Comments to CMS re End Stage Renal Disease Prospective Payment System

September 10, 2018

Seema Verma
Administrator
Centers for Medicare and Medicaid Services
Room 314G
Hubert H. Humphrey Building,
200 Independence Avenue, SW
Washington, DC 20201

RE: Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments to Correct Existing Regulations Related to the CBP for Certain DMEPOS (CMS-1691-P)

Dear Administrator Verma:

The Academy of Nutrition and Dietetics (the "Academy") is pleased to provide comments on the proposed rule "Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments to Correct Existing Regulations Related to the CBP for Certain DMEPOS (CMS-1691-P)" published in the July 11, 2018 issue of the Federal Register. Representing more than 104,000 registered dietitian nutritionists (RDNs),1 dietetic technicians, registered (DTRs), 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. 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 dietitian nutritionists and other healthcare professionals.

The Academy generally supports CMS's continued implementation and improvement of the case-mix adjusted bundled prospective payment system (PPS) for Medicare outpatient End-Stage Renal Disease (ESRD) and efforts to develop and improve the Comprehensive ESRD Care Model. The Academy also continues to support quality improvement programs (QIPs) when conscientiously designed to effectively assess facility performance measures and assure and incentivize quality ESRD services that foster improved patient outcomes without overburdening providers.

Overall, the Academy supports efforts aimed at achieving CMS's goals of 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 many chronic diseases, including renal disease, as well as in the reduction of risk factors for these conditions. Medicare has reimbursed MNT for chronic kidney disease (CKD) since 2002, but is presently underutilized. 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 Notably, recent research shows that patients with CKD receiving MNT were able to delay the time to dialysis and improve significant nutritional biomarkers, thereby saving Medicare money and improving patients' quality of life.3

A. Burden on Providers

The Academy remains concerned about the proliferation of quality measures generally and appreciates CMS’s willingness to review measures used in the ESRD QIP for reasonableness. While the Conditions for Coverage recommend the holistic approach to a patient centered care model, the QIP has become increasingly unmanageable. While we agree that some of these measures improve the quality of care to our patients, some Academy members question the value of having such a comprehensive list given the reporting burden imposed upon providers. Providers receive their QIP reports with a large amount of somewhat disorganized data, with performance year and achievement year often mixed, and not infrequently including blatantly inaccurate data, Given the related financial impact, access to data that has been thoroughly vetted is paramount.

The RDN has an integral role on the interdisciplinary team (IDT) and works closely with the patient and team on measures related to adequacy of dialysis, hypercalcemia, and bone mineral management in addition to providing complete nutritional assessment and care planning for each individual patient on an ongoing basis. The complexities of the QIP coupled with the increased acuity and comorbid conditions of this patient population are increasingly time consuming and counterproductive to the primary role of the RDN – patient nutritional care. By allowing more independent order writing for RDNs with regards to nutritional supplementation and follow up, laboratory data and nutrition orders, the RDN can participate more efficiently to maximize quality outcomes for individual patients while maintaining the requirements for quality reporting. Integration of checks and balances by CMS and a simplified, more efficient reporting mechanism would also lead to better data.

In virtually every study evaluating the nutritional status of maintenance hemodialysis (MHD) patients report some degree of abnormality. Unfortunately, many different diagnostic tools were used in the separate studies so the actual prevalence of protein-energy wasting (PEW) in MHD patients varies widely, ranging from 20% to 60%.4,5 Although there is evidence that nutritional parameters improve within 3 to 6 months following initiation of hemodialysis, there also is evidence that PEW is present in up to 40% or more of the MHD population; the prevalence seems to increase with time of MHD treatment.6 Nutrition intervention is essential to improving and maintaining outcomes for these patients. Simplifying the documentation side of the RDN responsibilities will allow more time for patient interaction and intervention.

B. Associate with National Kidney Foundation Comments

The Academy associates itself with the comments submitted by the National Kidney Foundation on August 21, 2018, in particular sections A(iii) "Factors for Removing Measures," A(iv) "Removal of Measures," B(i) "Proposed Measures Beginning in 2022" supporting the "Medication Reconciliation for Patients Receiving Care at Dialysis Facilities" reporting measure to the QIP; and B(iii) "2022 Remaining Measures Continuing from 2021" related to hypercalcemia.

The Academy notes that bone mineral disease is a significant and growing problem, particularly in certain patient populations. We support efforts to enhance focus on CKD bone mineral disease parameters rather than just calcium and phosphorus, and encourage CMS to retain phosphorus as a reporting measure until we have a better parameter for bone mineral disease. We encourage CMS to assess and share facilities' compliance with drawing phosphorus, which believe to be nearly uniformly performed. We recognize that the hypercalcemia measure is not superior to measuring ionized calcium, but that ionized calcium tests may be impracticable given the need to handle and test samples immediately.

We support adding the "Medication Reconciliation for Patients Receiving Care at Dialysis Facilities" reporting measure to the QIP, which we believe will have a positive impact on phosphorus, assist with proper and improved used of binders, and enhance transitions from care from hospital settings to other facilities.

C. Therapeutic Diet Ordering

The ESRD Conditions for Coverage address a dietitian's personnel qualifications but do not address the RDN ordering therapeutic diets or other nutritional components. We note that CMS has recently used rulemakings to specifically permit RDNs to order therapeutic diets in accordance with state law in hospitals, critical access hospitals, and long term care facilities, and further note that the practical implications for defining and ordering therapeutic diets are consistent across the continuum of care. Thus, the Academy encourages CMS to uniformly adopt its most recent interpretive coding guidelines for understanding therapeutic diets for dialysis facilities and across the continuum of care. In point of fact, therapeutic diets are both ordered in renal dialysis facilities, regulated by state and federal regulators, and essential to enhancing patient care.

RDNs' training and education best qualifies them to order patient diets both initially upon admission and after a nutrition assessment that considers the connection between a patient's complex medical problems, nutrition status, and actual nutrition risk. The Academy strongly encourages CMS to ease patient and provider burdens by specifically allowing qualified RDNs, upon delegation of the authority by the attending physician, to independently:

  • Order all patient diets, including therapeutic diets;
  • Order both standard house and disease-specific nutrition supplements;
  • Order enteral nutrition or parenteral nutrition;
  • Order nutrition-related laboratory tests needed to inform nutrition decisions and orders; and
  • Order therapeutic diets in states that do not license RDNs if delegated ordering privileges by the attending physician and consistent with state law.

The Academy sincerely appreciates the ongoing opportunity to offer comments regarding this important ongoing initiative, specifically related to proposed changes to the ESRD QIP. Please contact either Jeanne Blankenship at 312-899-1730 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.

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

Pepin Andrew Tuma, Esq.
Senior Director
Government & 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 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 De waal D, Heaslip E, Callas P. Medical Nutrition Therapy for Chronic Kidney Disease Improves Biomarkers and Slows Time to Dialysis. J Ren Nutr. 2015.

4 Pifer TB, McCullough KP, Port FK, et al. Mortality risk in hemodialysis patients and changes in nutritional indicators: DOPPS. Kidney Int. 2002;62:2238–2245. [PubMed]

6 Cano NJ, Roth H, Aparicio M, et al. Malnutrition in hemodialysis diabetic patients: evaluation and prognostic influence. Kidney Int. 2002;62:593–601. [PubMed]