Academy Comments to CMS re Medicare's Physician Fee Schedule and its Quality Improvement and Shared Savings Programs

September 10, 2018

Ms. Seema Verma, MPH
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attn: CMS-1693-P
P.O. Box 8016-8013
Baltimore, MD 21244-8016

Re: File Code- CMS-1693-P; Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program

Dear Administrator Verma:

The Academy of Nutrition and Dietetics (the "Academy") is pleased to provide comments on File Code- CMS-1693-P; Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program published in the Federal Register on July 27th, 2018. Representing over 107,000 registered dietitian nutritionists (RDNs),1 nutrition and dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of nutrition and dietetics practitioners and is committed to a world where all people thrive through the transformative power of food and nutrition. RDNs independently provide professional services such as medical nutrition therapy (MNT)2 under Medicare Part B and are recognized as Qualified APM Participants (QPs)3 in Medicare's Advanced Alternative Payment Models (APMs) under Track Two of the Quality Payment Program.

Overall, the Academy supports changes in the payment policies under the Physician Fee Schedule and modifications to the Quality Payment Program (QPP) and Medicaid Promoting Interoperability Program that incentivize and enable the health care system to provide the right care at the right time. The Academy urges CMS to carefully consider how policies under the Physician Fee Schedule and changes to the QPP can incentivize or preclude consumer (Medicare beneficiary and Medicaid enrollee) access to clinically effective services provided by non-physician Medicare providers. Payment policies and the changes to the QPP should also leverage and engage such providers in both MIPS and Advanced APMs.

MNT provided by RDNs is a widely recognized component of medical guidelines for the prevention and treatment of heart disease, diabetes, renal disease, obesity, and many other chronic diseases and conditions as well as in the reduction of risk factors for these conditions. As primary prevention, strong evidence supports optimal nutritional status as a cost-effective cornerstone in the maintenance of health, well-being, and functionality. As secondary and tertiary prevention, MNT is a cost-effective disease management strategy that reduces chronic disease risk, delays disease progression, enhances the efficacy of medical/surgical treatment, reduces medication use, and improves patient outcomes including quality of life.4 RDNs provide high quality, evidence-based care to patients and deliver substantial cost-savings to the health care system as a whole.

The Academy offers specific comment on the following proposed rule items:

  1. Determination of Practice Expense for Relative Value Units
  2. Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services
  3. Bundled Episode-Payment for Substance Use Disorders
  4. Eliminating Prohibition on Billing Same-Day Visits by Practitioners of the Same Group and Specialty
  5. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
  6. Updates to the Quality Payment Program
  7. Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs)
  8. Analysis of the Fee Schedule Impact on Specialties

1. Determination of Practice Expense (PE) Relative Value Units (RVUs)

HCPCS codes G0108 (Diabetes outpatient self-management training services, individual, per 30 minutes) and G0109 (Diabetes outpatient self-management training services, group session (2 or more), per 30 minutes) were identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. For CY 2019, CMS is proposing the HCPAC-recommended work RVU of 0.90 for HCPCS code G0108 and the HCPAC-recommended work RVU of 0.25 for HCPCS code G0109, which the Academy supports.

For the direct PE inputs, CMS noted that there is a significant disparity between the specialty recommendation and the final recommendation submitted by the HCPAC. CMS noted its concern about the significant decreases in direct PE inputs in the final recommendation when compared to the current makeup of the two codes. The final HCPAC recommendation removed a series of different syringes and the patient education booklet that currently accompanies the procedure. CMS notes in the proposed rule that they believe that injection training is part of these services and that the supplies associated with that training would typically be included in the procedures. Several anti-glycemic medications other than insulin require injection with a syringe and a significant number of persons with both type 1 and type 2 diabetes are prescribed these medications. However, the list of supplies in the current direct PE inputs does not include syringes. The Academy therefore recommends CMS add to direct PE inputs for HCPCs codes G0108 and G0109 the series of different syringes noted in our recommendation to the HCPAC.

2. Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services

The Academy recommends that CMS reimburse all members of the health care team for using technology based services as a way to ensure timely access to care and determine whether utilization of other health care services are necessary. The Academy supports actions that improve Medicare beneficiaries' access to all members of the health care team that are routinely furnished via communication technology. Technology-based services should be leveraged as one strategy to improve timely access to care as well as avoid unnecessary care; physicians and other qualified healthcare professionals should be compensated for using communication technology to assess and determine whether evaluation and management or other services are indicated.

