Comments to CMS re Draft Quality Measure Development Plan

March 1, 2016

Andrew Slavitt, MBA Acting Administrator, Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
CMS MACRA Team
Health Services Advisory Group, Inc.
3133 East Camelback Road, Suite 240
Phoenix, AZ 85016-4545

Re: CMS Draft Quality Measure Development Plan Supporting the Transition to the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs)

The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the United States Department of Health and Human Services (HHS) Draft Quality Measure Development Plan (the "Draft MDP"). Representing more than 90,000 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 — conducting research and providing medical nutrition therapy (MNT)1 and other evidence-based nutrition counseling services that meet the health needs of all citizens.

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) set health care payments to physicians and non-physician Medicare providers on a new course.  The goals set forth under MACRA are lofty, envisioning a perfect world of health care delivery and patient engagement. The Academy largely supports the strategic vision and operational approach of the Draft MDP, and are confident that CMS will be successful as it "strive[s] to ensure the availability of carefully evaluated and tested clinical quality measures for use across multiple care settings—a critical objective in the transition from paying for volume to rewarding value."

The Academy's specific comments and requests for clarification to the Operational Requirements of both MACRA and the Quality Measure Development Plan, Quality Domains and Priorities, and Challenges in Quality Measure Development and Potential Strategic Approaches detailed in the Draft MDP are below.

I. Performance and Vision

A. Performance

1. Development of Performance Score

As the Merit-Based Incentive Payment System (MIPS) is developed, the Academy encourages CMS to ensure that it designs a system that rewards not only continuing improvement, but consistently high performing practices as well. When practices become high performers, their margin for continued improvement diminishes, but their contributions to quality, cost-effective care are still worthy of recognition and incentivizing. One of the flaws of some of the Medicare ACO models is that high performers had to pay money back to CMS even though they had high Star ratings. As a result, some of these high-performing organizations stopped participating in these programs. Maintaining a high level of performance should be rewarded in addition to rewarding new improvements in performance.

The Academy also recommends CMS consider improvement at the composite performance score level rather than at the measure level or performance category level. As performance is analyzed at a more granular level, the amount of data needed to produce valid and reliable measures increases and therefore may not be realistic or attainable for a solo Eligible Provider (EP) or small practice to report.

2. Flexibility in Weighting Performance Categories

The Academy is pleased to note that MACRA requires the Secretary of HHS (if there are not sufficient measures and activities applicable and available to each type of EP) to assign different scoring weights (including a weight of zero) from those that apply generally under the MIPS. The Academy recommends that CMS make determinations at the specialty level when weighting the performance categories, as we believe situations will vary based on the provider type, particularly when it comes to non-physician health care providers such as RDNs.  The Academy believes CMS would benefit from Technical Expert Panels in designing this aspect of the MIPS.

B. Physician Quality Reporting Programs Strategic Vision

Accommodate Specialized Providers by Amending PQRS' Reporting Criteria

The Academy appreciates the opportunity to comment on Physician Quality Reporting System (PQRS) Programs and potential implications for the Quality Performance Category. We recommend that CMS retain all current PQRS reporting mechanisms under the MIPS.  However, rather than also retaining all current PQRS reporting criteria under MIPS, the Academy urges CMS to consider an alternate, lower reporting requirement for highly specialized Medicare providers providing a limited scope of services with concomitantly limited applicable measures on which to report. As many different provider types have represented to CMS in the past, the current PQRS requirement to report at least nine measures is simply impossible for many EPs to meet, thus creating an administrative burden for CMS as it applies the MAV process. Furthermore, the current set of quality measures does not create equitable opportunities across all provider types to support a payment system that places more weight on outcomes measures.  Until such time that the opportunities from weighting outcomes measures are more balanced , the Academy supports efforts by CMS and other organizations to develop more outcomes-based measures to support such a system in the future.

II. Operational Requirements

A. Multi-Payer Applicability of Measures

The Academy appreciates CMS's ongoing efforts to investigate and identify the availability and use of various quality and access measures in Medicaid and looks forward to hearing more about the initiatives CMS has "underway to improve the availability of Medicaid and CHIP information on covered services across states, including detail regarding benefit amount, duration, and scope."2 In addition, we encourage enhanced coordination between Medicare, Medicaid, and individual states that leads to a more uniform system of measures that minimizes methodological problems when calculating data. As MACPAC notes, "[e]ven for standardized measures, different methods to collect and report data may affect results." Further, "Notwithstanding the detailed technical specifications on the measures provided by CMS, NCQA, and others, states (and other payers generally) may use different methods to collect and report data for the same measures."3 The Academy strongly agrees with MACPAC and urges that "CMS should consider noting when states use varying methods to calculate data for the same measures so that differences in results are not incorrectly attributed to health care quality."4

In addition, we note significant and questionable variation in certain of CMS's core sets of health quality measures for both adults and children identified by MACPAC.  Although "[b]oth of the core sets include a measure to document weight status using Body Mass Index (BMI)[, t]he adult core set [only] includes an 'Adult BMI Assessment' measure [and t]he child core set includes a 'Weight AssessmentandCounseling for Nutrition and Physical Activity for Children/Adolescents: Body Mass Index for Children and Adolescents' measure."5 There is no explanation why there is no corresponding counseling or treatment measure for adults, despite intensive behavioral counseling for obesity being recommended for adults by both the USPSTF and national clinical guidelines.

The final rule with comment period states "that access needs may vary between pediatric and adult populations and we are requiring states to describe within their plans, the characteristics of the beneficiary populations, including considerations for care, services, and payment variations for pediatric and adult populations, as well as individuals with disabilities." However, upon consideration of putatively covered preventive services, it is unclear whether the specified putative coverage conforms to (or even resembles) the underlying USPSTF recommendations or national clinical guidelines that form the basis for mandated or medically necessary coverage.

We encourage CMS to include measures related to utilization, provider type, and the frequency and intensity of covered services in Medicaid.  Coverage of a service without the matching frequency or intensity that is either deemed medically necessary or is recommended by the USPSTF is coverage in name, but not in substance.The state of South Carolina has offered potentially helpful measures related to obesity worthy of CMS's consideration.29

B. Coordination and Sharing Across Measure Developers

The Academy supports CMS's efforts to "coordinate across CMS programs, as well as with initiatives in other public programs and in the private sector."  We have noticed the efforts CMS has been making to break down programmatic silos to promote consistency in the agency, and we are pleased to report that our experience indicates the efforts have been successful thus far. CMS's ongoing efforts to engage "private payers and other stakeholders to develop consensus around core sets of quality measures that would be used by all payers" is wise and should lead to greater consistency and efficiency.

