Academy Comments to CMS re Medicare Program; CY 2018 Updates to the Quality Payment Program

August 21, 2017

Ms. Seema Verma, MPH
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attn: CMS-5522-P
P.O. Box 8013
Baltimore, MD 21244-8013

Re: File Code- CMS-5522-P; Medicare Program; CY 2018 Updates to the Quality Payment Program

Dear Administrator Verma:

The Academy of Nutrition and Dietetics (the "Academy") is pleased to provide comments on CMS-5522-P; Medicare Program; CY 2018 Updates to the Quality Payment Program published in the June 30, 2017 issue of the Federal Register. The Academy represents over 98,000 Registered Dietitian Nutritionists1 (RDNs) who independently provide professional services such as medical nutrition therapy (MNT) under Medicare Part B.

Overall, the Academy supports efforts aimed at achieving better care, smarter spending and healthier people. MNT provided by RDNs is a widely recognized component of medical guidelines for the prevention and treatment of heart disease, hypertension, diabetes, renal disease, obesity, and many other chronic diseases and conditions as well as in the reduction of risk factors for these conditions. As primary prevention, strong evidence supports optimal nutritional status as a cost-effective cornerstone in the maintenance of health, well-being, and functionality. As secondary and tertiary prevention, MNT is a cost-effective disease management strategy that reduces chronic disease risk, delays disease progression, enhances the efficacy of medical/surgical treatment, reduces medication use, and improves patient outcomes including quality of life.2 As such, MNT provided by RDNs can and should be an important component of any alternative health care delivery model and appropriately recognized in any new APMs and associated payment incentives.

RDNs previously participated in the Medicare Part B Physician Quality Reporting System, providing high quality, evidence-based care to patients and delivering substantial cost-savings to the health care system as a whole. And, they are currently participating in some of the CMS Innovation Center's APMs and Advanced APMs. While RDNs are not yet considered "eligible clinicians" (ECs) under the Merit-based Incentive Payment System (MIPS), many are choosing to voluntarily report so as to continue to demonstrate their contributions to improved patient outcomes and wise spending.

The Academy offers specific comments on the following aspects of the Quality Payment Program Year 2 proposals:

  1. General Comments
  2. The Merit-Based Incentive Program System (MIPS)
    1. Low-Volume Threshold
    2. Submission Mechanisms
    3. Virtual Groups
    4. Quality Performance Category
    5. Cost Performance Category
    6. Improvement Activities Performance Category
    7. Advancing Care Information Performance Category
    8. Complex Patients Bonus
    9. Performance Standards and Scoring
    10. Improvement Scoring
    11. Feedback Reports and Public Reporting
  3. Advanced Alternative Payment Models (Advanced APMs)
    1. All-Payer Combination Option
    2. Performance Standards and Scoring
    3. Physician-Focused Payment Models

1. General Comments

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) sets health care payments to physicians and non-physician Medicare providers on a new course. Overall the goals set forth under MACRA are lofty ones with a vision of a perfect world of health care delivery and patient engagement. As CMS works to implement the provisions of MACRA related to MIPS and APMs, the Academy overall urges CMS to consider the needs of non-physician providers. Based on 2015 data, "other professionals" (meaning not an MD, DO, NP, CNS, PA, or CRNA) represent a large proportion of Eligible Professionals (EPs) for the Physician Quality Reporting System, representing approximately 26% in 2015.3 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 Quality Payment Program (QPP). 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 strongly recommends CMS convene a Technical Expert Panel (TEP) comprised of individuals representing these "other professionals" to inform adaptation of the Quality Payment Program to meet their needs before these professionals become eligible clinicians under this program. Representatives from the AMA RUC HCPAC could serve as members of such a TEP, as they are knowledgeable about the PFS, PQRS, and APMs.

RDNs are eager to participate in value-based payments and be held accountable for the outcomes of their effective services. Some RDNs are already participating in alternative payment models as part of some forward-thinking physician office practices as well as through some Innovation Center initiatives (e.g., the Comprehensive Primary Care Plus initiative and the Oncology Care Model). 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 part of the patient-centered health care team. Unfortunately, the traditional fee-for-service payment system simply has not adequately recognized the value of MNT services provided by RDNs for multiple chronic conditions and disease states despite compelling evidence and national clinical practice guidelines explicitly supporting their contributions to the goals of better care, smarter spending and healthier people. As a result, access to vital MNT services only happens under a system that is heavily reliant on referrals to RDNs who work in their own non-physician practice settings. In order to achieve CMS's ideal health care delivery and patient engagement system envisioned under MACRA and afford Medicare beneficiaries better opportunities for improved health through such proven effective services, the following are required to effectively design the Quality Payment Program:

  1. Physicians should be either mandated or incentivized to utilize non-physician providers such as RDNs.
  2. Non-physician providers, such as RDNs, need to be afforded the same opportunities to earn value based payments as physicians and other Medicare providers, given RDNs' contribution to better care, smarter spending, and healthier people.
  3. Non-physician providers, such as RDNs, should not be financially penalized due to a lack of recognition under the MIPS and Advanced APMs. The systems must provide equitable opportunities (meaning equitable to physicians) for non-physician providers to earn value based payments.

