Academy Comments to CMS re Medicare Payment, Physician Fee Schedule, and Proposed Medicare Diabetes Prevention Program

September 6, 2016

Andrew M. Slavitt
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attn: CMS-1654-P
P.O. Box 8013
Baltimore, MD 21244-8013

Re: File Code-CMS-1654-P; Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2017; Medicare Advantage Pricing Data Release: Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; (July 15, 2016).

Dear Acting Administrator Slavitt:

The Academy of Nutrition and Dietetics (the "Academy") is pleased to provide comments on CMS-1654-P Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2017; Medicare Advantage Pricing Data Release: Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model published in the July 15, 2016 Federal Register. 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 Telehealth Services
  • Improving Payment Accuracy for Primary Care, Care Management Services, and Patient-Centered Services
  • Improving Payment Accuracy for Preventive Services: Diabetes Self-Management Training (DSMT)
  • Valuation of Specific Codes
  • Medicare Advantage Provider Enrollment
  • Proposed Expansion of the Diabetes Prevention Program (DPP) Model
  • Analysis of the Fee Schedule Impact on Specialties

1. Medicare Telehealth Services

CMS is proposing how a Place of Service (POS) code for telehealth services would be used under the Physician Fee Schedule if such a code were to be created. The Academy supports the CMS proposal as presented as it provides clarity on appropriate billing and Practice Expense for telehealth services.

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, including the restriction of originating sites to those located in rural health professional shortage areas. 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.

2. Improving Payment Accuracy for Primary Care, Care Management Services, and Patient-Centered Services

Chronic Care Management Codes 99487 and 99489
The Academy supports the proposed changes by CMS to payment policies for the Chronic Care Management codes. Expansion to include CPT Codes 99487 and 99489 and CMS's proposal to align guidelines for billing for these services with the CPT guidance should help to increase utilization of these services when necessary to achieve the goals of Better Care, Smarter Spending and Healthier People.

Medicare Beneficiaries with Disabilities – GDDD1
CMS notes that the resources involved in furnishing care, including and especially routine care of both acute and chronic illness, to beneficiaries with disabilities may be routinely and systematically underestimated under PFS payment relative to resource needs for practitioners who more frequently serve such patients, which could negatively impact access or quality of care for beneficiaries with disabilities. CMS is proposing to establish an add-on code (GDDD1) that could be billed with new and established patient office/outpatient Evaluation & Management codes.

GDDD1: Resource-intensive services for patients for whom the use of specialized mobility-assistive technology (such as adjustable height chairs or tables, patient lifts, wheelchair accessible scales, and adjustable padded leg supports) is medically necessary and used during the provision of an office/outpatient evaluation and management visit.

The Academy supports the need to recognize the additional resources involved in providing care to Medicare beneficiaries with disabilities. The costs of the equipment needed to provide appropriate, high-quality care to these individuals represents a significant expense to practitioners. Also, extra work time is needed to provide the service to allow for necessary transfers and positioning. By recognizing these additional resources through establishment of this add-on code, CMS can help to ensure these Medicare beneficiaries have adequate access to the medically necessary care they need in a patient-centered manner.

The Academy recommends that CMS establish add-on code GDDD1 and allow it to be billed by qualified health care professionals who provide services to Medicare beneficiaries with disabilities for use beyond the Evalution & Management codes. Not all medically necessary services for Medicare beneficiaries with disabilities are billed using Evaluation & Management codes. While CPT and HCPCS codes for some such services may already capture these resources (e.g., Physical Medicine and Rehabilitation services), others do not. The add-on code should be available for use by RDNs when providing MNT services (97802, 97803) and for practitioners when providing Intensive Behavioral Therapy for Obesity services (G0447) as similar specialized equipment, such as wheelchair accessible scales and lift devices to facilitate transfers, and additional time are necessary when providing such services to these patients. According to the CDC, 68.9% of persons with diabetes 65-74 years of age and 81.4% 75 years or older report mobility limitations.4 For persons with chronic kidney disease (CKD), 24.5-27% of persons with CKD over the age of 65 report limitations in walking.5

