September 2, 2014
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attn: CMS-1600-P P.O. Box 8016
Baltimore, MD 21244-8016
Re: File Code-CMS-1612-P; Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015; Proposed Rule; (July 11, 2014).
Dear Administrator Tavenner:
The Academy of Nutrition and Dietetics (the “Academy”) is pleased to provide comments on CMS-1612-P Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015 published in the July 11, 2014 Federal Register. The Academy has over 75,000 members including Registered Dietitian Nutritionists1 (RDNs) who independently provide professional services such as medical nutrition therapy (MNT) under Medicare Part B.
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.2 RDNs participate in the Medicare Part B Physician Quality Reporting System, providing high quality, evidence-based care to patients and delivering substantial cost-savings to the health care system as a whole.
The Academy offers specific comment on the following proposed rule items:
- Potentially Misvalued Services Under the Physician Fee Schedule - Obesity Behavioral Group Counseling
- Facility and Nonfacility Costs
- Malpractice Relative Value Units (RVUs)
- Medicare Telehealth Services
- Valuing New, Revised, and Potentially Misvalued Codes
- Chronic Care Management (CCM)
- Removal of Employment Requirements for Services Furnished “Incident to” Rural Health Clinic and Federally Qualified Health Center Visits
- Physician Compare Website
- Physician Payment, Efficiency, and Quality Improvements - Physician Quality Reporting System
- Value-Based Payment Modifier and Physician Feedback Program
- Analysis of the Fee Schedule Impact on Specialties
1. Potentially Misvalued Services Under the Physician Fee Schedule - Obesity Behavioral Group Counseling
To improve payment accuracy, CMS proposes to create two new HCPCS codes (GXXX2 and GXXX3) for the reporting and payment of group behavioral counseling for obesity. CMS proposes valuing the code by scaling the work RVU of HCPCS code G0447 to reflect the differences in codes in terms of the time period covered by the code and the typical number of beneficiaries per session (4 and 9, respectively). Using the same logic, CMS proposes to use the direct PE inputs for GXXX2 and GXXX3 currently included for G0447, prorated to account for the differences in time and number of beneficiaries described by the new codes. Finally, CMS proposes to crosswalk the malpractice risk factor from HCPCS code G0447 to both HCPCS codes GXXX2 and GXXX3. The Academy supports creation of new HCPCS codes as such codes are needed to recognize and reimburse provision of behavioral counseling for obesity in a group setting. Research evaluating individual vs. group nutrition counseling found group counseling to be an effective mode of service delivery for patients with diabetes and/or obesity.3 4 5 However, we question the need for 2 HCPCS codes when such an approach has not been used for other group counseling services within the PFS and the nature of the work is the same irrespective of the number of participants. When it comes to valuation of these codes, the Academy does not support CMS’s logic. When HCPCS code G0447 was first created, its value was established using CPT code 97803 as a reference code. The Academy proposes using a similar logic to value a new single HCPCS code for groups comprised of 2 or more beneficiaries using 97804 as a reference code (RVU .25).
The Academy urges CMS to clarify billing guidelines when delivering obesity behavioral counseling as either an individual or group service. Since code G0447 was first created, CMS has been equivocal as to whether the code can be billed in multiple units on the same day of service. CMS has deferred this question to the Medicare Administrative Contractors (MAC). The Academy has sought an answer to this question from each MAC with answers varying from “yes,” to “no,” to “we don’t know,” to “try billing it and see what happens.” It is unsustainable for Medicare beneficiaries and Medicare providers to operate in a climate with such uncertainty around coverage for a recognized medically necessary service and could potentially lead to less than ideal outcomes and disease progression The Academy recommends that CMS allow G0447 to be billed for up to 4 units on the same day of service for the first visit and then for up to 2 units on the same day of service for subsequent visits during the same episode of care. Such a policy would allow the provider to spend the necessary time up front to conduct an adequate assessment (part of the 5-As) as the foundation for development and implementation of an appropriate, individualized plan of care. Flexibility in the length of subsequent sessions is needed to support the 5-As process and increase the likelihood of achieving the desired results. This proposed pattern of care delivery is consistent with the Academy’s Evidence-Based Nutrition Guidelines for Adult Weight Management. We recommend that the code description for the new group service codes be changed to say “each 30 minutes” to allow billing for group sessions longer than 30 minutes. In an effort to promote good beneficiary outcomes while managing costs, we recommend that CMS allow any new HCPCS code(s) created for this service to be billed for up to 2 units on the same day of service. Results from the Academy’s 2013 Coding Survey indicates the typical group service is 60 minutes in duration.
