, Stewart K, Phillips KM; DELTA Investigators. Comparison of monounsaturated fat with carbohydrates as a replacement for saturated fat in subjects with a high metabolic risk profile: studies in the fasting and postprandial states. Am J Clin Nutr. 2007 Dec; 86 (6): 1,611-1,620.

[27] Knopp RH, Fish B, Dowdy A, Retzlaff B, Walden C, Rusanu I, Paramsothy P. A moderate-fat diet for combined hyperlipidemia and metabolic syndrome. Curr Atheroscler Rep. 2006 Nov;8(6):492-500.

[28] Musunuru K. Atherogenic dyslipidemia: cardiovascular risk and dietary intervention. Lipids. 2010 Oct;45(10):907-14.

[29] Details of cited studies are provided in Appendix A. Class description of data is provided in Appendix D.

[30] World Health Report 2002: Reducing risks, promoting healthy life. Geneva, Switzerland: World Health Organization, 2002. http://www.who.int/whr/2002.

[31] Nelson, Mark."Drug treatment of elevated blood pressure". Australian Prescriber(33): 108–112. Retrieved August 11, 2010.

[32] Wolz M, Cutler J, Roccella EJ, Rohde F, Thom T, Burt V. Statement from the National High Blood Pressure Education Program: prevalence of hypertension. Am J Hypertens. 2000 Jan;13(1 Pt 1):103-4.

[33] Chobanian AV et al; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003 Dec;42(6):1206-52

[34] Julius S, Valentini M, Palatini P. Overweight and hypertension: a 2-way street? Hypertension 2000; 35: 807–813.

[35] American Association of Clinical Endocrinologists (AACE) Hypertension Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of hypertension. Endocr Pract2006 Mar-Apr;12(2):193-222.

[36] See Appendix B for systolic blood pressure reduction estimates with lifestyle changes.

[37] Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, Jones DW, Materson BJ, Oparil S, Wright JT, Roccella EJ, and the National High Blood Pressure Education Program Coordinating Committee. Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003;42:1206-1252.

[38] Institute for Clinical Systems Improvement (ICSI). Hypertension diagnosis and treatment. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2010 Nov. 68 p.

[39] Details of cited studies are found in Appendix B.

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September 9, 2011

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 coverage decision memo for Intensive Behavioral Therapy for Cardiovascular Disease (CAG-00424N). 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, procedures, and treatments that can improve health outcomes, as determined by current and robust clinical evidence. Health insurance plans have a long-standing commitment to preventive services and provide coverage for services recommended by the U.S. Preventive Services Task Force (USPSTF). Health plans are currently implementing the three USPSTF recommendations this proposed coverage decision memo addresses: encouraging aspirin use for the primary prevention of cardiovascular disease (CVD) when the benefits outweigh the risks for men age 45-79 years and women 55-79 years; screening for high blood pressure in adults age 18 years and older; and intensive behavioral counseling to promote a healthy diet for adults with hyperlipidemia, hypertension, advancing age and other known risk factors for cardiovascular and diet-related chronic disease.

Our members support face-to-face CVD risk reduction visits every two years for Medicare beneficiaries 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.

Because the USPSTF aims to update its recommendations every five years¹ and one recommendation prompting this proposed decision memo, intensive behavioral dietary counseling for adults at risk for CVD, 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 process² on the USPSTF web site. It is important that CMS coverage policy align with any updated USPSTF recommendations once finalized.

Thank you for the opportunity to comment on this important issue.

Sincerely,

/s/
Carmella Bocchino
Executive Vice President
Clinical Affairs and Strategic Planning

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1 U.S. Preventive Services Task Force Procedure Manual. AHRQ Publication No. 08-05118-EF, July 2008. http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanual2.htm
2 Topics in Progress. U.S. Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/uspstf/topicsprog.htm

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September 8, 2011

The Honorable Donald Berwick, MD
Administrator, Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC

TRANSMITTED BY EMAIL
RE: Proposed Decision Memo for Intensive Behavioral Therapy for Cardiovascular Disease (CAG-0042N)

Dear Dr. Berwick:

Transformation of our nation's health care system from an illness-treatment system to a value-based, quality health and wellness system is a vital and achievable goal. It can be accomplished through integration of strong primary care and preventive care services with acute and community-based care. Skyrocketing rates of weight-related chronic disease, like cardiovascular disease (CVD), only increase the importance of Medicare coverage policy on this topic.