Additional Models of Inter-Professional Collaboration
CMS is proposing a new G-code and payment policies to support integration of behavioral health services into primary care. CMS is interested in whether there should be changes under the PFS to reflect additional models of inter-professional collaboration for health conditions, in addition to those we are proposing for behavioral health integration. The Academy is pleased to see CMS is exploring additional opportunities to recognize person-centered care provided by an interdisciplinary team of qualified health professionals. As CMS explores additional avenues to recognize such work through appropriate payment mechanisms, the Academy urges CMS to think beyond the role of the primary care providers and explicitly recognize the wide range of qualified non-physician practitioners located within or outside of a primary care provider's office setting who effectively provide care management services. These non-physician team members are critical to achieving successful patient and population health outcomes and controlling the progression of chronic and complex chronic disease. Thus, there needs to be a payment mechanism for these essential services that is not exclusively tied to the primary care provider.

The Academy specifically urges CMS to 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.6 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 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.7,8 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.9 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.10

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.11 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.

Improving Care Coordination/Collaboration
The Academy also urges CMS to recognize and implement separate payment beginning January 1, 2017 for other services utilized to improve care coordination and care collaboration that have already been defined by the CPT Editorial Panel and valued by the RUC. These services include:

  • Anticoagulant Management (CPT Codes 99363 and 99364)
  • Education and Training for Patient Self-Management (CPT Codes 98960-98962)
  • Medical Team Conference (CPT Codes 99366-99368)
  • Telephone Services (CPT Codes 99441-99443 and 98966-98969)
  • Analysis of Computer Transmitted Data (CPT Code 99091)

Payment for these services either does not currently exist under the PFS or is bundled under an Evaluation and Management (E/M) service, precluding access by non-physician members of the health care team who cannot bill using E/M codes. For example, while physician time spent in a medical team conference is recognized as part of an E/M service, non-physicians, such as RDNs and physical and occupational therapists, are not allowed to separately report the time that they spend in such conferences, whether the patient is present (CPT 99366) or not (CPT 99368). All of these services are clearly separate and distinct from E/M services.

RDNs have the education and training to provide all of these services and often do so as part of team based care. For example, many RDNs train patients with diabetes on the use of continuous glucose monitoring devices and assist the physician in the analysis of data transmitted from such devices. RDNs within primary care provider practices play a role in managing patients on anticoagulant therapy per established protocols because of their in-depth knowledge of drug-nutrient interactions.12 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 all of the above services within the Medicare program is important in capturing real costs to both physician and non-physician practices. Immediate implementation of the anticoagulant management (CPT codes 99363-99364), education and training for patient self-management (CPT codes 98960-98962), medical team conferences (CPT codes 99366-99368), telephone services (CPT codes 98966-98969), and analysis of computer transmitted data (CPT code 99091) codes are recommended to recognize the costs associated with team based care.

The Academy recommends that CMS begin separate payment for such inter-professional consultation services provided by physicians or other Medicare providers utilizing the existing CPT codes 99446-99499. Physicians and other qualified health care professionals rely on the expertise of their professional colleagues to assist in the diagnosis and/or management of complex patients. Under certain circumstances such consultation can appropriately be provided without the consultant qualified health care professional providing a face-to-face service to the patient, thus supporting the delivery of timely, cost-effective care. 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 (laboratory results, medications, physical examination and review of systems documented by the physician) and conversation with the physician via telephone or internet. We do agree with CMS that appropriate beneficiary protections need to be in place, such as patient advanced consent to the consultation. Any consultative services delivered via the Internet should be performed in a HIPAA-compliant manner. It is important that such services not take the place of face-to-face or telehealth encounters when indicated as a component of evidence-informed practice. The Academy does not believe it is necessary for CMS to differentiate between such services and other PFS payments because these CPT codes have already factored such a need into account in their development and should be implemented in accordance with existing CPT guidelines. Payment for such services should be tied to a beneficiary encounter by the patient's treating physician or other qualified health care professional as defined under section 1861(s) of the Social Security Act [42 U.S.C. 1395x(s)] (within 7 days) to ensure documentation of a current physical examination.

