March 2, 2015
Sylvia Mathews Burwell, Secretary, HHS
Jacob J. Lew, Secretary, Department of the Treasury
Thomas E. Perez, Secretary, Department of Labor
Office of Health Plan Standards and Compliance Assistance
Attn: Summary of Benefits and Coverage
Employee Benefits Security Administration, Room N-5653
U.S. Department of Labor
200 Constitution Ave., NW
Washington, DC 20210
Re: Summary of Benefits and Coverage and Uniform Glossary (CMS-9938-P)
Dear Secretaries Burwell, Lew, and Perez:
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments related to the December 30, 2014 proposed rulemaking "Summary of Benefits and Coverage and Uniform Glossary" by your respective agencies (the "Departments"). Representing more than 90,000 registered dietitian nutritionists (RDNs),1 dietetic technicians, registered (DTRs), and advanced-degree nutritionists, 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 medical nutrition therapy (MNT)2 and other clinically effective evidence-based nutrition counseling services that meet the health needs of all citizens.
The Academy recommends that your respective agencies enhance transparency of covered services to improve consumers' ability to compare plans on the marketplace in part by clarifying the definitions of certain services in Essential Health Benefit categories in the Uniform Glossary and mandating their inclusion in the Summary of Benefits and Coverage (SBC).
1. Consumer Comprehension and Comparability
a. Variation in Terminology and Coverage of MNT Impedes Comparability
The proposed rule intends to "help plans and individuals better understand their health coverage, as well as to gain a better understanding of other coverage options for comparison." The Academy notes that a level playing field to facilitate easy comparison can only be achieved if all stakeholders operate under a clear and consistent understanding of the bases upon which comparisons between plans are made with consistency in plan terms and benefit categories. Unfortunately, the lack of definition, specificity, and consistency of nutrition services coverage among insurers precludes a rational comparison of the high-quality insurance plans available to consumers who lack expertise in analyzing variant coverage.
At present, there is far too much variance between definitions and coverage of nutrition services and MNT in insurance plans to fully achieve the objectives of the proposed rule or to enable consumers to adequately compare plans. Although some plans include specific benefit language referring to "MNT," "nutrition counseling," "diet counseling," "preventive services," "intensive behavioral therapy," or "weight loss services," terminology and actual coverage for these nutrition care services are not as consistently and explicitly detailed as that of other specialist services, such as physician specialists and physical/occupational/speech therapy services. As a result, consumers cannot easily determine if they have coverage for nutrition services and MNT and the extent of that coverage. Without such information, consumers cannot make informed choices about health plan selection when considering their personal needs related to nutrition and prevention or management of chronic disease. When a consumer calls their insurance plan to ask about coverage, they are frequently given misinformation because they have not used the "right term" in their inquiry. This confusion leads to either denied claims (and the associated consumer dissatisfaction that naturally arises) or to consumers not accessing cost-effective, clinically effective nutrition services that were actually available to them.
The Social Security Act defines MNT as "nutritional diagnostic, therapy, and counseling services for the purpose of disease management which are furnished by a registered dietitian or nutrition professional . . . pursuant to a referral by a physician."3 MNT is thus distinctly different than mere nutrition education4 or wellness programs and requires the advanced skill set of specialists such as RDNs rather than differently qualified nutritionists, health coaches or primary care physicians without a nutrition background. MNT is covered differently in health plans than wellness programs or weight loss services. For example, some insurance plans specifically exclude "weight loss services" (which are usually understood to mean programs like Weight Watchers® or Nutrisystem®), but include MNT or bariatric surgery as chronic disease management for obesity. Coverage for MNT varies widely in terms of medical diagnoses covered and number of visits per year, thus necessitating clear articulation for consumers of such coverage for the purposes of comparing plans and accessing benefits. We agree with the Institute of Medicine (IOM) that the appropriate distinction for determining the extent of coverage for MNT versus simple nutrition education and wellness services is whether the nutrition-related service provided is medical rather than non-medical.5 Both nutrition counseling and MNT are well-recognized as medical services, embodied as necessary preventive services by the United States Preventive Services Task Force (USPSTF), covered by Medicare and private health insurance plans, and coded by the Current Procedural Terminology (CPT 97802-97804).