While wisely identifying the importance for CVD risk reduction, one key component of the proposed coverage decision - intensive behavioral counseling for healthy diet - disregards both published clinical research and USPSTF documented details about what is effective. Simply, one primary care visit does not meet the well defined standard for intensive behavioral counseling for healthy diet which is consistently documented as weekly visits over a period of 3 to 12 months.

In a landmark study published in today's The Lancet those patients randomized to community based 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. It is imperative, for the nation's future health that coverage policy begin to adopt such research findings. Unfortunately, the proposed decision memo for CVD risk reduction lays out a coverage policy that would set back progress in addressing life-style modification in weight related chronic disease and obesity.

We recommend that CMS replace 'Intensive Behavioral Counseling for Healthy Diet' when finalizing its coverage policy with 'Evaluation and, as appropriate, referral to evidence-based intensive behavioral counseling on healthy diet.'

This modification would align Medicare coverage policy with the clinical care that research identifies as the first steps essential to effective intensive behavior counseling for life-style modification. Further, evaluation and referral can be conducted in a time limited primary care visit that is conducted every 24 months.

Weight Watchers, based on its 50 year history of delivering effective, community-based care to millions of people and its decades of clinical research, offers more detailed comments and key clinical evidence in the remainder of its comments to ensure that all components of this important CMS National Coverage Decision are based on the vast array of clinical evidence.

Our work, coupled with other extensive clinical and research evidence on intensive behavioral counseling for healthy eating and lifestyle, shows that:

• Intensive Behavioral Counseling for Healthy Eating and Lifestyle should be delivered for one hour per week for a minimum of 12 weeks. This service cannot be delivered as proposed, once every 24 months as part of a primary care visit, rather, it can and should be delivered to the CVD patients who can benefit and are committed to engage in effective programs; it can and should be delivered by evidence based programs that meet the standards clearly established for effective programs.
• Trained lay leaders for group counseling on healthy lifestyles provide consistent and evidence-based results that are either as good as, or better than, standard of care (WEEKLY physician office based counseling for a minimum of 12 weeks).

Replacing the intensive behavioral counseling for healthy diet with 'evaluate diet lifestyle and risk factors, and, when appropriate, recommend evidence based intensive behavioral counseling program for healthy diet/lifestyle' in a National Coverage Decision on Intensive Behavioral Counseling for CVD would align Medicare coverage to deliver better quality care, improve population health, and lower health costs. If such a modification is not made, we recommend CMS simply eliminate intensive behavioral counseling for healthy diet as part of the care to be delivered in the once every 2 year primary care visit.

Below, please find the irrefutable evidence to support these comments.

The prevalence of risk factors for cardiovascular disease, which includes obesity, and the looming crisis it poses for our health care system will require a full-range of effective, scalable, scientifically proven, and consistent (similar outcomes across all sites of service) providers of intensive behavioral counseling for healthy diet that is essential to CVD risk reduction. Many primary care providers do not have the time, expertise, or interest in conducting evidence based intensive behavioral counseling for a healthy diet, which requires weekly counseling visits over a minimum of 12 weeks. Given the size, scope and time needed to address life-style modification for CVD risk reduction, traditional office-based physicians simply cannot meet the need without assistance from evidence based programs that add capacity, value, and consistency. The following are three key studies examining primary care's role in delivery of intensive behavioral counseling for healthy diet.

• The Prescription for Health Project, operated at 17 sites through the U.S. found few primary care practices are organized or have resources to provide intensive counseling for healthy behavior and life-style modification, rather, the projects multiple projects consistently found that clinicians limited time is better spent identifying behaviors leading to chronic disease risk, communicating theimportance of change, and referring, as appropriate, to evidence-based intensive behavioral counseling programs. [S. Woolf, R Glasgow, A Krist, C Bartz, S Flockr, J Holtrip S Rothemich, E Wald. Annals of Family Medicine July/August 2005:3 (Supple 2): S20].
• Evidence, including extensive European studies of patients referred by primary care providers to lay-trained group behavioral counseling programs, demonstrates consistent, high levels of performance across community based intensive behavioral counseling sites of care. In Spain, performance was measured in 2003 and then again in 2008. Average participation was 12 to 14 weeks with an average total weight loss of 3.3Kg in both 2003 and 2008, even with a doubling of participation between 2003 and 2008. [Z Hellman, K Miller-Kovach. Obesity Reviews 2010; 11 (Suppl 1):S249.]
• Among 29,326 participants referred by primary care providers to community based lay-led healthy diet intensive counseling by the National Health Service in the UK, 33% lost 5% or more of their initial body weight after 12 weeks. Among those who attended at least 10 of the 12 sessions, 55% lost at least 5%. [AL Ahern et al. Obesity Reviews 2010; 11(Suppl 1):S242.]