  • The Academy supports adoption and payment for physicians and non-physician Medicare providers for code GVCI1 that describes brief communication technology-based services (e.g., virtual check-in) by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M services provided within the previous 7 days, nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment, 5-19 minutes of medical discussion. Adoption and payment for GVCI1 for non-physician Medicare providers who do not bill E/M services would support improved adherence to treatment plans for Medicare beneficiaries with diabetes, chronic kidney disease, and renal transplants. RDNs are increasingly receiving inquiries from patients through a variety of communication technologies about physiological data (e.g., blood glucose self-monitoring results, blood pressure, weight), medications, physical activity, adverse symptoms and/or food intake related to their nutrition care plan. RDNs make decisions about whether or not an MNT encounter may be necessary based on these inquiries. Often a brief virtual check-in offers the opportunity to make simple adjustments in a nutrition care plan that helps to avoid higher cost encounters with the health care system (e.g., hospitalizations, emergency department or urgent care center visits) and/or additional long distance trips to health care professionals for patients located in rural areas.
  • The Academy also supports unbundling the following Interprofessional Internet Consultation codes (CPT codes 994X6, 994X0, 99446, 99447, 99448, and 99449) making them available for separate billing by all Medicare Part B providers. Unbundling these codes would make it easier for physicians or other qualified healthcare professionals to obtain expert opinion without the need for the face-to-face interaction between the patient and the consultant, thus supporting the delivery of timely, cost effective care. The value of these services extends beyond physicians. For example, for patients receiving enteral or parenteral nutrition, a RDN can assist the treating physician with making appropriate changes to the feeding regimen to address intolerance issues based on a review of the patient's medical record (e.g., laboratory results, medications, physical examination and review of systems documented by the physician) and conversation with the physician via telephone or internet.
  • To fully leverage communication technology to improve timely access to care with cost effective providers and decrease unnecessary care and avoidable costs, the Academy urges CMS to recognize and implement payment beginning January 1, 2019 for telephone and on-line assessment and management services (CPT codes 98966-98969) that have already been defined by the CPT Editorial Panel and valued by the RUC. Medicare should follow the lead of other payers that already recognize the value of the above services in improving patient care and managing health care costs. Recognition of these services within the Medicare program is important in capturing real costs to non-physician practices.

3. Bundled Episode-Payment for Substance Use Disorders

In response to CMS's request for comments on whether a bundled episode-payment would be beneficial to improve access, quality and efficiency for substance use disorders (SUDs), the Academy supports CMS in doing so. Current federal guidelines for opioid treatment programs include "comprehensive care management and support services" and "health promotion." MNT services provided by RDNs are a critical treatment component for SUDs as these individuals frequently suffer from gastrointestinal issues, flare-ups of previously dormant auto-immune diseases, eating disorders/disordered eating and malnutrition in all its forms.5 This population often also benefits from life-skills training, including grocery shopping, meal planning and preparation, for which RDNs and NDTRs are best qualified to provide. Due to the multi-dimensional nature of opioid treatment programs, including the need to address all of the social determinants of health, the Academy believes it is essential that CMS build a payment model that leverages the unique expertise of the full health care team, including RDNs. Doing so requires the ability of these team members to be able to bill as independent billing providers as they are currently recognized under state and federal law. The Academy welcomes the opportunity to participate in development of such a bundled episode-payment.

4. Eliminating Prohibition on Billing Same-Day Visits by Practitioners of the Same Group and Specialty

The Academy supports actions to remove the current prohibition that prevents billing same-day visits by practitioners of the same group and specialty when there is a need to address unrelated problems which could not be provided during the same encounter. Current CMS guidelines prevent patients from receiving benefits of multi-specialty practices and also prevent a provider from addressing medical needs in a timely manner. The Academy encourages CMS to extend this policy to Federally Qualified Health Centers (FQHCs). Currently encounters with more than one FQHC practitioner on the same day constitute a single visit, except when the patient has an illness or injury requiring additional diagnosis or treatment subsequent to the first encounter or a qualified medical visit and qualified mental health visit on the same day. The Academy urges CMS to grant an exception for qualified medical visits and DSMT/MNT visits on the same day, similar to the current exception for medical and mental health visits. Many patients served by FQHCs have nutrition-related chronic conditions (e.g., 21% presenting with diabetes6) and would benefit from MNT and DSMT services. While a medical encounter and an MNT encounter are each considered billable visits in a FQHC under the Prospective Payment System, if such encounters are provided on the same day they constitute a single visit. With 92% of FQHC patients with incomes < 200% of the Federal Poverty Level7, making multiple visits on separate days presents a real barrier to medically necessary, cost-effective care.

