Effects of Oral Nutritional Supplements on Mortality, Missed Dialysis Treatments, and Nutritional Markers in Hemodialysis Patients.

OBJECTIVE: Protein-energy wasting is common in end-stage renal disease patients undergoing dialysis and is strongly associated with mortality and adverse outcomes. Intradialytic oral nutritional supplements (ONS) reduce risk of mortality in these patients. Large studies characterizing the impact of ONS on other outcomes are lacking. We assessed the associations between administration of ONS and clinical and nutritional outcomes. DESIGN: Retrospective evaluation of a pilot program providing ONS to patients at a large dialysis organization in the United States. The pilot program provided ONS to in-center hemodialysis patients with serum albumin ≤3.5 g/dL at 408 facilities. SUBJECTS: ONS patients were compared to matched controls with serum albumin ≤3.5 g/dL, identified from facilities not participating in the ONS program (n = 3,374 per group). INTERVENTION: Receipt of ONS. MAIN OUTCOME MEASURES: Death, missed dialysis treatments, hospitalizations, serum albumin, normalized protein catabolic rate, and postdialysis body weight were abstracted from large dialysis organization electronic medical records. RESULTS: There was a 69% reduction in deaths (hazard ratio = 0.31; 95% confidence interval = 0.25-0.39), and 33% fewer missed dialysis treatments (incidence rate ratio = 0.77; 95% confidence interval = 0.73-0.82) among ONS patients compared to controls (P < .001 for both). The effects of ONS on nutritional indices were mixed: serum albumin was lower, whereas normalized protein catabolic rate values, a surrogate for dietary protein intake, and postdialysis body weights were higher for ONS patients compared to controls during follow-up. CONCLUSIONS: Our evaluation confirmed the beneficial effects of ONS in reducing mortality and improving some indices of nutritional status for hypoalbuminemic hemodialysis patients. We also report the novel finding that ONS can reduce the number of missed dialysis treatments. These results support the use of intradialytic ONS as an effective intervention to improve the outcomes in hemodialysis patients with low serum albumin.

Nephrologists and Integrated Kidney Disease Care: Roles and Skills Essential for Nephrologists for Future Success.

As the costs of caring for patients with end-stage renal disease have grown, so has the pressure to provide high-quality care at a lower cost. Prompted in large part by regulatory and legislative changes, reimbursement is shifting from a fee-for-service environment to one of value-based payment models. Nephrologists in this new environment are increasingly responsible not only for direct patient care, but also for population management and the associated clinical outcomes for this vulnerable population. This Perspective article aims to recognize the key role and skills needed in order to successfully practice within these new value-based care models. The new paradigm of delivering and financing care also presents opportunities for nephrologists to shape how care is delivered, define meaningful quality metrics, and share in the financial outcomes of these approaches. Though it will take time, the training and mind-set of nephrologists must evolve to accommodate these expanded practice expectations required by a system that demands measurement, reporting, accountability, and improvement, not only for individuals but also for populations of patients.

Delivering Better Quality of Care: Relentless Focus and Starting with the End in Mind at DaVita.

The care of patients with end-stage renal disease has been evolving since the implementation of the Medicare entitlement for ESRD in 1973. Over the past 43 years, patients with ESRD have become increasingly complex with multiple comorbid conditions and the average age of new ESRD patients has continued to climb. Despite these challenges, progress has been made in improving mortality and morbidity, but the pace has generally been slow. The consolidation of the US dialysis industry has afforded large providers to achieve economies of scale and efficiencies. By reinvesting resources in innovative programs, the improvements in outcomes have accelerated. At DaVita, we have reimagined care for our ESRD patients by creating a Patient-Focused Quality Pyramid, an approach to holistic, patient-centered care that builds on the foundation of well-known dialysis metrics like adequacy and anemia management to drive more complex programs like fluid, medication, diabetes, and infection management. The ultimate goal is to improve survival, keep patients healthy and out of the hospital, enhance the patient experience of care, and thereby achieve optimal health-related quality of life. For two consecutive years, DaVita facilities, using this approach, have achieved superior performance in the CMS 5-Star rating program, most recently with 46% of facilities achieving 4 or 5 stars compared with only 23% of facilities outside of DaVita receiving 4 or 5 stars. This rating system has components of fundamentals, and more complex outcomes and our results are an external validation of the success of our approach in improving the lives of patients.