Recognizing Obesity as a Chronic Condition
The Academy also urges CMS to recognize obesity as a chronic condition for the purposes of all care coordination services. Obesity is an astronomically expensive problem for our nation and families. Medicare and Medicaid patients with obesity cost $61.8 billion per year.13 As such, CMS should recognize obesity as one of the chronic conditions that qualifies beneficiaries for any and all care coordination services. In June 2013, the American Medical Association's House of Delegates voted to recognize obesity as a disease. Over the last 20 years, obesity rates have doubled among adults, resulting in more than 35% of adults living with obesity and an additional 33% being overweight.14 Evidence suggests that without concerted action, roughly half the adult population will have obesity by 2040. These numbers are particularly troubling because one out of every eight deaths in America is caused by an illness directly related to obesity; therefore, millions of Americans are at risk from this preventable and treatable disease.15 Research studies document the harmful health effects of excess body weight, which increases the risk for conditions such as prediabetes and type 2 diabetes, hypertension, heart failure, dyslipidemia, sleep apnea, hip and knee arthritis, multiple cancers, renal and liver disease, musculoskeletal disease, asthma, infertility and depression.

3. Improving Payment Accuracy for Preventive Services: Diabetes Self-Management Training (DSMT)

The Academy commends CMS for recognizing the under-utilization of DSMT services and seeking comment on barriers to access that could be addressed by CMS. 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. We appreciate CMS' interest in whether Medicare payment for these services is accurate. RDNs represent the primary specialty performing these services (43% G0108; 50% G0109). The Academy agrees with the barriers already noted by CMS in the proposed rules. In addition, 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:

  1. 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.16 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.
  2. 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.
  3. 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.17 Furthermore, when payers eliminate cost-sharing measures, they can expand the number of beneficiaries utilizing DSMT services, which will further enhance cost-savings.18 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,"19 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.
  4. Ten Hours/Two Hours and Done: Currently, beneficiaries are limited to only 10 hours of initial DSMT in the first twelve consecutive months and 2 hours of follow-up hours in each subsequent 12 month period. Many beneficiaries require additional hours of DSMT in each episode of care due to: changes in medications, lack of required understanding/learning of diabetes self-care behaviors due to impaired cognition, and/or the onset of diabetes complications requiring tighter control in multiple behaviors.20 The Academy recommends CMS reimburse for extra hours of initial DSMT and extra hours of follow-up DSMT, consistent with the regulations for extra hours of MNT services (i.e., requiring another provider referral documenting medical necessity and number of extra hours ordered).21 In addition, the Academy recommends CMS extend the time frame during which beneficiaries can receive the initial DSMT hours. Beneficiaries with a new diagnosis of diabetes often need time to cope with this new disease. They may attend their first DMST session but may not be at the appropriate Stage of Change22 to be ready to return to complete the initial DSMT services in the first 12 consecutive months. As a result, many beneficiaries lose access to such services at a later time when they would benefit from them. Diabetes is a chronic disease that requires beneficiaries to make challenging lifestyle and behavior changes. Persons with diabetes need ongoing education and support to make and solidify these changes.
  5. Telehealth and Other Virtual Means: 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. Beneficiaries requiring DSMT services who do not reside in rural, non-metropolitan statistical areas may not have the ability to receive DSMT services at the provider's site due to transportation issues, mobility issues, and financial issues (e.g., insufficient funds to pay for public transportation). The Academy recommends CMS remove the DSMT telehealth requirement that the originating site be in a rural, non-metropolitan statistical area to enhance access to the benefit.
  6. Inability to provide DSMT and MNT services on the same date of service: Current regulations, which do not allow DSMT and MNT to be provided on the same date of service, negatively impact quality and access to care and create undue scheduling and financial challenges for persons with diabetes, especially for disparate populations. Many Medicare beneficiaries forego necessary DSMT and MNT care because they cannot schedule services on the same day. CMS has cited the dual positive impact of both DSMT and MNT Medicare services for qualifying individuals with diabetes, and has acknowledged data indicating that, "provision of both Medicare benefits may be more medically effective for some beneficiaries than receipt of just one of the benefits." CMS's proposed rationale for not allowing same day services is its intent to spread services over time to provide necessary reinforcement of information. However, the Academy believes this rationale is flawed as the nutrition component of DSMT services is not the same as MNT. In addition, DSMT services include a broad range of topics necessary to aid a patient in self-management of their disease, such as instructions in self-monitoring of blood glucose; education about healthy eating and physical activity, and development of an insulin treatment plan for beneficiaries who require insulin to control glucose levels. Hence, the only potentially legitimate reason to limit same day services would be to limit provision of the nutrition component of a DSMT program and MNT on the same day. MNT and DSMT are distinct from each other, but are both necessary for improved beneficiary health outcomes. Same day provision allows for more effective multidisciplinary care.23 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.24 Compared with no prevention, self-management reduces a high-risk person's 30-year chances of getting diabetes by about 11%, the chances of a serious complication by 8% and the chances of dying of a complication of diabetes by 2.3%.25 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. The Academy recommends CMS allow Medical Nutrition Therapy (MNT) and Diabetes Self-Management Training (DSMT) be allowed on the same date of service.
  7. Site of service limitations for hospital accredited DSMT programs: Hospital outpatient patient departments (HOPD) should be allowed to furnish its DSMT program at the same alternate, off-site payable places of services that CMS has approved for physician office DSMT and MNT benefit. Many patients simply cannot get to the hospital due to transportation, work hours and general anxiety associated with the hospital setting. Hospitals who maintain traditional DSMT programs in their outpatient settings should be allowed to provide DSMT in community and other convenient settings. According to statistics for the American Association of Diabetes Educators and the American Diabetes Association, the 2 major accrediting bodies for DSMT programs, well over 1,200 programs are located in a HOPD. Under current CMS regulations for DSMT services, these programs are not able to reach out into the community they serve, creating a significant barrier to access. HOPD should be allowed to furnish its DSMT program at the same alternate, off-site payable places of services that CMS has approved for its MNT benefit. The Academy recommends CMS allow hospital accredited DSMT programs to have the same ability to provide DSMT in off-site locations as physician office accredited DSMT programs.