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 use. 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.4 RDNs are recognized as the most qualified food and nutrition experts by the National Academies of Sciences, Engineering and Medicine's Health and Medicine Division (formerly the IOM), most physicians, and the United States Preventive Services Task Force (USPSTF) for providing nutrition care more effectively at a lower cost than physicians, nurse practitioners, and physician assistants.5

The Academy reminds CMS of the NAM'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."6 As CMS continues its efforts to achieve its goals of better care, smarter spending, and healthier people through the Quality Payment Program, it is important that it sets policies that fully leverage the contributions of all highly qualified members of the health care workforce, including both primary care and specialty care providers. The Academy urges the Secretary to exercise his authority under Section 1834 (n) (42 USC 1395(m))7 of the Social Security Act to modify the current Part B Medicare MNT benefit to include diet-related chronic diseases as a significant step towards achieving CMS's goals of better care, smarter spending, and healthier people. The pool of RDN Medicare providers working in these disease states and conditions would grow, increasing access to clinically effective, low cost services that would be more appropriately incentivized through both pathways of the Quality Payment Program.

The Academy recognizes and appreciates CMS'S efforts to offer a transition year for participation in the QPP and to continue aspects of that transition into Year 2. The program is complex as evidenced by the amount of resources CMS has invested in provider outreach and education as well as technical assistance. Both ECs and those Medicare providers, such as RDNs, who elect to voluntarily report, have been challenged to master new terminology, performance measures, reporting standards and requirements along with in many cases implementing practice redesign. While overall MACRA and the proposed rules set forth requirements intended to provide flexibility and support the needs of small practices, rural providers, and specialty providers, the Academy is concerned that it is being done only through a physician-provider lens. As a result, CMS may not be maximizing opportunities to fully transform the delivery and payment systems to meet its stated goals. The Academy looks forward to continued opportunities to work with CMS to design a health care delivery and payment system that improves the health of the nation and meets the needs of all stakeholders.

MACRA gives the Secretary the authority under section 1848(q)(1)(C)(i)(II) to expand the definition of MIPS eligible clinician to include additional eligible clinicians (as defined in section 1848(k)(3)(B) of the Act) through future rulemaking. Currently the "other professionals" noted above (including RDNs) are excluded from the definition of an eligible clinician for the first two years of the program. The Act requires the Secretary to permit any eligible clinician who is not a MIPS eligible clinician the option to volunteer to report on applicable measures and activities under MIPS and CMS strongly encourages these providers to do so to gain experience with the program to prepare for future eligibility. Such a statement implies that the MIPS will be rolled out to other Medicare Part B providers in a design similar to what is published in the finalized rules for Year 1 and Year 2 of the program. The new Quality Payment Program must be designed in a manner from the outset that meets the needs of these essential health care providers, without whom the overarching goals of better care, smarter spending, and healthier people cannot be achieved. Such providers should also be afforded the opportunity for a similar ramp-up period for payment adjustments as the initial cadre of eligible clinicians.

2. The Merit Based Incentive Program System (MIPS)

Low-Volume Threshold

CMS proposes to increase the low-volume threshold beginning in performance year 2018 to exclude MIPS clinicians or groups who treat 200 or fewer Part B beneficiaries or have Part B allowed charges less than or equal to $90,000 in an attempt to be sensitive to the needs of small practices and those in rural and Health Professional Shortage Areas. While we support the intent of excluding low-volume providers and increasing the low-volume threshold, we have serious concerns about the potential unintended consequences of this proposed change. Based on data from Medicare Physician and Other Supplier NPI Aggregate Report CY20158, the majority of RDN Medicare providers would be excluded from participation based on the number of Part B beneficiaries they treat. These low-volumes are a direct result of the limited scope of the current Part B MNT benefit (i.e., limited at this time to diabetes and non-end stage kidney disease), restrictions on referring provider types, and limited provider and beneficiary awareness of the benefit. Payments to these RDNs would continue to fall under the Physician Fee Schedule (PFS). The Academy has major concerns that an unintended consequence of this scenario will be driving these proven effective providers out of the Medicare program as payments under the PFS will essentially decrease over time based on other provisions of MACRA. In addition, these providers will be disadvantaged as their primary opportunity for earning incentive payments under the Medicare program will be through participation in APMs. As previously noted, it is still the exception for physician office practices to directly employ and/or contract with RDNs due to a lack of explicit recognition by CMS and other payers of the value of RDNs as part of the patient-centered health care team. While we recognize that CMS's proposal for ECs to participate in MIPS via virtual groups might mitigate this concern, RDNs and other non-physician health care professionals participating in the Medicare program should not have fewer options for participation than their physician peers. The Academy recommends that if the Secretary exercises his authority in the future to expand the definition of eligible clinicians, that as previously stated CMS convene a Technical Expert Panel (TEP) comprised of individuals representing these "other professionals" to inform adaptation of the Quality Payment Program to meet their needs, including determination of appropriate volume caps based on provider type.

If the Secretary would exercise his authority under Section 1834 (n) (42 USC 1395(m))9 of the Social Security Act to modify the current Part B Medicare MNT benefit to include diet-related chronic diseases experienced by Medicare beneficiaries, it would go a long way toward achieving CMS's goals of better care, smarter spending, and healthier people and to avoiding a migration of RDN providers out of the Medicare program. The pool of RDN Medicare providers would grow, increasing access to clinically effective, low cost services that would be more appropriately incentivized through both pathways of the Quality Payment Program.

CMS is also proposing the opportunity to allow clinicians to opt-in to MIPS, starting with the 2019 MIPS performance period, if they exceed one of the low-volume threshold components. Taking into consideration the Academy's overarching concerns about the low-volume threshold noted above, we do support the "opt-in" concept as we view it as an opportunity for certain providers who otherwise would be excluded from MIPS to participate and potentially earn positive financial adjustments that they otherwise would not be eligible to receive.