Finally, the Academy urges CMS to enhance beneficiary access to qualified, effective providers of obesity management services by allowing RDNs and nutrition professionals as already defined in the Social Security Act to independently provide intensive behavioral therapy for obesity services to Medicare beneficiaries. RDNs possess the necessary knowledge, skills and training needed to deliver the service and are proven to be cost-effective providers of obesity counseling services.6 7 By allowing RDNs to independently provide intensive behavioral therapy for obesity, CMS can reduce costs and enhance effectiveness while simultaneously ensuring coverage is limited to a small, effective group of qualified existing Medicare providers working in consultation with primary care providers.
2. Facility and Nonfacility Costs
With the growth of hospital-based provider practices, CMS started last year to look at how it calculates practice expense for facility and non-facility providers and to make sure the methodology is “fair” and results in appropriate values across the Physician Fee Schedule and the outpatient prospective payment system. In this year’s proposed rules, CMS proposes to create a HCPCS modifier to be reported with every code for physician and hospital services furnished in an off-campus provider-based department of a hospital. The modifier would be reported on both the CMS-1500 claim form for physicians’ services and the UB-04 (CMS form 1450) for hospital outpatient claims. Collection of this information would allow CMS to assess the accuracy of PE data currently used to value PFS services as well as develop proposed improvements that would appropriately account for the different resource costs among tradition office, facility, and off-campus provider-based settings. The Academy supports use of a code modifier, in the short term, as a reasonable assessment/tracking methodology. Once a determination is made, the need for continued use of a modifier should be reassessed.
3. Malpractice Relative Value Units (RVUs)
As part of its routine review of malpractice RVUs, CMS proposes to cross-walk RDNs to allergy and immunology since available data from state departments of insurance premium rates for RDNs was deemed unreliable. The Academy supports this approach to setting the malpractice RVU component of fees for RDNs as it appropriately places RDNs on par with malpractice RVUs for other non-physician health care professionals who incur similar levels of risk when providing services.
4. Medicare Telehealth Services for the Physician Fee Schedule
CMS proposes to add HCPCS codes G0438 (Annual Wellness Visit – initial) and G0439 (Annual Wellness Visit – subsequent) to the list of telehealth services for CY 2015. RDNs within physician office practices frequently provide this service under the supervision of the physician. The required components of the Annual Wellness Visit lend themselves well to delivery as a telehealth service. Adding these codes to the list of telehealth services expands beneficiaries’ access to these services that are an important component of preventive health care, supports the Triple Aim and reduces disparities based solely on geography. Therefore, the Academy supports CMS’s proposal to add HCPCS codes G0438 and G0439 to the list of telehealth services for CY 2015.
5. Valuing New, Revised and Potentially Misvalued Codes
In an effort to respond promptly to the call for greater transparency in the valuation process, CMS proposes several changes in the timing of publication and implementation of coding and RVU changes as part of the Medicare Physician Payment Schedule rule-making process beginning in CY 2016. The Academy supports the comments submitted by the American Medical Association/Specialty Society RVS Update Committee (RUC) and CPT Editorial Panel related to this CMS proposal. While we agree with the general intent of the CMS proposal and support additional transparency and comment opportunity in the valuation of physician and other healthcare professional services, we feel this alternative proposal will avoid a lengthy delay in Medicare adoption of 2016 coding changes already nearly through the development process.