Along similar lines, the Academy urges CMS to allow billing same-day visits for MNT and Diabetes Self-Management Training (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 these two 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 both have been proven necessary and cost-effective for improved beneficiary health outcomes. Further, same day provision allows for more effective multidisciplinary care.8 A regulatory change would allow beneficiaries to consolidate often-difficult and increasingly expensive trips to ambulatory care settings to receive needed care.

5. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

The Academy supports both the inclusion of the new CPT code 994X7 in the calculation of HCPCS code G0511 as well as the proposed new Virtual Communications G code for use by RHCs and FQHCs to encompass BVCI1 and GRAS1. The use of technology for such purposes can be efficient, cost-effective and better utilization of time from both the patient and provider perspectives. We do not support applying frequency limitations to virtual check-ins as the populations served by these health centers often have multiple chronic conditions that result in medical needs that arise over their lifetime. The cost of such virtual visits, even if unlimited, would more than offset even one avoided emergency room visit. We also do not support applying co-payments to such services as it could deter patients from communicating with their providers, a practice that once again could result in avoidable encounters with higher cost providers (e.g., emergency departments, urgent care centers).

6. CY 2019 Updates to the Quality Payment Program

General Comments

The Academy recognizes and appreciates CMS's efforts to try to simplify what is a very complex program, 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 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 through the lens of physician-providers only. 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.

MIPS Eligible Clinicians

As noted in the proposed rules, CMS blood that if the quality measures considered for removal are not finalized, then they would include registered dietitians in the definition of MIPS eligible clinicians (ECs) beginning with the 2021 payment year, provided that "we determine that…[they] would have at least 6 MIPS quality measures available to them." The Academy believes CMS’S rationale for not including RDNs in the list of ECs is flawed. RDNs currently have the following 7 quality measures available to them for reporting:

  • Quality ID#001: Diabetes: Hemoglobin A1c Poor Control (>9%)
  • Quality ID#126: Diabetes Mellitus: Diabetes Foot and Ankle Care, Peripheral Neuropathy – Neurological Evaluation
  • Quality ID#127: Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention, Evaluation of Footwear
  • Quality ID#128: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan
  • QualityID#130: Documentation of Current Medications in the Medical Record
  • Quality ID#181: Elder Maltreatment Screen and Follow-up Plan
  • Quality ID#431: Preventive Care and Screening: Unhealthy Alcohol Use – Screening and Brief Counseling

None of these measures are included in the list of proposed quality measures for removal in Appendix 1, Table C of the proposed rules. Several current MIPS ECs have fewer than 6 quality measures in their specialty measure sets (Dentists – 2; Electrophysiology Cardiac Specialists – 3; Radiation Oncologists – 4). Based on this flawed rationale, the Academy urges CMS to modify the definition of a MIPS eligible clinician, beginning with the 2021 MIPS payment year, to include registered dietitians. RDNs 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 cost-effectively improve the health and well-being of the Medicare population. RDNs are eager to participate in value-based payments and be held accountable for the direct patient outcomes of their effective services.

Finally, as the definition of MIPS eligible clinicians expands, 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 no 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.

Low-Volume Threshold and Opt-in

CMS proposes to add a third criterion to the low-volume threshold determination, namely providing < 200 covered professional services under the Physician Fee Schedule. The Academy appreciates such attempts by CMS to be sensitive to the needs of small practices and those in rural and Health Professional Shortage Areas. We seek clarification from CMS as to how "professional services" are to be defined for services that are billed in multiple units (e.g., MNT CPT codes 97802, 97803, 97804). For example, is 1 professional service defined by total units of the CPT code billed on a single date of service or defined by 1 unit of the code billed? At the same time, we continue to have serious concerns about the potential unintended consequences of the current levels for the low volume threshold. Based on data from Medicare Physician and Other Supplier NPI Aggregate Report CY20169, the majority of RDN Medicare providers would be excluded from participation based on both the number of Part B beneficiaries they treat and the Part B allowed charges. 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, non-end stage kidney disease, and 36 months post-renal transplant), 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 the current low volume thresholds is 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 Quality Payment Program will be through participation in APMs. While 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, 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 several existing and proposed options might mitigate this concern (e.g., the option to participate in MIPS via virtual groups, the addition of the proposed third criterion, and the proposed opt-in option), 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 as the Secretary exercises her authority to expand the definition of eligible clinicians, that 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 her authority under Section 1834 (n) (42 USC 1395(m))10 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. 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.11 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.12

The Academy reminds CMS of the National Academy of Medicine'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."13 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 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 or two, but not all, of the low-volume threshold criterion. 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.