Submission Mechanisms

CMS proposes allowing ECs to use multiple submission mechanisms to submit measures and activities within each of the MIPS performance categories (other than cost) for both individual and group reporting. The Academy supports this option as it allows for increased flexibility for reporting based on the needs and capabilities of individual and group practices. It also provides ECs with the opportunity to move to new submission methods as their practice capabilities evolve (e.g., adoption of CEHRT). We do have some concerns that more flexibility may create more complexity and confusion as well as administrative burden on CMS. We strongly support CMS in counting the submission that gives the EC the higher score. We encourage CMS to include in provider feedback reports EC scores on all submissions to help ECs select submission mechanisms in future reporting periods.

Virtual Groups

CMS is proposing Virtual Groups as a new third option for participating under MIPS as a means for interested small groups to meet the threshold required to be considered an EC. The Academy strongly supports this option as it provides a realistic and attractive mechanism for providers to participate in MIPS and be eligible for positive payment adjustments not otherwise available to them. As noted above, if the definition of ECs is expanded in the future to include "other professionals," most RDN Medicare providers would be excluded from MIPS based on not meeting the low-volume threshold. Virtual Groups provides a solution to this concern. The virtual group option may help to enhance the viability of small practices, which in turn enhances patient access to necessary, efficacious services, thus helping to meet the goals of better care, smarter spending, and healthier patients.

CMS proposes multiple provisions around the virtual group concept. The Academy overall supports the proposed provisions. In particular, we support CMS in creating a sample "Model Agreement" for use by virtual groups and offering technical assistance. The Academy urges CMS to provide technical assistance to support virtual groups beyond the first two years of virtual group implementation to take into consideration "other professionals" being added to the list of ECs in the future and needing similar support. We also support CMS in not restricting virtual groups by specialty or geographic location, as we believe such restrictions would impose unnecessary constraints on ECs with no clear benefits to patients, providers or the Medicare program. We do not recommend imposing a limit on the size of virtual groups in the future as we see no benefit in doing so from either the EC or Medicare program perspective. Before recommending such a limit, the Academy recommends CMS review several years of data from virtual groups to determine if there is an optimal size associated with best patient outcomes or reporting success.

Quality Performance Category

The Academy supports CMS's proposal to retain the final score performance weight of the Quality category at 60% and Cost at 0% for one more year. While we recognize that if this proposal is confirmed in the final rule, it would result in a large adjustment in category weighting in the 2019 performance year, we agree with CMS that an additional year would be beneficial to improve clinicians' understanding of the measures and to continue to create new episode based measures.

The Academy also supports CMS in maintaining the data completeness threshold at 50% for the 2018 MIPS performance period for data submitted via QCDRs, qualified registries, EHR or Medicare Part B claims. We agree with CMS that an additional year to gain experience with MIPS is important before increasing this threshold and caution CMS to move cautiously as it proposes increases in data completeness thresholds in future years. While the Quality performance category is similar to PQRS, with which ECs are already familiar, the overall MIPS is new to providers and requires time to master the complexities of reporting options, thresholds, and scoring. Thus a continued "transition" approach to the program is a wise move to help ensure its success and understanding by both providers and patients. Once again, the Academy urges CMS to offer "other professionals" a similar ramp-up period as the initial cadre of ECs once they are deemed ECs for the program. While CMS is offering such providers the opportunity to voluntarily report, the reality is that there is not concrete incentive for doing so. Thus, the perceived benefits do not exceed the time and resources necessary to do so and providers are not opting to take advantage of this opportunity. We recognize that CMS may be restricted from doing so based on provisions in the MACRA. If such is the case, we recommend that CMS offer technical assistance to ECs new to MIPS for at least their first two years of participation and also consider offering one-time bonus payments for voluntary reporting.

CMS proposes a new method for dealing with Topped Off Measures, outlining a four-year process for identification, scoring and discontinuation of the Quality measure from the inventory. The Academy considers the method reasonable and in particular supports applying removal of a measure only to the specific submission mechanism where the measure is topped out. However, while we support the general direction proposed by CMS for the Quality performance category, the Academy continues to have concerns that the current set of quality measures does not provide equitable opportunities across all provider types to support a payment system that places more weight on outcomes measures. Until such time, the Academy supports efforts by CMS and other organizations to create more outcomes-based measures to support such a system in the future. Also, as the Academy and other Medicare providers have noted in responses to previous rule-makings under the PFS, many eligible providers do not have six measures to report, thus creating an administrative burden on CMS through application of the MAV process.

Finally, the Academy agrees with the proposed change in Quality#128 Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan to change the frequency of documenting BMI from six to twelve months as it aligns with current research and does not preclude more frequent documentation.

Cost Performance Category

The Academy supports CMS's proposal to maintain the final score performance weight at 0% for the 2018 performance reporting period/2020 MIPS payment year. While we recognize that if this proposal is confirmed in the final rule, it would result in a large adjustment in category weighting in the 2019 performance year, we agree with CMS that more time is needed to improve clinician understanding of the measures and to continue to create new episode based measures.

The Academy also supports CMS's proposal to not include the previous episode based measures in scoring this category. The Academy is currently participating in several of the clinical care subcommittees that are developing new episode based measures and looks forward to continued opportunities to do so in the future. The Academy urges CMS to continue to include the full range of provider types in the development of such measures so as to fully capture the total cost of care involved in these episodes of care.

Improvement Activities (IA) Performance Category

The Academy supports CMS's proposals to maintain the current weight to final score, number of activities to report and scoring policies for APMs and MIPS APMs for the Improvement Activities Performance Category. For group reporters, CMS is proposing to increase the requirement from one practice to 50% of the number of practices within a tax identification number (TIN) must be recognized as a certified or recognized patient-centered medical home or comparable specialty practice in order for the TIN to get the full credit for this category. While the Academy supports increasing the requirement to be more fully representative of performance improvement efforts of the TIN, we are concerned that the jump is rather large for one year and recommend CMS consider a more gradual increase over time. This performance category represents a new area of reporting for ECs and, while the intent is worthy, it warrants a more gradual transition.