6. Chronic Care Management
CMS proposes a payment rate of $41.92 for HCPCS code GXXX1 for chronic care management (CCM) services that can be billed no more frequently than once per month per qualified patient. CMS also proposes to allow greater flexibility in the supervision of clinical staff providing CCM services by removing the requirement that the clinical staff person must be a direct employee of the practitioner or the practitioner’s practice and also removing the restriction that such services may only be counted if they are provided outside of the practice’s normal business hours. It is proposing that CCM services must be furnished with the use of an electronic health record or other health IT or health information exchange platform that includes an electronic care plan that is accessible to all providers within the practice, including being accessible to those who are furnishing care outside of normal business hours, and that is available to be shared electronically with care team members outside of the practice. Such EHR technology must be certified by a certifying body authorized by the National Coordinator for Health Information Technology.
The Academy supports CMS’s decision to pay for CCM services as they are critical to quality of care, improved outcomes, and cost-savings. The Academy also supports the additional flexibility in both the requirements for clinical staff persons as well as when such services are provided. Removal of these restrictions, coupled with use of electronic care plans, better recognizes the range of staffing practices within physician office practices and the fact that delivery of such services happens throughout the day and warrants payment whenever it is delivered.
The Academy urges CMS to explicitly recognize the wide range of qualified non-physician practitioners located within or outside of a primary care provider’s office setting who spend time providing care management services as their efforts are critical to successful patient and population health outcomes and controlling the progression of chronic and complex chronic disease. Depending on the individual patient and their needs at a particular point in time, leadership in CCM services may shift amongst members of the care team, including the RDN. 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. 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.8 RDNs are trained and qualified to perform care management, particularly for patients with complex health needs. As such, they should be recognized as clinical staff who can provide CCM services.
The Academy also urges CMS to recognize obesity as a chronic condition for the purposes of this service. Obesity is an astronomically expensive problem for our nation and families. Medicare and Medicaid patients with obesity cost $61.8 billion per year. As such, it behooves CMS to recognize obesity as one of the chronic conditions that qualifies beneficiaries for CCM 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.9 Evidence suggests that without concerted action, roughly half the adult population will be obese 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 a preventable and treatable disease.10 Research studies document the harmful health effects of excess body weight, which increases the risk for conditions such as diabetes, hypertension, heart failure, dyslipidemia, sleep apnea, hip and knee arthritis, multiple cancers, renal and liver disease, musculoskeletal disease, asthma, infertility and depression.
7. Removal of Employment Requirements for Services Furnished “Incident to” Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Visits
CMS proposes to remove the requirement that services furnished “incident to” an RHC or FQHC visit must be furnished by an employee of the RHC or FQHC to allow nurses, medical assistants, and other auxiliary personnel to furnish “incident to” services under contract in RHCs and FQHCs. This proposed change would enhance the ability of RHCs and FQHCs to recruit highly qualified health care professionals to provide services to populations in areas that often struggle to recruit and retain providers, thus increasing access to care. RDNs serve as a critical part of the health care team in many RHCs and FQHCs across the country, providing medical nutrition therapy, diabetes self- management training, intensive behavioral counseling for obesity, and Annual Wellness Visits to the patients served by these clinics. Depending on the size of the RHC or FQHC, the RDN may be an employee of the clinic or under contract. Removing the employment requirement for “incident to” services enhances beneficiary access to intensive behavioral counseling for obesity and the Annual Wellness Visit, as well as other important Medicare services, thus helping to further promote beneficiary health while utilizing qualified, lower cost providers.
8. Physician Compare Website
CMS proposes to increase the Physician Quality Reporting System (PQRS) measures publicly reported on the Physician Compare website. CMS proposes that all measures posted must meet the criteria of a minimum sample size of 20 patients and will have been analyzed for statistical validity and reliability prior to posting. CMS also proposes to conduct consumer testing to ensure the information is consumer-friendly and understood and aids in health care decision-making. The Academy supports public reporting of performance rates on quality measures to help consumers choose their healthcare providers. We do have concerns about meaningful use of this data with respect to RDN Medicare providers as their patient sample size for PQRS measures often is limited as Part B MNT currently covered services are currently limited to beneficiaries with diabetes and renal disease. Therefore the Academy encourages CMS to make it clear to users of the website that lack of data on a provider may be due to low sample size and/or few measures available for reporting and is not necessarily a reason to not seek services from the provider. In addition, it is important to note that many PQRS measures represent the collective input of many providers involved in a beneficiary’s care, as well as the beneficiary themselves. For example, blood pressure and HbA1c control are impacted by primary and specialty care medical providers ordering practices, medical nutrition therapy, beneficiary compliance and other factors. Thus, lower quality outcomes may not be a direct reflection of an individual provider’s health care practices. The Academy supports validation as well as consumer testing of information before it is posted as it is critically important that the information truly reflects quality of care and serves its intended purpose.