The Academy strongly believes Medicare payment rates for DSMT services need to be valued appropriately so as not to present a barrier to access. As the primary specialty performing these services, RDNs report their DSMT programs frequently operate at a loss and many programs have closed as a result of financial unsustainable. The Academy will be collaborating with other specialty societies performing these services to develop and present recommendations to CMS through the AMA RUC processes.

4. Valuation of Specific Codes

CMS is proposing to begin recognizing CPT code 961X0 Administration of patient-focused health risk assessment instrument for payment unless the service is explicitly included in another service being furnished, using the RUC recommended direct PE inputs. CMS is seeking input on whether or not this code would be better categorized as an add-on code. The Academy appreciates CMS' recognition of CPT code 961X0 as such assessment instruments provide valuable information used by qualified health care professionals to inform a patient's plan of care. The Academy recommends CMS categorize it as an add-on code to ensure the tool is not used without consultation with a qualified health care professional to discuss the results. The Academy urges CMS to recognize the code for payment by a wide range of Medicare practitioners, including RDNs. The Nutrition Care Process (NCP) used by RDNs is a systematic approach to providing high quality nutrition care. The first step in the NCP is "nutrition assessment" and involves collection and documentation of information critical to guiding selection of the appropriate nutrition diagnosis. Data obtained via a patient-focused health risk assessment instrument may provide critical input that enables the RDN to individualize the patient's care, taking into account specific health risks that may impact nutrition status and/or development of an appropriate care plan.

5. Medicare Advantage (MA) Provider Enrollment

CMS wants to create consistency with provider and supplier enrollment requirement for all Medicare programs (Part A, Part B, Part C and Part D). By doing so, CMS believes it will help to ensure Medicare enrollees received items or services from providers and suppliers that are fully compliant with the requirements for Medicare enrollment and that are in an approved enrollment status in Medicare. They believe it will also help to prevent fraud, waste and abuse and protect Medicare enrollees. Currently, MA organizations are not required to review a supplier's final adverse action history nor to verify a provider or supplier's practice location, ownership, or general identifying information.

The proposed rule would require MA suppliers to be enrolled in Medicare in an approved status (i.e., a status whereby a supplier is enrolled in, and is not revoked from, the Medicare program). Out-of-network or noncontract suppliers would not be required to enroll in Medicare to meet the requirements of this proposed rule. The proposed effective date of this rule would be approximately November 2018.

The Academy supports CMS proposal to required MA suppliers to be enrolled in Medicare in an approved status as we believe such action will achieve CMS's stated goals.

