September 7, 2017
Ms. Seema Verma, MPH
Centers for Medicare and Medicaid Services
Department of Health and Human Services
P.O. Box 8013
Baltimore, MD 21244-8013
Re: File Code- CMS-1676-P; Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program
Dear Administrator Verma:
The Academy of Nutrition and Dietetics (the "Academy") is pleased to provide comments on CMS-1676-P; Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program published in the Federal Register on July 21, 2017.
Representing more than 100,000 registered dietitian nutritionists (RDNs)1 nutrition and dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation's health through food and nutrition across the lifecycle. Every day we work with Americans in all walks of life — from prenatal care through end of life care — providing nutrition care services and conducting nutrition research. RDNs independently provide professional services such as medical nutrition therapy (MNT)2 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, 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.3 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:
- Medicare Diabetes Prevention Program
- MACRA Patient Relationship Categories and Codes
- Medicare Telehealth Services
- Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment
- Payment Accuracy for Prolonged Preventive Services
- Request for Information on CMS Flexibilities and Efficiencies
- Analysis of the Fee Schedule Impact on Specialties
1. Medicare Diabetes Prevention Program
The Academy is pleased to see the proposals on topics of interest to potential Medicare suppliers of the Medicare Diabetes Prevention Program (MDPP) as CMS and providers prepare to deliver and receive payment for these new covered services. As noted in the proposed rules, diabetes presents a significant burden on the Medicare program, behooving CMS to take actions geared toward prevention of this disease so as to meet its goal of Better Care, Smarter Spending, and Healthier People. The Academy appreciates the opportunity to provide input on this next set of proposed rules with the intention of helping CMS design a benefit that helps reduce the burden of diabetes on individuals and the Medicare program itself while maintaining necessary program integrity.
- The Academy is pleased that in the proposed rule CMS has repeatedly underlined its intent to align with CDC's Diabetes Prevention Recognition Program (DPRP) guidelines. We urge CMS to maintain close alignment with the DPRP so MDPP suppliers are not hampered by conforming to two different regimes.
- The Academy urges CMS to establish pilot programs to continue testing specific changes of the program that could improve beneficiary access and progress toward MDPP clinical goals and program savings. We are particularly interested in the potential for pilot programs to examine the impact of changes to lifetime limits and the maintenance session framework.
- The Academy urges CMS to offer Technical Assistance programs for potential and existing MDPP suppliers, similar to what is offered for CMMI projects (e.g., Comprehensive Primary Care Plus).
- The Academy urges CMS, as part of its evaluation of the expanded MDPP model test, to calculate the total cost of care for MDPP services based on various personnel types (e.g., community health workers, RDNs, CDEs, other qualified health care professionals) as well as study the effectiveness of various methods of delivery of the MDPP based on personnel. Such efforts would meet two of the future research needs identified by the Institute for Clinical and Economic Review (ICER) in its 2016 Final Evidence Report – Diabetes Prevention Programs: (1) Identify specific elements of DPPs that are associated with participant success, and (2) Examine the long-term impact of DPPs on population health, and diabetes prevention, and on health care utilization and costs.4
The Academy offers the following comments related to specific components of the proposed rules:
Expanded Model Start Date
The Academy commends CMS for moving forward with MDPP implementation in a timely fashion and are delighted that services will begin on April 1, 2018. We agree that a 90 day delay from January 1, 2018, is both reasonable and necessary to ensure MDPP suppliers will be ready to deliver services by April 1. Many potential suppliers are awaiting publication of the final rules before deciding how to move forward. At the same time, many programs are ready to enroll as a Medicare supplier and have waiting lists of Medicare beneficiaries eager to begin receiving these services under the Medicare program. We encourage CMS to move quickly to create a process and provide guidance about the enrollment of MDPP providers so that the process can move as smoothly as possible. Since you plan to create a MDPP-specific enrollment application prior to January 1, 2018, we encourage you to make the application available as soon as possible
Mid-Program Diabetes Diagnosis
The Academy recommends that beneficiaries who develop type 2 diabetes while receiving MDPP services be allowed to continue to receive services until the end of the current service period (i.e., core sessions, core maintenance session interval, or ongoing maintenance session interval). There should be mandatory referrals for MNT and DSMT services and programs should have referral sources in place. While the Academy supports CMS' intention of allowing beneficiaries who develop type 2 diabetes to continue to receive MDPP services after they have begun the program, we have concerns about potential unintended consequences related to utilization of the existing MNT and DSMT benefits. We agree that it may be burdensome for suppliers to verify diabetes status and blood test results continually, however someone who develops type 2 diabetes should be receiving appropriate medical care and associated self-management training services from qualified health care professionals. Coordination of care between the MDPP suppliers and the beneficiaries' health care team is imperative for the delivery of patient-focused, quality, cost-effective care. We commend CMS for allowing individuals who develop type 2 diabetes to also receive MNT and DSMT services while receiving MDPP services, but are concerned that these individuals may not receive the necessary referrals to MNT and DSMT services as more confusion is introduced into the health care system about the differences and distinct benefits of each of these services. While the education gained in MDPP programs is appropriate for individuals with type 2 diabetes and will help them better manage their disease, it is not sufficient in and of itself for individuals with type 2 diabetes. Unless the lifestyle coach is a RDN or certified diabetes educator, they may not have the necessary knowledge and skills to provide appropriate support to individuals with diabetes.
The Academy is glad to see that CMS reduced the burden on suppliers from offering maintenance for an indefinite period. While individuals often need ongoing support to maintain behavior change, experience of our members shows that individuals start dropping out of programs at 12 months. It is not clear in the proposed rules as to whether beneficiaries must receive consecutive months of maintenance services or if there can be a break in services due to major life events, such as a newly developed health condition by the participant or a loved one; or death of a loved one; assuming successful participation up to that point.
As CMS finalizes this part of the regulation, we urge CMS to consider that seniors who enter maintenance sessions may desire to receive their maintenance sessions in a different location than where they received their core sessions. Many seniors travel to warmer climates for the winter or to be near far-flung family and would need to change their supplier accordingly. Furthermore, as the baby boom generation ages into Medicare, we expect those seniors will be more accustomed to changing providers and "shopping around" for different experiences than previous cohorts of seniors. This has important implications not only for the maintenance sessions but also the ability of seniors to switch MDPP suppliers mid-program, as proposed by CMS elsewhere in this rule. A pilot study to examine this issue could help CMS determine how this part of the benefit should be structured in future iterations.