The Academy supports the proposed annual Call for Activities process as an important mechanism for provider and other organizations to add to the inventory of Improvement Activities to ensure it includes an appropriate quantity and types of measures that are meaningful to each specialty (including non-physician Medicare providers), most appropriately captures their role on the patient-centered health care team, and have a positive impact on patient care. One of the strategic goals of MIPS is to use design incentives that drive movement toward APMs, so the system must continue to roll out in a manner that recognizes the challenges faced by non-primary care health care professionals to become integrated into APMs.

We agree with the proposed additions to the IA measure inventory as noted in Table F. In particular we support "[i]mplementation of systemic preventive approaches in clinical practice with documentation of referring eligible patients with pre-diabetes to a CDC-recognized diabetes prevention program." We recommend strengthening and expanding this measure to change "referring eligible patients to a CDC-recognized diabetes prevention program" to "completed referral of eligible patients with pre-diabetes to appropriate providers based on their risk level, including RDNs and CDC-recognized diabetes prevention programs." "Completed" referral would be defined to mean a referral that is acted upon. While we recognize many factors influence whether a referral is acted upon, such a change in the measure would require referring providers to close the loop on the referral process and move the system closer to an outcomes-based one. Also, as CMS notes in its CY 2018 proposed rules for the expansion of the Medicare Diabetes Prevention Program model, "We recognize that some Medicare beneficiaries may have other serious conditions, such as heart disease or cancer, and therefore may also have specific dietary requirements. We recommend that beneficiaries with complex dietary needs consult their health care provider as to whether they should participate in MDPP." It is critical for providers to refer the "right patient" to the "right service" at the "right time" in the context of Improvement Activities. MNT provided by an RDN is designed to meet the needs of Medicare beneficiaries with complex dietary needs. Research shows that MNT provided by a RDN is an effective evidence-based practice that can result in weight loss, obesity prevention and improved prediabetes insulin markers which are the same essential outcomes of other diabetes prevention programs.10,11,12

The Academy agrees with the proposed revisions to IA_AHE_3, Leveraging a QCDR to Promote Use of PRO Tools. In particular, we support including the additional examples of patient-reported Wound Outcome and patient reported Nutritional Screening. For the latter, we recommend use at this time of the DETERMINE Checklist as a valid nutrition screening tool used throughout the United States in non-institutionalized older persons.13 By removing the QCDR specific language it opens up the opportunity to promote use of PRO tools across all submission mechanisms. Assessing nutrition status using validated tools in all settings across the continuum of health care is a vital first step in improving the health of Medicare beneficiaries, and our nation as a whole, as noted in The National Blueprint: Achieving Quality Malnutrition Care for Older Adults.14 Malnutrition is associated with many adverse outcomes. Beyond nutrition screening, it is imperative that patients identified at nutrition risk be referred to RDNs for a complete nutrition assessment and, as appropriate, development and implementation of an individualized plan of care aimed at improving nutrition status. Unfortunately, a disconnect often exists between screening for nutrition risk and appropriate referrals and follow-up. Far too often identification and treatment of malnutrition does not occur until a person gets admitted to a hospital. The importance of malnutrition prevention and identification and intervention of at-risk and malnourished individuals is magnified by malnutrition's impact on independence, healthy aging, and the severity of medical conditions and disabilities. In short, older adults are a particularly vulnerable population for poor nutrition. They are at higher risk of malnutrition than other age groups and will therefore benefit substantially from improved malnutrition care. Chronic diseases such as cancer, stroke, diabetes, gastrointestinal, pulmonary, and heart disease and their treatments can result in changes in nutrient intake that can subsequently lead to malnutrition.15,16 Two separate reports recently published by the AHRQ Hospital Cost Utilization Project (HCUP) clearly detail the burden of malnutrition on patients in the hospital setting and the significant increased costs of care.17,18 Overall, the economic burden of disease-associated malnutrition in the U.S. is estimated to be as high as $157 billion in 2014, with $51.3 billion associated with older adults.19 With the number of adults aged 65 years and older expected to reach 74 million by 2030, it is critical that CMS incorporate into the QPP the necessary performance measures to support early identification and treatment of this potentially costly condition in the non-institution setting to help improve patient outcomes and decrease health care spending.

The Academy also recommends several other additions to the IA measure inventory. The Academy has completed work on Improvement Activity tools for use by RDNs. One such resource tool is the Standards of Excellence (SoE) Metric Tool. The SoE Metric Tool directly aligns with the IA component within the MIPS program. The MIPS IA component encourages providers to establish and conduct practice improvement activities best suited for their practice. The SoE Metric Tool is a self-assessment tool for RDNs to measure and evaluate their practice's programs, services and initiatives that identify and distinguish the RDN brand as the professional expert in food and nutrition. RDNs utilizing this tool will be able to input pertinent data, identify gaps within performance, and ultimately generate quality improvement programs and activities. The Academy recommends CMS incorporate the SoE tool into the IA inventory and allow RDNs to report CPIA activities through this tool when they become eligible clinicians under MIPS.

The Academy recommends CMS consider including in the IA Inventory under Population Management the integration of a registered dietitian onto the care team. This IA is evidence-based, aligns well with several of the existing activities under this domain, and is consistent with the existing recommendation to integrate a pharmacist into the care team to assist with medication management.