An example of the need to clarify the extent of coverage for USPSTF-recommended services was present in Ohio, where one benchmark plan (Community Insurance Company/Anthem BCBS) would exclude coverage for all obesity treatment services. Such an exclusion both fails to meet the requirement that plans provide EHBs that include all USPSTF recommended services with an A or B rating (such as intensive, multicomponent behavioral interventions for management of obesity and prevention of cardiovascular disease) and will likely result in significantly added costs to the system and worsened overall health. To avoid confusion, and as detailed below, HHS must define and clarify the nature and extent of coverage for preventive services management of obesity and other chronic diseases.
b. Coverage Examples
The Public Health Act section 2715(b)(3)(F) requires "a coverage facts label that includes examples to illustrate common benefits scenarios, including pregnancy and serious or chronic medical conditions and related cost sharing, such scenarios to be based on recognized clinical practice guidelines." As the proposed rule notes, the existing coverage examples, developed in conjunction with the National Association of Insurance Commissioners, were effective in "facilitat[ing] individuals' understanding of the benefits and limitations of a plan or policy and helped them make more informed choices about their options."
The Academy supports the use and content of the current "well-controlled type 2 diabetes" coverage example in the SBC and recommends the Departments continue its use. The diabetes coverage example appropriately notes that the patient visits a variety of specified health care professionals and we encourage the Departments to make the narrative6 consistent by including RDNs as the specified provider for nutrition services, consistent with national clinical guidelines. In addition, consistent with the Social Security Act, we encourage the Departments to utilize the terms "diabetes self-management training" or "diabetes outpatient self-management training" abbreviated as DSMT (rather than "diabetes self management education")7 and "medical nutrition therapy" abbreviated at MNT (rather than "medical nutrition therapy education").8 Thus, we suggest the relevant sentence in the narrative be amended to read: "In addition, he visits his registered dietitian nutritionist regularly to receive diabetes self-management training and medical nutrition therapy."
In addition, given the fact that two-thirds of Americans have overweight or obesity, we encourage the Departments to consider adding another coverage example for an obesity diagnosis. Coverage might include primary care visits, consultation with an endocrinologist, intensive behavioral dietary therapy or MNT with an RDN, pharmacologic agents, bariatric surgery, and other services.
The Academy generally approves of the manner in which the Departments presented relevant medical items and services, dates of service, billing codes, and allowed charges for the coverage examples, but encourages the Departments to revise the spelling of "dietician" to the preferred "dietitian" in the well-controlled type 2 diabetes coverage example.
c. Inclusion of "Other Covered Services" and "Excluded Services"
To the extent that it aids consumers in understanding and comparing various insurance options, the Academy supports permitting plans and issuers to add additional benefits that are either covered or excluded in the "other covered services" and "excluded services" section that are not already required to be disclosed by the instructions. We encourage the Departments to continue to scrutinize these disclosures to ensure they aid in consumer understanding.
d. Length and Appearance of the SBC
The Departments are sure to receive multiple requests for inclusion of items in the SBC in this comment period, and the Academy appreciates the difficulty associated with meeting the statutory requirement that SBC "does not exceed 4 pages in length and does not include print smaller than 12-point font."9 The proposed rule notes that "plans and issuers have informed the Departments that they are concerned about including all of the required information in the SBC while also satisfying the limitation on the length of the document of four double-sided pages."
Thus, in the event that the Departments are able to implement the recommendations herein for including specifically defined nutrition services and MNT terms in the SBC but could not do so while keeping its length to four pages, the Academy encourages the Departments to devise and implement novel ways to provide consumers with this important information. Technology could be utilized by developing easily accessible Internet links to provide additional information that satisfies the intent and purpose of the statute and facilitates comparison, but which could not (for space reasons) be included on a four page SBC.