Medicare Advantage associated with lower mortality for incident dialysis patients.

Physicians across the care continuum are increasingly aligned around the belief that coordinated care can improve patient outcomes. As the principal caregivers for one of the most medically fragile patient groups in healthcare, nephrologists are especially attuned to the potential value of integrated care. Medicare Advantage (MA) offers one way to test this hypothesis. By law, end-stage renal disease patients currently cannot enroll into an MA plan, but if they develop ESRD while in such a plan, they may continue to be enrolled. The contrast between these patients and their counterparts who carry Medicare fee for service (MFFS) thereby represents a natural experiment that affords an opportunity to examine whether enrollment in a coordinated care system may improve outcomes. In order to promote (unbiased) comparison of patients in a non-randomized context, we propensity score-matched incident dialysis patients enrolled in MA versus those in MFFS. The data demonstrate that patients who were enrolled in an MA plan upon initiation of dialysis had a 9% lower mortality rate than their MFFS counterparts. This beneficial association of MA enrollment was found to be sustained over the first two years of dialysis treatment.

The evolving role of the medical director of a dialysis facility.

The medical director has been a part of the fabric of Medicare's ESRD program since entitlement was extended under Section 299I of Public Law 92-603, passed on October 30, 1972, and implemented with the Conditions for Coverage that set out rules for administration and oversight of the care provided in the dialysis facility. The role of the medical director has progressively increased over time to effectively extend to the physicians serving in this role both the responsibility and accountability for the performance and reliability related to the care provided in the dialysis facility. This commentary provides context to the nature and expected competencies and behaviors of these medical director roles that remain central to the delivery of high-quality, safe, and efficient delivery of RRT, which has become much more intensive as the dialysis industry has matured.

ESRD special needs plans: a proof of concept for integrated care.

Since the completion of the Centers for Medicare and Medicaid Services' end-stage renal disease (ESRD) demonstration projects, passage of the Affordable Care Act, and announcement of ESRD Seamless Care Organizations (ESCOs) by CMS' Innovation Center, it seems that ESRD-centered accountable care organizations will be the future model for kidney care of Medicare beneficiaries. Regardless of what you call it--managed care organization, special needs plan, ESCO--balancing quality of health care with costs of health care will continue to be the primary directive for physicians and institutions using integrated care management (ICM) strategies to manage their ESRD patients' health. The renal community has had previous success with ICM, and these experiences could help to guide our way.

Association of serum phosphorus concentration with mortality in elderly and nonelderly hemodialysis patients.

OBJECTIVE: Hypo- and hyperphosphatemia have each been associated with increased mortality in maintenance hemodialysis (MHD) patients. There has not been previous evaluation of a differential relationship between serum phosphorus level and death risk across varying age groups in MHD patients. DESIGN AND SETTINGS: In a 6-year cohort of 107,817 MHD patients treated in a large dialysis organization, we examined the association between serum phosphorus levels with all-cause and cardiovascular mortality within 5 age categories (15 to <45, 45 to <65, 65 to <70, 70 to <75, and ≥75 years old) using Cox proportional hazards models adjusted for case-mix covariates and malnutrition inflammation complex syndrome (MICS) surrogates. MAIN OUTCOME MEASURE: All-cause and cardiovascular mortality. RESULTS: The overall mean age of the cohort was 60 ± 16 years, among whom there were 45% women, 35% Blacks, and 58% diabetics. The time-averaged serum phosphorus level (mean ± SD) within each age category was 6.26 ± 1.4, 5.65 ± 1.2, 5.26 ± 1.1, 5.11 ± 1.0, and 4.88 ± 1.0 mg/dL, respectively (P for trend <.001). Hyperphosphatemia (>5.5 mg/dL) was consistently associated with increased all-cause and cardiovascular mortality risks across all age categories, including after adjustment for case-mix and MICS-related covariates. In fully adjusted models, a low serum phosphorus level (<3.5 mg/dL) was associated with increased all-cause mortality only in elderly MHD patients ≥65 years old (hazard ratio [95% confidence interval]: 1.21 [1.07-1.37], 1.13 [1.02-1.25], and 1.28 [1.2-1.37] for patients 65 to <70, 70 to <75, and ≥75 years old, respectively), but not in younger patients (<65 years old). A similar differential cardiovascular mortality risk for low serum phosphorus levels between old and young age groups was observed. CONCLUSIONS: The association between hyperphosphatemia and mortality is similar across all age groups of MHD patients, whereas hypophosphatemia is associated with increased mortality only in elderly MHD patients. Preventing very low serum phosphorus levels in elderly dialysis patients may be associated with better outcomes, which needs to be examined in future studies.