The Academy recommends development and inclusion of an IA measure on referrals to RDNs for MNT services for patients with nutrition-related chronic conditions (including chronic renal disease stage 3 and 4 and diabetes, for which Medicare Part B benefits exist and are underutilized) in accordance with clinical practice guidelines. 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 use. 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.20 RDNs are recognized as the most qualified food and nutrition experts by the National Academy of Medicine (formerly IOM), most physicians, numerous clinical guidelines, and as evidenced by recommendations of the United States Preventive Services Task Force (USPSTF), providing nutrition care more effectively at a lower cost than physicians, nurse practitioners, and physician assistants.21 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 more effective. 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 cost-effective and an integral component of treatment. Given the low utilization of MNT when it could make a significant impact, CMS should develop process and outcome quality measures of appropriate use that recognize the benefits of referring patients to RDNs for MNT, consistent with the explicit recommendations of the USPSTF.

The Academy also strongly encourages CMS to allow MNT and Diabetes Self-Management Training (DSMT) to be allowed on the same date of services as an IA.  Current regulations around these services are another example of a serious, burdensome disconnect between theory in this set of proposed rules and other current regulatory constraints. Several activities under the proposed IA inventory subcategories of Care Coordination and Beneficiary Engagement incentivize self-management services, which by definition includes DSMT. Existing Medicare regulations do not allow DSMT and MNT to be provided on the same date of service, thus burdening quality and access to care and creating undue hardships for persons with diabetes. Many Medicare beneficiaries forgo 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.22 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.23 Compared with no prevention, self-management reduces a high-risk person's 30-year chances of getting diabetes by 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.24 With 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.

We also support the proposed provisions to accommodate small practices and practices located in rural areas, or geographic HPSAs as we believe such adjustments will enable these providers to successfully participate in this important component of the program.

Advancing Care Information (ACI) Performance Category

The Academy is committed to embracing adoption and optimization of Health Information Technology (health IT) to improve health and health care in the United States. Despite not being considered as an Eligible Professional (EP) in the EHR Meaningful Use program, the Academy has been an active, consistent participant in the Health Information Technology for Economic and Clinical Health (HITECH) initiatives since 2009, including presence at a majority of the face-to-face Health IT Standards Committee and Policy Committee meetings held in Washington, DC; have commented in writing and in-person; and have actively participated in Office of the National Coordinator (ONC) Initiatives for development and harmonization of health IT standards, vocabularies and policies. The Academy continues to align existing nutrition care processes and strategies in order to include nutrition care in CEHRT requirements. In particular, we remain committed to those initiatives which we believe will help us embrace an improved health care system and optimal nutritional status for individuals and the population as a whole.

The Academy has participated in Health Level Seven (www.hl7.org) standards development consistently since 2010. Our strategy has been to advocate for nutrition inclusion in cross-cutting, balloted standards in efforts to document nutrition care across care situations and settings. Efforts are directed at assuring nutrition inclusion where possible in guidance from the Office of the National Coordinator of Health IT, and in particular, standards identified in the 2015 Edition Health IT Certification Criteria25, the 2017 Interoperability Standards Advisory26, and in subsequent guidance which supports nationwide interoperability. In particular, the 2017 ONC Interoperability Standards Advisory (ISA) now includes key nutrition health IT standards in the "Diet and Nutrition" chapter. The 2017 ISA also includes new reference content supporting systematic inclusion of food allergies along with all other allergies in health IT. The September 2017 HL7 ballot includes beginning value sets for food, medication and environmental allergies based upon frequency data from 81 million patient records. The Academy has focused on nutrition inclusion in health IT standards which support transitions of care across care settings, including nutrition content sections in the now mandated HL7 Consolidated Clinical Document Architecture Release 2.1. We are dedicated to providing nutrition in health IT standards and guidance in a way that supports optimal nutrition care according to CEHRT.

Since RDNs have not been EPs under Meaningful Use, the Academy strongly supports the exclusion for the e-Prescribing Measure and Health Information Exchange Measures for certain MIPS ECs.

We view this proposal as a critical step by CMS to design the QPP in a manner that respects the roles of all qualified health care professionals and to meet their needs, no matter the size or location of the practice. It also addresses concerns about alignment of these measures with current scope of practice and state laws. Such steps may increase the ability of "other professionals," such as RDNs, who are deemed ECs in the future, to be able to be scored under this performance category rather than reassigning the weight to other categories.

The Academy encourages CMS to expand its existing programs of financial and technical support to all such providers to help them achieve not just successful performance under the Quality Payment Program, but more importantly to achieve the overall benefits of leveraging health information technology into our nation's health care delivery system. We continue to have concerns that the degree of reweighting that may be necessary across the four performance categories for certain provider types may create undesirable inequities within the system that could lead to a mass exodus of Medicare providers. For this specific performance category, the model of support that has been in place for physicians could be expanded to other provider types to proactively address this concern. For example, we support CMS's proposal to offer a bonus of 10 percentage points under the ACI performance category for MIPS ECs who report the ACI Measures using only 2015 Edition CEHRT and recommend that CMS offers similar incentives as new categories of ECs are added in the future. We also encourage CMS to consider creating a financial assistance program to support development and adoption of Application Programming Interfaces as one method to support interoperability.

We support the proposed new Improvement Activities eligible for the ACI bonus. Leveraging health IT is an important piece of practice for all health care providers, albeit there are challenges in doing so for small practices due to limited resources and lack of financial support/incentives from federal agencies such as CMS. RDNs are already incorporating technology into their practice and, at such time as they become ECs under the QPP, would welcome the opportunity to earn a bonus for doing so. The Academy has developed health IT standards via HL7 which support nutrition content in all appropriate areas, including representation of our Nutrition Care Process in the C-CDA R2.1, which is included in both the 2015 Edition and the IMPACT Act. At the recommendation of industry experts, the Academy is now developing a HL7 C-CDA R2.1 Nutrition Implementation Guide to guide EHR vendors and implementers in appropriate coded and narrative data which supports nutrition care by the RDN.