Once-Per-Lifetime Set of Services
The Academy commends CMS for striving to limit Medicare program costs, but is concerned that a once-per-lifetime limit will punitively deny some beneficiaries the benefits of a program that reduces Medicare program costs while also improving quality of life for those at risk for diabetes. We have concerns that beneficiaries who might benefit from the program, yet at first initiate it before they are at the appropriate stage of change, would be precluded from the opportunity to access the MDPP at a later time when they would be ready to successfully complete the program. Stages of change lie at the heart of the trans-theoretical model of change,5 an evidence-based framework that states that persons move through a series of stages when modifying behavior. Only a minority of a population at risk is prepared to take action at any given time. In addition, significant life events, such as death of an immediate family member, divorce, or serious illness may cause an individual who may otherwise be successful in the program to have to drop out. A precedent for such an opportunity already exists within Medicare regulations as the Intensive Behavioral Therapy for Obesity benefit is not limited to once-in-a-lifetime, which is also a program designed to help beneficiaries achieve weight loss to reduce risk for other chronic diseases. To recognize these legitimate reasons for non-completion of the MDPP core sessions, the Academy recommends CMS allow individuals the opportunity to access MDPP services a second time based on a referral from their primary care provider. This opportunity would only apply to the core sessions and not the maintenance session.
We also urge CMS to work with NIH to study the effect of allowing a beneficiary to enroll in the program multiple times. If this is undertaken, we encourage CMS and NIH to study the following:
- Weight loss is extremely difficult and complex and some beneficiaries may need multiple attempts to be successful. The literature on tobacco cessation supports the difficulty of making such a dramatic lifestyle change and the need of some patients to make multiple attempts.6 Psychological literature may also be instructive here. We note that Medicare already covers tobacco cessation for eight visits in a 12 month period, which can be repeated annually with no cap.
- Is continual weight lost a requirement to re-enter the program? Those who may benefit most from maintenance sessions are those who have re-gained weight lost during the core sessions and require maintenance sessions to "get back on track."
- At what point should beneficiaries re-enter the program for greatest effect and efficiency? For example, under what circumstances should beneficiaries re-enter the program at the maintenance session and under what circumstances should they repeat the entire core curriculum from the beginning?
- How much time can elapse before each new re-attempt? How many re-attempts are allowable?
Any re-enrollment mechanism contemplated should allow beneficiary choice and access while also discouraging a "revolving door" or potential gaming, particularly during the first year of the program when the most reimbursement is at stake.
Payment Structure, Bridge Payment, Billing Codes
The Academy applauds CMS for moving toward performance-based payment. This structure, in accordance with how the Medicare DPP model test was performed and stated goals of CMS, promotes valuable, cost-saving interventions at the expense of a volume-based focus.
The Academy is extremely concerned that the new proposed payment levels do not adequately cover the cost of providing core and maintenance session services, respectively. Organizations with higher overhead costs and those programs that use the most qualified individuals as lifestyle coaches (e.g., RDNs, NDTRs, CDEs) may opt not to enroll as suppliers of the MDPP. As a result, CMS may once again experience significant underutilization of important services that could benefit both beneficiaries and the Medicare program as a whole as we contend with the dual epidemics of obesity and diabetes. As noted in our comments for the CY 2017 MPFS proposed rules, we once again request that CMS provide information on how payment rates have been determined, similar to information published in the Medicare PFS rules for any services covered under the Part B Medicare program. While the proposed rules contain extensive information on payment rates, they do not clearly explain the derivation of the proposed payment numbers.
We also urge CMS to apply geographic adjustment of payments for MDPP services so as to equitably incentivize potential MDPP suppliers across the country and support adequate access to these services. We understand that the MDPP model test was conducted in limited geographic areas, but we believe CMS has enough experience with geographic payment adjustments in performance based payment structures to apply such adjustments to payments for these services.
The Academy also urges CMS to consider the distribution of payments over the course of the program. For example, most supplier costs (e.g., administrative costs, staffing, beneficiary engagement, recruitment, etc.) are incurred up front or in the initial weeks of the program. This will require MDPP suppliers to amass enough capital to pay for this largely on their own until they receive the first outcomes-based payments.
Another issue is how the payments are distributed when a beneficiary "switches" between suppliers. While we applaud CMS for anticipating this and proposing a bridge payment to make up for costs, this may not be enough depending on the timing of the switch. For example, if the beneficiary has already met most of their weight goals or entered the maintenance portion of the program, most of the payments will have already gone to Supplier A while Supplier B is then responsible for administering the entire maintenance session portion of the benefit without reaping any of the rewards of the performance-based payment. Even if the volume of such switching is low, capital will still be required to fill in the gap between the cost to administer the program and the amount of funds the supplier is eligible to receive at that point based on how far the beneficiary has gone through the program. We recommend CMS make available to suppliers an on-line system to verify if a beneficiary has received coverage of MDPP services from another supplier similar to systems used to verify other Medicare benefits.
The Academy understands CMS's need to balance Medicare program costs but also believes that to increase access of Medicare beneficiaries to Medicare DPP, we must ensure that providers are incentivized to invest in these critical programs.
Finally, the Academy has concerns about the proposed HCPCS G-Codes for MDPP services (Table 33). While the code structure will provide rich data for program evaluation purposes, it provides an unnecessary level of complexity, especially for program personnel with limited knowledge and skills in medical billing. We recommend CMS consider a simplified code structure that perhaps includes 1 G-code for each of the following:
- Core sessions
- Core maintenance sessions
- Ongoing maintenance sessions
- 5% weight loss
- 9% weight loss
While this proposal does not provide the same degree of granularity that may be beneficial from a research/program evaluation perspective, we believe it retains the performance-based payments in a manner that will reduce administrative burden on suppliers and reduce potential billing errors. No matter how CMS ultimately establishes billing codes for MDPP services, the Academy recommends CMS include the following items in their billing instructions:
- A grid with G-codes and payment amounts (similar to Table 33)
- Groupings of codes most likely to be billed together
- Sample completed CMS 1500 claim forms for various scenarios
- ICD-10 codes that can be used when billing for these services
MDPP Supplier Enrollment and Preliminary Recognition
The Academy continues to urge CMS to require MDPP services to be delivered by or under the supervision of qualified health care providers, such as an RDN, NDTR, or CDE. We feel such a requirement provides better program integrity by ensuring quality oversight of coaches. Many MDPP participants may have comorbidities that put them in a high-risk category. The current CDC program recognition standards do not include any specific requirements to ensure these individuals are identified and appropriately referred to necessary health care services and providers. In addition, experience of Academy members delivering Diabetes Prevention Programs or providing MNT services to participants of such programs reveals the unfortunate frequent occurrence of participants being provided with incorrect nutrition information and advice that is detrimental to their health. Data to date on CDC recognized programs indicates some of the most successful programs use both lay coaches and health professional coaches, such as RDNs. Finally, one of the barriers to expansion of the DPP noted in the ICER report is "the extensive efforts required to screen, identify, train, and retain skilled lifestyle program coaches who can connect to the community targeted by the DPP."7 RDNs and NDTRs already possess these skills and so provide a readily available workforce for the MDPP program.
