DCI comments to the 2014 proposed rule

August 30, 2013
Ms. Marilyn Tavenner
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
Room 445-G
200 Independence Avenue, SW
Washington, D.C. 20201
RE: CMS–1526–P: Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies; Proposed Rule
Dear Ms. Tavenner:
Dialysis Clinic, Inc. (DCI) appreciates the opportunity to comment on the Proposals to Update Policies and Payment Rates for End Stage Renal Disease Prospective Payment System for 2014 released on July 1, 2013. DCI is a 501(c)(3) nonprofit dialysis provider treating more than 13,500patients at 215 dialysis facilities in 27 states. Ninety percent of these patients are insured by Medicare, Medicaid, HMO Medicare or the Department of Veteran Affairs.
DCI has provided excellent care efficiently for many years. USRDS reports that DCI, a national non-profit dialysis organization, has patient mortality, hospitalization rates and cost to Medicare significantly lower than those of national for-profit providers. Just last month, an analysis of USRDS data, using DCI as a point of reference, showed that non-profit dialysis providers have higher nurse to patient ratios, and higher overall patient care to staff ratios, than for-profit providers.[1]
As a nonprofit dialysis provider that has cared for patients for kidney disease for more than 42 years, we are concerned that the proposed reduction in reimbursement—particularly that attributable to rebasing–will prevent many independent providers from continuing to care for their patients. As a result, patients served by these providers will have fewer choices, limited access, and face longer distances to receive care, and for some, this will also mean diminished quality of care.
DCI Experience with the 2011 Bundled Payment System
The implementation of the end-stage renal disease (ESRD) payment bundle in 2011 has led to an alignment of clinical and payment incentives which have sparked innovation and better care. It has been a catalyst to challenge many historical customs, leading to improved patient care at lower cost.
Prior to the bundle, Medicare had tacitly allowed payments for separately billable laboratory services and injectable drugs–most prominently erythropoietin–to subsidize the ESRD composite rate. MEDPAC in its reports, assessing the adequacy of overall reimbursement, and earnings projections by publically traded dialysis providers, made this subsidy explicit. There was a financial incentive to increase utilization of these separately billable services, and the magnitude of the incentive varied inversely with their acquisition cost.
Payment for injectable drugs outside the composite rate was also associated with a number of other problems:
1.      There was no incentive to limit medication wastage, but actually a financial incentive was to increase wastage;
2.      Payment was based on average sales price (ASP), not cost of the medication, providing for the potential financial incentive to use a medication with a higher price, but also a higher ASP; and
3.      There was no incentive to look for more efficient ways to provide medications, such as the use of smaller vials and multi-dose vials.
The 2011 bundled payment system changed the rules of the game for the better. It provides a financial incentive to provide appropriate, cost effective care to our patients. In addition, we have a financial incentive to implement innovative strategies to improve care for our patients, at a lower cost to CMS. DCI’s patients have benefited from the 2011 bundle.
We decided that all DCI facilities would “jump in” to the bundled payment system instead of having some facilities transition into the new bundled payment arrangement. We did this so that all of our clinics would address the new challenges and opportunities of the bundled payment system together and we could be most effective in addressing this challenge and identifying opportunities to improve care at a lower cost to CMS.
We had two goals as we developed our strategy to respond to the new bundled payment system:
1.      Implement changes that improve care for our patients at a lower cost to CMS and DCI (the ideal “win, win, win” solution)
2.      Implement changes to provide comparable care to our patients at a lower cost, so that we would have the resources to invest in innovative strategies to improve care for our patients.
Working with our Medical Directors, in all our sites, we identified four primary areas to improve care for our patients:
1.      Increase the number of patients dialyzing at home
2.      Decrease the number of patients dialyzing in center with a catheter; increase the percent of patients dialyzing with a fistula