III. Quality Domains and Priorities

A. Clinical Care

1. Priorities

CMS specifically seeks comment on "specific areas and specialties to prioritize through MACRA funding over the next five years." In response, the Academy respectfully suggests that CMS prioritize nutrition care, including malnutrition e-measures, nutrition-specific obesity e-measures, and more generally relevant measures around nutrition care for the millions of Americans with one or more chronic conditions. Consumers and patients should have access to information on how well providers are helping them manage their nutrition-related chronic diseases. Existing measures around chronic diseases largely focus on whether or not certain desirable clinical outcomes are achieved, such as HgA1c levels. While this is useful, as we already recognize that nutrition care is a critical component of health care and disease treatment for these individuals, the Academy suggests CMS has an opportunity to transform the measures system into one that helps drive utilization of highly beneficial and cost-effective nutrition services provided by RDNs.6

2. Adherence to Clinical Practice Guidelines

The Academy wholeheartedly supports CMS's approach to collaborate with specialty groups and associations to develop measures including "measures assessing adherence to clinical practice guidelines."  MNT provided by RDNs is a widely recognized component of numerous clinical practice guidelines for the prevention and treatment of heart disease, diabetes, renal disease, obesity, cancers, and many other chronic diseases and conditions as well as in the reduction of risk factors for these conditions.7 As primary prevention, strong evidence supports optimal nutritional status as a cost-effective cornerstone in the maintenance of health, well-being, and functionality. A s 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.8,9

3. Added Complexities of Measures for Multiple Chronic Conditions

We appreciate CMS's efforts to ensure clinical guideline developers address multiple chronic conditions, which are likely to require more complex care decisions than guidelines focused on a single disease or condition. We wish to underscore that nutrition care per the dietetics and nutrition profession should be recognized as a component of care in patient populations with "one or more chronic conditions."

As noted in CMS' "Chronic Conditions among Medicare Beneficiaries: 2012 Chartbook," more than half of Medicare beneficiaries have one or more chronic conditions, such as diabetes, hypertension, high blood cholesterol, heart disease and kidney disease.10 Heart failure has already been identified as a condition where clinical outcomes, patient quality of life, and health care spending can all be improved with proper medical management and care coordination and thus would also be an appropriate medical condition to include in such a model. Heart failure is the primary cause of hospitalizations among the Medicare population. Hospitalizations are most often the result of non-compliance with medications or diet.  Efforts to improve quality of care and control spending in these high cost, high volume populations would significantly advance efforts to achieve the CMS Quality Strategy.  Studies on the patient-centered medical home model of care consistently demonstrate significant clinical and financial improvements with care coordination efforts focused on such populations.11,12

Because so many chronic diseases have associated etiologies and patients have multiple comorbidities, effective care (such as MNT) that transcends a single disease state or condition and improves various aspects of a patient's health is uniquely valuable. In fact, the single most transformative policy to improve outcomes with patients living with four of the top six leading causes of death is cost-effective nutrition and diet counseling and interventions provided by RDNs. Thus, any meaningful reform should include services that demonstrably improve the nutritional status of Americans and reduce the rates of obesity, cardiovascular disease, renal disease, hypertension, diabetes, HIV, forms of cancer, celiac disease, stroke, and other medical conditions. 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

B. Care Coordination

The Academy agrees with CMS's philosophy that payment for care management services is critical to achieving the goals of Better Care, Smarter Spending and Healthier People.  Person-centered care provided by an interdisciplinary team of qualified health care professionals specific to the person's needs and coordinated by a primary care provider helps to achieve these goals. The Academy recognizes that the qualifications, skills, education, training, and credentials of the practitioner delivering the service is more important in assuring effectiveness than the service location, but appreciates that both current and newer models of health care delivery affirm the importance of the primary care provider (PCP) coordinating care, while recognizing that the PCP does not deliver all of the care.  Instead, PCPs rely upon a team that is not bound by physical walls, but rather connected through coordination, communication, and technology.

1. Non-Physicians in Care Coordination

As CMS explores additional avenues to recognize such work through appropriate payment mechanisms, the Academy urges CMS to think beyond the role of the primary care providers and explicitly recognize the wide range of qualified non-physician practitioners located within or outside of a primary care provider's office setting who effectively provide care management services. These non-physician team members are critical to achieving successful patient and population health outcomes and controlling the progression of chronic and complex chronic disease. Thus, there needs to be a payment mechanism for these essential services that is not exclusively tied to the primary care provider.

RDNs are recognized as the nation's nutrition experts, but they have extensive training, competencies, and expertise in multiple other areas as well. Quality care can be coordinated by a wide variety of health care professionals beyond only physicians and nurses. RDNs have the necessary skill set, leading many to serve in such roles within Patient Centered Medical Homes (PCMHs). Concerns about provider shortages should inspire CMS to think creatively about the skill sets of providers, such as RDNs and NDTRs, and how it may best utilize the skill sets and enable these providers to perform to the greatest extent of their training.

The Academy greatly appreciates that CMS recognized the importance of including a nutrition professional on patient care teams, but we are compelled to note significant confusion surrounding the title "nutritionist." In many states across the country, one may hold himself or herself out as a "nutritionist" without having any relevant experience or training in the field whatsoever. Clinicians and consumers trust the RDN credential for reasons the IOM has identified: "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."14

2. Telehealth Options to Enhance Care Coordination

We strongly support the proposed expansion of PQRS #374 to include specialists' reports back to the primary care provider, as it enhances shared accountability among various providers. In addition, we strongly encourage CMS and Congress to prioritize modernization of our telehealth statutes and regulations to enhance care coordination. 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 new measures and payment and delivery models as they offer 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 the payment model.

The Academy requests that CMS clarify the meaning and underlying intent of the Draft MDP provision that, "when evaluating and/or funding measure development specific to CPIAs submitted for telehealth, CMS and measure developers must be cognizant of the services Medicare covers in this area[.]" Is this assertion limited to telehealth services, or is it applicable more broadly to Medicare coverage generally? We request that CMS clarify the extent to which the provision suggests that CMS and measure developers should look at the scope of Medicare's existing coverage when determining whether to pursue development of particular measures and how the presence or absence of coverage is anticipated to affect the determination. As an example, Medicare's present lack of coverage for highly cost-effective and clinically-effective MNT recommended by numerous clinical guidelines actually hinders furtherance of the CMS Quality Strategy. Thus, the development of associated measures should not be predicated upon Medicare coverage.

C. Patient and Caregiver Experience

1. Patient Reported Outcome Measures

The Academy supports CMS's desire to focus on and prioritize Patient Reported Outcome Measures (PROMs), which the Draft MDP says, "assess patient-reported experiences and outcomes that reflect involvement of persons and families in the care process and demonstrate knowledge, skill, and confidence to self-manage healthcare." We welcome deeper engagement and enhanced shared decision making with patients and those closest to them. HHS's commitment to a patient-centered approach is manifested throughout the agency, but particularly at CMS and the Office of the National Coordinator (ONC).

The Academy agrees with the American Heart Association (AHA) and the American College of Cardiology (ACC) that "[t]he ultimate decision about care of a particular patient must be made by the healthcare provider and patient in light of the circumstances presented by that patient[,]" which manifests the need for qualified, independent practitioners such as RDNs to provide more complex, individualized care when formal intervention programs or protocols may be unavailable, ineffective, or non-indicated.

