Academy Comments to CMS re End Stage Renal Disease Medical Information Facility Survey

December 12, 2016

CMS, Office of Strategic Operations and Regulatory Affairs
Division of Regulations Development
Attention: Document Identifier/OMB Control Number __
Room C4-26-05
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Re: CMS-2744 End Stage Renal Disease (ESRD) Medical Information Facility Survey

Dear Sir or Madam:

The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the Centers for Medicare & Medicaid Services (CMS) in response to the information collection published in the October 14, 2016 Federal Register regarding the End Stage Renal Disease (ESRD) Medical Information Facility Survey (the "Survey"). The Academy is the world’s largest organization of food and nutrition professionals, with more than 100,000 members comprised of registered dietitian nutritionists (RDNs),1 dietetic technicians, registered (DTRs), and advanced-degree nutritionists. We are committed to improving the nation's health through food and nutrition and providing medical nutrition therapy (MNT)2 and other nutrition counseling services to meet the health needs of all citizens. Academy member RDNs provide medical nutrition therapy in dialysis facilities, clinics, hospitals, university settings, and private practice. Through their direction and leadership, RDNs strive to advance the nephrology nutrition clinical practice, education and research while promoting continuing education programs for dietitians and other health-care professionals.

The Academy supports the proposed information collection as necessary for the proper performance of the functions of the agency, particularly given the practical utility resulting from the Survey. We respectfully offer recommendations below for potential improvements to the data collection and urge CMS not to eliminate any currently collected data elements.

A. Utility and Necessity of the Proposed Information Collection

Data on the Survey are critically important for research and quality improvement activities. When paired with outcomes data such as standardized mortality ratio and standardized hospitalization rate, they allow for analysis of the relationship between staffing and patient outcomes. CMS could add significant value to the Survey by adding questions to ascertain the extent to which facility-assigned administrative and coordination activities allow adequate time for nutrition assessment and nutrition counseling, which are both CMS specified duties of renal dietitians.

1. Assessing Sufficiency of RDNs' Time with Patients

The Academy notes the clear connection between poor nutrition status and mortality and morbidity in patients with ESRD on hemodialysis.3 Research shows that nutrition counseling can improve patient outcomes, but it is a time-consuming process.4,5 In a study of nutrition education to improve phosphorus control in patients with serum phosphorus >6 mg/dl at baseline, a 20-30 minute monthly education session with each patient over 6 months successfully and significantly increased patient knowledge and lowered serum phosphorus compared to a control group.6 Extrapolating this time requirement and assuming a patient population of 120 for one RDN and 30% of patients with phosphorus over 6 mg/dl (similar to the prevalence in Ford et al);7 between 13 and 20 hours per month of RDNs' time would need to be dedicated to phosphorus education alone. This lack of time for patient education has been cited as reasons for the high mortality rate of American dialysis patients compared to those in other developed countries.8

Research using self-reported survey data suggests that ratios around 120 dialysis patients per full-time equivalent RDN are common, but that approximately 25% of RDNs are responsible for more than 150 patients.9 The Kidney Disease Outcomes Quality Initiative (KDOQI) Nutrition Guideline suggests that 150 patients per FTE RDN is the highest acceptable ratio, but asserts that 100:1 is more ideal.10 Assuming an RDN has a 40 hour workweek, sees 120 patients, and spends 100% of his or her time on patient care, the RDN is limited to a mere 1.33 hours per patient per month, which is inadequate for truly effective counseling. Given the research cited above, this would indicate that just 1/3 of the total time with each patient would need to be dedicated to phosphorus,11 which is only one of many nutrition problems with which the RDN needs to assist. In fact, estimates suggest that 50% patient care is more realistic,12 which would leave even less time for RDNs to do patient counseling and provide other evidence-based nutrition care. In a survey of dialysis professionals, nurses identified the ideal patient:RDN ratio as 48:1, nephrologists identified it as 56:1, and administrators were willing to accept 70:1.13 Notably, each of these ratios are substantially lower than those reported in surveys (115:1).14 In response, Texas has legislated that there be no more than 100 patients per RDN,15 but many states exceed these ratios, with Washington state having the worst ratio of 280:1.16

