December 13, 2019
Ms. Seema Verma, MPH
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Re: Oncology Care First Model: Informal Request for Information
Dear Administrator Verma:
The Academy of Nutrition and Dietetics (the "Academy") is pleased to provide input on the proposed Oncology Care First (OCF) Model. Representing over 107,000 registered dietitian nutritionists (RDNs),1 including RDNs possessing Board Certification as Specialists in Oncology Nutrition,2 nutrition and dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of nutrition and dietetics practitioners committed to accelerating improvements in global health and well-being through food and nutrition. RDNs independently provide professional services such as medical nutrition therapy (MNT)3 under Medicare Part B and are recognized as Eligible Clinicians (ECs) and Qualified APM Participants (QPs) in Medicare's Quality Payment Program. RDNs provide high quality, evidence-based care to patients and deliver substantial cost-savings to the health care system.
The Academy appreciates the opportunity to offer input on aspects of the first two multi-faceted questions in the RFI:
Question 1: "How could the potential model support participants' care transformation through practice redesign activities? Specifically, how could the potential model build on lessons learned from the implementation of the practice redesign activities included in the Oncology Care Model (OCM)? What revisions or additions should be made to the OCM practice redesign activities in the potential model?"
Question 2: "We welcome feedback on the potential payment methodology, including the structure and design of the monthly population payment and the performance-based payment. We are considering the inclusion of additional services in the monthly population payment, such as imaging or lab services, and seek feedback on adding these or other services to the monthly population payment."
The Academy recommends the routine provision of MNT as part of the OCF, urge CMS to include MNT as an additional service factored into the population-based payments, and offers suggestions for the payment design.
Recommended additions to the OCM practice redesign activities (Question #1):
There is strong (grade I) evidence for evaluation of nutritional status as a key component of the oncology patient care process.4 The American Society of Clinical Oncology Guidelines for Geriatric Oncology includes a strong recommendation for an evaluation of nutritional status in persons 65 and older receiving chemotherapy.5 OCF practice redesign activities could bolster care transformation through the routine provision and integration of MNT provided by RDNs throughout the continuum of care. This recommendation aligns with standards and guidelines as well as specific aspects of the Institute of Medicine care plan. The OCF practice redesign could require nutrition services while still allowing for flexibility in integration and delivery.
MNT is an evidence-based, low-cost intervention shown to improve patient outcomes. The provision of MNT may include one or more of the following: nutrition assessment, reassessment nutrition diagnosis, nutrition intervention, monitoring, and evaluation that typically results in prevention, delay or management of diseases and/or conditions, and education and counseling.6
A plethora of evidence supports "that MNT in cancer patients improves treatment tolerance, reduces treatment breaks, decreases weight and lean body mass loss, increases quality of life, decreases unplanned hospitalizations by more than 50%, reduces length of hospital stay, and improves survival."7
MNT is connected to specific elements of the IOM care plan, including #4, Treatment Goals (curative, life-prolonging, symptom control, palliative care), specifically through symptom management. Anorexia, weight loss, dysphagia, xerostomia, mucositis, taste changes, early satiety, nausea, vomiting, diarrhea, and constipation are chemotherapy- induced effects on nutritional status in older adults with cancer.8 Preliminary results from an Academy of Nutrition and Dietetics Health Informatics Infrastructure (ANDHII) registry and medical chart review study underway at six outpatient cancer treatment centers9 identify nausea, diarrhea, constipation, and early satiety as the most common nutrition impact symptoms in patients aged 65 and older. In addition to the patient burden of nutrition impact symptoms, a meta-analysis previously articulated the direct (hospitalization, emergency department, tests, procedures, and supportive care) and indirect economic costs of nausea, vomiting, diarrhea, and oral mucositis associated with cancer treatment.10
MNT has a role in care plan component #6, Expected Response to Treatment.