Toward population management in an integrated care model.

Under the Patient Protection and Affordable Care Act of 2010, accountable care organizations (ACOs) will be the primary mechanism for achieving the dual goals of high-quality patient care at managed per capita costs. To achieve these goals in the newly emerging health care environment, the nephrology community must plan for and direct integrated delivery and coordination of renal care, focusing on population management. Even though the ESRD patient population is a complex group with comorbid conditions that may confound integration of care, the nephrology community has unique experience providing integrated care through ACO-like programs. Specifically, the recent ESRD Management Demonstration Project sponsored by the Centers for Medicare & Medicaid Services and the current ESRD Prospective Payment System with it Quality Incentive Program have demonstrated that integrated delivery of renal care can be accomplished in a manner that provides improved clinical outcomes with some financial margin of savings. Moving forward, integrated renal care will probably be linked to provider performance and quality outcomes measures, and clinical integration initiatives will share several common elements, namely performance-based payment models, coordination of communication via health care information technology, and development of best practices for care coordination and resource utilization. Integration initiatives must be designed to be measured and evaluated, and, consistent with principles of continuous quality improvement, each initiative will provide for iterative improvements of the initiative.

Toward population management in an integrated care model.

Under the Patient Protection and Affordable Care Act of 2010, accountable care organizations (ACOs) will be the primary mechanism for achieving the dual goals of high-quality patient care at managed per capita costs. To achieve these goals in the newly emerging health care environment, the nephrology community must plan for and direct integrated delivery and coordination of renal care, focusing on population management. Even though the ESRD patient population is a complex group with comorbid conditions that may confound integration of care, the nephrology community has unique experience providing integrated care through ACO-like programs. Specifically, the recent ESRD Management Demonstration Project sponsored by the Centers for Medicare & Medicaid Services and the current ESRD Prospective Payment System with it Quality Incentive Program have demonstrated that integrated delivery of renal care can be accomplished in a manner that provides improved clinical outcomes with some financial margin of savings. Moving forward, integrated renal care will probably be linked to provider performance and quality outcomes measures, and clinical integration initiatives will share several common elements, namely performance-based payment models, coordination of communication via health care information technology, and development of best practices for care coordination and resource utilization. Integration initiatives must be designed to be measured and evaluated, and, consistent with principles of continuous quality improvement, each initiative will provide for iterative improvements of the initiative.

The IMPACT (Incident Management of Patients, Actions Centered on Treatment) program: a quality improvement approach for caring for patients initiating long-term hemodialysis.

BACKGROUND: Patients beginning dialysis therapy are at risk of death and illness. The IMPACT (Incident Management of Patients, Actions Centered on Treatment) quality improvement program was developed to improve incident hemodialysis patient outcomes through standardized care. STUDY DESIGN: Quality improvement report. SETTING & PARTICIPANTS: Patients who started hemodialysis therapy between September 2007 and December 2008 at DaVita facilities using the IMPACT program (n = 1,212) constituted the intervention group. Propensity score-matched patients who initiated hemodialysis therapy in the same interval at DaVita facilities not using the IMPACT program (n = 2,424) made up the control group. QUALITY IMPROVEMENT PLAN: IMPACT intervention included a structured intake process and monitoring reports; patient enrollment in a 90-day patient education program and 90-day patient management pathway. OUTCOMES: Mean dialysis adequacy (Kt/V), hemoglobin and albumin levels, percentage of patients using preferred vascular access (arteriovenous fistula or graft), and mortality at each quarter. RESULTS: Compared with the non-IMPACT group, the IMPACT group was associated with a higher proportion of patients dialyzing with a preferred access at 90 days (0.50 [95% CI, 0.47-0.53] vs 0.47 [95% CI, 0.45-0.49]; P = 0.1) and 360 days (0.63 [95% CI, 0.61-0.66] vs 0.48 [95% CI, 0.46-0.50]; P < 0.001) and a lower mortality rate at 90 days (24.8 [95% CI, 19.0-30.7] vs 31.9 [95% CI, 27.1-36.6] deaths/100 patient-years; P = 0.08) and 360 days (17.8 [95% CI, 15.2-20.4] vs 25.1 [95% CI, 20.7-25.2] deaths/100 patient-years; P = 0.01). LIMITATIONS: The study does not determine the care processes responsible for the improved outcomes. CONCLUSIONS: Intense management of incident dialysis patients with the IMPACT quality improvement program was associated with significantly decreased first-year mortality. Focused attention to the care of incident patients is an important part of a dialysis program.

