February 3, 2020
Don Wright, M.D.
Deputy Assistant Secretary for Health
Disease Prevention and Health Promotion
Department of Health and Human Services
Re: HHS-OS-2019-0015, Solicitation for Public Comments on Questions from the National Clinical Care Commission
Dear Dr. Wright,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to provide comments to the National Clinical Care Commission on policies, effectiveness of coordination, promising practices, and limitations and gaps related to prevention and treatment of diabetes and its complications. Representing more than 107,000 registered dietitian nutritionists (RDNs), dietetic technicians, registered (DTRs), and advanced-degree nutritionist researchers, the Academy 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. Every day we work with Americans in all walks of life—from birth through old age—providing professional services such as medical nutrition therapy (MNT)1 for people with diabetes and other diseases and medical conditions under Medicare Part B, some state Medicaid programs, and all major private payers.
A. Recognize Obesity as a Chronic Condition
The Academy urges the Commission to advise HHS to recognize obesity as a chronic condition for the purposes of all care coordination services within CMS as well as within the Healthy People objectives. Over the last 20 years, obesity rates have doubled among adults, resulting in more than 35% of adults living with obesity and an additional 33% being overweight.2 Evidence suggests that without concerted action, roughly half the adult population will have obesity by 2040. These numbers are particularly troubling because one out of every eight deaths in America is caused by an illness directly related to obesity; therefore, millions of Americans are at risk from this preventable and treatable disease and its associated comorbidities.3 Research studies document the harmful health effects of excess body weight, which increases the risk for conditions such as prediabetes and type 2 diabetes, hypertension, heart failure, dyslipidemia, sleep apnea, hip and knee arthritis, multiple cancers, renal and liver disease, musculoskeletal disease, asthma, infertility and depression.
Obesity is an astronomically expensive problem for our nation and families. As of more than 10 years ago, the costs of treating Medicare and Medicaid beneficiaries with obesity totaled $61.8 billion per year, with present-day spend levels undoubtedly much higher.4 In June 2013, the American Medical Association's House of Delegates voted to recognize obesity as a disease. In June 2019, experts convened by the STOP Obesity Alliance released a proposed standard of obesity care for all providers and payers.5
As such, the Commission should advise CMS to recognize obesity as one of the chronic conditions that qualifies beneficiaries for any and all care coordination services. Likewise, the Commission should advise HHS that the Health People objectives should reflect the status of obesity as a treatable chronic disease in line with how it describes and tracks diabetes, heart disease and stroke, cancer, and other chronic diseases and medical conditions.
Effectiveness of Coordination
A. Coordination Between CMS and ACL
Regarding effective collaboration across federal agencies, the Academy encouraged the Commission to recommend better coordination between CMS and the HHS Administration for Community Living, which administered the senior nutrition programs authorized by the Older American Act. By effectively bridging congregate and home-delivered nutrition services programs with both Medicare and Medicare Advantage, the coordination could better facilitate access to MNT for individuals with diabetes or prediabetes. These nutrition program offers a unique opportunity to connect those seniors who are screened through the congregate or home-delivered nutrition programs with healthcare services. To achieve these synergies, state and local administrators of senior nutrition programs will require coordinated technical support and guidance from ACL and CMS.
The Academy encourages the Commission to recommend that CMS 1) cover medical nutrition therapy for prediabetes and 2) remove burdensome limitations on coverage for intensive behavioral therapy (IBT) for obesity that prevent RDNs and other existing, qualified Medicare providers from effectively treating beneficiaries outside of primary care settings. Currently RDN can provide and bill Medicare directly for MNT for diabetes rather than "incident-to" a physician. This streamlined billing processes decreases the cost of coverage for Medicare and the patient and reduces the administrative burden for providers. While not "promising practices" in terms of novelty within clinical care, these are services that would be novel for CMS coverage.