PROMs provide patients and caregivers with the capability to report if they have gained weight, increased strength, consumed appropriate calories, and many other measures.  Developing a shared, standardized set of consumer-centric terms that patients understand and use can be critical to a successful experience, and contribute to shared accountability.  We are pleased that, "To understand and measure patient and caregiver experience of care, CMS implements patient experience surveys across multiple programs and settings of care."  Finally, although some observers initially raised questions about potential biases and the methodology and reliability of PROMs, research and analysis show PROMs are an imperfectly valuable tool to provide important information and improve care.15

2. Reporting Quality Data Stratified by Certain Demographic Variables

As the Academy noted in our comments on the CY2016 Physician Fee Schedule proposed rules, we have concerns about the reporting of quality data stratified by race, ethnicity, sex, primary language, and disability status. Although we support efforts to reduce health disparities, we note that the collection of race information in particular poses unique challenges in that it is important to consider who will determine the categories used and who will select the category for a specific Medicare beneficiary. Specifically, we query whether the provider will be asked to select the category or will the patient self-report? Oftentimes assumptions about race may be made by the provider. Sufficient numbers of categories must exist to more accurately reflect the race of patients. The current Black, non-Hispanic White, Hispanic, Asian, and Other categories currently in use do not provide enough differentiation for evaluators of the data. Therefore, the Academy recommends that CMS work with the National Institute on Minority and Health Disparities and the HHS Office of Minority Health to determine appropriate race categories.

The Academy also recommends CMS consider collecting this data at the agency, rather than at the individual provider level. Most of these items are constants and could be collected on each beneficiary as part of the Medicare application process, although we note that the one exception may be disability status as it may change over time. By capturing these data elements with eligibility information, it not only minimizes burden on providers but also ensures consistent and accurate data on each beneficiary. Alternately, CMS could establish an automated prompt to collect the data elements via claims systems. The request for the demographic information could be submitted to the eligible treating provider types who have submitted the most claims for individual patients within a certain time period. Once the demographic information is received by CMS, the request for information would be turned off.  Such a system would prevent the need for multiple treating providers to be collecting and reporting the same information on the same patients. CMS could then leverage technology to analyze quality data stratified by each of these factors.

D. Efficiency and Cost Reduction

CMS describes efficiency and cost reduction quality measures as those "that reflect efforts to lower costs, reduce errors, and significantly improve outcomes." The Draft MDP's used unnecessary imaging and laboratory studies as examples of inappropriate care that does not place the person's health at risk and thus categorizes them in the efficiency and cost reduction quality domain rather than the safety domain. Although the Draft MDP's categorization of a measure for an underutilized but effective treatment is uncertain, it is clear that higher utilization of RDN-provided MNT will result in lower long term costs and improved health outcomes, thereby underscoring the importance of developing appropriate quality measures.

MNT provided by RDNs for prevention, wellness, and disease management improves patient health and increases productivity and satisfaction levels through decreased doctor visits, fewer hospitalizations and re-admissions, and reduced prescription drug usage.  RDNs' expertise and extensive training enable them to deliver coordinated, cost effective care for a variety of chronic diseases, including obesity, hypertension, diabetes, disorders of lipid metabolism, HIV infection, unintended weight loss in older adults, and chronic kidney disease.16 RDNs are recognized as the most qualified food and nutrition experts by the Institute of Medicine (IOM), most physicians, numerous clinical guidelines, and as evidenced by recommendations of the USPSTF, providing nutrition care more effectively at a lower cost than physicians, nurse practitioners, and physician assistants.17 Given the lack of coverage for MNT services for all but a handful of disease states, it is not surprising that the service is underutilized when it might be most effective.

RDN-provided MNT is not only clinically effective, but 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. Another study found that for every dollar invested in an RDN-led lifestyle modification program there was a return of $14.58. 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." 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. 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 percent and disability days by 87.2 percent, compared with those receiving usual medical care.  Nutrition interventions reduce and even eliminate the need for costly long-term medications and reduce hospitalizations. HHS 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.

Despite these results, MNT is not reimbursed, except for patients with diabetes or certain renal conditions, meaning it is infrequently utilized, particularly as a preventive service when risk factors for disease have been identified. The result of low utilization at this critical time before progression to disease can be costly. RDN-provided MNT for prediabetes has been shown to cost-effectively prevent onset of Type 2 diabetes, yet Medicare does not currently cover this service and the lack of utilization of the MNT service results in the progression to disease diagnosis. A beneficiary must wait until he or she is diagnosed with diabetes before she has access to nutrition services that are at the cornerstone of diabetes care. RDN-provided MNT for prediabetes and diabetes is highly relevant to CMS's efficiency and cost reduction quality domain.  The Lewin Group documented a 9.5 percent reduction in hospital utilization and a 23.5 percent reduction in physician visits when MNT was provided to persons with diabetes mellitus. A well-designed randomized controlled clinical research trial published last year by Parker, et al showed that individualized MNT provided by RDNs resulted in weight loss and improved blood glucose, which are key outcomes for diabetes prevention programs.

Medicare's limited coverage of nutrition services for obesity is also problematic in that beneficiaries (1) must already be diagnosed with obesity (based on BMI) before Medicare will pay for intensive behavioral therapy services and (2) those services are not reimbursed if provided by the most effective providers in the most effective settings - RDNs. These highly restrictive rules limiting the providers and venues eligible for coverage are likely factors leading to the Congressional Budget Office's (CBO's) finding that "relatively few Medicare beneficiaries currently receive intensive behavioral therapy for obesity—a benefit that has been covered since 2011. According to CBO's analysis of claims, approximately 0.5 percent of fee-for-service beneficiaries who are classified as obese used this service in 2013.  Additionally, most participants used fewer visits than are recommended for a full course of treatment."18

Nutrition coverage for beneficiaries at risk for cardiovascular disease (CVD) or those with cancer, eating disorders, or numerous other disease states and conditions is non-existent.  To solve long-term problems in the Medicare program, we must aim for both earlier intervention and for prevention in cases where it is demonstrated to pay off. Nutrition-related chronic diseases and conditions, such as hypertension, obesity, and diabetes mellitus are both costly and common in the United States. Nutrition management of multiple chronic conditions by improving overall nutrition intake is both efficient and an integral component of treatment.  Given the low utilization of this service when it could make a significant impact, CMS should develop process and outcome quality measures that recognize the benefits of referring patients to RDNs for MNT, consistent with the explicit recommendations of the USPSTF.

E. Gap Analysis

1. Non-Disease Specific Considerations

The Academy supports the development of measures and policies that reward changes in patient behaviors that will positively impact risk factors for chronic disease (rather than just anthropometrics, such as BMI). Although it is important to focus on outcomes, such as nutritional status and functional status, process measures are also needed, such as the number of patients with one or more chronic diseases who receive nutrition care from a RDN. These process measures provide the foundational framework for capturing PROM data within EHR systems and bridge the gap to future corresponding outcome measures. Measures should provide data both on (i) whether a referrals to an RDN is being made (using referral codes and tracked in value sets) and (ii) if patients who complete those referrals have better outcomes. We strongly encourage CMS to recognize the need for a gap analysis for non-physician providers of the health care team, or at minimum, those providers recognized or reimbursed as Medicare providers.