Tasks that RDNs complete that are not directly related to patient nutrition care include documenting quality measures and participating in QAPI activities for the Centers for Medicare and Medicaid Services (CMS).17 Patient care plans, which are lengthy forms and often meetings, are required from the interdisciplinary team when a followed parameter is out of range.18 In addition, past research shows that RDNs are frequently used as administrative personnel to maintain the units' regulatory status, with responsibilities that include ensuring other team members complete plans of care.19 Our member RDNs also report being utilized by one of the main dialysis chains as pharmacy benefits managers responsible for moving patients to the company pharmacy in advance of the ESRD Prospective Payment System for prescription medications.20 RDNs are frequently asked to lead or assist with changes in care (including medication dosing) based on protocols for anemia, bone mineral disease, and management of interdialytic weight gain.21,22 RDNs are also frequently asked to assess dialysis adequacy and perform kinetic modeling.23,24

A 2006 study indicates that renal RDNs were generally satisfied with their jobs but were unhappy with the limited amount of time for patient interaction and felt that paperwork should be reduced.25 Adding responsibilities not perceived as relevant to RDNs' formal education—including the tasks listed above—is likely to cause similar dissatisfaction. Poor job satisfaction is likely to lead to increased staff turnover and could negatively impact patient care. In Sullivan et al's 2006 study, increasing patient:RDN ratios (assessed categorically as more than or fewer than 145 patients per FTE RDN) were associated with lower mean job satisfaction scores; non-nutrition related tasks also decreased satisfaction.26 Our own previous work indicates that patient:FTE RDN ratios above this cutoff for job satisfaction are frequent,27,28 creating concern for burn-out and high staff turnover.

Understanding staff turnover through the Survey could provide a substantial additional benefit to researchers seeking to understand the relationship between staffing and patient outcomes. This assessment could be relatively simple; for example, the Survey could identify how many positions are filled by incumbents who have been present more than 6 months.

2. Staffing Levels

In one important example of research using the Annual Facility Reports, Yoder et al used the 2009 data to report that the average patient:RDN ratio is 56:1 with a median of 83:1 (recalculated from results reported as RDNs per 100 patients).29 For-profit facilities had more patients:RDN, as did freestanding clinics compared to hospitals.30 However, these differences were not statistically significant when adjusted for other characteristics including chain ownership and census region.31 Chain-affiliated, freestanding facilities had significantly fewer nurses per hundred patients (a higher patient:nurse ratio) compared to non-profit facilities and hospital-based facilities.32 Regional variation in staffing levels were also identified, with the Midwest having lower numbers of nurses than the referent region of the Northeast.33 These differences in nurse staffing remained significantly different when all characteristics were adjusted for, lending credence to the concept that staffing levels could play a part in the variation in outcomes observed among for vs non-profit facilities.34 The number of patients per RDN reported by the Annual Facility reports are significantly lower than those obtained through self-report, likely due to a limitation of the Survey, which define a full time staff position as 32 or more hours per week and a part time position as less than 32 hours per week, but are not more specific. Yoder et al assumed that 2 part time staff positions were equal to one full time staff position;35 which means that a part time RDN who works 8 hours vs. a part time RDN who works 30 hours is not captured differently. To truly strengthen the AFS data and allow for exploration of the relationship between patient outcomes and staffing, data collection needs to be more specific about the hours worked by part-time professionals.

Early discussions of Dialysis Facility Compare included patient:staff ratios as reported measures, demonstrating the importance and value of the data collected on the AFS.36 However, staffing ratios were deemed difficult to understand by patients and concerns were raised about data quality among dialysis providers, so staffing was removed.37 The changes proposed above could improve data quality and interpretation for both patients and researchers so that staffing could be considered as an element Dialysis Facility Compare again.

