November 20, 2017
Ms. Seema Verma, MPH
Centers for Medicare and Medicaid Services
Department of Health and Human Services
P.O. Box 8013
Baltimore, MD 21244-8013
Re: Request for Information (RFI)
Centers for Medicare & Medicaid Services: Innovation Center New Direction
Dear Administrator Verma:
The Academy of Nutrition and Dietetics (the "Academy") is pleased to provide comments to support the Centers for Medicare & Medicaid Services' (CMS's) efforts to help the nation achieve the aims of Better Care, Smarter Spending and Healthier People through the important work of the Center for Medicare and Medicaid Innovation (CMMI). Representing more than 100,000 registered dietitian nutritionists (RDNs)1, nutrition and dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of dietetics and nutrition professionals in the United States and is committed to accelerating improvements in global health and well-being through food and nutrition. Every day we work with Americans in all walks of life — care that spans from prenatal through end of life — providing nutrition care and conducting nutrition research. RDNs independently provide professional services such as medical nutrition therapy (MNT)2 under Medicare Part B. The Academy has been a Health Care Payment Learning and Action Network (LAN) Committed Partner since 2016, and Academy members work in, or with, practices participating in CMMI Innovation Models.
The Academy offers the following comments related to the guiding principles for new model design and potential model concepts put forth in the Request for Information (RFI) issued on September 20, 2017. The Academy recommends that CMS look to the updated Health Care Payment Learning & Action Network Framework principles to inform the guiding principles of CMMI. The mission of the LAN is "to accelerate the health care system’s transition to alternative payment models (APMs) by combining the innovation, power, and reach of the private and public sectors."3 The LAN principles emphasize APMs as important vehicles that can create the financial incentives to improve the delivery of care, but also include principles that address the limitations of APMs alone in achieving cost-effective and person-centered care. Furthermore, the LAN framework and other resources are used by numerous stakeholders, including state and federal agencies, to accelerate the adoption of APMs nationwide.
The Academy has the following recommendations related to the guiding principles:
Modify the 3rd proposed guiding principle from "patient-centered care" to "person-centered care." In order to achieve meaningful improvement in population health, reductions in per capita costs and the total cost of care, CMS would benefit from engaging consumers in their health and value-based care before they become "patients" or even Medicare beneficiaries. As CMS and other stakeholders look beyond the traditional medical setting to provide both health care and related social services in cost-effective settings such as the home and community-based settings, "person-centered care" may also more accurately capture the possibilities associated with this trend. The Health Care Payment Learning and Action Network (LAN) Updated Alternative Payment Model Framework "advances a working definition of person-centered care because it treats payment reform as one means to accomplish the larger goal of person-centered care. This working definition rests on three pillars: quality, efficiency, and patient engagement."4
CMS is likely to benefit from the LAN's efforts to advance the concept of person-centered care among other stakeholders. Modification of the language to "person-centered care" would strengthen the Innovation Center's guiding principles to advance a population management approach to care. CMS's focus on the "low hanging fruit" of reducing avoidable hospitalizations and visits to the emergency department has been critical, yet reducing disease burden in the two-thirds of Medicare beneficiaries with two or more chronic conditions5 will require additional strategies that engage beneficiaries as consumers to prevent and/or delay the onset of disease. According to the Centers for Disease Control and Prevention, "lack of exercise or physical activity, poor nutrition, tobacco use, and drinking too much alcohol—cause much of the illness, suffering, and early death related to chronic diseases and conditions."6 CMS may be more successful in engaging beneficiaries and enrollees as consumers in their care and in value-based care with the focus more broadly on person-centered care.
The Academy requests CMMI provide more information for the proposed guiding principle #4, benefit design and price transparency. Would a principle of "data-driven insights inform price transparency, outcomes, and benefit design" more accurately capture the intent of this draft guiding principle? When taken together, data on outcomes and cost could be used to inform beneficiary and provider choices regarding treatment, and also enable CMS to incentivize beneficiaries that select cost-effective providers through benefit design. Each of the terms in this draft principle could be elaborated on substantially; therefore, we request that CMMI provide more information related to this principle.