The Academy also supports CMS's efforts to ensure that measures with an evidence-based focus, that have been submitted for peer review, and has a compelling and rigorous business case, but which have not been endorsed, will be eligible for inclusion for MIPS, consistent with MACRA's authorization.

2. Nutrition-Specific Measures

In addition to helping to prevent or manage chronic conditions, adequate and proper nutrition ensures that older adults maintain an appropriate weight. Between 2007 and 2010, more than one-third (35 percent) of older adults had obesity,19, and although the Institute of Medicine (IOM) has cited obesity as the most common nutritional disorder in older persons, undernutrition continues to be a pervasive problem among older adults as well.20 Undernutrition is a particularly costly problem for older adults in community settings, with a close connection between inadequate income and food insecurity.21 The consequences of undernutrition include increased risk of falls and subsequent injuries, which can not only impair an individual's ability to live independently but also translate into over $19 billion in health care costs for nonfatal falls nationwide.22 Given the important connection of nutrition with chronic diseases, we encourage the development of nutrition-specific measures, which follow the patient across the continuum of care and across health care settings. Aligning these measures with, for example, requirements from The Joint Commission (1) to screen all patients for nutrition risk and (2) to refer those at-risk to an RDN meet CMS's General Principles specified in the Draft MDP.

a. Malnutrition

Malnutrition is a leading cause of morbidity and mortality, especially among the elderly.

Evidence suggests that 20 percent to 50 percent of patients are at risk for or are malnourished at the time of hospital admission,23 resulting in a significant impact on patient outcomes, resource use, and costs. Furthermore, malnutrition may be exacerbated during hospital stays due to a variety of factors, including age, surgical procedures, and comorbidities. Malnutrition is most simply defined as any nutrition imbalance that affects both overweight and underweight patients alike and is generally described as either "undernutrition" or "overnutrition."24,25

A consensus statement by the Academy for Nutrition and Dietetics and the American Society for Parenteral and Enteral Nutrition (ASPEN) further defines malnutrition as a presence of two or more of the following characteristics: insufficient energy intake, weight loss, loss of muscle mass, loss of subcutaneous fat, localized or generalized fluid accumulation, or decreased functional status.26 While clinical guidelines recommend screening, assessment and diagnosis, nutritional intervention, education/counseling, discharge planning and use of care plans for patients who are malnourished or at high risk of being malnourished, evidence suggests a gap remains in the delivery of care.27,28,29,30

Patients who are malnourished while in the hospital have an increased risk of complications, readmissions, and length of stay, which is associated with up to a 300 percent increase in costs.31 Furthermore, research suggests initiatives that target improving quality of care related to malnutrition in the hospital setting can reduce the burden of malnutrition in the hospital and improve patient outcomes.32,33

When malnutrition is effectively measured, it can be effectively treated; further, it is important to know where the system is failing patients in this regard. The Academy, in-conjunction with Avalere Health and Abbott, has been supporting efforts enhancing quality care delivered to malnourished patients. These efforts led to multi-stakeholder dialogues during which participants discussed how to design and implement specific activities to support improved malnutrition care in acute care settings. Reference below links to review dialogue proceedings.

  • Academy-Avalere Health-Abbott Dialogue Proceedings - Launching the Malnutrition QI Initiative - White Paper, December 2014;34
  • Measuring the Quality of Malnutrition Care in the Hospitalized Elderly Patient, May 2014.35

In 2015, the Academy and Avalere Health engaged in a two-part effort to (1) launch a Malnutrition Quality Improvement Initiative in the hospital setting and (2) create de novo electronic clinical quality measures to facilitate optimal, evidence-based malnutrition care. Clinical guidelines recommend screening, assessment, diagnosis, nutrition intervention, care plan use, counseling, and discharge planning for patients malnourished or at-risk of malnutrition. Evidence suggests gaps remain in care delivery questioning clinical workflow process.

The Academy has developed four (4) de novo clinical quality measures (CQMs) which are currently being field tested.  Feasibility assessments with electronic health record vendors are being conducted.  The composite set of four (4) measures include: malnutrition screening; diet orders within 24 hours; nutrition assessment for patients identified at risk for malnutrition within 24 hours of the screening; and documentation of malnutrition diagnosis. The Academy is also launching a hospital Malnutrition Quality Improvement Initiative (MQii) demonstration toolkit which implements the quality improvement model of the PDSA (plan-do-study-act) and addresses performance gaps by analyzing the clinical process work-flow of malnutrition care. MQii may be utilized for application and implementation across settings, use clinical practice improvement, and have electronic specifications. Malnutrition care is an opportunity for RDNs with interdisciplinary teams to champion positive patient outcomes.

b. Pediatric Malnutrition

Using a standardized set of measurements will help health professionals more accurately diagnose malnutrition among children ages 1 month to 18 years, as well as improve their treatment, according to a December 2014 joint statement from the Academy and the American Society for Parenteral and Enteral Nutrition (ASPEN) that was endorsed by the American Academy of Pediatrics: "The universal use of a single set of diagnostic parameters will expedite the recognition of pediatric undernutrition, lead to the development of more accurate estimates of its prevalence and incidence, direct interventions and promote improved outcomes."36

The Academy and ASPEN recommend that "a standardized set of diagnostic indicators be used to identify and document pediatric malnutrition (undernutrition) in routine clinical practice."37 These indicators include "z scores for weight for height/length, body mass index for age, mid-upper arm circumference, rate of weight gain or loss and inadequate nutrient intake," among other measures.38 The indicators should become part of routine practice by clinicians caring for pediatric patients in all health care settings.  In addition, the organizations stated that, "Clinicians should use as many data points as available to identify and document the presence of malnutrition…. A standardized diagnostic approach will also inform the prediction of the human and financial responsibilities and costs associated with the prevention and treatment of undernutrition in this vulnerable population, and help to further ensure the provision of high-quality, cost-effective nutrition car."39 Clinical quality measures specific to pediatric malnutrition, and similar to those for adult malnutrition, should be a focus of development under the MDP.

3. Obesity Measures

With multiple obesity measures used by various payers, issues of redundancy, variability, and reliability create a significant administrative burden for providers and health systems and, more importantly, limits opportunity for improved outcomes due to diffusion of focus for quality improvement. The Academy and other researchers are examining the possibility of creating "value sets" for each well-adopted, small component of the Nutrition Care Process.  Further, given the complex etiologies of obesity, we encourage CMS to consider a measure related to team-based care for prevention and treatment of overweight/obesity that recognizes referral to RDNs, which is consistently included in clinical guidelines.