9. Physician Payment, Efficiency, and Quality Improvements – Physician Quality Reporting System (PQRS)
While RDNs currently only qualify as eligible providers (EPs) under PQRS, the Academy supports CMS’s efforts to align all of its quality improvement programs, reporting systems and quality measures. We believe this alignment will lighten the administrative burden on EPs while harmonizing the various CMS quality programs.
CMS proposes to continue to require individual EPs to report at least 9 measures, covering at least 3 of the NQS domains, to meet the criteria for satisfactory reporting for the CY 2017 payment adjustment. While the CMS proposal allows for reporting 1-8 measures, this reporting will be subject to the Medicare Applicability Validation (MAV) process. As a specialty provider currently only able to direct bill for MNT services for Medicare beneficiaries with diabetes and renal disease, the number of PQRS measures that an RDN might report is limited and falls below the 9 measure threshold. As a result, the agency will continue to routinely incur the administrative burden of the MAV process for all RDN Medicare providers reporting in the PQRS. As the number of RDNs participating in the PQRS continues to grow, so too will this administrative burden on CMS. The Academy urges CMS to consider an alternate, lower reporting requirement for highly specialized Medicare providers with a limited scope of services and therefore limited applicable measures on which to report.
CMS also proposes that eligible professionals who see at least 1 Medicare patient in a face-to-face encounter report on at least 2 measures contained in the proposed cross-cutting measure set. While the Academy supports the intent of this new reporting requirement, we are concerned that in the future the number of required measures will increase, as has been the case with PQRS reporting requirements in general. As noted above, RDNs are limited in the number of PQRS measures available to report. The current cross-cutting measure set includes only 2 measures reportable by RDNs. So while RDNs may be able to meet this reporting requirement for CY 2017, they may not be able to do so in the future if the threshold for reporting is raised.
CMS continues to note its intent to move away from claims-based reporting for the PQRS. While the Academy recognizes the challenges of this reporting mechanism for both providers and CMS, we urge CMS to retain the claims-based reporting mechanism. In the case of RDNs, the claims-based reporting mechanism is often the only option available for reporting as they may not yet be linked to EHR systems or may be using electronic systems that are not recognized as certified EHR technology.
Many RDNs providing services to Medicare beneficiaries practice in small single-specialty practices or as part of small multi-provider specialty practices.
10. Value-Based Payment Modifier (VM) and Physician Feedback Program
CMS proposes to apply the VM to all physicians and non-physician eligible providers (EPs) in groups with 2 or more EPs and to solo practitioners starting in CY 2017. Quality of care would be based on the quality data submitted under the PQRS. All of the PQRS GPRO reporting mechanisms available to groups and all of the PQRS reporting mechanisms available to individual EPs for the PQRS reporting periods in CY 2015 would be included. For the cost composite, Medicare beneficiaries will be attributed to the groups and solo practitioners based on methodology that looks at E/M services. If a cost composite cannot be calculated using this methodology, CMS proposes to classify the group or solo practitioner’s costs composite as “average.” The Academy supports applying the VM to all non-physician eligible providers starting in CY 2017. However, the Academy has concerns about the alternate methodology for classifying costs. While the proposal prevents the group or solo practitioner from being subject to downward adjustments based on “high” costs, it does not allow a mechanism to recognize these providers as being “low” cost and thus potentially be eligible for the maximum upward payment adjustment. The Academy encourages CMS to work with all of the non- physician specialty societies to develop a more equitable alternative. In addition, as noted above, it is important to note that many PQRS measures represent the collective input of many providers involved in beneficiaries’ care, as well as the beneficiaries themselves. So lower quality outcomes may not be a direct reflection of an individual provider’s health care practices and thus individual providers should not be penalized for outcomes beyond their control.