A. Medical Nutrition Therapy is an Evidence-Based Intervention to Prevent Diabetes
Medical nutrition therapy provided by registered dietitian nutritionists (RDNs) is an evidence-based lifestyle intervention to prevent or delay the development of diabetes for people with prediabetes. A growing evidence-base shows that MNT for prediabetes provided by RDNs for prediabetes is a cost-effective strategy for preventing the onset of Type 2 diabetes.6 A randomized controlled clinical trial published in 2014 by Parker, et al., showed that individualized MNT provided by RDNs resulted in statistically significant improvements in HbA1c, which is a key outcome for diabetes prevention.7 A 2015 study found that it is critical to have the option of an individualized approach like MNT in addition to a group approach, since patients will respond based on their individual needs.8 Furthermore, MNT is not only beneficial for the patient, but is also cost-effective and cost-saving according to a 2012 study published in JAND, which found that MNT is more cost effective and more individualized than other intensive lifestyle intervention programs.9
There is also broad consensus among experts and stakeholders that MNT for prediabetes is an evidence-based service that should be a primary option for treating individuals with prediabetes.10 The American Association of Clinical Endocrinologists/American College of Endocrinology issued Clinical Practice Guidelines for Developing a Diabetes Mellitus Comprehensive Care Plan published in Endocrine Practice April 2015, concluding:
Medical nutrition therapy (MNT) is recommended for all people with prediabetes and diabetes. MNT must be individualized, generally via evaluation and teaching by a trained nutritionist or registered dietitian or a physician knowledgeable in nutrition.11
The American Diabetes Association issued its Consensus Report on Nutrition Therapy for Adults with Diabetes or Prediabetes in Diabetes Care in May 2019, recommending:
Refer people with prediabetes and overweight/obesity to an intensive lifestyle intervention program that includes individualized goal-setting components, such as the Diabetes Prevention Program (DPP) and/or to individualized MNT.12
The United States Preventive Services Task Force (USPSTF) issued a final 2015 Grade B recommendation on screening for type 2 diabetes, which concludes, "Clinicians should offer or refer patients with abnormal blood glucose to intensive behavioral counseling interventions to promote a healthful diet and physical activity."13 Medicare currently covers MNT provided by RDNs for beneficiaries with diabetes chronic kidney disease. To prevent or delay the onset of diabetes and its extraordinary attendant costs associated with the disease, the Commission should support coverage of MNT for beneficiaries with prediabetes, rather than simply delaying reasonable and necessary care for patients in need waiting for their status to worsen to diabetes before they receive the care they need.
B. RDNs are Qualified and Effective Providers of Intensive Behavioral Therapy
Medicare Part B covers intensive behavioral therapy for obesity consistent with the limitations and requirements in the decision memorandum issued November 29, 2011.14 The decision memorandum defines the benefit as consisting of three services falling squarely within the scope of practice of registered dietitians as part of nutrition assessments and nutrition interventions:
- Screening for obesity in adults using measurement of BMI calculated by dividing weight in kilograms by the square of height in meters (expressed in kg/m2);
- Dietary (nutritional) assessment; and
- Intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high intensity interventions on diet and exercise.
Moreover, the intensive behavioral counseling benefits for obesity are nutritional diagnostic, therapy, and counseling services for the purpose of disease management that closely corelate with RDN-provided "Medical Nutrition Therapy" preventive services defined in section 1861(vv)(1) of the Social Security Act that RDNs provide and independently bill for as an existing Medicare provider.15 Significantly, according to the National Academies of Sciences, Engineering, and Medicine (formerly 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."16 Allowing RDNs and other qualified providers to directly bill Medicare for IBT for obesity would reduce costs for Medicare and for patients and would reduce administrative burdens for health care providers.
Limitations and Gaps
Coverage for services to prevent, manage, and/or treat diabetes, prediabetes, and obesity currently exists as a patchwork within CMS with persistent gaps and limitations related to the receipt of same-day service, referrals, coverage levels, payment, and sites of service. Antiquated telehealth laws also act as a barrier to obtain these services.
A. Gap: Lack of Medicare Coverage for Effective Nutrition Care Services
As outlined above, MNT is an evidence-based service from which many seniors could benefit.
Medicare covers MNT for people with diabetes but does not cover this service for individuals with prediabetes or many other chronic diseases. As detailed in the MNT Effectiveness Project published in the Academy's Evidence Analysis Library, MNT and other evidence-based nutrition services, from pre-conception through end-of-life, are an essential component of comprehensive health care, whether provided as frontline therapy to prevent disease, delay disease progression, or as an intervention in chronic care management.17
Virtually all prevalent chronic illnesses have a nutrition component, yet there remain gaps in the way our health care system addresses the important role of nutrition in preventing and treating such diseases — particularly in the Medicare program. Under current law, Medicare only covers outpatient medical nutrition therapy services provided by RDNs for beneficiaries with diabetes, chronic renal insufficiency/non-end-stage renal disease (non-dialysis) or post kidney transplant.18 The current Medicare program offers insufficient nutrition care and does not promote or incentivize the use of other members of the health care team with specific expertise in areas such as nutrition counseling (i.e., RDNs).