We recommend CMS not move forward with the proposed MDPP interim preliminary recognition standard but rather wait until the new CDC DPRP guidelines are finalized. Creating this new category of recognition specific to the MDPP will create unnecessary confusion in the supplier community and impose undue administrative burden on the Medicare program. The CDC DPRP guidelines will be finalized in a timely enough manner so as to expand the pool of potential MDPP suppliers available to service this population.
On these sections, the Academy would like to once again emphasize the need for timely guidance from CMS. To help ensure a successful implementation of MDPP, we suggest:
- Creating a timeline of when suppliers and other stakeholders can expect to receive guidance from CMS and what will be contained in each portion of the guidance
- Creating a process through which MDPP suppliers can get questions answered outside of the regular rulemaking process as they begin the process of enrollment and claims submission, which will be new both to most MDPP suppliers as well as the Medicare program. CMS should consider making some answers public if the topic is not proprietary for an individual MDPP supplier.
MDPP Supplier Standards
Regarding MDPP supplier enrollment forms, the Academy urges CMS to use sub-regulatory processes to provide MDPP suppliers with as much advance notice and guidance as possible to enable providers to be ready to begin accepting beneficiaries on April 1, 2018. To this end, we encourage CMS to (1) share as early as possible the forms MDPP suppliers will need to fill out to enroll as Medicare suppliers; (2) solicit input on the form from key stakeholders; and (3) work with the Medicare Administrative Contractors (MACs) to ensure they are ready to work with MDPP suppliers as they become enrolled.
Class Size Limits
The Academy supports the current proposal by CMS to not require a specific class size limit for MDPP sessions. We agree that suppliers should have the flexibility to determine optimal class size to effectively deliver MDPP services to help beneficiaries achieve their weight loss and other behavior change goals.
The Academy is pleased to see that CMS is contemplating engagement incentives that support patients in their pursuit of the clinical goals of MDPP. Items or services that are not traditionally covered by Medicare may significantly improve beneficiary access and use of the MDPP benefit and even further enhance its savings potential. Additionally, the learnings from such incentive use may be studied by CMS to contemplate additional engagement incentives in other parts of the program. We note that Medicare Advantage plans already provide beneficiaries with non-covered items and services, which has helped those plans lower chronic disease costs among their plan members.
However, we believe the mechanics of this incentive require further development by CMS in a careful manner so as not to drive actual or potential MDPP suppliers out of the marketplace based solely on their financial capacity to compete based on incentive offerings. Smaller suppliers who deliver programs with equally effective outcomes as larger suppliers may not be able to sustain their programs if individuals are lured by the engagement incentives offered by the larger organizations. While we recognize CMS' intent to disallow advertisement of available incentives, in reality individuals talk to one another and thus word will spread within the community. We highlight the following areas that require further development:
- First, while we agree that the concept of a proposed engagement incentive period is a reasonable safeguard, the proposed end date determination conditions may be difficult to operationalize, especially if an engagement incentive (e.g., a month-long gym membership) is already "in motion" when the incentive period is supposed to end. This also has implications for the supplier switching scenario described in the rule. For example, a month-long gym membership provided by Supplier A could overlap the new incentive eligibility period once a beneficiary switches to Supplier B.
- Second, we request more clarification on the meaning of "furnished directly" and how MDPP suppliers could contract with other entities to provide items that are unable to be furnished by the supplier such as gym memberships or transportation services.
- Third, the conditions for an incentive stress that the services be connected to the curriculum AND a preventive service or item. We believe that not all items will meet both criteria. For example, a digital scale is connected to the MDPP program but is not in itself a preventive service or item. We commend CMS for disconnecting the engagement incentives from achievement of outcomes.
- Fourth, we believe that more clarity is needed to illuminate the difference between MDPP suppliers providing a specific non-covered item or service as an incentive and CMS' intent that use of specific suppliers will not "steer" particular beneficiaries away from or to the supplier.
- Finally, the monetary value of a non-technology incentive is undefined by CMS which could invite competition based on the value of the incentive and not based on quality or clinical outcomes of the program.
Regarding the use of technology incentives, we urge CMS to consider the following:
- The rule says that smartphones are "broadly used technology that is more valuable to the beneficiary" and therefore forbidden. However, the rule also states that a tablet or smartwatch or fitness tracker pre-loaded with apps that would support the beneficiary's weight loss goals is an example of an acceptable incentive.
- Pursuant to our lifetime limit comments above, we also request that CMS clarify if the $1,000 technology incentive limit can "reset" if the member re-engages with the program after a long absence.
- We encourage CMS to provide more information on the evidence basis for the $100 (permanent use) and $1,000 (temporary loan) thresholds or if there is a similar incentive or a similar rate used elsewhere in Medicare or another program.
Finally, we urge CMS to solicit further input regarding the feasibility of MDPP suppliers bearing the costs of such incentives given that it may be difficult for suppliers to amass the resources needed to provide such incentives before claims payments are received without cost-shifting.
Virtual Medicare DPP
The Academy supports CMS' proposed direction for limiting virtual MDPP to a specific number of make-up sessions. We feel this approach is heading in the right direction and allows MDPP suppliers as well as other providers of diabetes prevention programs the opportunity to further demonstrate outcomes. Based on our members' experiences, there are benefits to engaging individuals in person before moving toward virtual services.
We are encouraged that your intention is to run a separate model test of virtual MDPP services in parallel with the MDPP expanded model, since this will ensure quicker access for all Medicare beneficiaries to DPP services in a format of their choosing. We urge CMMI to be as transparent as possible in the development of the virtual model test (ideally, opening it for public comment) and work closely with stakeholders to ensure a successful test and future implementation.
2. MACRA Patient Relationship Categories and Codes
CMS is seeking comment on the May 2017 operational list of patient relationship categories and codes developed pursuant to MACRA along with the proposed Level II HCPCS Modifiers. The Academy supports the current list and associated codes and recommends their use on all claims submitted to Medicare, whether or not the service delivered is a covered benefit under Medicare, regardless of whether claims are submitted for individual services or delivered as part of bundled of population-based payments in Alternative Payment Models (APMs), and beyond the current pool of MIPS eligible clinicians. This requirement would enable CMS to better understand both quantitative and qualitative differences in both patient outcomes and the total cost of care for various conditions and episodes. For example, data show that MNT provided by an RDN is linked to improved clinical outcomes and reduced costs related to physician time, medication use and hospital admissions for people with obesity and disorders of lipid metabolism, as well as other chronic diseases,8 yet Medicare does not currently include these diagnoses in the Medical Nutrition Therapy (MNT) benefit.