Evaluation of nutritional status in the care design can inform the expected response to treatment. It would enable identification of sub-populations at risk who might not otherwise be identified, such as those with the co-existence of obesity and malnutrition.1 Evaluation of nutritional status in the care design facilitates the possibility of timely interventions to reduce the risk of complications. Results of an evidence analysis published in 2017 referenced more than forty studies that "provide strong evidence that poor nutritional status in adult cancer patients is associated with higher rates of hospital admissions or readmissions, increased length of stay, lower quality of life, and mortality, and with decreased tolerance to chemotherapy and radiation therapy."12 The role of MNT in the expected response to treatment is demonstrated across cancers and across treatment modalities.13
In turn, cancer and cancer care increase the risk of malnutrition, which is a "multifactorial syndrome in older adults."14 Malnutrition is common in older cancer patients being treated with chemotherapy and is a risk factor for chemotherapy toxicity.15,16 Older patients with cancer are one of the patient populations most underdiagnosed with malnutrition.17 "Malnutrition carries a high toll in terms of costs for hospital care. A 2018 analysis of US hospital discharges found that the average cost for all hospital stays (excluding neonatal and maternal) was $12,900, and patients diagnosed with malnutrition had costs averaging up to $22,200."18,19
"Early identification and diagnosis of malnutrition leading to intervention can positively impact body composition, functional status, quality of life, treatment tolerance, and other clinical outcomes."20 Health care teams cannot treat what has not been identified. "Adult oncology patients should be screened for malnutrition using a malnutrition screening tool validated in the setting in which the tool is intended for use."21 Patients identified as at-risk for malnutrition should be referred to an RDN for a comprehensive nutrition assessment, including a nutrition focused physical exam, to identify physical signs of nutrient deficiencies and the presence of malnutrition and to identify interventions to maximize adequate intake.22
The vast majority of cancer patients do not have access to oncology nutrition services in the outpatient setting, where 90% of treatment occurs.23 MNT is not consistently included in multidisciplinary outpatient cancer care24 and 30-66% of patients report that their nutrition information needs were unmet.25 Most cancer patients never receive nutritional counseling during their treatment.26
There is reported variation in access to nutrition care among OCM practices. The Academy identified a select number of RDNs working in or with OCM-participating practices who reported screening and intervention protocols and characterized the degree of nutrition integration at OCM practices. In one practice, the RDN meets with all patients as part of the initial visit. In another practice, only the OCM patients are screened for malnutrition, once, using a validated tool; the screening results inform RDN interventions related to nutrition impact symptoms. In another setting, referrals are made to RDNs at the discretion of individual providers. If CMS would like to learn more about these cases, contact information is available upon request.
OCF model design is a powerful catalyst to "fix" gaps in nutrition care.
A 2016 National Academy of Sciences, Engineering and Medicine (NASEM) workshop, Examining Access to Nutrition Care in Outpatient Cancer Centers, examined challenges to accessing nutrition care in ambulatory oncology settings. Lack of integration of nutrition services into the cancer health care system and inadequate RDN staffing in cancer centers were identified as major limitations to adequately accessing and implementing oncology nutrition care.27 A recent survey of 215 cancer centers reports the RDN-to-patient ratio is a dismal 1 RDN:2,308 patients in outpatient oncology settings; this survey also identifies a lack of payment for MNT in the outpatient setting as a significant barrier to nutritional care.28 The OCM model design provides a unique opportunity to integrate MNT, evidence-based nutritional care that is critical to many patients, while also helping CMS reduce the total cost of care.
Other entities identify nutrition as an essential component of cancer care.
The American College of Surgeons' Commission on Cancer (CoC), the Association of Community Cancer Centers, The National Comprehensive Cancer Network's 2019 Guidelines for Older Adult Oncology, the American and European Societies of Parenteral and Enteral Nutrition, the National Institute for Health and Care Excellence of Great Britain, and the Victorian Department of Health in Australia all "…advocate for formalized nutrition screening and assessment, nutrition care plans, and early medical nutrition therapy (MNT) when deficits are detected among patients with cancer."29,30,31,32,33,34,35,36,37 The CoC's 2020 Standards for Oncology Nutrition Services also specify that oncology nutrition services be provided by an RDN. The standards identify the RDN as "uniquely trained to address treatment-related symptom management, nutrition support, and quality of life concerns through MNT and education. In addition, RDNs are qualified to discuss diet, nutrition, lifestyle recommendations for survivorship, health promotion and disease prevention."38
Inclusion of additional services in the monthly population payment (Question #2):
The care design should factor into the monthly population-based payments, the cost of providing Medical Nutrition Therapy (MNT) services throughout the episode. This revenue stream for MNT would enable practices to do what they are unable to do under Traditional Medicare (fee for service): use MNT for cancer care to improve outcomes and to reduce short-term and down-stream costs.
Rationale for allocating a portion of monthly payments to facilitate the delivery of care. The rationale for specifying MNT in the additional services that should be factored into the monthly payments is multi-faceted. MNT exemplifies value-based care. It should be accessible to Medicare beneficiaries, and others, whenever it is indicated throughout the course of care. Responses to the first question of the RFI identified the importance of nutrition in cancer care, referenced standards and guidelines that advocate for the routine provision of MNT, highlighted the dismal access to care in outpatient cancer centers, documented the patient and economic burden associated with nutrition impact symptoms and malnutrition, and the benefits and outcomes of MNT in cancer care.