RDNs' evidence-based national practice guidelines and Evidence Analysis Library19 are leading, respected tools for effecting positive health outcomes. The Academy urges the Commission to support a legislative solution to ensure beneficiaries can have coverage of cost-effective MNT provided by RDNs for all nutrition-related chronic diseases, including prediabetes, obesity, hypertension, cancer, and CVD, consistent with USPSTF recommendations and national clinical guidelines.
B. Gap: Preclusion Against Receiving DSMT and MNT in the Same Day
The Social Security Act provides, in part, that the determination of the provision of Diabetes Self-Management Training (DSMT) and MNT services is deferred to the discretion of the Secretary.20 In a 2002 national coverage determination, CMS indicated that MNT and DSMT cannot be provided on the same date of service.21 Senator Mark Kirk's letter to CMS identifies problems with the burdensome, costly regulation and its negative impact on patient care:
This current regulation burdens quality and access to care and creates undue hardships for persons with diabetes, especially those for disparate populations. Many beneficiaries forego necessary DSMT and MNT care because they cannot schedule services on the same day. A regulatory change would allow beneficiaries to consolidate often difficult and increasingly expensive trips to ambulatory care settings to receive care.
CMS has cited the dual positive impact of both DSMT and MNT Medicare services for qualifying individuals with diabetes, and has acknowledged data indicating that, "provision of both Medicare benefits may be more medically effective for some beneficiaries than receipt of just one of the benefits." MNT and DSMT are distinct from each other but are both necessary for improved beneficiary health outcomes. Further, same day provision allows for more effective multidisciplinary care.22
The MNT and DSMT benefits act synergistically to improve beneficiaries' quality of care, allowing for individualized and general nutrition planning and blood glucose monitoring by qualified non-physician providers such as registered dietitians. The current regulation limiting same day DSMT/MNT services creates burdensome impediments to quality patient-centered care and increases health care costs at both the individual and systems level. If the 2002 coverage determination were reformed to allow for the provision of same day service for DSMT and MNT in this circumstance, a beneficiary would be more likely to receive ample disease management and education. Associated diabetes education and disease management by non-physician providers saves money and decreases healthcare utilization.23 Compared to no prevention, self-management reduces a high-risk person's 30-year chances of a diabetes diagnosis by about 11%, the chances of a serious complication by 8% and the chances of dying of a complication of diabetes by 2.3%.24 With the flexibility of having both services available on the same day, the likelihood of beneficiaries maintaining their appointments will likely increase. Preventive self-management combined with reduced numbersof individuals who fail to present at appointments as scheduled and lost days from work and school will result in significant cost savings to the health care system. We thus encourage the Commission to support the allowance of the same-day provision of these differently valuable, synergistic services.
C. Limitations on DSMT and MNT that Reduce Beneficiary Access
Diagnostic Lab Eligibility Criteria for DSMT and MNT for Diabetes
Currently, CMS guidelines for diagnosing diabetes for the purposes of the DSMT benefit, as well as the MNT benefit, do not include the HbA1c test. HbA1c has been a recognized diagnostic criterion for diabetes by the American Diabetes Association since 2010. CMS is considering accepting the HbA1c test to diagnose prediabetes; the Academy urges CMS to accept it for diagnosing diabetes for the DSMT benefit, as well as the MNT benefit. HbA1c is the most commonly used test for diagnosing diabetes today as compared to fasting plasma glucose (FPG), 2-hour oral glucose tolerance test (OGTT) or a random glucose test. The traditional diagnostic tools of FPG and OGTT are sensitive, however they measure glucose levels only in the short term, require fasting or glucose loading, and give variable results during stress and illness. HbA1c assays reliably estimate average glucose levels over a longer term (2-3 months), do not require fasting or glucose loading, have less variability during stress and illness, and are more specific for identifying individuals at increased risk for diabetes. Therefore, the American Diabetes Association recommends HbA1c > 6.5% as an additional alternative for diagnosing diabetes.25 The Academy urges CMS to add HbA1c as a diagnostic criterion for diabetes to overcome the current barrier of diagnostic criteria for the DSMT benefit not aligning with national clinical practice.
Burdensome Limits on Referrals for MNT and DSMT
Currently, the MNT for diabetes referral must come from a physician and cannot come from other qualified non-physician primary care providers (i.e., clinical nurse specialists, physician assistants, nurse practitioners, and nurse midwives, as appropriate. We encourage the Commission to support a legislative solution to allow CMS to leverage partnerships with qualified non-physician providers treating Medicare beneficiaries by expanding the referral base for MNT services to these provider types. At present, patients who receive care at clinics without physicians are simply ineligible for referrals, even though advanced practice nurses and physician assistants can practice independently in many states.26,27 Accordingly, they should also be recognized for referral purposes. This reform would also benefit beneficiaries receiving care in non-rural areas as we're seeing a rise in non-physician providers to meet the primary care physician shortage.