Quality Performance Category

CMS proposes that once a measure has reached an extremely topped out status, CMS may propose the measure for removal in the next rulemaking cycle due to the extremely high and unvarying performance where meaningful distinctions and improvement in performance can no longer be made. While the Academy agrees in concept with eliminating topped out measures, we encourage CMS to consider the impact of doing so as new types of ECs are added to the Quality Payment Program. Performance on these measure may not be topped out for these provider types so that removal of the measures may create an important missed opportunity for performance improvement. CMS should consider an option whereby topped out measures might be removed by provider type rather than for all ECs or waiting to remove measures once expansion of ECs to all Medicare provider types is complete.

CMS is proposing that individual ECs would be able to submit a single quality measure via multiple submission types as opposed to currently needing to select one. CMS would then score on the data submission with the greatest number of measure achievement points. The Academy supports this flexibility in reporting and scoring since through the course of a performance year ECs access to submission types may change.

The Academy agrees with the proposed change in Quality#128 Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan to update the denominator exception logic for the eCQM Specifications collection type to allow medical reasons for not obtaining the BMI based on recommendations from the Technical Expert Panel convened by the measure steward.

Finally, the Academy urges CMS to adopt the following malnutrition eCQMs adopted by the National Quality Forum14:

  • NQF #3087/MUC16-294: Completion of a Malnutrition Screening within 24 hours of Admission
  • NQF #3088/MUC16-296: Completion of a Nutrition Assessment for Patients Identified as At-Risk for Malnutrition within 24 hours of a Malnutrition Screening
  • NQF #3089/MUC16-372: Nutrition Care Plan for Patients Identified as Malnourished after a Completed Nutrition Assessment
  • NQF #3090/MUC16-344: Appropriate Documentation of a Malnutrition Diagnosis

Through the QPP and other regulatory initiatives, CMS has already noted their intent to align quality measures across all care settings. Adoption of the malnutrition eCQMs provides an important opportunity to address malnutrition beyond the hospital and throughout the community at-large, as described in The National Blueprint: Achieving Quality Malnutrition Care for Older Adults,15 and to make sure care is delivered safely, effectively, equitably, and timely.

Cost Performance Category

The Academy is pleased to see proposals to add some episode-based measures to the cost performance category starting with the 2019 MIPS performance period. 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.

The Academy also supports a gradual increase of the weighting of the Cost performance category. We reiterate our concerns that as new provider types are added to the definition of MIPS ECs, they should be afforded the opportunity to transition into scoring as was afforded the first group of ECs.

Improvement Activities (IA) Performance Category

The Academy supports the proposed expansion of the annual Call for Activities to give stakeholders more time to submit new Improvement Activities to ensure the inventory 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.

We agree with the proposed changes to IA¬_PM_13: Chronic Care and Preventive Care Management for Empaneled Patients and recommend DSMT and MNT services be included in the description as appropriate services to be included in an individualized plan of care for persons with diabetes. The 2015 Joint Position Statement of the American Diabetes Association, the Association of Diabetes Educators, and the Academy of Nutrition and Dietetics "recommends that all health care providers and/or systems develop processes to guarantee that all patients with type 2 diabetes receive diabetes self-management education and support services (DSME/S) and ensure that adequate resources are available in their respective communities to support these services."16 MNT is noted to be an important adjunct to DSME/S that should be provided to all patients with type 1 and type 2 diabetes.17>

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 Improvement 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.18 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.19> 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.

Finally, the Academy recommends inclusion of the Malnutrition Quality Improvement Initiative (MQii) Toolkit and accompanying composite measure under the Improvement Activity performance category. This resource could serve as an opportunity for practitioners in clinics to use the tools to implement care coordination and improve transitions of care across settings in their system.