Medicare (Part B) benefits for MNT do not include coverage for any oncology diagnoses, nor related complications that include nutrition impact symptoms or malnutrition.39 A CMS Innovation Model that allows the allocation of payment for MNT as a component of integrated cancer care would overcome an immense barrier that would otherwise require congressional action to address. Congressional action would likely rectify one facet of patient access, but it would not address the overall integration aspect.
CMS could allocate a portion of the proposed per-beneficiary, per-month payments for the provision of nutrition care and incentivize practices through shared savings.
The Academy recommends that CMS use the Medicare benefit (Part B) for diabetes and chronic kidney disease (3 hours of MNT)40 as the foundation for the nutrition interventions for the 6-month OCF episode. A minimum of 3 hours of MNT should be allocated for each beneficiary per episode and factored into the payments. CMS can use the Medicare Physician Fee Schedule to inform and estimate the cost of providing MNT per beneficiary for the 6-month episode. The total amount could be divided into six per- beneficiary per-month capitated payments. The payment rates for CPT® 97802 (4 units) for the assessment and CPT® 97803 (x 8 units) for reassessment and follow up could inform the minimum starting point for estimating the cost of care.
The payments should account for screening, reassessment, and intervention throughout the episode, completion of the Nutrition Focused Physical Exam when indicated, and the delivery of nutrition care that is medically necessary. CMS already acknowledges that more MNT may be medically necessary for diabetes and chronic kidney disease and the need for the same flexibility applies here. The payments must be adequate to enable more intensive or specialized intervention for higher risk populations. Some examples of high-risk populations include but are not limited to those with enteral or parenteral feedings, head and neck, gastrointestinal, pancreatic and lung cancer, as well as patients diagnosed with cancer cachexia and malnutrition. A recent publication cites three studies that reported "RDN led interventions resulting in improved quality of life and nutrition outcomes include 8 to 9 counseling sessions over a 4.5-month period."41 Conversely, other patient populations will require less intensive intervention. The Academy is available to engage in further discussion or provide guidance to operationalize payments.
The Academy recommends that CMS incentivize practices to effectively leverage MNT to prevent avoidable care through shared savings for preventing/reducing emergency department visits for nutrition impact symptoms including anorexia, weight loss, dysphagia, xerostomia, mucositis, taste changes, early satiety, nausea, vomiting, diarrhea, and constipation. CMS can examine historical claims for practices (both fee-for-service and OCM, if applicable) to identify benchmarks for improvement and to inform the amount of shared savings.
Additionally, the Academy recommends that CMS require OCF practices to report MNT utilization in the model to help all stakeholders. This can be accomplished through the submission of statistical claims using the MNT CPT® codes and report units that accurately reflect the time spent with patients and caregivers. Statistical claims would enable analysis using other CMS data. It would enable CMS to examine utilization patterns and gain an understanding of the spectrum of MNT needs from a lower-risk patient to a higher-risk patient. This information could also be used to adjust the payment amounts or methodology.
CMS could use the OCF model to examine the impact of MNT on care, outcomes, and costs. There are opportunities to evaluate avoidable utilization and costs associated with management of nutrition impact symptoms and the treatment of malnutrition in the outpatient setting. CMS could examine whether a diagnosis of malnutrition as a result of the routine provision of care in the model prevents hospitalization, and whether identification and treatment in the outpatient model is less costly compared with a similar fee-for-service population(s) diagnosed with malnutrition in the hospital setting. Because of the range of cancers in the model and overlapping treatment modalities, practices should report the MNT interventions/OCF beneficiary.
Inclusion of nutrition in the additional services as part of the model could have an enormous impact on care. Inclusion of nutritional care would be a game-changer for multiple stakeholders, most especially for patients.
Thank you for your careful consideration of the Academy’s input on the proposed OCF model that would begin in 2021. The Academy welcomes any opportunities to discuss the recommendations or provide additional information that would help CMS determine the feasibility of the Academy's proposition. Please do not hesitate to contact Jeanne Blankenship by phone at 312-899-1730 or by email at email@example.com or Michelle Kuppich at 312-899-4735 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
Michelle Kuppich, RDN
Senior Manager, Nutrition Services Integration
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 Commission on Dietetic Registration https://www.cdrnet.org/certifications/board-certification-as-a-specialist-in-oncology-nutrition Accessed December 5, 2019.
3 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 September 2019. Accessed November 22, 2019.