Currently the DSMT referral must come from the beneficiary's "treating provider" and that provider must be a physician. If beneficiaries with diabetes are admitted to the hospital, emergency room or ambulatory surgical center, they cannot be referred by the provider(s) who treat them in these locations. Beneficiaries discharged from the hospital may not follow-up with their primary care provider and so may not get a referral for DSMT services, resulting in increased hospital readmissions. In addition, a physician specialist treating a beneficiary's comorbidity (e.g., gangrene, vision loss) cannot refer the beneficiary for the DSMT benefit. A common scenario is that a specialist is aware of the DSMT benefit, but the treating provider is not.
The Academy urges the Commission to support legislative solutions to expand eligible referral sources for the MNT benefit to include qualified non-physician providers and to expand eligible referral sources for the DSMT benefit to include providers who treat beneficiaries within the hospital, the emergency room and surgical centers, as well as physician specialists who treat beneficiaries' co-morbid diabetes conditions.
Beneficiary Co-Payment for DSMT and Meeting High Annual Deductible
Many beneficiaries simply cannot afford DSMT services due to the copayment and to the annual Medicare deductible, which is often very high. Seniors typically have limited income, and many do not have supplemental health insurance. The Academy urges the Commission to support a zero co-pay and deductible for DSMT services as an additional means to increase utilization. A recent economic analysis indicated that DSMT is cost-effective, finding that plans that eliminated co-payments and deductibles would have cumulative cost-savings that outweigh cost-sharing in the majority of circumstances.28 Furthermore, when payers eliminate cost-sharing measures, they can expand the number of beneficiaries utilizing DSMT services, which will further enhance cost-savings.29 While the Academy recognizes that CMS is not bound by the same requirements under the ACA as certain commercial payers to provide coverage for preventive services with a Grade A or B rating by the US Preventive Services Task Force at no cost to the individual, we encourage CMS to do so based on the USPSTF recommendation, "Screening for Abnormal Glucose and Type 2 Diabetes Mellitus,"30 which recommends clinicians should refer persons 40-70 years of age with overweight or obesity and an abnormal glucose to intensive behavioral counseling interventions to promote a healthy diet and physical activity.
Inadequate DSMT Coverage Levels
Currently, beneficiaries are limited to only 10 hours of initial DSMT in the first twelve consecutive months and 2 hours of follow-up hours in each subsequent 12-month period. Many beneficiaries require additional hours of DSMT in each episode of care due to: changes in medications, lack of required understanding/learning of diabetes self-care behaviors due to impaired cognition, and/or the onset of diabetes complications requiring tighter control in multiple behaviors.31 The Academy recommends the Commission advise CMS reimburse for extra hours of initial DSMT and extra hours of follow-up DSMT, consistent with the regulations for extra hours of MNT services (i.e., requiring another provider referral documenting medical necessity and number of extra hours ordered)32. In addition, the Academy recommends CMS extend the time frame during which beneficiaries can receive the initial DSMT hours. Beneficiaries with a new diagnosis of diabetes often need time to cope with this new disease. They may attend their first DMST session but may not be at the appropriate Stage of Change33 to be ready to return to complete the initial DSMT services in the first 12 consecutive months. As a result, many beneficiaries will not have adequate access access to such services in subsequent years when they may benefit from them more. Managing the chronic disease of diabetes effectively requires beneficiaries to make challenging lifestyle and behavior changes that are rarely successful without ongoing education and support.
Limited Sites of Services for DSMT
Hospital outpatient patient departments (HOPD) should be allowed to furnish its DSMT program at the same alternate, off-site payable places of services that CMS has approved for physician office DSMT and MNT benefit. Many patients simply cannot get to the hospital due to transportation, work hours and general anxiety associated with the hospital setting. Hospitals who maintain traditional DSMT programs in their outpatient settings should be allowed to provide DSMT in community and other convenient settings. According to statistics for the American Association of Diabetes Educators and the American Diabetes Association, the 2 major accrediting bodies for DSMT programs, well over 1,200 programs are located in an HOPD. Under current CMS regulations for DSMT services, these programs are not able to reach out into the community they serve, creating a significant barrier to access. HOPD should be allowed to furnish its DSMT program at the same alternate, off-site payable places of services that CMS has approved for its MNT benefit. The Academy recommends that the Commission advise CMS to allow hospital accredited DSMT programs to have the same ability to provide DSMT in off-site locations as physician office accredited DSMT programs.