CMS is proposing an initial period during which time use of these HPCPS modifiers would be voluntary and would not be a condition of payment. The Academy strongly supports such an opportunity as we anticipate a steep learning curve as Medicare providers, as well as CMS, understand the nuances of the definitions and application of the categories. We seek clarity as to the length of this "initial period." In addition, we recommend that a similar "grace period" be afforded to any new groups deemed "eligible clinicians" for the Merit-based Incentive Payment System (MIPS) in the future per authority of the Secretary. We recommend CMS provide technical support and guidance to Medicare providers, such as:
- A checklist or algorithm for category/code selection
- Videos that walk providers and administrative staff through the process of code selection, including multiple examples using multiple settings (places of service) for both physicians and other qualified health care professionals.
- A support line at the beginning of 2018
- Post examples of less-clear-cut scenarios online for other providers, with rationale for the selection of the clinician-patient relationship category.
3. Medicare Telehealth Services
CMS is proposing to eliminate the required use of the GT modifier on professional claims as doing so would be redundant due to creation of the new Place of Service (POS) code for telehealth services. The Academy supports the CMS proposal as presented as we agree it is now a redundant practice that imposes unnecessary administrative burden on providers.
The Academy supports the addition of CPT codes 96160, 96161 and HCPCS code G0506 to the list of Medicare telehealth services as add-on codes to be used with a base code that is also on the telehealth list. These services are often a critical component of a comprehensive patient assessment performed as part of other services such as Medical Nutrition Therapy. A variety of qualified health care professionals find the results of such health risk assessments extremely valuable when designing a patient-focused care plan as well as for determining the need for referrals to other qualified health care professionals. We seek clarification from CMS as to any restrictions on the types of Medicare providers who may use these add-on codes.
The Academy also encourages CMS to expand its efforts on coverage for Medicare services via telehealth by removing some of its current restrictions in its PFS coverage guidelines. The emergence and rapid growth of telehealth and mobile technologies designed to improve the health of individuals, enhance patient engagement and lower costs should be more fully recognized as it offers new opportunities to increase access to care in urban, suburban and rural areas. CMS should update its telehealth coverage guidelines, which date back to 2001, to reflect the current and future world of telehealth practice.
4. Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment
The Academy supports CMS' proposal to revise the previously finalized satisfactory reporting criteria for the CY 2016 reporting period to align with Quality performance category requirements under the Merit-based Incentive Payment System for the purposes of determining whether individual EPs and group practices are subject to the CY 2018 PQRS downward payment adjustment. We agree that this proposal will help decrease some of the confusion in the provider community due to the overlap of the Quality Payment Program (QPP) with the sun-setting of the PQRS, as well as help providers transition into the QPP.
5. Payment Accuracy for Prolonged Preventive Services
CMS is proposing to make payment for prolonged preventive services using two new HCPCS G codes that could be billed along with the Medicare-covered preventive service codes, to more accurately reflect the differential resource costs when additional time is required to furnish a Medicare-covered preventive service. The Academy supports this proposal in concept and recommends G0447 Intensive Behavioral Therapy for Obesity be added to the list of Medicare-covered preventive service codes with which these proposed new codes may be used. Very few cognitive services are included on the list, yet such services, by the nature of the work involved, may require additional time to furnish the service in a patient-focused, quality manner. Current CMS guidelines do not provide clear guidance to the Medicare Administrative Contractors (MAC) as to limits on units billed for this code on the same day of service. As a result, many MACs pay for only 1 unit of service (i.e., 15 minutes). Obesity is a complex disease requiring intensive interventions to produce the desired outcomes, as noted by the USPSTF. Due to the multi-factorial nature of this disease along with some unique characteristics of the Medicare population (e.g., hearing and cognitive deficits), a prolonged service time may be necessary to meet the beneficiary's needs while following the 5As framework.
6. Request for Information on CMS Flexibilities and Efficiencies
The Academy appreciates the invitation from CMS to offer suggestions for regulatory, sub-regulatory, policy, practice and procedural changes to reduce unnecessary burdens for clinicians, other providers, and patients and their families to increase quality of care, lower costs, improve program integrity and make the health care system more effective, simple and accessible. With those goals in mind, we offer the following recommendations that are explained below:
- The Academy urges the Secretary to exercise her 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 all diet-related chronic diseases, including obesity and malnutrition.
- Expand the current MNT benefit to include persons with prediabetes or risk factors for diabetes, based on similar eligibility criteria for the MDPP.
- Allow MNT and Diabetes Self-Management Training (DSMT) be allowed on the same date of services.
- Reduce barriers to access and utilization of DSMT services by:
- Adding HbA1c as a diagnostic criteria for diabetes to overcome the current barrier of diagnostic criteria for the DSMT benefit not aligning with national clinical practice guidelines.
- Expanding eligible referral sources for the DSMT benefit to include providers who treat beneficiaries within the hospital, the emergency room and surgical centers, as well as physician specialists who treat beneficiaries' co-morbid diabetes conditions.
- Waiving the co-pay and deductible for DSMT services as an additional means to increase utilization.
- Create payment policies to support integration of MNT services into primary care and/or inter-professional collaboration for the management of nutrition-related chronic diseases.
- Allow order-writing privileges for inpatient RDNs to write referrals to outpatient/ambulatory care RDNs for nutrition services.
- Update Medicare payment rules for home TPN
- Require consistent documentation of malnutrition in rehab facilities
- Order Writing Privileges for RDNs in Dialysis Centers
- Implement policies to require routine assessment of nutritional status across the continuum of care
Modify the current Part B Medicare MNT benefit to include all diet-related chronic diseases
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.10 RDNs are recognized as the most qualified food and nutrition experts by the National Academies of Sciences, Engineering and Medicine's Health and Medicine Division (formerly the IOM), most physicians, and the United States Preventive Services Task Force (USPSTF), providing nutrition care more effectively at a lower cost than physicians, nurse practitioners, and physician assistants.11
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."12 The Academy urges the Secretary to exercise her authority under Section 1834 (n) (42 USC 1395(m))13 of the Social Security Act to modify the current Part B Medicare MNT benefit to include the diet-related chronic diseases Medicare beneficiaries experience as a significant step towards achieving CMS' goals of Better Care, Smarter Spending, and Healthier People. The pool of RDN Medicare providers would grow, increasing access to clinically effective, low cost services.
Expand the current MNT benefit to include persons with prediabetes or risk factors for diabetes, based on similar eligibility criteria for the MDPP.