Adopt or incorporate a principle similar to the LAN APM Principle #6: Value-based incentives should be considerable enough to motivate providers to invest in and adopt new approaches to care delivery without subjecting them to unmanageable financial and clinical risk.7 The Academy recommends that CMS also include a guiding principle or principles that promote organization and practice transformation to improve care through value-based incentives. Including a principle about the adequacy of value-based incentives could also serve the purpose of minimizing risks related to the rationing of care or the quality of care provided to Medicare beneficiaries and Medicaid enrollees. Unintended consequences of inadequate APM design could include reductions in access to care, or the omission of evidence-based and cost-effective care provided by other members of inter-professional teams, such as RDNs. Carefully designed value-based incentives along with reductions in "burdensome requirements and unnecessary regulations" referred to in the RFI, support the ability of physicians and other providers to focus on providing high quality health care.
- The Academy supports the proposed guiding principle of transparent model design and evaluation, and recommends that the principle evolve to encompass an intent to factor the delivery of cost-effective services provided by other members of the inter-professional team, including nutrition care provided by RDNs, into the total cost of care (model design). In order for CMS to adopt and scale a model design that works, it would benefit from understanding the "secret sauce" of successful models in an effort to achieve value-based care. Setting cost targets is a critical step in APM model design. Claims data remain a significant "signal" for the types of care and services provided and are used to inform model design. However, claims data is vastly insufficient to glean a complete understanding of the contribution and/or cost-effectiveness of numerous health care services and providers. Model design and evaluation should strive to incorporate care provided by cost-effective providers emphasized in evidence-based guidelines. MNT provided by RDNs is a widely recognized component of medical guidelines for the prevention and treatment of heart disease, diabetes, renal disease, obesity, and many other chronic diseases and conditions as well as in the reduction of risk factors for these conditions. As primary prevention, strong evidence supports optimal nutritional status as a cost-effective cornerstone in the maintenance of health, well-being, and functionality. As secondary and tertiary prevention, MNT is a cost-effective disease management strategy that reduces chronic disease risk, delays disease progression, enhances the efficacy of medical/surgical treatment, reduces medication use, and improves patient outcomes including quality of life.8 RDNs provide high quality, evidence-based care and deliver substantial cost-savings to the health care system as a whole.
APMs with adequate payment streams ideally enable greater provider flexibility to deliver person-centered care which may include services not paid for in a straight fee-for-service model. For example, consumer access to MNT provided by RDNs has the potential to improve through APMs and the CMS Innovation Models, but nutrition care and the RDN may be "invisible" to analysts trying to understand differences in care and personnel. Because of inflexible and overly burdensome regulations, only a small percentage of Medicare beneficiaries currently benefit from MNT that reduces hospitalizations, emergency room visits, the risk of complications, and reduces the need for physician visits in individuals.9,10 Medicare beneficiaries have a benefit for MNT for diabetes, chronic renal insufficiency/non-end-stage renal disease (non-dialysis) or post kidney transplant under Part B.11 However; beneficiaries do not have a benefit for MNT for any other diagnoses/conditions, including obesity (over-nutrition) and malnutrition (under-nutrition), conditions which may coexist. Overall, the economic burden of disease-associated malnutrition in the U.S. is estimated to be as high as $157 billion in 2014, with $51.3 billion associated with older adults.12
If a practice participating in a current CMS Innovation Model (e.g. The Oncology Care Model or the Comprehensive Primary Care Plus Model) decided that it would like to provide MNT to improve outcomes and reduce avoidable costs for Medicare beneficiaries with other conditions (e.g., cancer, hypertension, gastrointestinal disorders, malnutrition), the practice would need to factor the cost of providing nutrition care into the model and evaluate whether the revenue streams could support such care, as well as establish a system to track the evidence of care and measure outcomes. The Academy recommends that the development of the principle encompass the intent to factor the cost of providing nutrition care and other evidence-based services provided by other members of the inter-professional team into the model design, increasing the likelihood of adequate revenue streams to support the care, thereby improving beneficiary access to cost effective care.