Based on an extensive evidence review, the 2003 USPSTF recommended a B rating for intensive dietary counseling for adult patients with hyperlipidemia and other known risk factors for cardio vascular and diet-related chronic disease. According to the USPSTF Evidence Review, 'studies using higher intensity interventions produced larger effect sizes than studies using lower intensity interventions.' These studies generally involved group or individual sessions that took place, on average, once per week. This evidence review also found that reduction in either frequency or duration of counseling reduced efficacy and did not earn the B rating. Bottom line: anything less than high-intensity behavioral counseling should not be considered. [Pignone, Ammerman, Fernandez, Orleans, Pender, Woolf, Lohr, Sutton, Counseling to Promote a Health Diet in Adults: A Summary of the Evidence for the U.S. Preventive Services Task Force, AHRQ Pub. No. 03-514B, January 2003.]

Since the 2003 USPSTF Evidence Review, new research continues to demonstrate that regular, weekly behavioral counseling over at least 12 weeks leads to sustained, clinically significant CVD risk reduction. The following is a sampling of those studies:

• 2010: In a one- year trial comparing community based, trained lay-leader run group counseling on healthy diet to physician-based standard care behavioral counseling on healthy diet, substantially more of those enrolled in community based, trained lay-leader run group counseling lowered cardiovascular risks compared to physician-based standard care. Those enrolled in Weight Watchers lost 6.87kg (compared to 3.17kg for physician-based care), 7.08cm waist circumference (compared to 4.35 for physician-based care), and 5.58kg fat mass (compared to 2.49 for physician based care). Over 60% of the community based program completers lost over 5% of their body weight compared to 33% of those completing physician-based care standard care. [SA Jebb, Slide Presentation at Sebrell Award and Symposium on Changing the Lens on Reversing the Global Obesity Epidemic, Monday, 12 July, 2010. Medical Research Council.]
• 2010: In a 12 week trial, 132 adults with BMI of 27-35 followed a communnity based lay-lead healthy diet group counseling program. Upon completion, significant decreases were seen in body weight, triglycerides, total cholesterol and LDL cholesterol. There were trends toward reductions in fasting glucose, systolic blood pressure, and HDL cholesterol, demonstrating improvements in cardiovascular risk. [V. Milsom, R. Malcolm, G Cronan, S Pechon, K Miller-Kovach, S Rost, PM O'Neil. Obesity Reviews 2010; 11 (Suppl 1):S244.
• 2007: Weight-loss maintenance after successful completion of a program was assessed in 699 lifetime members of the Weight Watchers program. One, two and five years after successful completion of the program, 79.8%, 71.0% and 50% of participants maintained at least 5% of their weight loss. [MR Lowe, TVE Kral, K Miller Kovach. British Journal of Nutrition 2007; 28:1-6.]
• 2006: Thirty -one overweight subjects in a 12 week study of a community based trained lay-leader run group counseling program on healthy diet had significant reductions in body weight, BMI, waist circumference, and LDL particle size. These changes may lower the risk of cardiovascular disease. [V Nguyen, L Zuckley, J Lowndes M Paul, T Angelopoulos, R Alvarado, D Knapp, N Meade, R Carpenter, J Fiutem, J Rippe. Obesity 2006; 14 (Suppl):A181.]
• 2006: Attendance at Weight Watchers meetings for a 24-week period was tracked among 40 individuals participating in a randomized clinical trial. Significant correlations were found between attendance and decreases in body weight, BMI, and waist circumference. These findings show that regular attendance at behavioral counseling sessions plays a significant role in CVD risk reduction. [L Zuckley, J Lowndes, V Nguyen, T Angelpoulos, J Rippe, Diabetes 2006; 55(Suppl 1):A518.]