Under a clear reading of the Social Security Act (SSA), as amended by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)14 and the Patient Protection and Affordable Care Act (PPACA)15 respectively, the Secretary of Health and Human Services (the "Secretary") has dual authority to (1) add coverage for new preventive services never before covered and (2) modify coverage of existing preventive services to cover additional disease states and conditions, provided the services are consistent with the recommendations of the USPSTF or listed as a service included in the initial preventive physical examination.16 Expanding coverage of RDN-provided, directly billed MNT services for obese beneficiaries and those with risk factors for CVD meets all requirements: MNT is a triggered preventive service under the SSA; the sought coverage modification is consistent with USPSTF recommendations;17,18 and the initial preventive physical examination specifically includes MNT pursuant to a referral.19
Medical Nutrition Therapy (MNT) is a nutritional diagnostic, therapy and counseling service for disease management. When provided by an RDN, MNT includes: 1) lifestyle, knowledge and skills assessment, 2) negotiation of individualized nutrition goals, 3) nutrition intervention, and 4) evaluation of clinical and behavioral outcomes. To ensure an individualized therapeutic plan, MNT is conducted through one-on-one sessions between an RDN and an individual. MNT provided by an RDN is similar to the one-on- one counseling provided during national trials that were found to prevent diabetes; people receiving MNT have shown successful weight loss and improved prediabetes insulin markers.20 MNT is a part of successful lifestyle modification to improve food choices, eating habits, and increase physical activity. Research shows that MNT provided by a dietitian 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.21,22,23 Based on a systematic review of the literature and/or recommendations from evidence-based guidelines developed by the American Diabetes Association and Project IMAGE, A European Evidence-Based Guideline for the prevention of type 2 diabetes, "the registered dietitian nutritionist (RDN) should provide medical nutrition therapy (MNT) encounters for individuals who are at high risk for type 2 diabetes and increase the frequency of encounters to optimize outcomes." In adults with metabolic syndrome, research regarding the impact of medical nutrition therapy (MNT) reported significant improvements:
- Decreased fasting blood glucose by 2.5mg to 9mg per dL (0.1mmol to 0.5mmol per L)
- Decreased A1C by 0.12% to 0.23%
- Decreased triglycerides by 21mg to 35mg per dL (0.2mmol to 0.4mmol per L)
- Increased HDL cholesterol by 2.4mg per dL (0.06mmol per L)
- Decreased body weight by 2.5kg to 4.1kg
- Decreased waist circumference by 1.9cm to 4.8cm
- Decreased systolic blood pressure by 4.9mm Hg.
In individuals with prediabetes, research regarding the impact of medical nutrition therapy (MNT) reported significant improvements:
- Decreased fasting blood glucose by 2mg to 9mg per dL (0.1mmol to 0.5mmol per L)
- Decreased two-hour post-prandial blood glucose by 9mg to 16.2mg per dL (0.5mmol to 0.9mmol per L).
- Decreased waist circumference by 3.8 to 5.9 cm"24
Per the 2015 national clinical practice guidelines of the American Association of Clinical Endocrinologists and the American College of Endocrinology, therapeutic lifestyle management, which includes MNT, should be discussed with all patients with prediabetes at the time of diagnosis and throughout their lifetimes. "MNT is an important aspect of therapeutic lifestyle management that should be discussed with every patient with prediabetes…Patient evaluation and teaching should be conducted by a registered dietitian (RD) or knowledgeable physician."25
Individuals with prediabetes have comorbidities such as hypertension, hyperlipidemias, chronic kidney disease and metabolic syndrome26,27,28,29,30,31,32,33,34 that require nutrition intervention of higher complexity than the basic nutrition education provided within a DPP. If CMS is to be truly successful at curbing the rising tide of diabetes within the Medicare population in a person-centered manner, it must provide beneficiaries with a full spectrum of preventive services including the MDPP, Intensive Behavioral Therapy for Obesity and MNT.
Allow MNT and Diabetes Self-Management Training (DSMT) be allowed on the same date of service.
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.35 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.36 Compared with no prevention, self-management reduces a high-risk person's 30-year chances of getting diabetes by 11%, the chances of a serious complication by 8% and the chances of dying of a complication of diabetes by 2.3%.37 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.
Reduce barriers to access and utilization of DSMT services
Diabetes is a chronic disease so it is important to break down barriers to access to DSMT (and MNT) services to achieve better health outcomes, control costs, and enhance patient satisfaction. The Academy has identified the following additional barriers as contributors to under-utilization of these important services aimed to educate Medicare beneficiaries on the successful self-management of diabetes:
Diagnostic Lab Eligibility Criteria: Currently, CMS guidelines for diagnosing diabetes for the purposes of the DSMT benefit, as well as the MNT benefit, do not include the HbA1c test. HbA1c has been a recognized diagnostic criteria for diabetes by the American Diabetes Association since 2010. CMS is considering accepting the HbA1c test to diagnose prediabetes and the Academy urges CMS to accept it for diagnosing diabetes for the DSMT benefit, as well as the MNT benefit. HbA1c is the most commonly used test for diagnosing diabetes today as compared to fasting plasma glucose (FPG), 2-hour oral glucose tolerance test (OGTT) or a random glucose test. The traditional diagnostic tools of FPG and OGTT are sensitive, however they measure glucose levels only in the short term, require fasting or glucose loading, and give variable results during stress and illness. HbA1c assays reliably estimate average glucose levels over a longer term (2-3 months), do not require fasting or glucose loading, have less variability during stress and illness, and are more specific for identifying individuals at increased risk for diabetes. Therefore, the American Diabetes Association recommends HbA1c > 6.5% as an additional alternative for diagnosing diabetes.38 The Academy urges CMS to add HbA1c as a diagnostic criteria for diabetes to overcome the current barrier of diagnostic criteria for the DSMT benefit not aligning with national clinical practice guidelines.
DSMT Referral from Treating Provider: Currently the DSMT referral must come from the beneficiary's "treating provider." If beneficiaries with diabetes are admitted to the hospital, emergency room or ambulatory surgical center, they cannot be referred by the provider(s) who treat them in these locations. Beneficiaries discharged from the hospital may not follow-up with their primary care provider and so may not get a referral for DSMT services, resulting in increased hospital readmissions. In addition, a physician specialist treating a beneficiary's comorbidity (e.g., gangrene, vision loss) cannot refer the beneficiary for the DSMT benefit. A common scenario is that a specialist is aware of the DSMT benefit, but the treating provider is not. The Academy urges CMS to expand eligible referral sources for the DSMT benefit to include providers who treat beneficiaries within the hospital, the emergency room and surgical centers, as well as physician specialists who treat beneficiaries' co-morbid diabetes conditions.