The Academy has the following recommendation for model concepts:
The Academy recommends that the model concepts include a category called "population management models". The Academy has reviewed the potential model concepts and is pleased to identify some model concepts where nutrition and RDNs could fit. With the draft principles' emphasis on engaging beneficiaries as consumers, consumer choice, and the need to give beneficiaries the tools and information they need to make decisions that work best for them, the Academy recommends a population management model category that embraces several of the aims of the proposed guiding principles. This model concept should also allow non-physician Medicare providers and inter-professional care teams to propose models to CMS, or work with CMS to develop models, for either specific populations or conditions across multiple settings. Examples might include inter-professional models for the prevention (all levels – primary, secondary, tertiary)13 and treatment of obesity in the Medicare and Medicaid populations. Other examples of areas of care that might fall into this category could be wound care, which is not necessarily handled by a particular specialty, but includes care for multiple types of wounds, the involvement of several members of inter-professional care teams, and across multiple care settings. Population management models for nutrition could be designed for specific populations and/or conditions and involve multiple specialties and care settings, the use of validated tools, and standardized care protocols throughout a continuum of care.
Assessing nutrition status using validated tools in all settings across the continuum of health care is a vital first step in improving the health of Medicare beneficiaries, and our nation as a whole, as noted in The National Blueprint: Achieving Quality Malnutrition Care for Older Adults.14 Malnutrition (over and under-nutrition) is associated with many adverse outcomes. Beyond nutrition screening, it is imperative that patients identified as at-risk for malnutrition be referred to RDNs for a complete nutrition assessment and, as appropriate, development and implementation of an individualized plan of care aimed at improving nutrition status. Far too often, identification and treatment of malnutrition does not occur until a person gets admitted to a hospital. The importance of malnutrition prevention and identification and intervention of at-risk and malnourished individuals is magnified by malnutrition’s impact on independence, healthy aging, and the severity of medical conditions and disabilities. In short, older adults are a particularly vulnerable population for poor nutrition. They are at higher risk of malnutrition than other age groups and will therefore benefit substantially from improved nutrition care. Chronic diseases such as cancer, stroke, diabetes, gastrointestinal, pulmonary, and heart disease and their treatments can result in changes in nutrient intake that can subsequently lead to malnutrition.15,16 Two separate reports recently published by the AHRQ Hospital Cost Utilization Project (HCUP) clearly detail the burden of malnutrition on patients in the hospital setting and the significant increased costs of care.17,18 With the number of adults aged 65 years and older expected to reach 74 million by 2030, it is critical that CMS develop cost-effective models for routine assessment of nutritional status across all health care settings, with referrals to RDNs as appropriate. CMMI provides an important avenue to test population based interventions for malnutrition, obesity or other high cost conditions.
Ultimately, the Academy would like the future Secretary of Health and Human Services to exercise his/her authority under Section 1834 (n) (42 USC 1395(m))19 of the Social Security Act to modify the current Medicare Part B MNT benefit to include all diet-related conditions, including obesity and malnutrition. Until that occurs, the Academy hopes that the CMS Innovation Center Models will remain as vital avenues to improve Medicare and Medicaid beneficiary access to nutrition care for more diagnoses and to allocate payment for services provided by RDNs that are not eligible for payment under straight fee-for-service.
We invite the CMMI team to reach out to the Academy for assistance regarding the integration of nutrition care in future models, model design, technical assistance, the measurement of outcomes and related matters. RDNs are recognized as the most qualified food and nutrition experts by the National Academies of Sciences, Engineering and Medicine's Health and Medicine Division (formerly the IOM), most physicians, and the United States Preventive Services Task Force (USPSTF), providing nutrition care more effectively at a lower cost than physicians, nurse practitioners, and physician assistants.20
Thank you for your careful consideration of the Academy's comments related to the new direction of the CMS Innovation Center. Please do not hesitate to contact Jeanne Blankenship by phone at 312-899-1730 or by email at email@example.com or Marsha Schofield at 312-899-1762 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Vice President, Policy Initiatives & Advocacy
Academy of Nutrition and Dietetics
Marsha Schofield, MS, RD, LD, FAND
Senior Director, Governance
Academy of Nutrition and Dietetics
1 The Academy has 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.
2 Medical 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/reassessment, 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 updated May 2017. http://www.eatrightpro.org/resources/practice/quality-management/scope-of-practice. Accessed November 2, 2017.