6. Proposed Expansion of the Diabetes Prevention Program (DPP) Model

The Academy is pleased that CMS is proposing to expand the Diabetes Prevention Program model as the Medicare Diabetes Prevention Program (MDPP) to Medicare beneficiaries with prediabetes. 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. We understand CMS intends to finalize proposed rules around provider eligibility and enrollment this year and will engage in additional rulemaking within the next year to establish specific requirements of the MDPP. The Academy looks forward to providing input throughout the process 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 offers the following comments related to specific components of the proposed rules:

a. Designation of MDPP services as "additional preventive services"

CMS proposes to waive requirements in section 1861(ddd)(3)(A) of the Social Security Act specifying the requirements for covering "additional preventive services," specifically section 1861(ddd)(1)(B) that requires additional preventive services to have been recommended by the United States Preventive Services Task Force (USPSTF) with a grade of A or B. CMs proposes to waive this statutory requirement "with respect to MDPP services because they have been recommended by the Community Preventive Services Task Force, which is similar to the USPSTF, and therefore a USPSTF recommendation is not necessary."(Emphasis added.)

The Academy is pleased that CMS and the Secretary are willing to use their statutory authority to modify or add preventive services that have been recommended by federal preventive services task forces, given the fact that CMS has been unwilling to modify coverage of USPSTF-recommended services such as intensive behavioral therapy for obesity to be consistent with the actual USPSTF recommendations. The willingness of CMS here to waive two of the three statutory requirements for adding preventive services is significant, particularly given that one waiver is proposed because of implementation issues regarding suppliers, which is the hurdle CMS has raised when it indicated to the Academy that it could not implement USPSTF recommendations to allow referral of patients with obesity to RDNs and other qualified providers outside of the primary care setting. Notably, the 2014 USPSTF recommendation specifically looking at these services made its recommendation based upon studies in which "[l]ifestyle coaches were dietitians or persons with a master's degree and training in exercise physiology, behavioral psychology, or health education."26 The Academy looks forward to working with CMS to ensure a consistent statutory interpretation and implementation of recommended preventive services.

b. Supplier Enrollment

CMS is proposing that any program with preliminary or full recognition would be eligible to apply for enrollment in Medicare as a supplier. CMS is also proposing that potential MDPP suppliers be screened according to the high categorical risk category because they acknowledge that MDPP may bring many organization types that are entirely new to Medicare. Before enrolling, DPP organizations must have either preliminary or full CDC recognition status. If an organization loses its CDC recognition status, withdraws from the CDC recognition program, or fails to move from preliminary to full recognition within 36 months of applying for CDC recognition, the organization would be subject to revocation of its Medicare billing privileges for MDPP services. Existing Medicare providers and suppliers that wish to bill for MDPP services would have to inform Medicare of that intention and satisfy all other requirements, but would not need to enroll a second time.

The Academy believes CMS is creating unnecessary confusion by creating a new type of recognition status, namely "preliminary recognition." The Academy also believes for program integrity purposes it is critical that CMS not pay suppliers who have not demonstrated their effectiveness as DPP providers or their ability to establish and maintain the necessary infrastructure to sustain a program. Therefore, the Academy recommends CMS only enroll DPP organizations with full CDC recognition status. Doing so would eliminate potential confusion created by the term "preliminary recognition" as well as provide a mechanism for a phased-in roll-out of the MDPP benefit. The Academy also supports screening potential MDPP suppliers according to the high categorical risk category for the reasons noted by CMS.

c. Requirements for MDPP Coaches

CMS proposes to require personnel who delivery MDPP services to obtain a NPI to help ensure the coaches meet CMS program integrity standards. MDPP suppliers would be required to submit the active and valid NPIs of all coaches who would furnish MDPP service on behalf of the MDPP supplier as an employee or contractor. The Academy supports CMS in requiring coaches to obtain a NPI. In addition to meeting CMS program integrity standards, such a requirement would aid CMS in calculating 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.27

CMS is considering requiring coaches to enroll in the Medicare program in addition to obtaining an NPI. The Academy does not feel it is necessary or appropriate for coaches to enroll in the Medicare program. Currently, CDC program recognition standards allow non-credentialed individuals to deliver the DPP with appropriate training. If CMS finalizes its proposed rules to enroll as MDPP suppliers programs with preliminary or full CDC recognition status, some of these coaches would not meet statutory requirements under the Social Security Act for Medicare provider status.