The Academy, in its capacity as a founding member of the Obesity Care Continuum (OCC), offered specific recommendations for improving the Agency for Healthcare Research Quality's (AHRQ) March 6, 2014 Technology Assessment Program Topic Refinement draft key question document entitled, "Topic Refinement Document: Therapeutic Options for Obesity in the Medicare Population."  Several of the OCC's recommendations were incorporated in AHRQ's "Final Refinement Document: Therapeutic Options for Obesity in the Medicare Population,"40 which will be highly relevant to the development of outcomes and quality measures for obesity.

The full OCC's 2014 comments to AHRQ are attached hereto; several specific, relevant recommendations include:

  • Adding measures of body composition based on validated methodologies;
  • Amending intermediate outcomes of interest to include weight cycling, weight regain, and weight maintenance among Medicare beneficiaries as well as percentage of fat, and peak exercise capacity;
  • Encouraging AHRQ to also consider the patient-recorded outcome of nutrition quality of life;
  • Encouraging AHRQ to include in the adverse effects outcome of interest the extent to which patients with obesity may be ineligible for certain transplants, such as kidney transplants. In addition, AHRQ should look at both hospital admission and hospital readmission; and
  • Lastly, the OCC recommends that AHRQ categorize its research and findings by class, or level of obesity, to align with and help to evaluate clinical practice guidelines that often structure recommendations based on such categorizations. This will help determine whether that categorization is relevant to quantitative outcome measures and an assessment of the effectiveness of particular interventions.

4. IMPACT Measures

The law Improving Medicare Post-Acute Care Transformation requires standardized patient/resident assessment data. RDNs are preparing to address and devise nutrition care services and MNT required to meet the cross-setting quality measures.  The Academy is in support of CMS' strategic implementation for public reporting of identified measures (pressure ulcers, skin integrity, readmissions, functional status, and falls management) and recommend to include MNT in national payment programs. Nutrition care is an integral component in prevention and treatment of pressure ulcers according to the clinical practice guidelines.41

The Academy established an IMPACT Taskforce to gather and assess information on the IMPACT Act of 2014 – Post-Acute Care (PAC) based on the 3 aims of the HHS National Quality Strategy and CMS Quality Strategy's Goals. Three (3) initiatives were identified by the Taskforce with subsequent corresponding tactics:

  • Evaluate of Post-Acute Care Tools;
  • Relate Measure domains and quality measures to nutrition care and food services;
  • Develop Tools/Resources for practitioner education and awareness and promote and communicate.

The Academy's IMPACT Taskforce reviewed and provided information and links to the following tools for inclusion in any food, nutrition and dietetics practice deliverables. The Taskforce also reviewed the data set points in each Tool that are the same for providing the standardized data.

  • Home Health Agencies (HHA) – HCBS CARE; OASIS-C1
  • Skilled Nursing Facilities (SNF) – MDS 3.0 – has separa;te D Section;
  • Inpatient Rehabilitation Facilities (IRF) – PAI – Version 1.4 corrected – effective Oct 2016 – used for Admission/Discharge; and
  • Long Term Care Hospitals (LTCH) – CARE Tool.

Deliverables for practitioner implementation include explanation of measure domains descriptions in relationship to nutrition care and dietetics practice with correlated case study examples. The tools and resources are located at eatrightPRO.org/IMPACT and cover the following standardized measure domains for development and public reporting of quality measures across settings:

  • Skin integrity and changes in skin integrity and pressure ulcers
  • Functional status, cognitive function, and changes in function and cognitive function
  • Incidence of Major Falls, Falls Prevention and Management
  • All-Condition Risk-Adjusted Potentially Preventable Hospital Readmissions Rates

The Academy's IMPACT Taskforce may also review additional identified measure domains for medication reconciliation and patient preferences related to food and nutrition care.  Learning modules and webinars are in development detailing the IMPACT Act of 2014 law, definitions of PAC settings, description of standardized PAC assessment tools, timeline for implementation, and interoperability within electronic health records. As we continue our efforts, we welcome the opportunity to share our findings and for CMS to adopt our work on measures domains for developing and public reporting of quality measures.

F. Applicability of Measures across Healthcare Settings

Another potentially applicable approach could be adapted from the End Stage Renal Disease (ESRD) program. Under Medicare Part A, nutrition services and RDNs are often considered a requirement under conditions of participation (e.g., hospital inpatient care, skilled nursing facilities, and dialysis centers). RDNs providing nutrition services in these settings have consistently proven their value in meeting the CMS Quality Strategy. For example, the ESRD program was revamped in 2010 for the first time since its inception in 1971 and funded a Medicare program for beneficiaries regardless of age and/or disability. This capitated program limits costs for services and medications related to the disease state while monitoring quality performance indicators to maximize patient outcomes. Cost savings to the Medicare system with improved indicators of patient quality and a modest improvement in patient mortality indicate this as a potential model for other disease states.24

We agree with CMS that appropriate beneficiary protections need to be in place, such as patient advanced consent to the consultation.  Any consultative services delivered via the Internet should be performed in a HIPAA-compliant manner. It is important that such services not take the place of face-to-face or telehealth encounters when indicated as a component of evidence-informed practice. The Academy does not believe it is necessary for CMS to differentiate between such services and other PFS payments as these CPT codes have already factored such a need into account in their development so they should be implemented in accordance with existing CPT guidelines. Payment for such services should be tied to a beneficiary encounter by the patient's treating physician or other qualified health care professional as defined under section 1861 (s) of the Social Security Act [42 U.S.C. 1395x] (within 7 days) to ensure documentation of a current physical examination.

G.  Clinical Practice Improvement Activities

The Draft MDP specifies that "MACRA requires the Secretary to consider clinical practice improvement activities (CPIAs) among the four MIPS performance categories in at least the following subcategories: expanded practice access; population management; care coordination; beneficiary engagement; patient safety and practice assessment; and participation in an APM." The Academy is optimistic that evaluation of clinical practice improvement activities will lead to innovative approaches to measure development and the ability to effectively address identified gaps. We are also excited that the work underway at HL7 has been completed in such a way as to create clinical decision support; this allows health IT "intelligence" to guide practitioners in the best clinical path consistent with nutrition research. We offer the following considerations as CMS begins this evaluative process:

1. Proposed and Potential Subcategories

CMS proposes a subcategory of Social and Community Involvement that might include measuring the number of completed referrals to community and social services. If such a measure is developed, the Academy recommends that a "completed referral" be defined as a referral that is madeand acted upon. While we recognize many factors influence whether a referral is actually acted upon, defining "completed referrals" in this manner would require referring providers to close the loop on the referral process and move the system closer to one based on outcomes. The Academy also recommends that CMS either broaden this subcategory or create a new one to capture referrals to other providers such as RDNs within the medical neighborhood. These referrals are consistent with clinical practice guidelines and have been shown to improve health outcomes, enhance patient satisfaction, and control costs.