4 Thompson, KL, Elliott, L, Fuchs-Tarlovsky, V, Levin, RM, Coble Voss, A, and Piemonte, T. Oncology evidence-based nutrition practice guidelines for adults. J Acad Nutr Diet. 2017; 117(2): 297-310.
5 Muhile, SG. et al. Practical assessment and management of vulnerabilities in older patients receiving chemotherapy: ASCO guideline for geriatric oncology. J of Clin Oncol. 2018;36(22): 2326-2347.
6 Academy of Nutrition and Dietetics' Definition of Terms list updated September 10, 2019. Accessed November 15, 2019.
7 Trujillo EB, Claghorn K, Dixon SW, Hill EB, Braun A, Lipinski E, Platek ME, Vergo MT, and Spees CK. Inadequate nutrition coverage in outpatient cancer centers: results of a national survey. J Oncol. 2019, Article ID 7462940 https://doi.org/10.1155/2019/7462940 Accessed December 6, 2019.
8 Zhang, X and Edwards, BJ. Malnutrition in older adults with cancer. Nature. 2019; 21(80):1-12.
9 Guest, DD, Cox T, Coble Voss, A, Nguyen A, McMillen K, Williams, V, Lee J, Beck P, Lenning K, Titus-Howard T, Petersen, J, Yakes-Jimenez E. Rationale and study protocol for the outpatient oncology outcomes feasibility study. J Acad Nutr Diet. 2019; 119(7):1205-1208.
10 Carlotto A, Hogsett VL, Mairini EM, Razulis JG, and Sonis ST. The economic burden of toxicities associated with cancer treatment: review of the literature and analysis of nausea and vomiting, diarrhoea, oral mucositis and fatigue. PharmacoEconomics. 2013; 31: 753-766.
11 Xiaotoa Z, Sun M, McKoy JM, Bhulani NNA, Valero V, Barcenas CH., Ropat UR., Karuturi Sri M., Shah JB., Dinney CP, Hedberg AM, Champlin R, Tripathy D, Holmes HM, Stroehlein JR, Edwards BJ. Malnutrition in older patients with cancer: appraisal of the Mini Nutritional Assessment, weight loss, and body mass index. Letter to the editor. J of Geriatr Oncol. 2018; 9:81-83
12 Thompson, KL, Elliott, L., Fuchs-Tarlovsky, V., Levin, RM, Coble Voss, A, and Piemonte, T. Oncology evidence-based nutrition practice guidelines for adults." J Acad Nutr Diet. 2017; 117(2): 297-310.
13 Lee JL, Leong LP, Lim SL. Nutrition intervention approaches to reduce malnutrition in oncology patients: a systematic review. Support Care Cancer 2016; 24:469-80.
14 Zhang, X and Edwards, BJ. Malnutrition in Older Adults with Cancer. Nature: 2019; 21(80): 1-12.
15 Extermann M, Boler I, Reich RR, Lyman GH, Brown RH, DeFelice J, et al. Predicting the risk of chemotherapy toxicity in older patients: the Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score." Cancer. 2012;118(13):3377–86. https://doi.org/10.1002/cncr.26646
16 Ferrat E, Paillaud E, Laurent M, Le Thuaut A, Caillet P, Tournigand C, et al. Predictors of 1-year mortality in a prospective cohort of elderly patients with cancer. J Gerontol A Biol Sci Med Sci. 2015;70(9):1148–55. https://doi.org/10.1093/gerona/glv025
17 Xiaotoa Z, Sun M, McKoy JM, Bhulani NNA, Valero V, Barcenas CH, Ropat UR, Karuturi Sri M, Shah JB, Dinney CP, Hedberg AM, Champlin R, Tripathy D, Holmes HM, Stroehlein JR, Edwards BJ. Malnutrition in older patients with cancer: appraisal of the Mini Nutritional Assessment, weight loss, and body mass index. Letter to the editor. Journal Geriatr Oncol. 2018; 9: 81-83.
18 McCauley, S, Barrocas A, and Malone, A. Hospital nutrition care betters patient clinical outcomes and reduces costs: the Malnutrition Quality Improvement Initiative story." J Acad Nutr Diet. 2019; 119(9): S11-S14.
19 Barrett, ML, Bailey, MK, and Owens, PL. Non-maternal and neo-natal inpatient stays in the United States involving malnutrition 2016 Healthcare Cost and Utilization Project. Accessed November 23, 2019.
20 Thompson, KL, Elliott, L, Fuchs-Tarlovsky, V., Levin, RM, Coble Voss, A, and Piemonte, T. Oncology evidence-based nutrition practice guidelines for adults." J Acad Nutr Diet. 2017; 117(2): 197-310.