D. Limitations on Intensive Behavioral Therapy for Obesity
Provider and Setting Requirements
Medicare Part B covers intensive behavioral therapy (IBT) for obesity consistent with the limitations and requirements in the decision memoranda issued November 29, 2011.34 The benefit has two coverage limitations that prevent RDNs and other Medicare providers from practicing at the height of their scope of practice: (1) IBT services must be provided by primary care providers and (2) IBT services must be provided in primary care settings. Neither coverage limitation, which were predicated upon an inaccurate understanding of how the USPSTF's applied an Institute of Medicine's definition of "primary care," were recommended by or consistent with the USPSTF recommendations from which the IBT benefits were derived. In fact, the USPSTF has since clarified that its "recommendations address services offered in the primary care setting or services referred by primary care professionals."35
The decision memoranda do not account for this critical fact that the USPSTF explicitly does not make recommendations limited to primary care providers or primary care settings. Instead, USPSTF declares that recommended services must be "primary care-relevant," defined as "[e]ither conducted in a primary care setting or judged to be feasible in primary care . . . or must be primary care–referable, such that it is available for referral in most communities."
Elsewhere, the Social Security Act explicitly contemplates physician referral to an RDN as a preventive service;38 the obesity NCD should have provided coverage for both the work of the physician and the work of the RDN. The Academy agrees with CMS that care coordination is critical, but the desired coordination is accomplished when a primary care provider refers a patient to an RDN for MNT or IBT services. CMS should recognize and adopt the USPSTF's broader understanding that preventive services includes services physically provided outside the primary care setting when driven by a coordinated referral from a primary care physician.39 CMS's limitations on the setting in which the IBT benefits can be provided also directly conflicts with the president's directive in Section 7 of the Executive Order emphasizing the importance of "rewarding care for site neutrality."40
Medicare already covers numerous preventive services—including counseling services—recommended by the USPSTF in which a specialist rather than a primary care provider is paid. The Academy strongly encourages the Commission to advice HHS to revise these coverage decisions that both dismiss the USPSTF's explicit recommendations and misapprehend the USPSTF's underlying concept of "primary care-relevant" services. In a subsequent revision, we urge the Commission to advise CMS to establish coverage consistent with the USPSTF recommendations, thereby enabling beneficiaries to access RDN-provided IBT that is both more cost-effective and demonstrated to produce better outcomes than available under the existing benefit.
"Incident-To" Billing Imposes Costly Burdens and Limits Access
As a result of the coverage limitations for IBT for obesity discussed above, only primary care providers can bill for these services and only if the services are rendered in a primary care setting.41 There remains a very limited, impracticable option for practitioners (such as RDNs, obesity medicine specialists, exercise physiologists, and clinical psychologists—or in fact many others who lack the same relevant training and expertise) to provide IBT services under the supervision of a physician who is able to bill the services as "incident-to." Primary care providers' offices simply do not have the additional functional space for an entirely new practitioner to setup a separate room for individual or group nutrition and behavioral counseling. Moreover, since RDNs and other non-primary care providers already have existing practices—of which Medicare beneficiaries may comprise merely a part—traveling from their own office to that of a primary care provider imposes incredible burdens and unnecessary expense.
The Academy appreciates that some of our members have taken advantage of this limited opportunity to bill as auxiliary providers incident-to physician services, and we agree with CMS that "preventive services should be furnished in a coordinated approach as part of a comprehensive prevention plan within the context of the patient's total health care."42 Coordinated approaches accord with both the 5As approach and the process recommended by the USPSTF in which primary care providers refer beneficiaries for covered medical nutrition therapy services. Referral to RDNs will not only improve outcomes, it would lower costs, because coordinated referrals to RDNs are less expensive than "incident-to" billing. RDNs working independently providing the service would be reimbursed 85% of the cost that Medicare would pay physicians billing if they contracted with RDNs to have the services provided "incident-to."