While overall the Academy would like to see accelerated movement to 2015 CEHRT as it provides a much greater use of interoperability of a complete data set of care, the Academy supports CMS's proposal to extend the use of the 2014 CEHR in 2017 for the reasons cited by CMS. We encourage CMS to consider offering a similar extension in future years of the QPP based on the landscape of use of CEHRT by small practices and solo practitioners.

Finally, the Academy supports CMS's proposed addition of a new category of hardship exceptions for small practices to reweight the ACI performance category to 0 and reallocate the ACI performance category weight of 25% to the Quality performance category. While overall we support designing the QPP in a manner that enables equal and equitable participation by all ECs, we do agree with CMS that small practices have unique needs that need to be addressed through the program design. We see this new significant hardship exception an important step to support small practices as many RDNs provide services to Medicare beneficiaries as solo practitioners or through small practices.

Complex Patients Bonus

The Academy is pleased to see efforts by CMS to take into account the multitude of factors that describe and have an impact on patient health outcomes, such as the health status and medical conditions of patients as well as social risk factors. As noted in CMS's "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.27 By the nature of the Medicare Part B MNT benefit, the majority of Medicare beneficiaries served by RDNs are complex based not only on the existence of multiple chronic conditions, but also based on social risk factors which are closely related to nutritional status. As noted by CMS, patient complexity is often directly related to resource utilization and impacts performance across all four MIPS categories. Current payments under the Medicare Physician Fee Schedule do not adequately address the impact of these factors on provider resource utilization, especially for non-physician health care providers such as RDNs who cannot directly bill for chronic care management services. Payment and incentive systems, such as the QPP need to be designed to appropriately recognize patient complexity and not create an unintended consequence of providers "cherry-picking" patients to avoid downward payment adjustments. As noted by CMS, selecting the method by which to do so is not an easy decision and the Academy supports CMS in moving gradually in this direction, utilizing simple methods as a start and then advancing and fine-tuning based on experience. In the spirit of "transition" that has been a cornerstone of the roll-out of the QPP, the Academy recommends that CMS implement the complex patients bonus as proposed in the rules for performance feedback purposes only in CY 2018 so both providers and the Medicare program can evaluate the validity of the methodology and potential impact on payment in future years of the program.

Performance Standards and Scoring

The Academy supports CMS in keeping the same performance category weights for performance year 2018. We also support the proposed "extreme and uncontrollable circumstances" to protect ECs from receiving negative payment adjustments due to poor reporting resulting from things outside of their control.

The Academy is concerned that the jump from a performance threshold of 3 points to 15 points in each category represents a significant jump and should not be made until there is adequate data from the first year of QPP reporting to determine if it is an appropriate and reasonable threshold on which to base payment adjustments. The QPP is in its early stages of implementation and ECs are still learning the system. CMS has offered ECs the "pick your pace" option and until all ECs are required to report a full year of data, we feel it would be premature to increase the threshold by 500% in one year.

CMS proposes to increase the minimum performance period for the Quality performance category from a minimum of 90 days to one year, the same as the Cost performance category, while keeping the minimum period for IA and ACI at 90 days. Due to the inter-relatedness of the Quality and Cost categories, the Academy feels it makes sense to use the same minimum reporting period for both performance categories. A full year of data provides a more accurate picture of an EC's performance, especially in the case where some Quality measures only need to be reported once per year.

The Academy is pleased that CMS continues to propose a performance scoring system that strives to keep clinician flexibility and administrative burden in mind. At the same time, we continue to be concerned that in an effort to build in flexibility CMS is not achieving one of its desired goals of creating a program that is understandable. Extensive and ongoing education, training and technical assistance continues to be required to ensure eligible clinicians fully understand how the Quality Payment Program works and how to successfully establish and implement appropriate reporting systems within their practices. Once again, before expanding the definition of eligible clinicians to include other categories of Medicare providers, this aspect of design of the MIPS would benefit from the creation of Technical Expert Panels.

Improvement Scoring

As mandated under MACRA, CMS proposes to implement Improving Scoring for the Quality and Cost performance categories. The Academy supports CMS's proposal to measure improvements at the performance category level for Quality category and at the measure level for the Cost category for the reasons cited. We support the overall concept of basing improvement scoring for Quality on the rate of improvement. One of the challenges with scoring under the MIPS is how best to recognize a high level of performance as well as achieving improvements in performance. CMS's proposed approach to calculate achievement percent scores upon which an improvement percent score would be added appears to be a reasonable approach to this challenge. The Academy continues to encourage CMS to be careful not to design the system in such a way that it only rewards continuing improvement. Such a goal becomes difficult under the statutory requirement for budget neutrality, but is critical to provider participation and retention. As practices become high performers, their margin for continued improvement diminishes. Yet their contributions to quality, cost-effective care are still worthy of recognition. One of the flaws of some of the Medicare ACO models is that high performers ended up paying money back to CMS, despite the fact that they had high Star ratings. As a result, some of these organizations stopped participating in these programs.

Feedback Reports and Public Reporting

Beginning July 1, 2018, CMS proposes to provide performance feedback to MIPS ECs and group for the Quality and Cost performance categories for the 2017 performance period, and if technically feasible, for the Improvement Activities and Advancing Care Information performance categories at least annually (more frequently, such as quarterly, as technically feasible). CMS also proposes to provide reports for clinicians who voluntarily report under MIPS. The Academy recommends providing quarterly feedback reports if possible to provide clinicians with regular, timely feedback that supports continuous practice improvement. We recommend providing feedback on all four performance categories to allow clinicians to understand their performance across the entire Quality Payment Program, recognizing that in any particular quarter an EC may not have reported data yet for the IA and ACI performance categories due to the minimum 90 day minimum performance period. The Academy also supports providing performance feedback reports to clinicians who voluntarily report under MIPS as this information will help them better understand the program and prepare for successful participation in the future when they are deemed ECs.