Since publication of the 2003 USPSTF Evidence Review and B-rated Recommendation for intensive dietary counseling for adult patients with hyperlipidemia and other known risk factors for cardio vascular and diet-related chronic disease, extensive clinical research has examined the effectiveness of trained, lay educators to deliver lifestyle, behavioral counseling. These studies find uniformly that trained, lay educators providing community-based group counseling are as effective or more effective than primary-care based counseling. The following identifies a few, key studies:

• 2011: Attendance at a weight-loss program using dietary and behavioral intensive counseling by trained-role models found reduction in cardiovascular risk factors.[V Milsom et al. Changes in Cardiovascular Risk Factors with Participation in a 12-Week Weight Loss Trial Using a Commercial Format. (In press).]
• 2010: Increased attendance at weight-loss program meetings facilitated by trained role models was associated with significant improvement in weight, waist circumference, fasting insulin and glucose, and HOMA among overweight and obese adults. [J Melanson and J Lowndes. Am J Lifestyle Med 4: 275-281, 2010.]
• 2010: A study evaluating usual source of care versus referral to community- based, trained, lay educators found statistically significant weight loss with the community-based, intensive behavioral counseling interventions. [DB Wilson, RD Johnson, RM Jones, AH Krist, SH Woolf, SK Flores. Patient Educ Counseling 2010; 79(3):338-343.]
• 2008: The DEPLOY study demonstrated significant reductions in risk factors among subjects with pre-diabetes with intensive group behavioral counseling by trained lifestyle coaches. [RT Ackerman et al. Am J Prev Med 35: 357-363, 2008.]
• 2007: A NIH funded pilot found weight loss results were comparable when behavioral interventions were provided by trained lay-people or health care professionals. [AM Pinto, M Kearns and RR Wing. Effectiveness of a Novel Weight Loss Approach that Combines Brief Standard Treatment and a Commercial Program. Annals of Behav Med 33 (Suppl):S140, 2007]
• 2003: A multi-center, randomized, parallel-group, 2- year trial found community- based, trained lay-education intensive behavioral counseling was correlated with both weight loss and weight-loss maintenance. [S Heshka et al. JAMA 289:1792-1798, 2003.]

With about one-third of the US population obese and another quarter overweight and at risk of obesity, it is essential to use a consistent, effective and efficient model to deliver intensive behavioral counseling on healthy diet and lifestyle. Group counseling delivered by trained lay leaders shows substantial evidence-based success and its lower cost of service offers value essential to address the public health crises our nation faces.

• Using the economic formula from the UK's NICE Guidance on Obesity, the cost-effectiveness of a trained lay, lead group counseling model that is among one of the NHS covered obesity service providers was found to have similar cost-efficacy as counseling or school-based interventions and offers a cost-effective means of providing weight management services. [P Trueman, S Flack. (Abstract). Clinical Excellence, Birmingham, December 2006.]
• A computer modeling methodology was used to predict future health and economic impacts of a 12-week trained lay, lead group counseling intervention in the UK. The findings suggested that the large scale application this methodology can translate into considerable savings to the Government and improvements in health outcomes for individuals. [M Brown and K McPherson. Obesity Facts 2009; 2(Suppl 2):115.]

Figure A below lays out average costs for the US and makes the case quite clearly.

Figure A: Cost for One Hour Group Session per Person

Medicare - Medical Nutrition Therapy [97804]
$28¹
Medicare- Diabetes Self Management [G0109]
$37.38²
Trained Lay Lead Behavioral Counseling [Published Price]
$9.99³

Conclusion:

To align Medicare coverage policy with clinical research and best practices, the Medicare Proposed Coverage Decision on Intensive Behavioral Therapy for Cardiovascular Disease must replace 'intensive behavioral counseling for health diet' with 'Evaluation and, as appropriate, referral to evidence based intensive behavioral counseling on healthy diet.'

If such a modification is not made, we recommend CMS simply eliminate intensive behavioral counseling for healthy diet as part of the care to be delivered in the once every 2 year primary care visit.

The clinical and research evidence supports and the well-defined standard of care shows:

• Intensive Behavioral Counseling for healthy diet for the purpose of weight loss and CVD risk reduction should be delivered for one hour per week for a minimum of 12 weeks.
• Trained lay leaders for group counseling on healthy lifestyles provide consistent and evidence-based results that are either as good as, or better than, standard of care (physician office based counseling delivered on a weekly basis).

The proposed coverage as written does not meet these standards. However, with the modification proposed above, the coverage would align with clinical literature. In addition, coverage of intensive behavioral counseling for healthy diet that meets USPSTF B graded standards would provide Medicare beneficiaries valuable life-style modification to reduce CVD risk. To provide intensive behavioral counseling for healthy diet, CMS would need to cover group sessions of intensive behavioral counseling for healthy diet that meet evidence based standards. This coverage decision should not and was not set up to address the issues and develop clinically sound coverage policy on intensive behavioral counseling for healthy diet.