Beneficiary Co-Payment and Meeting High Annual Deductible: Many beneficiaries simply cannot afford DSMT services due to the copayment and to the annual Medicare deductible, which is often very high. Seniors typically have limited income, and many do not have supplemental health insurance. The Academy urges CMS to waive the co-pay and deductible for DSMT services as an additional means to increase utilization. A recent economic analysis indicated that DSMT is cost-effective, finding that plans that eliminated co-payments and deductibles would have cumulative cost-savings that outweigh cost-sharing in the majority of circumstances.39 Furthermore, when payers eliminate cost-sharing measures, they can expand the number of beneficiaries utilizing DSMT services, which will further enhance cost-savings.40 While the Academy recognizes that CMS is not bound by the same requirements under the ACA as certain commercial payers to provide coverage for preventive services with a Grade A or B rating by the US Preventive Services Task Force at no cost to the individual, we encourage CMS to do so based on the USPSTF recommendation, "Screening for Abnormal Glucose and Type 2 Diabetes Mellitus,"41 which recommends clinicians should refer persons 40-70 years of age with overweight or obesity and an abnormal glucose to intensive behavioral counseling interventions to promote a healthy diet and physical activity.
Create payment policies to support integration of MNT services into primary care and/or inter-professional collaboration for the management of nutrition-related chronic diseases.
As noted in CMS' "Chronic Conditions among Medicare Beneficiaries 2012 Chartbook," more than half of Medicare beneficiaries have one or more chronic conditions, such as diabetes, hypertension, high blood cholesterol, heart disease and kidney disease.42 RDNs' training and qualifications enable them to provide effective care management, particularly for patients with complex health needs. In Patient-Centered Medical Home models, such as the Comprehensive Primary Care Plus initiative, the health care team is being expanded to include RDNs to leverage their proven effectiveness at improving health outcomes related to chronic conditions, enhancing patient satisfaction, and reducing health system costs.43,44 Data show that MNT provided by an RDN is linked to improved clinical outcomes and reduced costs related to physician time, medication use and hospital admissions for people with obesity, diabetes, and disorders of lipid metabolism, as well as other chronic diseases.45 Strong evidence exists to support the effectiveness of nutrition interventions and counseling provided by a nutrition professional when part of a healthcare team, the effectiveness of MNT provided by a nutrition professional on health outcomes in adults with overweight and obesity, and the effectiveness of MNT provided by an RDN to improve disorders of lipid metabolism outcomes.46
The current MNT CPT codes used by RDNs to bill for the Medicare Part B MNT benefit do not adequately capture the additional professional resources necessary to provide care management services to Medicare beneficiaries with such complex needs to assist them in selecting and accessing adequate foods/nutrient sources, and/or understanding how their food selections impact their disease state and/or overall health. Both diabetes and chronic kidney disease are long-term conditions requiring ongoing MNT services to address food and nutrition needs over both a beneficiary's lifetime as well as during episodic conditions, such as a stroke or hospitalization.47 RDNs provide critical care management services to ensure adequate access to healthful foods/nutrients, appropriate access to and use of medication, and to refer and facilitate access to appropriate health care and/or community-based resources (e.g., facilitating post-discharge nutrition care plans with post-acute care providers and community agencies such as Meals on Wheels). Such activities are time consuming but serve a necessary role in supporting patients' self-management of their chronic conditions. Everyone experiences challenges in everyday life related to their food choices and eating behaviors. RDN provided care management services provide consistent support rather than forcing the patient to wait for the next appointment with the RDN. Care management interactions often lead to modifications to a patient's goals and/or plan of care that require additional documentation in the patient's medical record. While RDNs may be considered "clinical staff" within some health care organizations, enabling CMS to consider their time spent in care coordination activities as already being captured under the existing Chronic Care Management (CCM) code, RDNs and other qualified health care professionals who already have the statutory authority to bill CMS for services do not currently have a mechanism for being paid for this important additional professional work.
Thus, the Academy urges CMS to create an add-on code that could be used by non-physician Medicare providers similar to the CCM code to capture care coordination services provided to Medicare beneficiaries with complex medical needs. Criteria for use of this code might include presence of 2 or more chronic conditions, professional time in excess of 30 minutes per one calendar month for team communication and coordination of care for services identified as part of the treatment plan beyond the time already captured in the relevant "office visit" CPT code (e.g., 97802-4 for RDNs) for beneficiaries with whom the non-physician provider has an existing relationship as evidenced by billing for services during the calendar year. Such care coordination could occur between a non-physician qualified health care professional and a physician (primary or specialist), between non-physician qualified health care professionals or between non-physician qualified health care professionals and community-based service providers.
Allow order-writing privileges for inpatient RDNs to write referrals to outpatient/ambulatory care RDNs for nutrition services.
RDNs working with hospitalized patients are usually the ones who know the outpatient nutrition counseling needs that are necessary to ensure a safe discharge and reduce the likelihood of readmission. Additionally, they are more likely to know which resources exist in the community.
For example, patients with an esophagectomy are often discharged to home with instructions for diet advancement over the several weeks following the surgery. However, without a referral to the qualified outpatient RDN, the patient and caregiver have no one to call for follow-up questions or concerns. Therefore, they often end up in the emergency room. Although the inpatient RDNs often contact the discharging physician to place the referral, this often does not happen. The Academy proposes that inpatient RDNs managing the nutrition care in the hospital be able to refer to an outpatient RDN to provide ongoing MNT that is then billable to Medicare.
Update Medicare payment rules for home TPN
- Specifically, change the "90 day permanency rule" to allow home parenteral nutrition (PN) for those with enterocutaneous fistulas or similar conditions that prevent all oral or enteral (tube feeding) intake but are expected to resolve in less than 90 days. Often, PN support is the only treatment keeping the patient hospitalized because PN isn't covered by Medicare at home.
- Eliminate the requirement that all patients with a "moderate abnormality" fail a tube feeding trial prior to coverage of home PN. In some patients, tube feeding trials are absolutely not appropriate for patient safety reasons.
- Currently, the patient must have a) a condition involving the small intestine and/or its exocrine glands which significantly impairs the absorption of nutrients or, b) disease of the stomach and/or intestine which is a motility disorder and impairs the ability of nutrients to be transported through the GI system. CMS should convene a taskforce of physicians, dietitians, nurses, and other healthcare professionals to determine if this should be redefined to include more diagnoses.
Hospitals are facing increasing pressure to discharge patients earlier from the acute care setting, including those dependent on TPN. Patients with GI disorders, complications from cancer, high output ostomies and/or fistulas, and other conditions may require continuation of PN therapy in the home setting but many of these patients do not meet criteria for home PN and related medically necessary infusion therapies under Medicare. In a 2015 abstract by a home infusion provider,48 42% of medical records reviewed for Medicare PN coverage over a 7 month period did not include objective testing required for reimbursement coverage, even though the physician had documented the appropriate diagnoses with potential for meeting Medicare payment criteria. Another abstract by a home infusion provider stated that only 10.5% of patients referred for home PN met the coverage requirements.49 When a patient with home PN coverage under a commercial policy is transitioned to Medicare due to a covered disability or age 65, they often have PN coverage immediately terminated.