Focused clinical campaign improves mineral and bone disorder outcomes.

As with other disease states, mineral and bone disorder (MBD) management is challenging and may benefit from more systematic management. To evaluate the effectiveness of a focused campaign to improve MBD outcomes, we compared the percentage of patients meeting 2003 Kidney Dialysis Outcomes Quality Initiative (KDOQI)-recommended MBD targets between baseline and 18 months after programme initiation. The four components of the clinical campaign were: (1) a set of grids allowing simultaneous evaluation of MBD test results, (2) a weighted, facility-level cumulative scoring system representing percent of patients within KDOQI-recommended MBD targets, (3) team involvement and (4) patient education. Eighteen months after programme initiation, the percent of patients simultaneously meeting all 2003 KDOQI targets increased 7% and the percent meeting calcium and phosphorus targets increased 24% and 8%, respectively. These findings suggest that a coordinated clinical campaign with effective tools, outcome tracking and sharing and team involvement is an effective strategy to improve MBD outcomes.

Association of pretransplant serum phosphorus with posttransplant outcomes.

BACKGROUND AND OBJECTIVES: Serum phosphorus levels are associated with mortality, cardiovascular disease, and renal function loss in individuals with and without chronic kidney disease. The association of pretransplant serum phosphorus levels with transplant outcomes is not clear. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Data of the Scientific Registry of Transplant Recipients (SRTR) up to June 2007 were linked to the database (2001 through 2006) of one of the U.S.-based large dialysis organizations (DaVita). The selected 9384 primary kidney recipients were divided into five groups according to pretransplant serum phosphorus levels (mg/dl): <3.5, 3.5 to <5.5 (reference group), 5.5 to <7.5, 7.5 to <9.5, and ≥9.5. Unadjusted and multivariate adjusted risks for transplant outcomes were compared. RESULTS: Patients were 48 ± 14 years old and included 37% women and 27% African Americans. After multivariate adjustment, all-cause and cardiovascular death hazard ratios were 2.44 (95% confidence interval: 1.28 to 4.65) and 3.63 (1.13 to 11.64), respectively, in recipients in the ≥9.5 group; allograft loss hazard ratios were 1.42 (1.04 to 1.95) and 2.36 (1.33 to 4.17) in recipients with 7.5 to >9.5 and ≥9.5, respectively. No significant association with delayed graft function was found. CONCLUSIONS: Pretransplant phosphorus levels 7.5 to <9.5 mg/dl and ≥9.5 mg/dl were associated with increased risk of functional graft failure and increased risk of all-cause and cardiovascular deaths, respectively, when compared with 3.5 to <5.5 mg/dl. Additional studies are needed to examine whether more aggressive control of pretransplant serum phosphorus may improve posttransplant outcomes.

Impact of race on hyperparathyroidism, mineral disarrays, administered vitamin D mimetic, and survival in hemodialysis patients.

Blacks have high rates of chronic kidney disease, are overrepresented among the US dialysis patients, have higher parathyroid hormone levels, but greater survival compared to nonblacks. We hypothesized that mineral and bone disorders (MBDs) have a bearing on survival advantages of black hemodialysis patients. In 139,328 thrice-weekly treated hemodialysis patients, including 32% blacks, in a large dialysis organization, where most laboratory values were measured monthly for up to 60 months (July 2001 to June 2006), we examined differences across races in measures of MBDs and survival predictabilities of these markers and administered the active vitamin D medication paricalcitol. Across each age increment, blacks had higher serum calcium and parathyroid hormone (PTH) levels and almost the same serum phosphorus and alkaline phosphatase levels and were more likely to receive injectable active vitamin D in the dialysis clinic, mostly paricalcitol, at higher doses than nonblacks. Racial differences existed in mortality predictabilities of different ranges of serum calcium, phosphorus, and PTH but not alkaline phosphatase. Blacks who received the highest dose of paricalcitol (>10 µg/week) had a demonstrable survival advantage over nonblacks (case-mix-adjusted death hazard ratio = 0.87, 95% confidence level 0.83-0.91) compared with those who received lower doses (<10 µg/week) or no active vitamin D. Hence, in black hemodialysis patients, hyperparathyroidism and hypercalcemia are more prevalent than in nonblacks, whereas hyperphosphatemia or hyperphosphatasemia are not. Survival advantages of blacks appear restricted to those receiving higher doses of active vitamin D. Examining the effect of MBD modulation on racial survival disparities of hemodialysis patients is warranted.