If you have any questions regarding the evidence cited in this letter or that is part of the publication record, I would be happy to speak with you in person of by phone. Please do not hesitate to contact me at Karen.kovach@weightwatchers.com

Sincerely,

Karen Miller-Kovach, MBA, MS, RD
Chief Science Officer

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1 www.findacode.com
2 www.findacode.com
3 www.weightwatchers.com

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September 8, 2011

Louis B. Jacques, MD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C 1-09-06
7500 Security Boulevard
Baltimore, MD 21244-8013

Re: Proposed Decision Memo for Intensive Behavioral Therapy for Cardiovascular Disease (CAG-00424N)

Dear Dr. Jacques:

Partnership for Prevention (PfP) is pleased to submit comments to the Centers for Medicare and Medicaid Services (CMS) on the proposed decision memo for Intensive Behavioral Therapy for Cardiovascular Disease. Partnership for Prevention is a non-profit, non-partisan member organization of leaders in business, health care, and government who are working to make evidence-based prevention an increased national priority.

Partnership for Prevention was the formal requestor asking CMS to initiate a national coverage determination (NCD) for aspirin counseling for treatment of cardiovascular disease, which is recommended with a grade A by the US Preventive Services Task Force (USPSTF). Specifically, we asked CMS to cover this service once every 5 years (or more frequently if relevant new risk factors are identified or pertinent patient values change) for at risk individuals who do not already have coronary artery disease or cardiovascular disease. We were pleased that CMS initiated a national coverage analysis in February 2011 for Intensive Behavioral Therapy for Cardiovascular Disease that includes assessment and counseling regarding aspirin use to prevent cardiovascular disease. We applaud CMS for their proposed decision to cover one face-to-face CVD risk reduction visit every two years for Medicare beneficiaries, which includes both a behavioral counseling intervention for aspirin use and healthy diet that should be consistent with the Five As approach (which has been adopted by the USPSTF to describe such services) and blood pressure management (measurement, counseling and intervention).

Partnership is supportive of several components of the proposed coverage decision. We strongly agree with the specific decision to include coverage of aspirin counseling in the coverage analysis as outlined in the initial NCD request letter. We think that the usage of the Five As approach for behavioral counseling intervention for aspirin use and healthy diet is appropriate and agree with the strong encouragement for shared decision making in the counseling process. We are pleased that the memo includes the recommended list from the NCD request of the “best practice” components that should be included when aspirin counseling occurs. We also agree with the decision to design the service as a new, bundled type of visit directed at cardiovascular risk reduction as suggested in the NCD request. Including screening for blood pressure and intensive behavioral counseling to promote a healthy diet for those with hyperlipidemia and other CVD risk factors creates a comprehensive CVD prevention visit that addresses three of the four (the fourth being tobacco use) major aspects of heart disease and stroke prevention.

We would like to make two recommendations to improve the covered service:

• Allow for flexibility in the time interval for the face-to-face CVD risk reduction visit.

While we support the coverage of this visit every 2 years, we feel that CMS should create a mechanism by which earlier repeat coverage of the service is permitted within the 2-year interval. As stated in the NCD request letter, the occurrence of certain triggers may necessitate reappraisal and should be covered. Specifically, we continue to recommend reappraisal whenever: 1) relevant new risk factors arise, including cardiovascular risk factors or risk factors for adverse events from aspirin use (e.g. new gastrointestinal bleeding event); and 2) relevant patient values regarding risks and benefits of aspirin therapy change significantly. CMS should provide coverage and reimbursement of the CVD risk reduction visit if these circumstances are sufficiently documented even if the visit occurs before the proposed 2 year time interval has elapsed.

• Provide for sufficient reimbursement for the covered service.

While discussion regarding payment and coding for billing of this new service were not addressed in the proposed decision memo, we anticipate those details will be addressed in the final decision memo. There is evidence that low reimbursement for prevention and wellness services (e.g. Initial Preventive Physical Examination) has been a factor in their low utilization. We recommend that CMS set the provider payment rate at a level that encourages delivery of the service and avoid setting reimbursement at a rate that discourages its use.

We wish to thank CMS for their hard work in developing the proposed decision memo for Intensive Behavioral Therapy for Cardiovascular Disease. If you have any questions or would like to reach us, please feel free to contact me at jspangler@prevent.org or 202-375-7819.

Sincerely,

Jason M. M. Spangler, MD, MPH, FACPM
Chief Medical Officer
Partnership for Prevention

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I am writing on behalf of the American Psychological Association (APA), the professional organization representing more than 150,000 members and associates engaged in the practice, research and teaching of psychology. Psychologists provide Medicare beneficiaries with critical mental and behavioral health services including psychotherapy, testing, and health and behavior assessments and interventions. APA wishes to take this opportunity to offer comments on the national coverage analysis for intensive behavioral therapy for cardiovascular disease.