Require consistent documentation of malnutrition in rehab facilities
The Inpatient Rehab Facility (IRF) Prospective Payment System (PPS) through Medicare is a Fee-For-Service Payment System. Payment is based on information found in the IRF-patient assessment instrument (IRF-PAI), which includes clinical, demographic, and other info. This classifies patients into distinct groups called Rehab Impairment Categories, according to the primary condition causing admission to the IRF and based on clinical characteristics and expected resource needs. The patient is then further grouped into case-mix groups (CMGs), which group similar cases according to their functional motor and cognitive scores and age. Finally, the patient is grouped into one of 4 tiers within each CMG, according to comorbidities. Each tier adds a successively higher payment amount to the case depending on whether the costs of the comorbidity are significantly higher than other cases in the same CMG.50
Thirteen medical conditions can be admitting diagnoses for a IRF, none of which are overtly a nutrition diagnosis but often require nutrition intervention, such as stroke, burns, or major multiple trauma. Additionally, BMI > 50 at the time of admission to the IRF is considered to add complexity when the admitting diagnosis is knee or hip joint replacement. Another requirement for admission to the IRF is the patient must require active and ongoing therapeutic intervention of multiple therapy disciplines (RDN could count as one) and require an intensive and coordinated interdisciplinary approach to care.
IRF Quality Reporting Program (QRP)
Facilities must report on quality measures to avoid penalties. QRPs related to nutrition:
- % of residents/patients with new or worsened pressure ulcers
- All cause unplanned 30 day post IRF discharge readmission
- Hospital-onset Cdiff infection
- Falls with major injury
- Potentially preventable 30-day post-discharge readmission
All comorbid conditions, not just those conditions that may affect Medicare payment, are supposed to be listed on the IRF-PAI. Since malnutrition is not currently a diagnosis that increases the severity level within the CMG, it is often not documented at all. Consistent documentation of the malnutrition diagnosis on the IRF-PAI would enable CMS to identify additional conditions that may affect payment as part of their ongoing research and efforts at refining the CMG system. The more complete and accurate this information is, the more precisely the payment system can reflect patient resource use in IRFs over time.
Order writing privileges for RDNs in dialysis centers
RDNs working in the End Stage Renal Disease (ESRD) program are guided by CMS Conditions for Coverage 2008 and the Quality Improvement Performance Measures (QIP) introduced in 2010. While the CfC recommended the holistic approach to a patient centered care model, the QIP has become almost unmanageable. The initial 3 clinical parameters have blossomed to 16 for PY2018. While all are not directly linked to nutrition, the RDN has an integral role in interdisciplinary team (IDT) and works closely with the patient and team on measures related to adequacy of dialysis, hypercalcemia, and mineral bone management in addition to providing complete nutritional assessment and care planning for each individual patient on an ongoing basis. The complexities of the QIP coupled with the increased acuity and comorbid conditions of this population can be time consuming and counterproductive to the primary role of the RDN – patient nutritional care. If RDNs are granted the ability to write independent orders for nutritional supplementation and follow up, laboratory data and nutrition orders, the RDN can participate more efficiently to maximize quality outcomes for individual patients while maintaining the requirements for quality reporting. Integration of checks and balances on the CMS side and a more efficient reporting mechanism would also lead to better data. Currently, the Crowne Web system does not allow the provider access to the system after a period of time or when they are required to defend data that is not consistent with the patient's medical record. Forty to 70% of dialysis patients are malnourished; 45% are diabetic and/or obese. Nutrition intervention is key to improve and maintain outcomes for these patients. Simplifying the documentation responsibilities of the RDN will allow more time for patient interaction and intervention.
Implement policies to require routine assessment of nutritional status across the continuum of care
Assessing nutrition status using validated tools in all settings across the continuum of health care is a vital first step in improving the health of Medicare beneficiaries, and our nation as a whole, as noted in The National Blueprint: Achieving Quality Malnutrition Care for Older Adults.51 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.52,53 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.54,55 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.56 With the number of adults aged 65 years and older expected to reach 74 million by 2030, it is critical that CMS develop policies requiring routine assessment of nutritional status across all health care settings, with referrals to RDNs as appropriate.
The Academy welcomes the opportunity to meet with officials at CMS to further discuss the above opportunities to improve the Medicare program to increase quality of care, lower costs, improve program integrity and make the health care system more effective, simple and accessible.
7. 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 40 "CY 2018 PFS Proposed Rule Estimated Impact on Total Allowed Charges by Specialty." CMS' omission of RDNs in Table 40 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.
Thank you for your careful consideration of the Academy's comments on the proposals for the 2018 Medicare Physician Payment Schedule. Please do not hesitate to contact Jeanne Blankenship by phone at 312/899-1730 or by email at firstname.lastname@example.org or Marsha Schofield at 312/899-1762 or by email at email@example.com with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Vice President, Policy Initiatives & Advocacy
Academy of Nutrition and Dietetics
Marsha Schofield, MS, RD, LD, FAND
Senior Director, Governance
Academy of Nutrition and Dietetics
1 The Academy has approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 Medical nutrition therapy (MNT) is an evidence-based application of the Nutrition Care Process. The provision of MNT (to a patient/client) may include one or more of the following: nutrition assessment/reassessment, nutrition diagnosis, nutrition intervention and nutrition monitoring and evaluation that typically results in the prevention, delay or management of diseases and/or conditions. [Academy of Nutrition and Dietetics' Definition of Terms list updated July 2016. http://www.eatrightpro.org/resources/practice/quality-management/scope-of-practice. Accessed August 8, 2016.]
3 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."
4 https://icer-review.org/wp-content/uploads/2016/07/CTAF_DPP_Final_Evidence_Report_072516.pdf. Accessed August 17, 2017.
5 Prochaska J O, Velicer W F. The transtheoretical model of health behavior change. Am J Health Promot.1997;12(1):38–48
6 Chaiton M, Diemert L, Cohen JE, et al Estimating the number of quit attempts it takes to quit smoking successfully in a longitudinal cohort of smokers BMJ Open 2016;6:e011045. doi: 10.1136/bmjopen-2016-011045
7 https://icer-review.org/wp-content/uploads/2016/07/CTAF_DPP_Final_Evidence_Report_072516.pdf. Accessed August 17, 2017.
8 Academy of Nutrition and Dietetics Evidence Analysis Library. Medical Nutrition Therapy Evidence Analysis Project 20013-15. Accessed August 17, 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—
(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 Academy of Nutrition and Dietetics Evidence Analysis Library. Medical Nutrition Therapy Effectiveness Systematic Review 2009, 2013-2015.
11 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).
12 IOM (Institute of Medicine). 2012. Geographic adjustment in Medicare payment: Phase II: Implications for access, quality, and efficiency. Washington, DC: The National Academies Press.