The Academy urges 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. As mentioned above, 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."28 RDNs and NDTRs already possess these skills and so provide a readily available workforce for the MDPP program.

d. Payment Structure

CMS proposes to tie payment to the number of sessions attended and achievement of a minimum weight loss of 5% of baseline weight. The Academy supports in concept such a value-based payment structure for the MDPP. However, the Academy requests 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. The Academy has concerns about the relative value of payments for the MDPP compared to other services to address risk for diabetes, such as Intensive Behavioral Therapy for Obesity (IBT). The proposed payment structure appears to be paying $22.50/hour for the first year of MDPP services (maximum total for first year of $360 for 16 core sessions) and $15/hour for maintenance sessions. The national payment rate for the IBT benefit for 30 minute group services, G0473, is $12.53 non-facility, $11.82 facility which translates to $25.05 or $23.64 per hour, respectively. IBT for Obesity services must be rendered by qualified health care professionals and requires a higher level of complexity and medical decision-making than the DPP. Payment rates for the MDPP should be determined via the RUC process or CMS should reduce the payment rate for MDPP services so as to be in relative alignment with other Medicare covered services. Alternatively, CMS may need to consider increasing payment rates for other Medicare covered services, which may also reduce barriers to utilization of such services.

The Academy also recommends that CMS clarify the payment structure since as presented in the proposed rules it is not clear that CMS is proposing to pay for the 1st, 4th and 9th core sessions, the 3rd, 6th and 9th maintenance session in year 1, and then the 3rd, 6th, 9th and 12th maintenance sessions every year thereafter. Changing language from "1 session attended" to "1st session attended" and so on would provide better clarity and avoid billing errors on the part of MDPP suppliers.

e. Eligible Beneficiaries

CMS proposes the following criteria for a Medicare beneficiary to be eligible to receive MDPP services:

  • Enrolled in Medicare Part B
  • As of the first date of attendance at the first Core Session a BMI of at least 25 if not self-identified as Asian and a BMI of at least 23 if self-identified as Asian.
  • Have within the 12 months prior to attending the first Core Session a hemoglobin A1c between 5.7 and 6.4 percent or a fasting plasma glucose of 110-125 mg/dl, or a 2-hour post-glucose challenge of 140-199 mg/dl.
  • Have no previous diagnosis of Type 1 or Type 2 diabetes
  • Does not have end-stage renal disease

The Academy applauds CMS for including HgA1c as a diagnostic criteria to determine eligibility for MDPP services. The Academy seeks clarification from CMS as to why it is proposing BMI levels different from those used by CDC for its Diabetes Prevention Recognition Program. Such misalignment may create problems with reconciling program status between CMS and CDC.

CMS also proposes to permit self-referral, community-referral, or health care practitioner-referral for the MDPP. While the Academy supports in theory the ability for individuals to be referred to MDPP services from sources other than a health care practitioner, we seek clarification from CMS as to how a MDPP supplier would be expected to confirm participants meet all of the eligibility criteria, in particular the laboratory tests for A1c levels.

CMS proposes that beneficiaries who meet coverage criteria will be able to enroll in the MDPP only once. While the Academy understands the intent behind this proposal, 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,29 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.

The Academy is also concerned that the above criteria may inadvertently prevent access to the MDPP by Medicare beneficiaries who are post kidney transplant based on the Medicare definition of end-stage renal disease. Waiting for these individuals to progress to diabetes before receiving nutrition and other lifestyle interventions represents a gap in care and poses unnecessary risks for higher cost treatments such as a return to dialysis or re-transplant. Allowing and facilitating treatment of prediabetes for these individuals demonstrates ethical and responsible use of limited resources including donor organs.

Program Integrity Initiatives

CMS justifiably has many concerns about potential program risk posed by permitting a new type of organization to receive payment from CMS for providing MDPP services. The Academy supports CMS considering ways to cross reference the data DPP organizations are currently required to submit to report to the CDC to identify potential discrepancies with data submitted to CMS. One strategy to mitigate risks and ensure program integrity would be to require a credentialed nutrition professional, such as a RDN or NDTR, or other qualified health care professional to serve as program coordinator for MDPPs. Such individuals are bound by state licensure, professional regulation, and professional codes of ethics. As Medicare providers, RDNs are already familiar with and bound by existing program integrity requirements.