APA commends the Centers for Medicare and Medicaid Services (CMS) for taking a proactive role in addressing potential cardiovascular and other health problems. We recognize that the reference to “intensive behavioral therapy” in this instance refers to educational activities involving physicians, nurses, and dieticians to address issues related to diet and obesity. We wish to point out, however, that more advanced behavioral health interventions are available to patients struggling with weight and other health issues. Provided largely by psychologists, health and behavior services help patients address physical health problems and often avoid more invasive and costly treatments. Having psychologists integrated into primary care will expand patient access to these valuable services. In addition, primary care providers should be aware of the health and behavior services furnished by psychologists and make appropriate referrals to benefit their patients.

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On behalf of WomenHeart: The National Coalition for Women with Heart Disease, the only national organization dedicated to advancing women’s heart health through advocacy, community education and patient support, we are writing in support of the CMS proposal to cover one face-to-face CVD risk reduction visit every two years for Medicare beneficiaries.

We concur that intensive behavioral therapy for cardiovascular disease (CVD), which consists of intensive behavioral counseling to promote a healthy diet, screening for high blood pressure and high cholesterol, and encouraging aspirin use for the primary prevention of cardiovascular disease when the benefits outweigh the risks for women 55-79 years, is reasonable and necessary for the prevention or early detection of illness or disability.

As the leading voice for the 42 million American women living with or at risk of heart disease, WomenHeart advocates for equal access to quality care and provides information and resources to help women take charge of their heart health. Heart disease is the leading cause of death of American women, killing more than a third of them. The relative risk for cardiovascular disease increases by 20% in women who are overweight and by 64% in women who are obese. Hypertension also increases the risk for cardiovascular disease.

A critical step in the process of taking charge of your heart health is to learn about nutrition and the benefits of physical activity, to be screened for high blood pressure and to adopt a diet that helps maintain weight and cholesterol levels within normal limits. By implementing Medicare coverage every two years for these CVD risk reduction services, women can have the opportunity to be aware of their risk factors and to take appropriate action.
WomenHeart is committed to the fight against heart disease and believes that helping women take responsibility for achieving heart health is an essential focus of our mission. We stand ready through our education and support efforts and with the help of the WomenHeart Governing Board, Scientific Advisory Council, staff and network of WomenHeart Champions to inform women about this coverage, should it be implemented and to encourage women to adopt the recommendations included in the intensive behavioral therapy for cardiovascular disease.

We will continue to promote efforts to help women make the necessary changes and choices to minimize the life shortening effects of heart disease and look forward to working with you.

Lisa M. Tate, CEO
WomenHeart: The National Coalition for Women with Heart Disease
September 8, 2011

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September 8, 2011

Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00424N

Dear Sir or 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 memo for intensive behavioral therapy for cardiovascular disease (CVD).

According to the proposed coverage decision, CMS plans to add intensive behavioral therapy for CVD as a covered benefit under the Medicare program. The benefit would include encouraging aspirin use for the primary prevention of CVD when the benefits outweigh the risks; screening for high blood pressure; and intensive behavioral counseling to promote a healthy diet for adults with hyperlipidemia, hypertension, advancing age, and other known risk factors for cardiovascular and diet-related disease. As AHA expressed in our previous comments to the Agency in March 2011, we appreciate and support the Agency’s proposal to add coverage of intensive behavioral therapy for cardiovascular disease to the Medicare program. All three services play a role in cardiovascular risk reduction, and counseling or behavioral therapy can increase the likelihood that beneficiaries will make and sustain lifestyle modifications.

We are, therefore, very supportive of a cardiovascular risk reduction benefit and we look forward to seeing one added to the Medicare program in the near future. We do, however, have a few concerns with the structure of the benefit as currently proposed. We are concerned that the proposed visit frequency of once every two years is inadequate, and we question the Agency’s decision to limit this benefit to primary care practitioners. In addition, we request that the Agency clarify that this benefit is available to all Medicare beneficiaries, including for the secondary prevention of cardiovascular diseases. We expand on these comments below.

Visit Frequency
As noted above, CMS has proposed covering one face-to-face cardiovascular risk reduction visit every two years. AHA is concerned that one visit every 24 months is insufficient to produce and sustain the desired behaviors, particularly for intensive behavioral counseling for a healthy diet.