In terms of public reporting of MIPS data, CMS proposes to make available all data submitted voluntarily across all MIPS performance categories, regardless of submission method, by all clinicians and groups not subject to the MIPS payment adjustments, as technically feasible. These clinicians and groups would have the option to opt out of having their data publicly reported. The Academy supports efforts to make provider data available to the public in an easily understandable format to support informed patient choice of their health care providers. We support the "opt out" option for these providers who are voluntarily reporting under MIPS as the system is still evolving to fit the unique needs of these other professionals, some of whom (such as RDNs) have not had experience reporting under all of the MIPS performance categories (such as ACI). It should be clear to consumers that these providers are not currently MIPS ECs with an easy to understand explanation of voluntary reporting status and how to interpret the data.

3. Advanced Alternative Payment Models ( Advanced APMs)

All-Payer Combination Option

CMS is proposing a new Advanced APM option, the All-Payer Combination Option, beginning in the 2019 QP performance period. The Academy supports development of this new option for determination of Qualified Participant status under the Advanced APM track of the QPP. As noted above, RDNs have limited opportunity to participate in Medicare Part B based on the limit in diagnoses currently covered under the MNT benefit. The Medicaid, Medicare Advantage, and Commercial Payer markets offer much more expanded access to patients to medically necessary MNT services for the wide variety of conditions for which it has been demonstrated to be effective. MNT provided by RDNs is a widely recognized component of medical guidelines for the prevention and treatment of heart disease, hypertension, diabetes, renal disease, obesity, and many other chronic diseases and conditions as well as in the reduction of risk factors for these conditions. 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.28 As such, MNT provided by RDNs can and should be an important component of any alternative health care delivery model and appropriately recognized in any new APMs and associated payment incentives. Creating this All-Payer Combination Option affords RDNs the opportunity to more fully demonstrate and be financially rewarded for the positive impact of their services on patient outcomes and health care spending.

Advanced APM Performance Standards and Scoring

The Academy supports CMS's proposal to add a 4th snapshot for determining which ECs are participating in a MIPS APM for purposes of the APM scoring standard as it provides participants who joined certain APMs in the 4th quarter of the performance year to benefit from the scoring standard. We also support other proposals related to the APM scoring standards for the quality payment category. These proposals help to better align the design of the Quality Payment Program with other value-based payment models, thereby reducing burden on participating providers.

As noted above, the Academy overall urges CMS to consider the needs of non-physician providers as it promotes Alternative APMs and incentivizes participation in such models. 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" PCMH rather than being employed by the entity. 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 Technical Expert Panel (TEP) comprised of individuals representing these "other professionals" to inform efforts to offer incentive payments for participation in APMs before these professionals become eligible clinicians under the Quality Payment Program. Representatives from the AMC RUC HCPAC could serve as members of such a TEP as they are knowledgeable about the PFS, PQRS, and alternate payment models. The Academy is currently developing some alternate payment models for nutrition services. We would welcome the opportunity to share our work with CMS in the hopes that the agency would adopt the models and/or use them to inform their work around promoting and incentivizing APMs.

Physician-Focused Payment Models

CMS proposes to broaden the definition of Physician-Focused Payment Models (PFPM) to include payment arrangements that involve Medicaid or the Children's Health Insurance Program (CHIP) as a payer even if Medicare is not included as a payer. The Academy supports this broader definition as it affords CMS and providers to design and test a wider array of new payment models that have the potential to demonstrate value to beyond just the Medicare program and the population it serves. Such a change has the potential to engage more stakeholders in designing PFPMs. For example, the Academy would welcome the opportunity to work with other stakeholders on alternative payment models for maternal and child health based on the critical role nutrition plays in these populations and existing gaps in care resulting from the fee-for-service payment system.

RDNs are eager to be part of value-based payments and be held accountable for the outcomes of their effective services. Some RDNs are already participating in alternative payment models as part of some forward-thinking physician office practices as well as through some Innovation Center initiatives (e.g., the Comprehensive Primary Care initiative and the Oncology Care Model). 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 part of the patient-centered health care team and unintended consequences of value-based payments (e.g., providers using low cost existing office staff who may not possess the necessary competencies or qualifications). Unfortunately, the traditional fee-for-service payment system simply has not adequately recognized the value of MNT services provided by RDNs despite compelling evidence and national clinical practice guidelines explicitly supporting their contributions to the goals of better care, smarter spending, and healthier people. As a result, access to vital MNT services only happens under a system that is heavily reliant on referrals to RDNs who work in their own non-physician practice settings.

Thank you for your careful consideration of the Academy's comments on these proposed rules. The Academy looks forward to continued opportunities to work with CMS to design a health care delivery and payment system that improves the health of the nation, meets the needs of all stakeholders. Please do not hesitate to contact Jeanne Blankenship by phone at 312-899-1730 or by email at jblankenship@eatright.org or Marsha Schofield at 312-899-1762 or by email at mschofield@eatright.org with any questions or requests for additional information.

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

Marsha Schofield, MS, RD, LD, FAND
Senior Director
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 Grade 1 data. Academy Evidence Analysis Library. [Grade Definitions: Strength of the Evidence for a Conclusion/Recommendation Grade I, "Good evidence is defined as: "The evidence consists of results from studies of strong design for answering the questions addressed. The results are both clinically important and consistent with minor exceptions at most. The results are free of serious doubts about generalizability, bias and flaws in research design. Studies with negative results have sufficiently large sample sizes to have adequate statistical power."