13 (n) Authority to Modify or Eliminate Coverage of Certain Preventive Services for Eligible Adults in Medicare.—Notwithstanding any other provision of this title, effective beginning on January 1, 2010, if the Secretary determines appropriate, the Secretary may—
(A) the coverage of any preventive service described in subparagraph (A) of section 1861(ddd)(3) to the extent that such modification is consistent with the recommendations of the United States Preventive Services Task Force; and the services included in the initial preventive physical examination described in subparagraph (B) of such section; and
(B) the services included in the initial preventive physical examination described in subparagraph (B) of such section; and
(2) provide that no payment shall be made under this title for a preventive service described in subparagraph (A) of such section that has not received a grade of A, B, C, or I by such Task Force.
14 Pub. L. no. 110-275, 122 Stat 2494 (2008).
15 Pub. L. no. 111-148, 124 Stat 119 (2010).
16 42 U.S.C. 1834(m)n.
17 See, 29 November 2011 CMS NCD on Intensive Behavioral Counseling for Obesity.
18 See,8 November 2011 CMS NCD on Intensive Behavioral Therapy for Cardiovascular Disease. The USPSTF recommended intensive behavioral dietary counseling for individuals with risk factors for cardiovascular disease and explicitly recommended that the services "can be delivered by primary care clinicians or by referral to other specialists, such as nutritionists or dietitians."
19 42 U.S.C. 1861(ww).
20 Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and its Burden in the US, 2014. Atlanta, GA: U.S. Department of Health and Human Services; 2014.
21 Redmon JB, et al. (2005). Two-year outcome of a combination of weight-loss therapies for type 2 diabetes. Diabetes Care. Vol. 28(6):1311-1315.
22 Corpeleign E. et al. (2006). Improvements 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. 49(10):2392-2401.
23 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 Nov;114(11):1739-48.
24 Academy of Nutrition and Dietetics Evidence Analysis Library. Prevention of Type 2 Diabetes Evidence Analysis Project, 2014. Strong, Imperative. Accessed August 17, 2017.
25 Handelsman Y, Bloomgarden ZT, Grunberger G, Umpierrez G, Zimmerman RS, Bailey TS, et al. American Association of Clinical Endocrinologists and American College of Endocrinology: clinical practice guidelines for developing a diabetes mellitus comprehensive care plan—2015. Endocr Pract. 2015;21:1-87.
27 Garber AJ, Handelsman Y, Einhorn D, Bergman DA, Bloomgarden ZT, Fonseca V, et al. Diagnosis and management of prediabetes in the continuum of hyperglycemia: when do the risks of diabetes begin? A consensus statement from the American College of Endocrinology and the American Association of Clinical Endocrinologists. Endocr Pract. 2008;14:933-46.
28 Jellinger PS, Smith DA, Mehta AE, Ganda O, Handelsman Y, Rodbard HW, et al. American Association of Clinical Endocrinologists' guidelines for management of dyslipidemia and prevention of atherosclerosis. Endocr Pract. 2012;18 Suppl 1:1-78.
29 Barr EL, Zimmet PZ, Welborn TA, Jolley D, Magliano DJ, Dunstan DW, et al. Risk of cardiovascular and all-cause mortality in individuals with diabetes mellitus, impaired fasting glucose, and impaired glucose tolerance: the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab). Circulation. 2007;116:151-7.
30 STOP-NIDDM Trial Research Group, Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, et al. Acarbose treatment and the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance: the STOP-NIDDM trial. JAMA. 2003;290:486-94.
31 Dagenais GR, Gerstein HC, Holman R, Budaj A, Escalante A, Hedner T, et al. Effects of ramipril and rosiglitazone on cardiovascular and renal outcomes in people with impaired glucose tolerance or impaired fasting glucose: results of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial. Diabetes Care. 2008;31:1007-14.
32 Levitzky YS, Pencina MJ, D'Agostino RB, Meigs JB, Murabito JM, Vasan RS, et al. Impact of impaired fasting glucose on cardiovascular disease: the Framingham Heart Study. J Am Coll Cardiol. 2008;51:264-70.
33 Hu FB, Stampfer MJ, Haffner SM, Solomon CG, Willett WC, Manson JE. Elevated risk of cardiovascular disease prior to clinical diagnosis of type 2 diabetes. Diabetes Care. 2002;25:1129-34.
34 Plantinga LC, Crews DC, Coresh J, Miller ER, 3rd, Saran R, Yee J, et al. Prevalence of chronic kidney disease in US adults with undiagnosed diabetes or prediabetes. Clinical journal of the American Society of Nephrology: CJASN. 2010;5:673-82.
35 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.
36 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.
38 Classification and Diagnosis of Diabetes. American Diabetes Association. Diabetes Care Jan 2017, 40 (Supplement 1) S11-S24; DOI: 10.2337/dc17-S005
39 Center for Health Law and Policy Innovation, Harvard Law School. Reconsidering Cost-Sharing for Diabetes Self-Management Education: Recommendation for Policy Reform. June 2015.
41 Siu A, U.S. Preventive Services Task Force. Screening for Abnormal Blood Glucose and Type 2 Diabetes Mellitus: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine. 2015;163(11):861-868.
42 Chronic Conditions among Medicare Beneficiaries: 2012 Chartbook. Accessed August 15, 2015.
43 Physician Payment Reform: Where Do I Fit In? Dividing the Pie in New Payment Models. AMA Innovation Committee, April 2014.
44 Peikes D, Reid R, Day T, Cornwell D, Dale S, Baron R, Brown R, Shapiro R. Staffing patterns of primary care practices in the Comprehensive Primary Care initiative. Ann Fam Med2014:142-140. doi: 10.1370/afm.1626.
45 Academy of Nutrition and Dietetics Evidence Analysis Library. Medical Nutrition Therapy Evidence Analysis Project 2008.
46 Academy of Nutrition and Dietetics Evidence Analysis Library. Medical Nutrition Therapy Evidence Analysis Project 2015.
47 Powers MA. 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. Journal of the Academy of Nutrition and Dietetics.2015;115(8):1323–1334.
48 Kinder LM. Medicare Part B and Home Parenteral Nutrition Coverage: How Often Is Objective Evidence Available? Clinical Nutrition Week 2016, American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), Austin, TX. Abstract S10:14
49 Allen P. Medicare parenteral nutrition policy 20 years later: need for change when 9 out of 10 do not qualify for benefits. Clinical Nutrition Week 2016, American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), Austin, TX. Abstract S21:25: http://pen. sagepub.com/content/suppl/2015/12/17/40.1.115.DC2/CNW16_ Sunday_Poster_Abstracts.pdf.
50 Medicare Learning Network. Department of Health and Human Services, Centers for Medicare and Medicaid Services. Inpatient Rehabilitation Facility Prospective Payment System, Payment System Series Fact Sheet. Updated January 2017. Accessed August 17, 2017.
51 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.
52 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.
53 Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008;27(1):5-15.
54 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.
55 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.
56 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.