Summary

The Academy appreciates the opportunity to offer comments regarding the ESRD Medical Information Facility Survey. We are pleased to offer our assistance and expertise, including information from our Evidence Analysis Library. Please contact either Jeanne Blankenship at 202-775-8277 ext. 6004 or by email at jblankenship@eatright.org or Pepin Tuma at 202-775-8277 ext. 6001 or by email at ptuma@eatright.org with any questions or requests for additional information.

Sincerely,

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

Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
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 Medical nutrition therapy (MNT) is an evidence-based application of the Nutrition Care Process focused on prevention, delay or management of diseases and conditions, and involves an in-depth assessment, periodic re-assessment and intervention. [Academy of Nutrition and Dietetics' Definition of Terms list, http://www.eatright.org/scope/, accessed 31 June 2012.]  The term MNT is sometimes used interchangeably with, but is sometimes considered different from, nutrition counseling in health insurance plans.

3 de Mutsert R, Grootendorst DC, Boeschoten EW, et al. Subjective global assessment of nutritional status is strongly associated with mortality in chronic dialysis patients. Am J Clin Nutr. 2009;89(3):787-793. doi: 10.3945/ajcn.2008.26970; 10.3945/ajcn.2008.26970.

4 Leon J, Albert JM, Gilchrist G, et al. Improving albumin levels among hemodialysis patients: A community-based randomized controlled trial. American Journal of Kidney Diseases. 2006;48(1):28-36.

5 Sullivan C, Sayre SS, Leon JB, et al. Effect of food additives on hyperphosphatemia among patients with end-stage renal disease. JAMA: The Journal of the American Medical Association. 2009;301(6):629-635. doi: 10.1001/jama.2009.96.

6 Ford JC, Pope JF, Hunt AE, Gerald B. The effect of diet education on the laboratory values and knowledge of hemodialysis patients with hyperphosphatemia. Journal of Renal Nutrition. 2004;14(1):36-44. doi: http://dx.doi.org/10.1053/j.jrn.2003.09.008.

7 Ibid.

8 Foley RN, Hakim RM. Why is the mortality of dialysis patients in the united states much higher than the rest of the world? Journal of the American Society of Nephrology. 2009;20(7):1432-1435. doi: 10.1681/ASN.2009030282.

9 Hand RK, Steiber A, Burrowes J. Renal dietitians lack time and resources to follow the NKF KDOQI guidelines for frequency and method of diet assessment: Results of a survey. J Ren Nutr. 2013;23(6):445-449. doi: 10.1053/j.jrn.2012.08.010; 10.1053/j.jrn.2012.08.010.

10 Kopple JD. National kidney foundation K/DOQI clinical practice guidelines for nutrition in chronic renal failure. Am J Kidney Dis. 2001;37(1):S66-S70. http://journals.ohiolink.edu/ejc/article.cgi?issn=02726386&issue=v37i0001_s2&article=s66_nkfkcpfnicrf. doi: 10.1053/ajkd.2001.20748.

11 Ford JC, Pope JF, Hunt AE, Gerald B. The effect of diet education on the laboratory values and knowledge of hemodialysis patients with hyperphosphatemia. Journal of Renal Nutrition. 2004;14(1):36-44. doi: http://dx.doi.org/10.1053/j.jrn.2003.09.008.

12 Burrowes JD, Russell GB, Rocco MV. Multiple factors affect renal dietitians' use of the NKF-K/DOQI adult nutrition guidelines. J Ren Nutr. 2005;15(4):407-426. doi: 10.1053/j.jrn.2005.05.002.

13 Desai AA, Bolus R, Nissenson A, et al. Identifying best practices in dialysis care: Results of cognitive interviews and a national survey of dialysis providers. Clinical Journal of the American Society of Nephrology : CJASN. 2008;3(4):1066-1076. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2440275/. doi: 10.2215/CJN.04421007.

14 Hand RK, Burrowes JD. Renal dietitians' perceptions of roles and responsibilities in outpatient dialysis facilities. J Ren Nutr. 2015. doi: S1051-2276(15)00091-6 [pii].