The evidence shows that frequent and prolonged contact increases the likelihood that individuals will initially achieve desired behavioral changes. The frequency of the contact also influences adherence with the desired behaviors; and as contact is reduced, adherence declines, and often when there is no contact, recidivism occurs. Thus, interventions that include scheduled followup visits are generally more effective.1 If there is no follow-up, the probability that an individual will change a behavior or implement a recommended treatment plan is reduced. AHA is therefore concerned that the proposed one time visit with no required follow-up for a two-year period will have little to no sustaining effect.

We are also concerned that the proposed visit frequency does not reflect the evidence review that was conducted by the U.S. Preventive Services Task Force (USPSTF) when it developed its recommendation for intensive behavioral counseling to promote a healthy diet. The USPSTF recommendation, which served as the basis for the healthy diet component of the proposed new Medicare benefit, found that “the largest effect of dietary counseling in asymptomatic adults has been observed with more intensive interventions among patients with hyperlipidemia or hypertension and among individuals at increased risk of diet-related chronic disease.”2 The USPSTF defined “intensive interventions” as multiple sessions lasting 30 minutes or longer (emphasis added). But as noted above, the Agency is proposing a single visit. A single visit is not “intensive” behavioral therapy.

In addition, a single visit every two years does not account for the fact that older adults tend to develop risk factors more often than younger people. Consider blood pressure, for example. Blood pressure increases with age, and in women, increases at menopause. Blood pressure must be more closely monitored if the individual has other risk factors such as tobacco use, diabetes, obesity, or hypercholesterolemia, or uses a medication known to affect blood pressure, since risks for complications are increased. Older adults are also particularly vulnerable to the effects of uncontrolled risk factors. Therefore, one visit every two years is unlikely to identify adverse changes in health status – especially cardiovascular risk factors in the Medicare population – early enough.

Finally, we are concerned that one visit may not provide enough time for a health care provider to cover all three of these services (aspirin, blood pressure, healthy diet) adequately. There is a significant amount of information for the provider to assess and review with the beneficiary, especially since the proposed benefit directs providers to follow the Five As approach (assess, advise, agree, assist, and arrange) for both the aspirin and healthy diet counseling. We believe it may not be possible to appropriately address all three components during one visit. We are also concerned that addressing all three components during a single visit may overwhelm the beneficiary and adversely affect patient comprehension.

We therefore urge CMS to reconsider the proposed visit frequency. Intensive behavioral therapy for cardiovascular disease should, as the USPSTF evidence review indicates, include multiple visits that allow for the provision of care conveyed by the term “intensive”, as well as allow for, and reimburse for, follow-up visits. Reimbursing providers for follow-up visits will increase the likelihood that ongoing assessment and support will be provided to patients.

Primary Care Practitioners
According to the proposed decision memo, the cardiovascular risk reduction visit must be conducted by a qualified primary care physician or other primary care practitioner and in a primary care setting. AHA questions the Agency’s decision to limit the provision of this benefit to these practitioners and settings. CMS should not exclude cardiologists and neurologists from providing this benefit, particularly since this benefit is focused on risk reduction for cardiovascular diseases, including stroke.

We understand that the Agency is appropriately focusing on the large patient population followed by primary care providers for primary prevention, but many patients, especially those with complex dyslipidemia, refractory hypertension, or a need for intensive behavioral therapy for secondary prevention, receive the majority of their care from cardiologists and neurologists and these patients should not be excluded from this benefit.

Secondary Prevention
While the USPSTF recommendations focused on the efficacy of these interventions for the primary prevention of cardiovascular diseases, a substantial number of patients in the Medicare age group present for the first time with already established cardiovascular diseases, including TIA and stroke. Intensive behavioral therapy for prevention should, of course, be provided to these patients. Thus, we request that CMS clarify that this benefit applies to all Medicare beneficiaries for both primary and secondary prevention.

Future Expansion of the Benefit
Finally, AHA is aware that the USPSTF is currently reviewing its recommendations on physical activity and healthy diet counseling as part of an evidence review for a new recommendation on behavioral counseling to promote physical activity and a healthy diet to prevent CVD in adults. If the Task Force assigns a grade of “A” or “B” to this recommendation, we encourage the Agency to reopen this coverage determination and add behavioral counseling to promote physical activity to this benefit. Increased physical activity, in conjunction with better food habits and appropriate weight management, can substantially reduce the risk of developing CVD.