The Malnutrition Quality Improvement Initiative (MQii) offers a paired set of quality improvement resources -- a quality improvement toolkit and the Global Malnutrition Composite Score (Composite Measure) -- to advance evidence-based, high-quality, patient-driven malnutrition care. The program consists of using an interdisciplinary toolkit to target areas of malnutrition quality improvement and accompanying composite measure to track and monitor improvement on four key steps of malnutrition care. These steps include screening patients for risk of malnutrition, performing a nutrition assessment for those found to be at-risk, and finally documenting a nutrition care plan as well as a medical diagnosis for patients found to be malnourished upon assessment.

The MQii Toolkit provides user guidance to identify, implement, and assess changes resulting from malnutrition quality improvement efforts for achieving optimal malnutrition care in their practice. It is targeted to patients ages 65+ but the information and resources in the Toolkit can be used for all adult patients. Similarly, the composite measure is designed for facility-level use for patients ages 65+, but can easily be adapted to clinician-level use. Clinicians can better coordinate care for malnourished patients as well as those at-risk by establishing a standardized process for identification, treatment and follow-up care. The standardized process supported by the Toolkit and composite measure use a model that involves an interdisciplinary care team to coordinate appropriate care and communicate patient needs based on level of risk and severity of malnutrition. The Toolkit and eCQMs are available at www.MQii.today.

Promoting Interoperability (PI) 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 Interoperability Standards Advisory (ISA) now includes key nutrition health IT standards in the "Diet and Nutrition" chapter. The 2018 ISA also includes reference content supporting systematic inclusion of food allergies and intolerances along with all other allergies in health IT. The Academy has also focused on nutrition inclusion in health IT standards which encourage interoperability to 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.

The Academy supports the proposed rule to require use of the 2015 Edition certification criteria beginning with the CY 2019 performance period. 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. An HL7 C-CDA R2.1 Nutrition Implementation Guide was developed and balloted in January 2018 to assist EHR vendors and implementers in appropriate coded and narrative data which supports nutrition care by the RDN. Additionally, the Academy has worked with HL7 to update the standard for trial use Electronic Nutrition Care Process Record System - EHR Functional Model Profile which is currently on the HL7 September 2018 ballot. Therefore, use of 2015 Edition CEHRT will best position the RDN for participation as MIPS eligible clinician.

We agree that use of the 2015 Edition will reduce duplicative testing burden for clinicians, health IT developers and ONC-Authorized Testing Labs. We believe this will accelerate the development and use of APIs, such as HL7 FHIR. This will also provide new means by which MIPS eligible clinicians can benefit from improved workflows. Continued development of APIs that allow both READ and WRITE actions will help make data freely available to patients and third-party apps for patients and clinicians alike. The Academy commends CMS and ONC for the MyHealthEData initiative to enable patients with better electronic access to their health data via these API-connected applications, devices, and innovative technology solutions. We further believe that APIs offer clinical registries new ways to leverage EHR data for research and quality reporting purposes. The Academy has continued its efforts to support the development and testing of nutrition content as part of the HL7 FHIR specification which includes the NutritionOrder resource and mapping of Nutrition Care Process elements to the CarePlan resource. We participated in the HIMSS 2018 Interoperability Showcase and Public Health Informatics Conference connected demonstrations highlighting these capabilities for a dietitian referral scenario. While current CEHRT criteria related to promoting interoperability are based on exchange of C-CDA documents, as the FHIR standard and APIs evolve, this pathway may provide RDNs and other specialty providers more efficient ways to support electronic referral loops among MIPS eligible and non-MIPS providers. We encourage CMS to consider creating future interoperability measures that support the adoption of Application Programming Interfaces as alternative means of demonstrating performance in this category.

The Academy supports the new scoring methodology which eliminates the base and performance scores provided exclusions are retained for the e-Prescribing measure category. We continue to advocate that CMS design the program and develop measures in which all qualified health care professionals, no matter the size or location of the practice, or specialty, can reasonably participate, and that which aligns these measures with current scope of practice and state laws. We do agree that redistribution of e-Prescribing points to the Health Information Exchange objective measures seems reasonable for the near future. However, given that the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure will require time for development and adoption, it is likely that many MIPS eligible clinicians may require an exclusion for CY 2019. We recommend CMS extended this option to CY 2020, especially for those new to the program overall.