CMS may add specific subcategories to the list of clinical practice improvement activities, and the Academy urges CMS to carefully consider the extent of the burden on practices to report such activities and whether or not payment should truly hinge on completion of such activities. For example, while health care providers appropriately participate in emergency preparedness and response activities, the Academy is concerned that payment should be tied to such participation as many factors influence an individual EP's ability to do so.

2. Reporting Mechanisms for CPIAs

When it comes to mechanisms for reporting CPIAs, the Academy supports annual self-attestation directly to CMS. Qualified registries, QCDRs, EHRs or other health IT systems are not designed to capture and report on this type of data, nor should they be expected to be redesigned to do so. CMS could then utilize the Recovery Audit Contractors to randomly audit a subset of providers to verify the quality and accuracy of the reported data.

3. Suggested Substantive CPIAs

As for activities that could be classified as CPIAs, the Academy urges CMS to consider menus of options based on provider type or be sure to incorporate activities so as to provide options that meet the needs of physicians, non-physicians and other qualified health care professionals. Specifically, the Academy recommends CMS consider including  the ability to provide same day appointments with RDNs and physicians (primary and specialty) to better meet patient needs and enhance access to care; provide expanded access through walk-in appointments; support care coordination via telehealth; enhance beneficiary engagement through self-management training services; and enhance beneficiary engagement through patient self-assessment tools such as checklists, Apps (e.g., a sodium counter) or "Healthy Plate" evaluation tools.

a. Same Date of Service for DSMT and CPIAs

The Academy also strongly encourages CMS to allow MNT and Diabetes Self-Management Training (DSMT) be allowed on the same date of service as a clinical practice improvement activity. Current regulations, which do not allow DSMT and MNT to be provided on the same date of service, burden quality and access to care and create undue hardships for persons with diabetes, especially for disparate populations. Many Medicare beneficiaries forego necessary DSMT and MNT care because they cannot schedule services on the same day. 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.13 A regulatory change would allow beneficiaries to consolidate often-difficult and increasingly expensive trips to ambulatory care settings to receive care.

The current regulation limiting same day DSMT/MNT services creates burdensome impediments to quality patient-centered care and increases health care costs. Associated diabetes education and disease management by non-physician providers saves money and decreases healthcare utilization.14 Compared with no prevention, self-management reduces a high-risk person's 30-year chances of getting diabetes by about 11 percent, the chances of a serious complication by 8 percent and the chances of dying of a complication of diabetes by 2.3 percent.15With the flexibility of having both services available on the same day, the likelihood of beneficiaries maintaining their appointments will increase. Preventive self-management, combined with reduced numbers of no-shows and lost days from work and school will result in significant cost savings to the health care system.

b. Threshold for Status as a Low-Volume Provider

Although the Academy does not presently have a recommendation regarding an appropriate low-volume threshold, we do recommend that any thresholds that are set be statistically valid so that upward or downward payment adjustments are based on reliable and valid data. We do not recommend using a minimum amount of billed charges under Medicare Part B as a criteria due to the wide variability in fees for services under the PFS.

H. Consideration for Electronic Specifications

The Academy recognizes the significant benefits and opportunities available from electronic data sources, and appreciates the need to develop and implement electronic clinical quality measures (eCQMs) deliberately and with the full cooperation of stakeholders. The Academy supports CMS's prioritization of eCQMs development, as electronic data should result in improved quality of measures and the reporting burden on providers is intended to be largely limited to existing workflow. We are grateful for the opportunity to work collaboratively with ONC and other stakeholders to ensure the effective roll-out of certified EHR technology and the inclusion of valuable nutrition content in the HL7 Consolidated Clinical Document Architecture Release 2.1, which is used for the "Common Data Elements" from ONC.

We enthusiastically offer the services and resources of the Academy and our member experts in supporting the successful implementation of eCQM. We strongly encourage CMS to work with stakeholders to define terms and standardize data elements to support practitioners and reduce costs and delays associated with individual measure developers. To that end, we would be pleased to meet with you to discuss a potential bridge to the eCQM process beyond HL7, perhaps linking a "referral to RDN" measure to all eCQMs. We urge CMS to require certified EHR technology in order to facilitate care coordination using aligned data elements, and a systematic, standardized, coordinated methodology to exchange and use data.

We continue to support promotion of "a simplified and consistent process across public and private payers by reducing the total number of measures, refining the measures, and relating measures to patient health—known as the 3Rs (reduce, refine, and relate)," but we recognize success depends upon all members' ongoing responsibility to make sure the Academy's Nutrition Care Process and Terminology (NCPT) Committee terms are "mapped" to the now-mandated clinical terminologies.

I. Strategic Vision of the Measure Development Plan

The Academy also supports the framework by which measure development priorities were developed and applauds CMS for its commitment to collaboration among and shared accountability across providers (e.g., incorporating both primary care and specialist accountability across care settings), but is concerned with the lack of clarity43 and certainty of the future for non-physician providers in the patient-centered measure portfolio and accountable care regime as it "evolves over time."

1. Non-Physician Providers in New Payment Models

As CMS maps-out both MIPS and the Physician-Focused Payment Models (PFPMs), the Academy strongly urges CMS to prioritize consideration and expeditious inclusion of provisions related to the needs of non-physician providers. Based on 2013 data, approximately 17 percent of EPs for the Physician Quality Reporting System (PQRS) are "other healthcare professionals" (i.e., not an MD, DO, NP, PA, or CRNA).44 These "other healthcare professionals" — many of whom are independently reimbursable providers — render critical services to Medicare beneficiaries that improve health outcomes, enhance patient satisfaction, and control spending. As vital components of Medicare's healthcare delivery system, these highly qualified providers deserve the opportunity to earn incentive payments in a manner that recognizes unique differences in practice and available quality reporting measures that create a fair and equitable merit-based incentive system.

If the MIPS is designed and measures are developed in a manner that does not meet these providers' needs, the Medicare program will disincentivize these providers from participating in the system, thereby creating access to care problems for beneficiaries and limiting the potential for improved health outcomes.  Given ongoing concerns over provider shortages, it is prudent to retain as many high performing professionals as possible within the Medicare program to effectively address the health needs of the Medicare population. The Academy recommends that CMS convene a Technical Expert Panel (TEP) comprised of individuals representing these "other professionals" to inform CMS's development of the MIPS to meet these critical needs. Representatives from the AMA RUC HCPAC could serve as members of such a TEP, as they are knowledgeable about the PFS, PQRS, and alternate payment models.  Throughout MACRA's implementation and CMS's other ongoing efforts to transform the nation's health care delivery and payment systems, the Academy will be remain diligent in working to enhance the integration of RDNs and other cost-effective and clinically-effective non-physician practitioners into the new systems.