The use of "incident-to" billing also creates "disparities in reimbursement between physicians and non-physician practitioners," which the Executive Order specifically seeks to eliminate.43 Despite the ability of RDNs to provide more effective care than primary care providers, they are not "reimbursed in accordance with the work performed," but instead solely based upon the clinician's occupation."44
Medicare should endeavor to end antiquated reliance on mandated "incident-to" billing models that increase costs and deny beneficiaries access to the most effective care. Reform should empower primary care providers to coordinate care with effective specialists, such as RDNs, endocrinologists, and bariatricians, in their respective clinical environments. The current system simply does not facilitate patient-centered care by the right providers in the most logical care settings. In addition, the current benefit's limitation to the primary care setting should be considered ripe for revision in light of the President's directive in the Executive Order to "encourage competition and a diversity of sites for patients to access care."45
Mandating services can only be provided "incident-to" is impracticable and fails to reflect how a Patient Centered Medical Neighborhood best operates: fostering an environment of collaboration and coordination without co-location. Given the increased costs associated with incident-to billing for IBT and its impracticability, it is hardly a surprise that utilization rates for the services are under one percent. We are facing a costly, harmful, and explosive chronic disease crisis; it makes no sense to retain arbitrary, burdensome, and financially imprudent limitations restricting the most qualified and effective individuals from helping to solve the problem. To ensure reasonable and timely access to Medicare benefits and fulfill the directives and priorities of the President's Executive Order 13890, the Academy urges the Commission to advise HHS to remove the "incident to" requirement for service provision of the IBT for obesity benefit as well as the IBT for cardiovascular disease.
E. Limitation: Antiquated Telehealth Requirements
Policies regarding telehealth services under the current Medicare program are antiquated and do not adequately address the needs of Medicare patients, providers, and the Medicare program itself. The emergence and rapid growth of telehealth and mobile technologies designed to improve the health of individuals, enhance patient engagement and lower costs should be recognized in this model as it offers new opportunities to increase access to care in urban, suburban and rural areas. Time spent by all qualified health care professionals (both physician and non-physician providers) using such technologies for assessment, treatment, evaluation and monitoring functions needs to be recognized in current and emerging payment models. CMS could expand traditional telehealth service policies beyond the current restrictions to incorporate rural Health Professional Shortage Areas (HPSA) or counties outside of a Metropolitan Statistical Area (MSA).
Telehealth and telenutrition practice are firmly within RDNs' professional scope of practice: "RDNs use electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health, and health administration. RDNs use interactive electronic communication tools for health promotion and wellness, and for the full range of MNT services that include disease prevention, assessment, nutrition focused physical exam, diagnosis, consultation, therapy, and/or nutrition intervention."46 Allowing RDNs to practice at the height of their scope of practice in providing telehealth services in Medicare aligns with the president's directive in the Executive Order to ensure "advances in telehealth services and similar technologies are appropriately reimbursed and widely available."47
Expanding current policies related to telehealth services beyond HPSAs and MSAs will assist Medicare beneficiaries living in urban and suburban areas who have limited mobility and transportation issues. Why not enable beneficiaries to receive health care services amenable to telehealth technology in their homes, taking advantage of the wide range of emerging e-health technology? Home-based access to services becomes even more important with the population's desire to "age in place" as well as the recognition of the cost savings of keeping people at home rather than in expensive institutional settings when possible.
The Academy looks forward to continuing to engage with the National Clinical Care Commission for the duration of their charter. Please contact either Jeanne Blankenship at 312-899-1730 or by email at firstname.lastname@example.org or Hannah Martin at 202-775-8277 ext. 6006 or by email at email@example.com with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Hannah Martin, MPH, RDN
Legislative & Government Affairs
Academy of Nutrition and Dietetics
1Medical nutrition therapy (MNT) is an evidence-based application of the Nutrition Care Process. The provision of MNT (to a patient/client) may include one or more of the following: nutrition assessment/ re-assessment, nutrition diagnosis, nutrition intervention and nutrition monitoring and evaluation that typically results in the prevention, delay or management of diseases and/or conditions. Academy of Nutrition and Dietetics' Definition of Terms list. Available at http://www.eatrightpro.org/resources/practice/quality-management/scope-of-practice. Accessed January 25, 2016. The term MNT is sometimes used interchangeably with, but is sometimes considered different from, nutrition counseling in health insurance plans.
2 Ogden et al. Prevalence of Obesity in the United States, 2009-2010. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. January 2012. http://www.cdc.gov/nchs/data/databriefs/db82.pdf
3 Carmona, Richard. The Obesity Crisis in America. Surgeon General's Testimony before the Subcommittee on Education Reform, Committee on Education and the Workforce, United States House of Representatives. 16 July 2003. www.surgeongeneral.gov/news/testimony/obesity07162003.htm
4Finkelstein et al. "Annual Medical Spending Attributable to Obesity: Payer- and Service-Specific Estimates." Health Affairs, 28, no. 5 (2009). 27 July. http://content.healthaffairs.org/content/28/5/w822.full.pdf+html
5 Dietz, W.H., Gallagher, C. 2019. A Proposed Standard of Obesity Care for All Providers and Payers. Obesity 27(7): 1059-62.