2. Defining Coverage of EHB Categories and Health Insurance Terms
The proposed rule notes that the Public Health Act section 2715(b)(3)(B)(i) requires "a description of the coverage, including cost sharing for . . . each of the categories of the essential health benefits . . . ." PHS Act section 2715 also requires the Secretary of HHS, "by regulation, [to] provide for the development of standards for the definitions of terms used in health insurance coverage, including the insurance-related terms described in paragraph (2) [of the statute] and the medical terms described in paragraph (3) [of the statute].
a. Defining Terms Used in Health Insurance Coverage
Specifically, just as the Departments defined rehabilitation services and habilitation services to make clear the distinction between the two in the Uniform Glossary, the Academy urges the Departments to define other benefit categories in the Uniform Glossary, detailing the coverage of MNT and other nutrition care services included within each of the mandated EHBs. The Academy urges the Departments to assist consumers in comparing plans by defining the terms "preventive and wellness services," "chronic disease management,” “ambulatory patient services," "medical nutrition therapy," "nutrition counseling," and "weight loss services."
The Academy supports explicitly defining at a minimum any nutrition-related preventive services as those services either mandated by states or encompassed by Section 2713(a) of the ACA, namely any nutrition-related preventive services recommended by the USPSTF with a rating of A or B. The USPSTF presently recommends three nutrition-related behavioral interventions with an A or B rating: (1) intensive, multicomponent behavioral interventions for management of obesity in adults; (2) intensive, multicomponent behavioral interventions for management of obesity in children ages 6 years and older; and (3) intensive behavioral dietary counseling for adult patients who are overweight or obese with additional risk factors for cardiovascular disease.10 The USPSTF's recommendation for MNT/intensive behavioral counseling for obesity management notes that "the most effective interventions were comprehensive and were of high intensity (12 to 26 sessions in a year)," but ambiguity raises questions of the extent to which putatively qualified health plans recognize the requirement to include these services as EHBs.11 In addition, the Academy believes that, at a minimum, the Departments should include management of obesity, cardiovascular disease, and diet-related risk factors for cardiovascular disease in the definition of chronic disease management services.
b. Description of Coverage within EHB Categories
The Academy's fundamental present concern regarding transparency and comparability of insurance plans has been that the vague, non-specific guidance for EHB categories "Preventive and Wellness Services and Chronic Disease Management" and "Ambulatory Patient Services" precludes any effective, reasonable comparison of nutrition services coverage. MNT and other nutrition care services should be clearly articulated either (1) as a separate line item of coverage or (2) readily available electronically through a single click or search function to help consumers make informed choices when comparing and selecting plans during enrollment.
Nutrition care services such as MNT could be properly included in many of the EHB categories. Numerous national clinical practice guidelines for the management of chronic diseases such as those for cardiovascular disease, diabetes and hypertension include a nutrition component and recommend referrals to registered dietitian nutritionists for their recognized expertise in delivering these services.12
A comparative review of various insurance plans confirms a troubling inconsistency and ambiguity in coverage for both MNT and other nutrition services. While most benchmark plans classify these services under "Preventive Services," they may be more appropriately classified as "Ambulatory Patient Services" since they are typically provided in an office or other ambulatory care setting. The Academy seeks specific clarification that MNT services are included in the EHBs for either or both preventive services and chronic disease management or as ambulatory patient services.
Preventive and wellness services cannot be limited to adult physical examinations and well-baby care. We remain concerned over the lack of specificity surrounding coverage for intensive, multi-component behavioral interventions. The Academy urges that preventive and wellness services as an element of the EHBs include all evidence-based interventions shown to work in reducing the risks of developing chronic disease, including referral for behavioral interventions with RDNs or other qualified specialists demonstrated to be clinically effective. Services should be covered if they are evidence-based, an otherwise covered category of service, and recommended by the primary care practitioner treating the patient.
3. Americans Need Cost Effective, Clinically Effective Nutrition Services
A lack of coverage—or ambiguous benefit categories that may permit a lack of coverage—for comprehensive nutrition counseling and behavioral interventions will simply shift care to pharmacological agents and other more invasive and costly modalities. To reduce costs and improve health, it is critical to ensure that insurance plans include specific and comparable chronic disease management, counseling, and self-care services to provide patients of all ages and medical conditions with more knowledge and the tools to improve their health. 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.13
a. RDNs Provide Clinically Effective Nutrition Services
RDNs remain the most cost-effective, qualified healthcare professionals to provide nutrition based lifestyle interventions, including MNT and evidence-based nutrition counseling and weight-loss management services. RDNs have demonstrated competencies and outcomes that different and less qualified providers of non-medical nutrition services have been yet unable to demonstrate. RDNs' evidence-based national practice guidelines and Evidence Analysis Library are leading, respected tools for effecting positive health outcomes. According to the 2000 IOM report, "The Role of Nutrition in Maintaining Health in the Nation's Elderly," both physicians and registered dietitians may provide nutrition services.14 The IOM concluded that "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."15 To ensure consumers will have access to demonstrably effective nutrition services, the Departments should work to ensure a definition of qualified providers of MNT and other nutrition services that is consistent with the Social Security Act and the recommendation of the IOM.