3 2015 Reporting Experience Including Trends (2007-2016), Physician Quality Reporting System. Centers for Medicare & Medicaid Services.

4 Academy of Nutrition and Dietetics Evidence Analysis Library. Medical Nutrition Therapy Effectiveness Systematic Review 2009, 2013-2015.

5 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).

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

7(n) Authority to Modify or Eliminate Coverage of Certain Preventive Services for Eligible Adults in Medicare.—Notwithstanding any other provision of this title, effective beginning on January 1, 2010, if the Secretary determines appropriate, the Secretary may—
(1)modify—
(A)the coverage of any preventive service described in subparagraph (A) of section 1861(ddd)(3) to the extent that such modification is consistent with the recommendations of the United States Preventive Services Task Force; and the services included in the initial preventive physical examination described in subparagraph (B) of such section; and
(B)the services included in the initial preventive physical examination described in subparagraph (B) of such section; and
(2)provide that no payment shall be made under this title for a preventive service described in subparagraph (A) of such section that has not received a grade of A, B, C, or I by such Task Force.

8 Medicare Physician and Other Supplier NPI Aggregate Report CY2015. Accessed August 6, 2017.

9 (n) Authority to Modify or Eliminate Coverage of Certain Preventive Services for Eligible Adults in Medicare.—Notwithstanding any other provision of this title, effective beginning on January 1, 2010, if the Secretary determines appropriate, the Secretary may—
(1) modify—
(A) the coverage of any preventive service described in subparagraph (A) of section 1861(ddd)(3) to the extent that such modification is consistent with the recommendations of the United States Preventive Services Task Force; and the services included in the initial preventive physical examination described in subparagraph (B) of such section; and
(B) the services included in the initial preventive physical examination described in subparagraph (B) of such section; and
(2) provide that no payment shall be made under this title for a preventive service described in subparagraph (A) of such section that has not received a grade of A, B, C, or I by such Task Force.

10 Redmon JB et al. Two-year outcome of a combination of weight-loss therapies for type 2 diabetes. Diabetes Care. 2005;28(6):1311-1315.

11 Corpeleign E. et al. Improvement in glucose tolerance and insulin sensitivity after lifestyle intervention are related to changes in serum fatty acid profile and desaturase activities: the SLM study. Diabetologia. 2006;49(10):2392-2401.

12 Parker, AR, Byham-Gray L. Denmark R, Winkle PJ. The effect of medical nutrition therapy by a registered dietitian nutritionist in patients with prediabetes participating in a randomized controlled clinical research trial. J Acad Nutr Diet. 2014;114(11):1739-48.

13 Posner BM, Jette AM, Smith KW, Miller DR. Nutrition and health risks in the elderly: the nutrition screening initiative. Am J Public Health. 1993;83(7):972-978.

14 Defeat Malnutrition Today. Avalere Health and Malnutrition Quality Collaborative. The National Blueprint: Achieving Quality Malnutrition Care for Older Adults. Defeat Malnutrition Today. Published March 2017.

15 Agarwal E, Ferguson M, Banks M, et al. Malnutrition and poor food intake are associated with prolonged hospital stay, frequent readmissions, and greater in-hospital mortality: results from the Nutrition Care Day Survey 2010. Clin Nutr. 2013:32(5):737-745.

16 Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008;27(1):5-15.

17 Weiss AJ, Fingar KR, Barrett ML, et al. Characteristics of Hospital Stays Involving Malnutrition, 2013: Statistical Brief #210. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville (MD) 2016.

18 Fingar KR, et al. Statistical Brief #281: All-Cause Readmissions Following Hospital Stays for Patients With Malnutrition, 2013. Agency for Healthcare Research and Quality, Healthcare Cost and Utilization Project. September 2016.

19 Snider J, et al. Economic burden of community-based disease-associated malnutrition in the United States.JPEN J Parenteral Enteral Nutr. 2014;38:55-165.

20 Academy of Nutrition and Dietetics Evidence Analysis Library. Medical Nutrition Therapy Effectiveness Systematic Review 2009, 2013-2015.

21 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).

22 Senator Mark Kirk letter to Donald Berwick, MD MPP, dated 23 September 2011, attached hereto (Quoting Centers for Medicare & Medicaid Services.  NCD Decision Memo for Medical Nutrition Therapy Benefit for Diabetes & ESRD (CAG-00097N). Centers for Medicare & Medicaid Services Website.

23 See Robbins JM, Thatcher GE, Webb DA, Valdmanis VG. Nutritionist visits, diabetes classes, and hospitalization rates and charges: the Urban Diabetes Study. Diabetes Care. 2008;31(4):655-60; Boren SA, Fitzner KA, Panhalkar PS2; Specker, J. Costs and Benefits Associated with Diabetes Education: A Review of the Literature. The Diabetes Educator. 2009;31(1):72-96.

24 Ibid.

25 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications Final Rule – October 6, 2015.  HealthIT.gov website. Accessed August 20, 2017.

26 2016 Interoperability Standards Advisory. HealthIT.gov website. Accessed August 20, 2017.

27 Chronic Conditions among Medicare Beneficiaries: 2012 Chartbook. Accessed August 15, 2015.

28 Grade 1 data. Academy Evidence Analysis Library. [Grade Definitions: Strength of the Evidence for a Conclusion/Recommendation Grade I, "Good evidence is defined as: "The evidence consists of results from studies of strong design for answering the questions addressed. The results are both clinically important and consistent with minor exceptions at most. The results are free of serious doubts about generalizability, bias and flaws in research design. Studies with negative results have sufficiently large sample sizes to have adequate statistical power."