2. RDNs and Nutrition Services in New Payment Models

RDNs are eager to be part of a value-based payment system in which they are held accountable for the outcomes of their effective services. A number of RDNs are already participating in alternative payment models as part of forward-thinking physician office practices or through various Innovation Center initiatives (e.g., the Comprehensive Primary Care initiative and the Oncology Care Model). And, despite not considered as an Eligible Professional (EP) in the EHR Meaningful Use program, the Academy has been an active participant in the policy, standards and vocabulary proceedings. However, we note it is still the exception for physician office practices to directly employ and/or contract with RDNs as a result of the lack of explicit recognition by CMS and other payers of the value of RDNs as an essential part of the patient-centered health care team. In addition, while RDNs currently only qualify as EPs under PQRS, the Academy supports CMS's continued efforts to align all of its quality improvement programs, reporting systems and quality measures. We believe this alignment will lighten the administrative burden on EPs while harmonizing the various CMS quality programs. Existing measures from PQRS, VM, and the EHR Incentive Program will be the starting point for measures to be used in MIPS and APMs.

The Academy is hopeful that innovative payment models will enable individuals to have access to covered nutrition services deemed to improve clinical outcomes, enhance patient satisfaction, and reduce/control spending. Virtually all prevalent chronic illnesses have a nutrition component, yet there remain huge 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.

Sadly, the traditional fee-for-service payment system has failed to recognize the value of MNT services provided by RDNs in treating or delaying progression of our most serious, common, and expensive chronic diseases, despite compelling evidence and national clinical practice guidelines explicitly supporting their contributions to the CMS Quality Strategy.  As a result, beneficiaries' access to most vital MNT services only happens under a system heavily reliant upon referrals to RDNs working in their own non-physician practice settings, who receive payment out of pocket from the elderly often on fixed incomes. The current Medicare program offers too little nutrition care too late and does not incentivize the use of other members of the health care team with specific expertise in areas such as nutrition counseling (i.e., RDNs).

3. Designing MIPS and Other APMs to Achieve MACRA's Ideal System

The Academy urges CMS to design accountable payment models supporting the IOM's recommendation that, "the Medicare program should support policies that would allow all qualified practitioners to practice to the full extent of their educational preparation."45 As CMS continues its efforts to achieve its goals of Better Care, Smarter Spending, and Healthier People, it is important that it sets policies to fully leverage the contributions of all highly qualified members of the health care workforce, including both primary care and specialty care providers.

In order to achieve CMS's ideal health care delivery and patient engagement system envisioned under MACRA, the following are required to effectively design the MIPS and other APMs:

  • Physicians should either be mandated or incentivized to utilize non-physician providers such as RDNs practicing at the height of their scope of practice.
  • Non-physician providers, such as RDNs, must be afforded the same opportunities to earn value-based payments as physicians and other Medicare providers, given RDNs' contributions to the CMS Quality Strategy of Better Care, Smarter Spending, and Healthier People.
  • Non-physician providers, such as RDNs, should not be financially penalized for non-recognition by the MIPS and APMs.  The systems must provide equitable opportunities (meaning equitable to physicians) for non-physician providers to earn value based payments.

J. Alternative Payment Models

MACRA not only established MIPS, it provided incentives for clinicians to participate in APMs that meet specified criteria. The draft MDP reiterates the statutory requirement to include quality measures for use in the APMs and require that measures used in APMs are comparable to those used in MIPS.

In addition to their shared interconnectedness under the MACRA statute, MIPS, quality measures, and APMs will be critical partners in developing policies and processes that enable non-physician providers to be significant contributors to the successful transformation of the U.S. health care payment and delivery systems.  CMS promotes APMs and incentivizes participation in such models, despite the fact that currently it is difficult for non-physician providers such as RDNs to participate in the existing APMs as they are only able to do so if a forward-thinking physician or ACO integrates an RDN into their organization.  In most cases the RDN is part of a "virtual" Patient Centered Medical Home rather than being employed by the entity.

1. APMs and EHRs

In addition, APMs tend to require the use of certified EHR technology, yet RDNs and other non-physician providers are not eligible to receive incentive payments to assist them in adopting such technology. Once again, the Academy recommends CMS convene a TEP comprised of individuals representing these "other healthcare professionals" to enable it to effectively develop incentive payments for participation in APMs. Representatives from the AMA RUC HCPAC could serve as members of such a TEP, as they are knowledgeable about the PFS, PQRS, and alternate payment models.

2. APMs, Allocating Payments, and Accountability

The Academy is currently developing some alternate payment models for nutrition services, and we welcome the opportunity to share our work with CMS in the hopes that the agency might adopt the models and/or use them to inform their work around promoting and incentivizing APMs.

If our APM models were adopted, nutrition services could be paid for as a fee-for-service payment to the RDN provider or via funds designated for such use as part of a per-patient-per-month payment to the practice (primary or specialty) serving as coordinator of care for the patient's plan of care. A value-based payment model could be utilized that specifically allows the RDN provider (and other non-physician members of the patient's health care team) to share in the savings achieved by the entire care team, as well as incentive payments received by the practice for the quality outcomes achieved.  Payment models continue to pose challenges as providers across practice settings who contribute to the care of an individual patient are often faced with the challenge of "carving up the pie" when it comes to bundled payments.

APMs raise a series of critical questions: How does one determine how to allocate the bundled payment, shared savings and incentive payments across the virtual team?  Which providers are considered part of the team and therefore held accountable for outcomes and eligible for payment? While providers should have the leeway to negotiate such business arrangement amongst themselves based on the unique needs of the local community and their businesses, the design of the model should recognize this challenge and be designed in ways that help to minimize it.

The payment mechanism for this model needs to recognize that health care can effectively be delivered via a medical "neighborhood" or virtual team, meaning the care team of physicians and qualified non-physician practitioners do not all need to be located within the primary care provider's office setting. The care model needs to be designed to go beyond the physical walls of any particular medical practice to allow patients to receive services where they work, live and play; in locations convenient to them; and at hours convenient to them. With such varied and dispersed care settings in this model, MACRA's requirement to consider applicability across healthcare settings when developing the measure portfolio for MIPS and APMs is sound.

Payment models need to hold the team accountable for care while providing the flexibility needed to attribute payment equitably among all members of the team, no matter their practice location. While a designated "primary" care provider is essential to achieving effective care coordination, the model needs to recognize that depending on the individual patient and their needs at a particular point in time, leadership in complex chronic care management services may shift amongst members of the care team, including the RDN.

IV. Conclusion

The Academy sincerely appreciates the ongoing opportunity to offer comments to HHS and CMS on the development of quality measures.  Please contact either Jeanne Blankenship by telephone at 202-775-8277 ext. 1730 or by email at jblankenship@eatright.org or Pepin Tuma by telephone at 202-775-8277 ext. 6001 or by email at ptuma@eatright.org with any questions or requests for additional information.

Jeanne Blankenship, MS RDN
Vice President
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics

Pepin Andrew Tuma, Esq.
Senior Director
Government and Regulatory Affairs
Academy of Nutrition and Dietetics


1 Medical nutrition therapy (MNT) is an evidence‐based application of the Nutrition Care Process.  According 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.  Available at http://www.eatright.org/scope/ . Accessed March 1. 2016.]  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)).