CMS proposes to make quality-tiering mandatory for groups and solo practitioners. Groups with between 2 and 9 EPs and solo practitioners would be subject only to any upward or neutral adjustment, and groups with 10 or more EPs would be subject to upward, neutral or downward adjustments. CMS also proposes to increase the amount of payment at risk from 2.0 percent in CY 2016 to 4.0 percent in CY 2017. The Academy supports the proposal to not penalize small groups and solo practitioners through downward adjustments. The Academy has concerns about increasing the amount of payment at risk. While the Academy recognizes such an increase may be designed to encourage greater participation by Medicare providers in quality reporting programs, we are concerned this change may lead to an unintended consequence of providers dropping out of the Medicare program. In particular, small group and solo practitioners already struggling to keep their practices active may be lost from the Medicare program, creating access to care problems for beneficiaries.
CMS proposes to define “solo practitioner” as a single Tax Identification Number (TIN) with 1 eligible provider who is identified by an individual NPI billing under the TIN. In light of the fact that RDNs often operate as solo practitioners, the Academy supports CMS’s proposed definition of a “solo practitioner.”
Overall, the Academy supports efforts aimed at achieving the Triple Aim of health care. MNT provided by RDNs for prevention, wellness, and disease management can improve a patient’s health and increase productivity and satisfaction levels through decreased doctor visits, fewer hospitalizations and re-admissions, and reduced prescription drug coverage. RDNs provide vital nutrition services and promote health and well-being to the public. They often operate as solo practitioners. By using their expertise and extensive training, RDNs deliver care that is coordinated and cost-effective in a variety of chronic diseases, such as obesity, hypertension, diabetes, disorders of lipid metabolism, HIV infection, unintended weight loss in older adults and chronic kidney disease.11
11. 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 60 “CY 2015 PFS Proposed Rule Estimated Impact on Total Allowed Charges by Specialty.” CMS’s omission of RDNs in Table 71 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.
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 prepared 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.”12 As CMS continues its efforts to achieve the Triple Aim, 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 2015 Medicare Physician Payment Schedule. Please do not hesitate to contact Jeanne Blankenship by phone at 202-775-8277 ext. 6004 or by email at [email protected] or Marsha Schofield at 312-899-4787 or by email at [email protected] with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Vice President, Policy & Advocacy
Academy of Nutrition and Dietetics
Marsha Schofield, MS, RD, LD
Director, Nutrition Services Coverage
Academy of Nutrition and Dietetics
1 The Academy recently approved the optional use of the credential “registered dietitian nutritionist (RDN)” by “registered dietitians (RDs)” to more accurately convey who they are and what they do as the nation’s food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 Grade 1 data. Academy Evidence Analysis Library, 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.”
3 Ashley JM, St. Jeor ST, Schrage JP, Permean-Chaney SE, Gilbertson MC, McCall NL, Bovee V. Weight Control in the Physician's office. Arch Internal Med, 161; 2001: 1,599-1,604
4 Gucciardi E, DeMelo M, Lee R, Grace S. Assessment of two culturally competent Diabetes education methods: Individual vs. Individual plus Group education in Canadian Portuguese adults with Type 2 Diabetes. Ethnicity and Health. 2007; 12 (2):163-187
5 Renjilian DA, Nezu A, Shermer RL, Perri MG, McKelvey WF, Anton SD; Individual versus group therapy for obesity: Effects of matching participants to their treatment preferences. Journal of Consulting and Clinical Psychology, 2001; 69 (4): 717-721.
6 Grade 1 data. ADA Evidence Analysis Library
7 Pritchard et al. “Nutritional Counseling in General Practice: A Cost-Effectiveness Analysis.” Journal of Epidemiology and Community Health, 53 (2009): 311-316
8 Academy of Nutrition and Dietetics Evidence Analysis Library. Medical Nutrition Therapy Evidence Analysis Project 2008. http://www.andevidencelibrary.com/mnt
9 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
10 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. 1616 July 2003. http://www.surgeongeneral.gov/news/testimony/obesity07162003.htm
11 Academy of Nutrition and Dietetics Evidence Analysis Library. Medical Nutrition Therapy Evidence Analysis Project 2008. http://www.andevidencelibrary.com/mnt
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.