3 Alternative Payment Model Framework Factsheet, http://hcp-lan.org/workproducts/apm-factsheet.pdf
4 Health Care Payment Learning & Action Network Alternative Payment Model APM Framework, http://hcp-lan.org/workproducts/apm-refresh-whitepaper-final.pdf 2017 p1.
5 Chronic Conditions Among Medicare Beneficiaries https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/Downloads/2012Chartbook.pdf. Accessed November 9, 2017.
7 Alternative Payment Model Framework Factsheet, http://hcp-lan.org/workproducts/apm-factsheet.pdf. Accessed November 7, 2017.
8 Grade 1 data. Academy Evidence Analysis Library, http://andevidencelibrary.com/mnt. [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."
9 Johnson R. The Lewin Group. . What does it tell us, and why does it matter? J Am Diet Assoc. 1999; 99: 426-427.
10 Academy of Nutrition and Dietetics. Evidence Analysis Library. http://www.andeal.org/topic.cfm?menu=5284&cat=4085 Published 2009. Accessed November 8, 2017.
11 National Coverage Determination (NCD) for Medical Nutrition Therapy (180.1) https://www.cms.gov/medicare-coveragedatabase/details/ncddetails.aspx?NCDId=252&ncdver=1&NCAId=53&NcaName=Medical+Nutrition+Therapy+Benefit+for+Diabetes+%2526+ESRD&IsPopup=y&bc=AAAAAAAAIAAA&. Accessed November 8, 2017.
12 Snider J, et al. Economic burden of community-based disease-associated malnutrition in the United States. JPEN J Parenteral Enteral Nutr. 2014;38:55-165.
13 Yong PL, Saunders RS, Olsen LA, The Healthcare Imperative: Lowering Costs and Improving Outcomes: Workshop Series Summary, Institute of Medicine (US) Roundtable on Evidence-Based Medicine 2010 http://www.ncbi.nlm.nih.gov/books/NBK53914/ Accessed November 20, 2017.
14 Defeat Malnutrition Today. Avalere Health and Malnutrition Quality Collaborative. The National Blueprint: Achieving Quality Malnutrition Care for Older Adults. Defeat Malnutrition Today. Published March 2017.
15 Agarwal E, Ferguson M, Banks M, et al. Malnutrition and poor food intake are associated with prolonged hospital stay, frequent readmissions, and greater in-hospital mortality: results from the Nutrition Care Day Survey 2010. Clin Nutr. 2013:32(5):737-745.
16 Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clinical Nutrition 2008;27(1):5-15.
17 Weiss AJ, Fingar KR, Barrett ML, et al. Characteristics of Hospital Stays Involving Malnutrition, 2013: Statistical Brief #210. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville (MD) 2016.
18 Fingar KR, et al. Statistical Brief #281: All-Cause Readmissions Following Hospital Stays for Patients With Malnutrition, 2013. Agency for Healthcare Research and Quality, Healthcare Cost and Utilization Project. September 2016.
19 (n) Authority to Modify or Eliminate Coverage of Certain Preventive Services for Eligible Adults in Medicare.—Notwithstanding any other provision of this title, effective beginning on January 1, 2010, if the Secretary determines appropriate, the Secretary may—
(A) the coverage of any preventive service described in subparagraph (A) of section 1861(ddd)(3) to the extent that such modification is consistent with the recommendations of the United States Preventive Services Task Force; and the services included in the initial preventive physical examination described in subparagraph (B) of such section; and
(B) the services included in the initial preventive physical examination described in subparagraph (B) of such section; and
(2) provide that no payment shall be made under this title for a preventive service described in subparagraph (A) of such section that has not received a grade of A, B, C, or I by such Task Force.
20 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).