We support CMS efforts to provide MIPS eligible clinicians the flexibility to use the CDA templates which best fit their clinical workflows for the purposes of the Health Information Exchange objectives. This would allow use of the C-CDA Supplemental Nutrition Templates for nutrition referrals.

Complex Patients Bonus

The Academy supports CMS's proposal to continue the complex patient bonus for the 2021 MIPS payment year as currently defined. As noted in our CY2018 comments, 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.20 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. 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.

Performance Standards and Scoring

The Academy is concerned that the jump from a performance threshold of 15 points to 30 points in each category represents a significant jump and should not be made until there is adequate data from 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. Therefore we feel it would be premature to double the threshold in one year.

Improvement Scoring

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. 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 Medicare Star ratings. As a result, some of these organizations stopped participating in these programs.

MIPS Public Health Priority Sets

The Academy is pleased to note CMS's intent to consider in future rulemaking MIPS public health priority sets, with an initial focus on areas that address the opioid epidemic, as well as other patient wellness priorities that are attributable to more complex diseases or clinical conditions (blood pressure, diabetes, general health/healthy habits). The Academy recommends CMS include as a public health priority assessment of nutrition status for early identification and treatment of malnutrition in all its forms (including both undernutrition and obesity). The electronic composite measure of optimal malnutrition care developed by the Academy and Avalere Health should serve as a foundational piece of this public health priority set. 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.21 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.

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.22,23 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.

Two separate reports 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.24,25 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.26 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.

Qualified Clinical Data Registries

The Academy supports the updated definition of a Qualified Clinical Data Registry (QCDR) and timelines for technical partnerships proposed. We agree with CMS that QCDRs that participate in MIPS should have clinical expertise within medicine or a specialty, not solely expertise in quality measure development or purely technical capabilities. Measures developed by QCDRs should adhere to sound scientific principles and evidence-based practice according to the clinical area of expertise. However, we further recognize that nearly all specialty societies seeking to become QCDRs would likely contract with technical partners for measure development and testing expertise, but the named QCDR and measure steward should be that of the clinical entity. Given the extensive time required to fully develop and test new measures, we see no issue with requiring such partnerships to be legally in effect by the new proposed date of September 1 of the year prior to the year for which the entity seeks to become a QCDR.

All approved MIPS measures should be freely available to any individual or entity for MIPS reporting purposes. The Academy believes that the underlying purpose of quality measures is to track current practice in order to adapt and improve care based on the findings. If barriers, such as fees for use, are imposed on use of existing measures, the result will be duplication of measures for specific groups. This will make aggregation of the data and findings segmented. Therefore, we agree that CMS should require QCDR measure owners to enter into licensing agreements with CMS permitting any approved QCDRs to submit data on the QCDR unmodified measure as a condition of approval.

The Academy is concerned that the proposed requirement that all QCDR measures follow the present MIPS "Call for Measures" process will be unnecessarily burdensome and limiting, especially for a QCDR focused on development of measures unique to sub-specialties such as nutrition. We agree that in general outcomes measures should be favored over performance measures; however, we assert the need to start with performance measures in order to help identify gaps in care before outcome measures can be adequately addressed. As our experience developing the malnutrition eCQMs demonstrated, it was essential to confirm whether effective processes were in place to identify patients with malnutrition before clinicians could demonstrate whether interventions were effective.

Feedback Reports and Public Reporting

CMS proposes to not publicly report quality and cost measures for the first 2 years a measure is in use. The Academy supports this proposed change from 1 to 2 years as we agree it will encourage clinicians and groups to report new measures, get feedback on those measures, and learn from the early years of reporting measures before such information is made public.

QP Determinations for APM Entities

The Academy supports CMS' proposal to provide a third alternative to allow requests for QP determinations at the TIN level in instances where all clinicians who have reassigned billing rights under the TIN participating in a single APM Entity. RDNs are examples of clinicians that reassign their billing rights to organizations which may qualify as an APM Entity. Please refer to the Academy's input, request and substantiation regarding MIPS Eligible Clinicians on page 6 which underscores the reason for input on this section. Providing clinicians who may qualify as QPs at multiple levels (TIN-level, APM Entity level, or individual level) with QP assessments for all levels is not only needed, but it is necessary for transparency and confidence in the process of determining the QP status that is most advantageous to the eligible clinician. Providing this option also has the potential to support a key principle of Alternative Payment Models identified by the HealthCare Payment Learning & Action Network: Value-based incentives should ideally reach care teams who deliver care.27 Providing this third option has the potential to engage more clinicians in value-based care.