21 Thompson KL, Elliott L, Fuchs-Tarlovsky V, Levin RM, Voss AC, Piemonte T. Oncology evidence-based nutrition practice guideline for adults. J Acad Nutr Diet. 2017;117(2): p 297-310.
22 Philips W, Janowski W, Brennan H, and Leger-LeBlanc G. Nutrition Focused Physical Exam improves accuracy of malnutrition diagnosis. J Acad Nutr Diet. 2019; 119(9); S68.
23 Trujillo EB, Dixon SW, Claghorn K, Levin RM, Mills JB, Spees CK. Closing the gap in nutrition care at outpatient cancer centers: ongoing initiatives of the oncology nutrition dietetic practice group. J Acad Nutr Diet. 2018;118:(4):749-760.
24 Platek ME, Johnson J, Woolf K, Makarem N, and Ompad DC. Availability of outpatient clinical nutrition services for patients with cancer undergoing treatment at comprehensive cancer centers. J Oncol Pract. 2015;11(1):1-5.
25 Van Veen MR, Beijer S, Adriaans AMA, Vogel-Boezeman J, and Kampman E. Development of a website providing evidence-based information about nutrition and cancer: fighting fiction and supporting facts online. JMIR Res Protoc. 2015. 4:33; e110.
26 Arends J, Bachmann P, Baracos V, et al. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017; 36(1):11-48.
27 Examining Factors in Access to Nutrition Care in Outpatient Cancer Centers Proceedings of a Workshop. National Academies of Sciences Engineering Medicine. August 15 2016. Accessed November 18, 2019.
28 Trujillo E.B., Claghorn K, Dixon SW, Hill EB, Braun A, Lipinski E, Platek ME, Vergo MT, and Spees CK. Inadequate nutrition coverage in outpatient cancer centers: results of a rational survey. J Oncol. 2019; Article ID 7462940 https://doi.org/10.1155/2019/7462940 Accessed December 6, 2019.
29 American College of Surgeons Optimal Resources for Cancer Care 2020 Standards Commission on Cancer. 2019. Accessed November 17, 2019.
30 National Comprehensive Cancer Network Clinical Guidelines Older Adult Oncology. 2019. Version 1. https://www.nccn.org/professionals/physician_gls/default.aspx#senior
31 Cancer Center Services: A Practical Guide for Cancer Programs Rockville MD: The Association of Community Cancer Centers; 2012.
32 Arends J, Baracos V, Bertz H, et al. ESPEN expert group recommendations for action against cancer-related nutrition. Clin Nutr. 2017; 36(5): 1187-1196.
33 August DA, Huhmann MB. A.S.P.E.N clinical guidelines: nutrition support therapy during adult anticancer treatment and in hematopoietic cell transplantation. JPEN. 2009; 33(5): 472-500.
34 National Institute for Health and Care Excellence. http://www.nice.org.uk/Guidance/Topic. Accessed December 11, 2019.
35 Victoria State Government. Patient Management Framework. Head and Neck Tumour Stream: Larynx, Pharynx and Oral Cancer. State of Victoria: Metropolitan Health and Aged Care Services Division, Victorian Government Department of Human Services; 2006. www.health.vic.gov.au/cancer. Accessed December 12, 2019.
36 Clinical Oncology Society of Australia. About. Sydney NSW: COSA; 2016. https://www.cosa.org.au/groups/nutrition/about/. Accessed December 11, 2019.
37 Trujillo EB, Dixon SW, Claghorn K, Levin RM, Mills JB, Spees CK. Closing the gap in nutrition care at outpatient cancer centers: ongoing initiatives of the oncology nutrition dietetic practice group. J Acad Nutr Diet. 2018.118(4): 749-760.
38> American College of Surgeons Optimal Resources for Cancer Care 2020 Standards Commission on Cancer. 2019. Accessed November 17, 2019.
39 Decision Memo for Medical Nutrition Therapy Benefit for Diabetes & ESRD February 28, 2002. Accessed November 17, 2019
40 Centers for Medicare & Medicaid Services National Coverage Determination for Medical Nutrition Therapy October 2002. Accessed December 11, 2019.
41 Trujillo EB, Claghorn K, Dixon SW, Hill EB, Braun A, Lipinski E, Platek ME, Vergo MT, and Spees CK. Inadequate nutrition coverage in outpatient cancer centers: results of a national survey. J Oncol. 2019; Article ID 7462940 https://doi.org/10.1155/2019/7462940 Accessed December 6, 2019.