b. RDNs Provide Cost-Effective, Clinically Effective Nutrition Services
Evidence confirms that RDNs provide highly effective MNT and other nutrition services. Some of the latest research regarding the effectiveness of RDN-provided MNT found:
- Overweight or obese adults participating in a medical nutrition therapy benefit sponsored through their insurer were compared with individuals who did not participate. After 2 years, the adults who received the MNT benefit provided by a registered dietitian were twice as likely to achieve a clinically significant reduction in weight, experience greater average reductions in weight, and were more likely to exercise more.16
- RDN-provided MNT for pre-diabetes has been shown to cost-effectively prevent onset of Type 2 diabetes.17
- Primary care physicians identify dietitians as the most qualified providers to care for obese patients. In a national cross-sectional survey of 500 primary care physicians, fewer than half (44%) thought they achieved success by helping their obese patients lose weight. Respondents identified dietitians as more qualified than primary care physicians, behavioral psychologists or nurses to help obese patients lose or maintain weight.18
- Community-based, point-of-testing nutrition counseling provided by registered dietitians (or a registered nurse under the supervision of a registered dietitian) may reduce risk factors for obesity and related chronic diseases among older adults.19
- During a 3-year intervention, individual screening and point-of-testing counseling sessions (20-40 minutes each) were offered every 6 months to 159 subjects ages 65 years and older. Significant improvements in BMI, serum LDL cholesterol, fasting blood glucose and diastolic blood pressure were noted for participants who attended three or more counseling sessions. Participants who attended all six sessions had the most favorable results in each value.20
RDN-provided MNT is not only clinically effective, including it in a health plan is cost effective. As just one example, a 2001 study conducted at Massachusetts General Hospital demonstrated a savings of $4.28 for each dollar spent on MNT.21 According to a recent Blue Cross Blue Shield study, "[h]ealth plans that have added these services to their benefits packages (up to unlimited visits) report the additional cost has been 3 cents per member per month."22 Additionally, according to Wolf, et al, for every dollar an employer invests in the lifestyle modification program for employees with diabetes, the employer would see a return of $2.67 in productivity.23 MNT provided by RDNs generally impacts productivity; the study indicated the RDN-led lifestyle intervention provided to patients with diabetes and obesity reduced the risk of having lost work days by 64.3% and disability days by 87.2%, compared with those receiving usual medical care.24 Nutrition interventions reduce and even eliminate the need for costly long-term medications and reduce hospitalizations. The Departments previously found that nutrition services for obesity alone reduce premiums by 0.05 to 0.1 percent. As such, they meet the criteria of good stewardship of resources.25
The Academy sincerely appreciates the ongoing opportunity to offer comments to various agencies throughout the iterative Summary of Benefits and Coverage and Uniform Glossary definition process throughout the broader health care reform implementation process. We recognize the complexity in defining terms and developing tools that enable consumers to compare coverage and the Academy offers our assistance and evidence analysis regarding implicated services. Please contact either Jeanne Blankenship by telephone at 202-775-8277 ext. 1730 or by email at email@example.com or Pepin Tuma by telephone at 202-775-8277 ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blakenship, MS, RDN
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy recently approved the optional use of the credential “registered dietitian nutritionist (RDN)” by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation’s food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2Medical nutrition therapy (MNT) is an evidence‐based application of the Nutrition Care Process. According to the Academy’s definition, 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. Accessed March 1, 2015. The term MNT is sometimes used interchangeably with, but is sometimes considered different from, nutrition counseling in health insurance plans. Further, the Academy’s definition of MNT is broader than the definition of MNT in the Social Security Act (42 U.S.C. 1395(vv)(1)).