2 MACPAC Comments to Congress on HHS Reports, dated June 30, 2011.  Accessed January 4, 2016. Available at https://www.macpac.gov/wp-content/uploads/2015/01/MACPAC_Comments-HHS_Reports_to_Congress_Dec2010.pdf.

3 Id. (Internal citations omitted.)

4 Id.

5 Id. (Internal citations omitted.)

6 Slinin Y, Guo H, Gilbertson DT, et al. Prehemodialysis care by dietitians and first-year mortality after initiation of hemodialysis. Am J Kidney Dis. 2011;58(4):583-90.

7 See, e.g., AACE/ACE Comprehensive Diabetes Management Algorithm, Endocr Pract. 2015;21(No. 4) ("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.")

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 See, e.g., Clinical Practice Guidelines for Chronic Kidney Diseases: Evaluation, Classification, and Stratification, National Kidney Foundation.  Accessed March 1, 2016 at http://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."). Chronic Conditions among Medicare Beneficiaries: 2012 Chartbook.  Available at http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/Downloads/2012Chartbook.pdf.  Accessed March 1, 2016.

10 Id.

11 Proof in Practice: A Compilation of Patient Centered Medical Home Pilot and Demonstration Projects, Patient-Centered Primary Care Collaborative, 2009.

12 Higgins S, Chawla R, Colombo C, Snyder R, Nigam S. Medical homes and cost and utilization among high-risk patients. A m J Manag Care. 2014:20(3):e61-e71.

13 Grade 1 data.  ADA Evidence Analysis Library, http:www.adaevidencylibrary.com/topic.cfm?cat=3949. [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."

14 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).

15 Gaunaurd I, Spaulding SE, Amtmann D, et al. U se of and confidence in administering outcome measures among clinical prosthetists: Results from a national survey and mixed-methods training program. P rosthet Orthot Int. 2015;39(4):314-21.

16 Academy of Nutrition and Dietetics Evidence Analysis Library.Medical Nutrition Therapy Evidence Analysis Project 2015, copyrighted by the Academy of Nutrition and Dietetics.

17 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).

18 Congressional Budget Office, "Estimating the Effects of Federal Policies Targeting Obesity: Challenges and Research Needs." Posted by Noelia Duchovny, Eamon Molloy, Lori Housman, and Ellen Werble, October 26, 2015. Accessed February 28, 2016 at https://www.cbo.gov/publication/50877.

19 Fakhouri, T.H.I; Ogden, C.L.; Carroll, M.D.; Kit, B.K.; Flegal, K.M. (2012). Prevalence of Obesity Among Older Adults in the United States, 2007-2010. NCHS Data Brief (106):1-8. Retrieved February 4, 2013 from http://www.cdc.gov/nchs/data/databriefs/db106.pdf.

20 Institute of Medicine (2000). The Role of Nutrition in Maintaining Health in the Nation's Elderly: Evaluating Coverage of Nutrition Services for the Medicare Population.

21 National Academy of Sciences (2012). Nutrition and Healthy Aging in the Community: Workshop Summary. Sheila Moats and Julia Hoglund, Rapporteurs; Food and Nutrition Board; Institute of Medicine. P. 22.

22 Stevens J.A., Corso P. S., Finkelstein E. A. et al. (2006). "The Costs of Fatal and Nonfatal Falls Among Older Adults," Injury Prevention. Vol. 12(5):290–95

23 Barker LA, Gout BS, and Crowe TC. Hospital malnutrition: Prevalence, identification, and impact on patients and the healthcare

system. International Journal of Environmental Research and Public Health. 2011;8:514-527.

24 Tappenden K, Quatrara B, Parkhurst, M et al. Critical role of nutrition in improving quality of care: An interdisciplinary call to action to address adult hospital malnutrition. Journal of Academy of Nutrition and Dietetics. 2013;113 (9): 482-497.

25 For the purposes of the Dialogue, undernutrition was the primary focus.

26 White JV, Guenter P, Jensen G, et al. Consensus Statement: Academy of Nutrition and Dietetics and American Society for Parenteral and Enteral Nutrition: Characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). Journal of Parenteral and Enteral Nutrition. 2012; 36:275-283.

27 Mueller C, Compher C, Ellen DM. A.S.P.E.N.Clinical guidelines: Nutrition screening, assessment, and intervention in adults. Journal of Parenteral and Enteral Nutrition. 2011;35(1):16–24.

28 NPUAP and EPUA Panel. National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel Pressure Ulcer Treatment Quick Reference Guide. Washington, DC; 2009.

29 Thomas DR, Ashmen W, Morley JE, and Evans WJ. Nutritional management in long-term care: Development of a clinical guideline. The Journal of Gerontology. 2000;55(12):M725–34.

30 Weimann A, Braga M, Harsanyi L, et al. ESPEN guidelines on Enteral Nutrition: Surgery including organ transplantation. Clinical Nutrition (Edinburgh, Scotland). 2006;25(2):224–44.

31 Isabel TD and Correia M. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clinical Nutrition. 2003;22(3):235–239.

32 Brugler L, DiPrinzio MJ, & Bernstein L. The five-year evolution of a malnutrition treatment program in a community hospital. The Joint Commission Journal on Quality Improvement. 1999; 25(4):191–206.

33 O'Flynn J, Peake, H, Hickson, M, et al. The prevalence of malnutrition in hospitals can be reduced: results from three consecutive cross-sectional studies. Clinical Nutrition. 2005;24(6):1078–88.

34 Academy-Avalere Health-Abbott Dialogue Proceedings - Launching the Malnutrition QI Initiative - White Paper, December 2014. Accessed February 29, 2016.  Available at

35 Dialogue Proceedings / Measuring the Quality of Malnutrition Care in the Hospitalized Elderly Patient, May 2014. Accessed February 29, 2016.

36 Becker PJ, Nieman carney L, Corkins MR, et al. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: indicators recommended for the identification and documentation of pediatric malnutrition (undernutrition). J Acad Nutr Diet. 2014;114(12):1988-2000.

37 Id.

38 Id.

39 Id.

40 AHRQ, "Final Refinement Document: Therapeutic Options for Obesity in the Medicare Population," May 22, 2014.  Accessed February 28, 2016 at http://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/topicrefinement/obesity_topic-refinement.pdf.

41

42 Slinin Y, Guo H, Gilbertson DT, et al. Prehemodialysis care by dietitians and first-year mortality after initiation of hemodialysis. Am J Kidney Dis. 2011;58(4):583-90.

43 For example, it is ambiguous whether "specialists" is defined to include non-physician providers, given the physician focused data in Table 1 of the Appendix.

44 2013 Reporting Experience Including Trends (2007-2014), Physician Quality Reporting System and Electronic Prescribing (eRx) Incentive Program. A pril 8, 2015. C enters for Medicare & Medicaid Services.

45 IOM (Institute of Medicine). 2012. Geographic adjustment in Medicare payment: Phase II: Implications for access, quality, and efficiency. Washington, DC: The National Academies Press.