Conclusion
In closing, we reiterate our appreciation of CMS’s proposed decision to add coverage of intensive behavioral therapy for cardiovascular disease to the Medicare program. All three services play a role in cardiovascular disease risk reduction and AHA has long recommended that health care providers assess patients who are at higher cardiovascular disease risk for aspirin use; measure, and if necessary treat, blood pressure in all patients; and counsel all patients to eat a healthy diet. We are hopeful that an expansion in Medicare coverage will reinforce the value of these services and increase both provider and patient participation rates.

In order to maximize this benefit, however, we recommended that the Agency increase the benefit frequency to allow for multiple visits, including follow-up visits, between the patient and the provider. As discussed above, the USPSTF found that intensive behavioral therapy with multiple visits had the greatest effect, and extensive evidence shows that frequent and prolonged contact is needed to maximize results.

In addition, we request that CMS add cardiologists and neurologists to the list of eligible providers, and clarify that the benefit is intended for both primary and secondary prevention of cardiovascular disease. And we encourage the Agency to reopen this coverage determination and add counseling to promote physical activity when the USPSTF releases its updated recommendation on physical activity counseling.

If you have any questions, 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,

/s/
Gordon F. Tomaselli, MD, FAHA
President
American Heart Association

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1 Artinian NT, et al. Interventions to Promote Physical Activity and Dietary Lifestyle Changes for Cardiovascular Risk Reduction in Adults: A Scientific Statement from the American Heart Association: 2010.
2 U.S. Preventive Services Task Force. Behavioral Counseling in Primary Care to Promote a Healthy Diet: Recommendations and Rationale. 2003.

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Mayo Clinic supports coverage of intensive behavioral therapy for cardiovascular disease. We would like to see coverage include not only primary care physicians and practitioners, but also coverage for cardiologists and non-physician practitioners working within the cardiovascular disease specialty. Will any non-physician practitioner (nurse practitioner, physician assistant, clinical nurse specialist) be covered or only those working within the primary care realm? Often these practitioners will work within the specialty areas and we would like CMS to comment on coverage of non-physician practitioners when they work within a specialty (non-primary care) area.

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I applaud the decision to implement this new service based on the body of scientific evidence supporting its need.

However, I question the effectiveness and the efficacy of one encounter every two years. There are a number of contributing factors to poor cardiovascular health. They include, but are not limited to, poor nutrition, sedentary lifestyle, stress, social isolation, troubling relationships, poor sleep, chemical hazards, poly-pharmacy, depression, lack of motivation, etc.
An effective intervention requires a holistic approach that identifies all major contributing factors and develops a plan in response to each. Furthermore, the engagement of the patient in undergoing change or behavioral modification often requires patience and a process such as motivational interviewing. Theories such as the Health Belief Model and the Transtheoretical model describe processes in which patients need time to develop motivation and evolve a strong commitment to change behavior.

The proposal to limit such specific and worthy encounters to a single visit every two years, while a step in the right direction, will hardly make a difference. Intensive Cardiac Rehabilitation, which demands many of the same interventional steps, is a 70 visit or so process.

Accordingly, I implore CMS to change the proposal to at least 3 to 5 visits per year as needed so that the physician can fully address all concerns and monitor and observe the patient's progress. Alternatively, CMS could initiate reimbursement for CPT Code 99078 to allow such encounters to take place in a group setting, which has been proven highly effective to facilitating individual change.

Even in this period of required fiscal austerity, recognizing the value of minimizing cardiovascular disease by effective behavioral modification, it would be penny-wise and dollar foolish to limit such an important intervention to a single visit.
As Benjamin Franklin once wrote, "an ounce of prevention is worth a pound of cure."

The money CMS will save on physician visits for treatment of high cholesterol, high blood pressure, and related heart disease, including strokes, the costs associated with reduced or eliminated prescriptions for the same, reduced ER visits, ambulance rides, hospitalizations, positive changes in the wellbeing of affected individuals, etc. alone warrant additional investment in this process.

As the CDC writes on its website, and CMS knows, the evidence for the power of prevention "is indisputable."

The benefits of such interventions are also not limited to cardiovascular disease. Concomitantly, the intervention necessary for reducing cardiovascular disease should have equal efficacy for reducing the ravages of diabetes and metabolic syndrome. The costs of treating these diseases also weigh heavily on government budgets.

In closing, I ask you to consider what Hippocrates once wrote, which is that "prevention is preferable to cure." With the government needing to make serious budgetary cost reductions and Medicare clearly on its bulls-eye, further investment in prevention may be one of the best long term and practical solutions.

I thank you for your consideration and pray that CMS will have the foresight to see the value of implementing a new service with a high probability of success.

To your health,

Steven S. Charlap, MD

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