The Academy also recommends that CMS develop a system to ensure claims for MDPP services for individual beneficiaries are not denied when there is a legitimate reason for beneficiaries to access services from more than one MDPP, such as the beneficiary moving to a new community, closure of a MDPP, or a MDPP losing its recognition status.

g. Site of Service Requirements

CMS proposes to allow MDPP suppliers to provide MDPP services in-person or via remote technologies. As part of CMS evaluation, to the extent feasible, they will evaluate the effectiveness of MDPP services, particularly in relation to virtual vs. in-person services. To do so, CMS is considering specifying the nature of the virtual service and the site of service in codes included on claims submitted for payment. Also CMS may collect data on the site of service at the beneficiary level. The Academy supports CMS in allowing MDPP services to be provided via both in-person and remote technologies. However, as noted in the ICER 2016 report, there is uncertainty as to whether digital programs are as efficacious as in-person programs. The proposed value-based payment structure for the MDPP provides protections for the Medicare program to not expend funds on services that do not produce the desired outcomes while allowing CMS to collect data on the relative effectiveness of virtual vs. in-person services. The Academy recommends CMS require the use of appropriate site of service codes on claims submitted for payment to aid in evaluation efforts.

Quality Measurement and reporting

CMS seeks input on other quality metrics that should be reported by MDPP suppliers in addition to attendance and weight loss or what is required by the CDC recognition program. While the Academy recognizes that many clinicians and researchers use weight loss as a surrogate measure for effective prevention of diabetes,30,31 we have concerns about limiting measures of success exclusively to attendance and weight loss. If the intent of the MDPP is to prevent progression of prediabetes to diabetes, HbA1c should also be used as a measure of success. Studies show that HbA1c decreases due to healthy eating and active lifestyle, in spite of individuals not losing 5% body weight.32 Other risk factors for diabetes, such as lipid levels and blood pressure, should also be measured and reported to demonstrate program effectiveness.

i. Timeframe

CMS is seeking input on whether the MDPP model should be expanded nationally in the first year of implementation or if there should be a phased-in approach with the goal of addressing technical issues prior to broader expansion.

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 43 "CY 2017 PFS Proposed Rule Estimated Impact on Total Allowed Charges by Specialty." CMS's omission of RDNs in Table 43 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.

8. Additional Recommendations

The Academy urges CMS to 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 SA), as amended by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)33 and the Patient Protection and Affordable Care Act (PPACA)34 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.35 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;36,37 and the initial preventive physical examination specifically includes MNT pursuant to a referral.38

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.39 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.40,41,42 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 - 5.9 cm"43

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." 44

Individuals with prediabetes have comorbidities such as hypertension, hyperlipidemias, chronic kidney disease and metabolic syndrome45,46,47,48,49,50,51,52,53 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.

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."54 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 2017 Medicare Physician Payment 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 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, http://andevidencelibrary.com/mnt. [Grade Definitions: Strength of the Evidence for a Conclusion/Recommendation Grade I, "Good evidence is defined as:  "The evidence consists of results from studies of strong design for answering the questions addressed. The results are both clinically important and consistent with minor exceptions at most. The results are free of serious doubts about generalizability, bias and flaws in research design. Studies with negative results have sufficiently large sample sizes to have adequate statistical power."

4 Centers for Disease Control and Prevention (CDC), National Center for Health Statistics, Division of Health Interview Statistics, data from the National Health Interview Survey. Data computed by personnel in CDC's Division of Diabetes Translation, National Center for Chronic Disease Prevention and Health Promotion. http://www.cdc.gov/diabetes/statistics/mobility/health_status/fig3.htm. Accessed August 21, 2016.

5 Age-Adjusted Percentage of the U.S. Population Aged 65 Reporting Disability by Definition and CKD Stage 1999-2012 National Health and Nutrition Examination Survey. Centers for Disease Control and Prevention. Chronic Kidney Disease Surveillance System—United States. http://www.cdc.gov/ckd. Accessed August 21, 2016.

6 Chronic Conditions among Medicare Beneficiaries: 2012 Chartbook. Available at http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and- Reports/Chronic-Conditions/Downloads/2012Chartbook.pdf. Accessed August 15, 2015.