Intravenous iron versus erythropoiesis-stimulating agents: friends or foes in treating chronic kidney disease anemia?

Patients with chronic kidney disease (CKD), especially those requiring maintenance hemodialysis treatments, may lose up to 3 g of iron each year because of frequent blood losses. Higher doses of erythropoiesis-stimulating agents (ESAs) may worsen iron depletion and lead to an increased platelet count (thrombocytosis), ESA hyporesponsiveness, and hemoglobin variability. Hence, ESA therapy requires concurrent iron supplementation. Traditional iron markers such as serum ferritin and transferrin saturation ratio (TSAT) (ie, serum iron divided by total iron-binding capacity [TIBC]), may be confounded by non-iron-related conditions. Whereas serum ferritin <200 ng/mL suggests iron deficiency in CKD patients, ferritin levels between 200 and 1,200 ng/mL may be related to inflammation, latent infections, malignancies, or liver disease. Protein-energy wasting may lower TIBC, leading to a TSAT within the normal range, even when iron deficiency is present. Iron and anemia indices have different mortality predictabilities, in that high serum ferritin but low iron, TIBC, and TSAT levels are associated with increased mortality, whereas hemoglobin exhibits a U-shaped risk for death. The increased mortality associated with targeting hemoglobin above 13 g/dL may result from iron depletion-associated thrombocytosis. Intravenous (IV) iron administration may not only decrease hemoglobin variability and ESA hyporesponsiveness, it may also reduce the greater mortality associated with the much higher ESA doses that have been used in some patients when targeting higher hemoglobin levels.

Effect of malnutrition-inflammation complex syndrome on EPO hyporesponsiveness in maintenance hemodialysis patients.

BACKGROUND: Elements of malnutrition-inflammation complex syndrome (MICS) may blunt the responsiveness of anemia of end-stage renal disease (ESRD) to recombinant human erythropoietin (EPO). METHODS: The authors examined cross-sectional associations between the required dose of EPO within a 13-week interval as prescribed by practicing nephrologists who were blind to the study and several laboratory values known to be related to nutrition and/or inflammation, as well as the malnutrition-inflammation score (MIS), which is a fully quantitative assessment tool based on the subjective global assessment of nutrition. RESULTS: A total of 339 maintenance hemodialysis (MHD) outpatients, including 181 men, who were aged 54.7 +/- 14.5 years (mean +/- SD), who had undergone dialysis for 36.3 +/- 33.2 months, were selected randomly from 7 DaVita dialysis units in Los Angeles South/East Bay area. The average weekly dose of administered recombinant human EPO within a 13-week interval was 217 +/- 187 U/kg. Patients were receiving intravenous iron supplementation (iron gluconate or dextran) averaging 39.5 +/- 47.5 mg/wk. The MIS and serum concentrations of high-sensitivity C-reactive protein, interleukin 6 (IL-6), tumor necrosis factor-alpha, and lactate dehydrogenase had positive correlation with required EPO dose and EPO responsiveness index (EPO divided by hemoglobin), whereas serum total iron binding capacity (TIBC), prealbumin and total cholesterol, as well as blood lymphocyte count had statistically significant but negative correlations with indices of refractory anemia. Most correlations remained significant even after multivariate adjustment for case-mix and anemia factors and other relevant covariates. Similar associations were noticed across EPO per body weight tertiles via analysis of variance and after estimating odds ratio for higher versus lower tertile via logistic regression after same case-mix adjustment. CONCLUSION: The existence of elements of MICS as indicated by a high MIS and increased levels of proinflammatory cytokines such as IL-6 as well as decreased nutritional values such as low serum concentrations of total cholesterol, prealbumin, and TIBC correlates with EPO hyporesponsiveness in MHD patients.

Clinical evaluation of heme iron polypeptide: sustaining a response to rHuEPO in hemodialysis patients.