342 U.S.C. 1395(vv)(1).
4The Academy defines nutrition education as "the formal process to instruct or train patient(s)/client(s) in a skill or to impart knowledge to help patient(s)/client(s) voluntarily manage or modify food choices and eating behavior to maintain or improve health." Academy of Nutrition and Dietetics. Definition of Terms List. Accessed March 1, 2015.
5Essential Health Benefits: Balancing Coverage and Cost. Institute of Medicine Report at 4-19 to 4-20. Released October 6, 2011. Accessed March 1, 2015 at www.iom.edu/Reports/2011/Essential-Health-Benefits-Balancing-Coverage-and-Cost.aspx.
6Management of Type 2 Diabetes. Centers for Medicare and Medicaid Services website. Accessed February 22, 2015 at www.cms.gov/CCIIO/Resources/Files/Downloads/diabetes-narrative-2-7-12.pdf.
7 As further evidence of the need for the Departments to adopt consistent terminology for nutrition services in the Uniform Glossary, the Academy notes that the American Diabetes Association Standards of Care for 2015 uses a different term "diabetes self-management education" (DSME) from that noted in the proposed rule or the Social Security Act. Standards of medical care in diabetes-2015: summary of revisions. Diabetes Care. 2015;38 Suppl:S4.
8 42 U.S.C. 1395x(qq)(1); 42 U.S.C. 1395x(vv)(1).
9 Public Health Act. Pub. Law 78-410, section 2715(b)(1).
10 USPSTF Recommendations. Accessed March 1, 2015 at www.uspreventiveservicestaskforce.org/BrowseRec/Index.
11 USPSTF Recommendations. Screening for and Management of Obesity in Adults. Accessed March 1, 2015 at www.uspreventiveservicestaskforce.org/Page/Topic/recommendation-summary/obesity-in-adults-screening-and-management.
12 See, e.g., Clinical Practice Guidelines for Chronic Kidney Diseases: Evaluation, Classification, and Stratification, National Kidney Foundation. Accessed 17 December 2012 at www.kidney.org/professionals/kdoqi/pdf/ckd_evaluation_classification_stratification.pdf. See also, Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2013; Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 ("The goals of the American College of Cardiology (ACC) and the American Heart Association (AHA) are to prevent cardiovascular (CV) diseases, improve the management of people who have these diseases through professional education and research, and develop guidelines, standards and policies that promote optimal patient care and CV health.").
13Grade 1 data. Academy of Nutrition and Dietetics Evidence Analysis Library. Accessed March 1, 2015 at www.andeal.org/topic.cfm?menu=3949&cat=3676. 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.'"
14Committee 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).
16 Bradley DW, Murphy G, Snetselaar LG, Myers EF, Qualls LG. The incremental value of medical nutrition therapy in weight management. Managed Care. January 2013: 40-45.
17 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.
18 Bleich SN, Bennett WL, Gudzune KA, et al. National survey of US primary care physicians' perspectives about causes of obesity and solutions to improve care. BMJ Open 2012;2:e001871.
19 Walker MH, Murimi MW, Kim Y, Hunt A, Erickson D, Strimbu B. Multiple point-of-testing nutrition counseling sessions reduce risk factors for chronic disease among older adults. Journal of Nutrition in Gerontology and Geriatrics, 31:2, 146-157.
21Delahanty LM, Sonnenberg LM, Hayden D, Nathan DM. Clinical and cost outcomes of medical nutrition therapy for hypercholesterolemia: A controlled trail. J Am Diet Assoc, 2001;101:1012-1016.
22 Bradley DW, Murphy G, Snetselaar LG, Myers EF, Qualls LG. The incremental value of medical nutrition therapy in weight management. Manag Care. 2013;22(1):40-5.
23Wolf AM, Conaway MR, Crowther JQ, et al. Translating lifestyle intervention to practice in obese patients with type 2 diabetes: Improving Control with Activity and Nutrition (ICAN) study. Diabetes Care. 2004; 27:1570–6.
25 Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under the Patient Protection and Affordable Care Act, 75 Fed. Reg. 41736 (July 19, 2010).