7 Physician Payment Reform: Where Do I Fit In? Dividing the Pie in New Payment Models. AMA Innovation Committee, April 2014.

8 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.

9 Academy of Nutrition and Dietetics Evidence Analysis Library. Medical Nutrition Therapy Evidence Analysis Project 2008. http://www.andevidencelibrary.com/mnt.

10 Academy of Nutrition and Dietetics Evidence Analysis Library. Medical Nutrition Therapy Evidence Analysis Project 2015. http://www.andevidencelibrary.com/mnt

11 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.

12 Wigle P, Bloomfield HE, Tubb M, Doherty M. Updated guidelines on outpatient anticoagulation. Am Fam Physician. 2013 (Apr 15);87(8):556-566

13 Finkelstein et al. "Annual Medical Spending Attributable to Obesity: Payer- and Service-Specific Estimates." Health Affairs, 28, no. 5 (2009). 27 July. http://content.healthaffairs.org/content/28/5/w822.full.pdf+html

14 Ogden et al. Prevalence of Obesity in the United States, 2009-2010. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. January 2012. http://www.cdc.gov/nchs/data/databriefs/db82.pdf

15 Carmona, Richard. The Obesity Crisis in America. Surgeon General's Testimony before the Subcommittee on Education Reform, Committee on Education and the Workforce, United States House of Representatives. 16 July 2003. www.surgeongeneral.gov/news/testimony/obesity07162003.htm

16 Classification and Diagnosis of Diabetes. American Diabetes Association. Diabetes Care Jan 2015, 38 (Supplement 1) S8-S16; DOI: 10.2337/dc15-S005

17 Center for Health Law and Policy Innovation, Harvard Law School. Reconsidering Cost-Sharing for Diabetes Self-Management Education: Recommendation for Policy Reform. June 2015. Accessed at: http://www.chlpi.org/wp-content/uploads/2014/01/6.11.15-Reconsidering-Cost-Sharing-for-DSME.pdf.

18 Id.

19 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.

20 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.

21 42 CFR §410.132(b)(5)

22 Prochaska J O, Velicer W F. The transtheoretical model of health behavior change. Am J Health Promot.1997;12(1):38–48

23 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. http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=53&. ).

24 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.

25 The Diabetes Prevention Program. DPP Results. 2008. http://diabetesniddk.nih.gov/dm/pubs/preventionprogram/#results. Accessed June 1, 2009.

26 http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/healthy-diet-and-physical-activity-counseling-adults-with-high-risk-of-cvd

27 https://icer-review.org/wp-content/uploads/2016/07/CTAF_DPP_Final_Evidence_Report_072516.pdf. Accessed August 21, 2016.

28 https://icer-review.org/wp-content/uploads/2016/07/CTAF_DPP_Final_Evidence_Report_072516.pdf. Accessed August 21, 2016.

29 Prochaska J O, Velicer W F. The transtheoretical model of health behavior change. Am J Health Promot.1997;12(1):38–48

30 Hamman R, Horton E, Barrett-Connor E, et al. Factors affecting the decline in incidence of diabetes in the Diabetes Prevention Program Outcomes Study (DPPOS). Diabetes. 2015;64(3):989-998.

31 Maruthur N, Ma Y, Delahanty L, et al. Early response to preventive strategies in the Diabetes Prevention Program. Journal of general internal medicine. 2013;28(12):1629-1636.

32 Tuomilehto J et. al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001;344(18):1343-50.

33 Pub. L. no. 110-275, 122 Stat 2494 (2008).

34 Pub. L. no. 111-148, 124 Stat 119 (2010).

35 42 U.S.C. 1834(m)n.

36 See, 29 November 2011 CMS NCD on Intensive Behavioral Counseling for Obesity.

37 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."

38 42 U.S.C. 1861(ww).

39 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.

40 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.

41 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.

42 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.

43 Academy of Nutrition and Dietetics Evidence Analysis Library. Prevention of Type 2 Diabetes Evidence Analysis Project, 2014. Strong, Imperative. https://www.andeal.org/topic.cfm?menu=5344&cat=5210. Accessed August 21, 2016.

44 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.

45 Id.

46 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.

47 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.

48 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.

49 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.

50 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.

51 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.

52 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.

53 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.

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