BACKGROUND: Optimizing iron and recombinant human erythropoietin (rHuEPO) therapy is necessary to achieve target hemoglobin levels and minimize costs as the end-stage renal disease (ESRD) population expands. Oral iron products in patients with ESRD have been largely abandoned, and the safety of intravenous (IV) iron preparations has improved with the introduction of new-generation compounds that have little allergenicity. Recent work suggests oral heme iron may be an effective supplement for hemodialysis (HD) patients because it is absorbed by patients with high ferritin levels, has fewer side effects, and its absorption is stimulated by erythropoietin administration. METHODS: We performed an open, 6-month, prospective evaluation of heme iron in HD patients who had been on maintenance IV iron therapy. IV iron was discontinued and replaced with oral heme iron. Serum iron level, hematocrit (Hct), and erythropoietin and IV iron dose were monitored. RESULTS: During 6 months, 4 of 37 patients (11%) dropped out because of insufficient iron supplementation or intolerance and 5 patients (14%) were dropped because of unrelated complications or protocol violation. A slight reduction in average transferrin saturation (TSAT) was seen early, but reversed, and no significant changes were seen in TSAT or Hct. A significant reduction in average serum ferritin level was seen at months 4 through 6 (P < 0.01). CONCLUSION: During the 6-month study period, heme iron polypeptide successfully replaced IV iron therapy in a majority of HD patients and maintained target Hcts with no concomitant use of IV iron. This treatment was associated with a significant increase in rHuEPO efficiency (P = 0.04).

L-carnitine use in dialysis patients: is national coverage for supplementation justified? What were CMS regulators thinking--or were they?

Careful review of all available clinical trials of L-carnitine leads to the conclusion that there is insufficient evidence to support the routine use of L-carnitine for any indication in dialysis patients. The literature suffers from a lack of adequately designed studies, and many of the studies which supposedly justify payment for L-carnitine supplementation are more than 10 years old. While some studies support a subjective improvement in symptoms after a few months of L-carnitine treatment, there is little confirming objective data. Biochemical parameters show minimal, if any, improvements. A major criticism is that many of the reported symptoms could be attributable to anemia, which at the time the L-carnitine studies were taking place, was generally being corrected with EPO. On the other hand, there is little data to support the hypothesis that L-carnitine enhances the response to EPO or overcomes EPO resistance. The decrease in the use of L-carnitine in the past several years may be related in part to difficulty with reimbursement. The decrease also suggests that practitioners have abandoned the hypothesis that L-carnitine supplementation provides substantial clinical benefits, and therefore no longer prescribe it for dialysis patients. For those physicians who plan to prescribe L-carnitine based on the recent CMS reimbursement decision, it must be remembered that the laboratory measurement of free carnitine may be difficult and inaccurate. For those patients with private insurance, payment for the lab test is out of pocket. If the free carnitine level is measured once dialysis starts, a value in the CMS "deficient" range can occur since carnitine drops early in the dialysis procedure and slowly rebounds after the treatment. Therefore, it is critical that the measurement be done pre-dialysis after a three-day interdialytic interval to obtain the most accurate value. If strict guidelines for use of L-carnitine are adhered to (i.e., the patient has true EPO-resistant anemia unexplained by any identifiable factor and true unexplained hypotension), then the use of L-carnitine in ESRD patients should be very uncommon. In conclusion, the clinical value of L-carnitine supplementation in hemodialysis patients remains to be documented by credible evidence from rigorous scientific studies. While "proof beyond a reasonable doubt" need not always be the requirement for reimbursement from payers, at a minimum "a preponderance of the evidence" should be documented in the literature. L-carnitine may prove to be a beneficial supplement. However, before justifying a national coverage policy, a new randomized, prospective controlled trial should be conducted to determine the utility of i.v. L-carnitine supplementation for anemia management and refractory dialysis-associated hypotension. Cost-benefit analysis is a critical aspect of such a study because it is important to determine the total cost (no matter who pays) of L-carnitine supplementation as compared to money saved by a reduction in EPO and iron administration. When reimbursement policies are developed, they need to be rational and based on the best evidence that is available. An NKF Carnitine Consensus Conference concluded that current literature and clinical experience leave unanswered questions regarding the use of L-carnitine in dialysis patients. Until there is scientific evidence to support use of L-carnitine supplementation, and it proves to be cost-effective, reimbursement is not justified. Therefore, the current CMS reimbursement decision for L-carnitine appears to be flawed.