7. Medicaid Promoting Interoperability Program Requirements for Eligible Professionals

CMS is proposing to give each state the flexibility to identify which of the available eCQMs selected by CMS are high priority measures for EPs in that state, with review and approval from CMS, through their State Medicaid HIT Plans (SMHP), similar to the flexibility granted states to modify the definition of Meaningful Use at §495.332(f). The Academy supports this proposal as we agree with CMS that doing so would give states the ability to identify as high priority those measures that align with their state health goals or other programs within the state.

8. Analysis of the Fee Schedule Impact on Specialties

CMS routinely and inexplicably omits analysis of the impact of the proposed physician fee schedule changes for the RDN specialty; RDNs are not listed in Table 94 "CY 2019 PFS Proposed Rule Estimated Impact on Total Allowed Charges by Specialty." CMS's omission of RDNs in Table 94 makes it difficult for the Academy and RDN Medicare providers to recognize the impact of fee schedule changes on their practices. The Academy urges CMS to annually include the RDN specialty in this table to facilitate an analysis of fee schedule changes on this vital healthcare specialty.

Finally, the Academy associates ourselves with the comments submitted by the Obesity Care Advocacy Network, Defeat Malnutrition Today, and the Diabetes Advocacy Alliance.

In closing, current Medicare program policies do not allow registered dietitian nutritionists to practice as independent providers for the full scope of services for which RDNs are qualified and which are clinically indicated for Medicare beneficiaries, including MNT, Annual Wellness Visits, and intensive behavioral therapy for obesity and risk factors for cardiovascular disease. The Academy supports the IOM's recommendation in its report, Geographic adjustment in Medicare payment: Phase II: Implications for access, quality, and efficiency, that states "the Medicare program should support policies that would allow all qualified practitioners to practice to the full extent of their educational preparation."28 As CMS continues its efforts to achieve its goals of Better Care, Smarter Spending, and Healthier People, it is important that it sets policies that fully leverage the contributions of all members of the health care workforce, including both primary care and specialty care providers.

Thank you for your careful consideration of the Academy's comments on the proposals for the 2019 Medicare Physician Fee Schedule. 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 Initiatives & Advocacy
Academy of Nutrition and Dietetics

Marsha Schofield, MS, RD, LD, FAND
Senior Director, Governance
Academy of Nutrition and Dietetics


1 The Academy has approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.

2 Medical nutrition therapy (MNT) is an evidence-based application of the Nutrition Care Process. The provision of MNT (to a patient/client) may include one or more of the following: nutrition assessment/reassessment, nutrition diagnosis, nutrition intervention and nutrition monitoring and evaluation that typically results in the prevention, delay or management of diseases and/or conditions. Academy of Nutrition and Dietetics' Definition of Terms list updated May 2017. Accessed August 23, 2018.

3 APMs Overview, accessed August 23, 2018

4 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.'"

5 Academy of Nutrition and Dietetics: Revised 2018 Standards of Practice and Standards of Professional Performance for Registered Dietitian Nutritionists (Competent, Proficient, and Expert) in Mental Health and Addictions Journal of the Academy of Nutrition and Dietetics, October 2018, Volume 118, Number 10.

6 Community Health Center Chart Book. National Association of Community Health Centers. June 2018. Accessed August 26, 2018.

7 Community Health Center Chart Book. National Association of Community Health Centers. June 2018. Accessed August 26, 2018.

8 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.

9 Medicare Physician and Other Supplier NPI Aggregate Report CY2016. Accessed August 25, 2018.

10 (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.

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

12 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).

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

14 www.eatrightpro.org/practice/quality-management/quality-improvement/malnutrition-quality-improvement-initiative. Accessed September 5, 2018

15 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.

16 Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Fischl AH, Maryniuk MD, Siminerio L, Vivian E. Diabetes self-management education and support in type 2 diabetes: A joint position statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. Jour Acad Nutr Diet. 2015; 115(8): 1323-2334.

17 Standards of Medical Care in Diabetes – 2018. American Diabetes Association. Diabetes Care. 2018: 41(1): S29-S30. Accessed September 4 2018.

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

19 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).

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

21 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.

22 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.

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

24 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.

25 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.

26 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.

27 Alternative Payment Model Framework 2017

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