6 Diabetes Prevention Program Research Group. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program outcomes study. Lancet. 2009. Vol 374.
7 Parker et. al., The effect of medical nutrition therapy by a registered dietitian nutritionist in patients with prediabetes participating in a randomized controlled clinical research trial. J Acad Nutr Diet. 2014 Nov;114(11):1739-48.
8 Miller CK, Nagaraja HN, Weinhold KR. Early weight-loss success identifies nonresponders after a lifestyle intervention in a worksite diabetes prevention trial. J Acad Nutr Diet. 2015;1-8.
9 Anderson, et al. Achievable Cost Savings and Cost-Effective Thresholds for Diabetes Prevention Lifestyle Interventions in People Aged 65 and Older: a Single-Payer Perspective. : J Acad Nutr Diet. 2012 Nov;112(11):1747-54.
10 Diabetes Advocacy Alliance. 2016. Letter to Senator Peters, Capito and Kirk. Available at: https://www.diabetesadvocacyalliance.org/pdf/letters/DAA_support_letter_Preventing_Diabetes_in_Medicare_Act.pdf.
11 Handelsman, Y., et. al. American Association of Clinical Endocrinologists and American College of Endocrinology-Clinical Practice Guidelines for Developing a Diabetes Mellitus Comprehensive Care Plan-2015. Endocrine Practice. Vol 21 (Suppl 1) April 2015.
12 Evert, A.B., et al. 2019. Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report. Diabetes Care 42(5): 731-54.
13 Final Update Summary: Abnormal Blood Glucose and Type 2 Diabetes Mellitus: Screening. U.S. Preventive Services Task Force. December 2015.
14 See Decision Memo for Intensive Behavioral Therapy for Obesity (CAG-00423N). Available at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=253.
15 "The term ‘medical nutrition therapy services' means nutritional diagnostic, therapy, and counseling services for the purpose of disease management which are furnished by a registered dietitian or nutrition professional (as defined in paragraph (2)) pursuant to a referral by a physician (as defined in subsection (r)(1))."
16 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).
17 Grade 1 data. Academy Evidence Analysis Library. [Grade Definitions: Strength of the Evidence for a Conclusion/Recommendation Grade I, "Good evidence is defined as: 'The evidence consists of results from studies of strong design for answering the questions addressed. The results are both clinically important and consistent with minor exceptions at most. The results are free of serious doubts about generalizability, bias and flaws in research design. Studies with negative results have sufficiently large sample sizes to have adequate statistical power.'"
18 42 U.S.C. 1395x(s)(2)(V)
19 Grade 1 data, see above.
20 42 U.S.C. 1395x(s)(2)(V)(i). "Medical nutrition therapy services (as defined in subsection (vv)(1)) in the case of a beneficiary with diabetes or a renal disease who - (i) has not received diabetes outpatient self-management training services within a time period determined by the Secretary . . ."
21 Centers for Medicare & Medicaid Services. NCD Decision Memo for Medical Nutrition Therapy Benefit for Diabetes & ESRD (CAG-00097N). February 28, 2002.
22 Senator Mark Kirk letter to Donald Berwick, MD MPP, dated 23 September 2011, attached hereto (Quoting Centers for Medicare & Medicaid Services. NCD Decision Memo for Medical Nutrition Therapy Benefit for Diabetes & ESRD (CAG-00097N). Centers for Medicare & Medicaid Services Website. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=53&fromdb=true.
23 See Robbins JM, Thatcher GE, Webb DA, Valdmanis VG. Nutritionist visits, diabetes classes, and hospitalization rates and charges: the Urban Diabetes Study. Diabetes Care. 2008;31(4):655-60; Boren SA, Fitzner KA, Panhalkar PS2; Specker, J. Costs and Benefits Associated with Diabetes Education: A Review of the Literature. The Diabetes Educator. 2009;31(1):72-96.
24 See Robbins JM, Thatcher GE, Webb DA, Valdmanis VG. Nutritionist visits, diabetes classes, and hospitalization rates and charges: the Urban Diabetes Study. Diabetes Care. 2008;31(4):655-60; Boren SA, Fitzner KA, Panhalkar PS2; Specker, J. Costs and Benefits Associated with Diabetes Education: A Review of the Literature. The Diabetes Educator. 2009;31(1):72-96.