15 Wolfe WA. Adequacy of dialysis clinic staffing and quality of care: A review of evidence and areas of needed research. American Journal of Kidney Diseases. 2011;58(2):166-176. Accessed 9/3/2016 11:37:00 AM. doi: http://dx.doi.org/10.1053/j.ajkd.2011.03.027.

16 Ibid.

17 Kent PS, McCarthy MP, Burrowes JD, et al. Academy of nutrition and dietetics and national kidney foundation: Revised 2014 standards of practice and standards of professional performance for registered dietitian nutritionists (competent, proficient, and expert) in nephrology nutrition. J Acad Nutr Diet. 2014;114(9):1448-1457.e45. doi: 10.1016/j.jand.2014.05.006 [doi].

18 Kent PS, McCarthy MP, Burrowes JD, et al. Academy of nutrition and dietetics and national kidney foundation: Revised 2014 standards of practice and standards of professional performance for registered dietitian nutritionists (competent, proficient, and expert) in nephrology nutrition. J Acad Nutr Diet. 2014;114(9):1448-1457.e45. doi: 10.1016/j.jand.2014.05.006 [doi].

19 Hand RK, Burrowes JD. Renal dietitians' perceptions of roles and responsibilities in outpatient dialysis facilities. J Ren Nutr. 2015. doi: S1051-2276(15)00091-6 [pii].

20 Ibid.

21 Kent PS, McCarthy MP, Burrowes JD, et al. Academy of nutrition and dietetics and national kidney foundation: Revised 2014 standards of practice and standards of professional performance for registered dietitian nutritionists (competent, proficient, and expert) in nephrology nutrition. J Acad Nutr Diet. 2014;114(9):1448-1457.e45. doi: 10.1016/j.jand.2014.05.006 [doi].

22 Thelen B, Byham-Gray L, Touger-Decker R, O'Sullivan Maillet J, Khan H. Survey of current job functions of renal dietitians. J Ren Nutr. 2009;19(6):450-461. doi: 10.1053/j.jrn.2009.05.009 [doi].

23 Burrowes JD, Russell GB, Rocco MV. Multiple factors affect renal dietitians' use of the NKF-K/DOQI adult nutrition guidelines. J Ren Nutr. 2005;15(4):407-426. doi: 10.1053/j.jrn.2005.05.002.

24 Thelen B, Byham-Gray L, Touger-Decker R, O'Sullivan Maillet J, Khan H. Survey of current job functions of renal dietitians. J Ren Nutr. 2009;19(6):450-461. doi: 10.1053/j.jrn.2009.05.009 [doi].

25 Sullivan C, Leon JB, Sehgal AR. Job satisfaction among renal dietitians. Journal of Renal Nutrition. 2006;16(4):337-340. doi: http://dx.doi.org/10.1053/j.jrn.2006.07.005.

26 Ibid.

27 Hand RK, Steiber A, Burrowes J. Renal dietitians lack time and resources to follow the NKF KDOQI guidelines for frequency and method of diet assessment: Results of a survey. J Ren Nutr. 2013;23(6):445-449. doi: 10.1053/j.jrn.2012.08.010; 10.1053/j.jrn.2012.08.010.

28 Hand RK, Burrowes JD. Renal dietitians' perceptions of roles and responsibilities in outpatient dialysis facilities. J Ren Nutr. 2015. doi: S1051-2276(15)00091-6 [pii].

29 Yoder LAG, Xin W, Norris KC, Yan G. Patient care staffing levels and facility characteristics in US hemodialysis facilities. American Journal of Kidney Diseases. 2013;62(6):1130-1140. doi: http://dx.doi.org/10.1053/j.ajkd.2013.05.007.

30 Ibid.

31 Ibid.

32 Ibid.

33 Ibid.

34 Ibid.

35 Ibid.

36 Frederick PR, Maxey NL, Clauser SB, Sugarman JR. Developing dialysis facility-specific performance measures for public reporting. Health Care Financ Rev. 2002;23(4):37-50. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4194761/.

37 Ibid.