25 Classification and Diagnosis of Diabetes. American Diabetes Association. Diabetes Care Jan 2015, 38 (Supplement 1) S8-S16; DOI: 10.2337/dc15-S005
26> See, e.g., State Practice Environment. American Association of Nurse Practitioners website. Available at https://www.aanp.org/advocacy/state/state-practice-environment. Accessed January 15, 2019.
27 See, e.g., Physician Assistants Overview. Scope of Practice Policy website. Available at http://scopeofpracticepolicy.org/practitioners/physician-assistants/ Accessed January 15, 2019.
<28 Center for Health Law and Policy Innovation, Harvard Law School. Reconsidering Cost-Sharing for Diabetes Self-Management Education: Recommendation for Policy Reform. June 2015. Accessed at: http://www.chlpi.org/wp-content/uploads/2014/01/6.11.15-Reconsidering-Cost-Sharing-for-DSME.pdf.
29 Center for Health Law and Policy Innovation, Harvard Law School. Reconsidering Cost-Sharing for Diabetes Self-Management Education: Recommendation for Policy Reform. June 2015. Accessed at: http://www.chlpi.org/wp-content/uploads/2014/01/6.11.15-Reconsidering-Cost-Sharing-for-DSME.pdf.
30 Siu A, U.S. Preventive Services Task Force. Screening for Abnormal Blood Glucose and Type 2 Diabetes Mellitus: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine. 2015;163(11):861-868.
31 Powers MA. Diabetes Self-Management Education and Support in Type 2 Diabetes: A Joint Position Statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. Journal of the Academy of Nutrition and Dietetics. 2015;115(8):1323–1334.
32 42 CFR §410.132(b)(5)
33 Prochaska J O, Velicer W F. The transtheoretical model of health behavior change. Am J Health Promot.1997;12(1):38–48
34 See Decision Memo for Intensive Behavioral Therapy for Obesity (CAG-00423N). Available at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=253.
35 Overview of U.S. Preventive Services Task Force Structure and Processes. Available at https://www.uspreventiveservicestaskforce.org/Page/Name/section-1-overview-of-us-preventive-services-task-force-structure-and-processes. Accessed January 15, 2019. (Emphasis added.)
36 Final Research Plan for Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Cardiovascular Risk Factors: Behavioral Counseling. Available at https://www.uspreventiveservicestaskforce.org/Page/Document/final-research-plan17/healthy-diet-and-physical-activity-counseling-adults-with-high-risk-of-cvd. Accessed January 15, 2019.
37 Archived Final Recommendation Statement Obesity in Adults: Screening and Management. Available at https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/obesity-in-adults-screening-and-management-2012. Accessed January 15, 2019.
38 Social Security Act, 42 U.S.C. 1395(x)(vv)(1).
39 See, e.g., USPSTF's assertion that it is clearly not limited to primary care disciplines or the primary care setting ("This Task Force represents primary care disciplines [nursing, pediatrics, family practice, internal medicine, and obstetrics/gynecology], preventive medicine, and behavioral medicine.") accessed 3 January 2012 at http://www.uspreventiveservicestaskforce.org/3rduspstf/behavior/behsum1.htm.
40 See Executive Order 13890, Section 7. Available at https://www.federalregister.gov/documents/2019/10/08/2019-22073/protecting-and-improving-medicare-for-our-nations-seniors
41 See https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?&NcaName=Intensive%20Behavioral%20Therapy%20for%20Obesity&bc=ACAAAAAAIAAA&NCAId=253 and https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=248
42 See, 29 November 2011 CMS NCD on Intensive Behavioral Counseling for Obesity.
43 See Executive Order 13890, Section 5(c). Available at https://www.federalregister.gov/documents/2019/10/08/2019-22073/protecting-and-improving-medicare-for-our-nations-seniors
44 See Executive Order 13890, Section 5(c). Available at https://www.federalregister.gov/documents/2019/10/08/2019-22073/protecting-and-improving-medicare-for-our-nations-seniors
45 See Executive Order 13890, Section 7. Available at https://www.federalregister.gov/documents/2019/10/08/2019-22073/protecting-and-improving-medicare-for-our-nations-seniors
46 Academy of Nutrition and Dietetics Quality Management Committee. Academy of Nutrition and Dietetics: Revised 2017 Scope of Practice for the Registered Dietitian Nutritionist. J Acad Nutr Diet. 2018;118(1):141-165.