3.      Treat malnutrition with nutritional supplements, provided free of charge to eligible patients
4.      Improve management of our patients’ anemia.
Increasing the Percent of Patients Dialyzing At Home
We have worked to increase the number of patients dialyzing at home. We see home dialysis as an improvement in care. Patients dialyzing at home have more independence, are more satisfied with their care, and are not burdened by frequent trips to the dialysis clinic. We have devoted much attention to increasing the number of patients dialyzing at home and will continue to work to ensure that all patients for whom it might be appropriate give this option serious consideration. Since January 1, 2011, the number of DCI patients dialyzing at home by peritoneal dialysis has grown by 18.7%. As a result of this change, 221 more DCI patients are dialyzing at home by peritoneal dialysis, with an estimated net savings of $4 million per year to CMS.[2]
Decreasing the number of patients dialyzing with a catheter and increasing the number of patients dialyzing with a fistula
For a patient dialyzing by hemodialysis, the best clinical change that we can make is to remove a dialysis catheter and place a permanent access, ideally a native vein arteriovenous fistula (AVF). Patients dialyzing by permanent access are less likely to have an infection, less likely to be hospitalized, and live longer than those dialyzing with a catheter. The new payment system, in part, has enabled us to decrease the number of patients dialyzing with a catheter, and we have devoted much effort to establishing an efficient process for removal of a catheter and placement of a permanent access (preferably a fistula) in each community in which we provide dialysis services to our patients. Since January, 2011, we have decreased the number of patients dialyzing with a catheter by 20%, increased the number of patients with a fistula by more than 13%, and decreased the number of patients using an AV graft by 9.5%.   We have reduced the number of patients dialyzing by catheter by more than 650 since January 1, 2011, with an estimated savings of more than $16 million per year to CMS.[3]
Treating Malnutrition with Nutritional Supplements
Since July of 2010, we have provided nutritional supplements to all eligible DCI patients free of charge.[4] During each year approximately 80% of DCI patients receive nutritional supplements at some time. We provide approximately 50,000 doses of nutritional supplements to our patients each month. We do not receive any reimbursement from Medicare for this service.
We provide this service free of charge, and driven by a computerized protocol. We believe that feeding people who are catabolic represents better care for individual dialysis patients. It appears to be associated with better health for the ESRD population: a carefully adjusted analysis of our results in press in the American Journal of Kidney Diseases, estimates that the mortality rate for patients assigned to our computerized nutritional supplements protocol may be up to 32% lower than the mortality rate of similar patients not assigned to the protocol.
Improving anemia management for our patients
 At DCI, we are very concerned about recent trends in ESRD anemia management.
Before the 2011 bundle, the flawed payment system encouraged just increasing the EPO dose to address anemia. This was a poor clinical response to the treatment of anemia. Since the implementation of the bundle, we have investigated innovative strategies to address anemia without giving large EPO doses. We now have a number of strategies to make a patient more EPO responsive and therefore treat anemia with a lower dose of EPO. These strategies include:
  • Ensuring that the patient has adequate iron stores
  • Removing the patient’s catheter
  • Providing nutritional supplements
  • Changing the patient to peritoneal dialysis so that there is no blood loss during a treatment
  • Providing subcutaneous EPO
  • Investigating the cause for inflammation (for example, diabetic foot infection or tooth abscess) and treating the cause of inflammation
The net result is that we have been able to manage anemia for our patients with a lower EPO dose than before the implementation of the bundle.
Innovative Strategies to Improve Care for Patients with Kidney Disease
In the last few years, we have worked to develop innovative strategies to improve care for patients with kidney disease. An example is our initiative on Chronic Kidney Disease (CKD) Care Coordination (coordination of patients not yet on dialysis) with the primary goal of decreasing the number of patients needing dialysis.
We have piloted CKD Care Coordination in Spartanburg, SC for more than five years and are now in the process of implementing this process in a number of communities served by DCI. In Spartanburg, we have tripled the percent of patients starting at home with peritoneal dialysis and, for those starting in center; have tripled the percent of patients starting with a functioning fistula. In 2012, of those new starts who had received CKD Care Coordination, more than 50% started with a fistula and never had a catheter. Most importantly, we are working with patients to slow progression of the CKD and closely monitor them as they approach dialysis so that they can delay the start of dialysis until later in the progression of their kidney disease. As an example, last year in Spartanburg, South Carolina, we successfully followed one patient with a GFR of 9 for ten months until he started dialysis with a functioning fistula.
We consider transplant to be the optimal therapy for patients with kidney disease since a patient with a transplant has more independence, a better quality of life, and can continue to work. To increase access to transplantation, DCI currently operates three organ procurement organizations (in Tennessee, New Mexico, and Northern California). Because of the hard work of the dedicated individuals at these organizations, 497 people received a kidney transplant in 2011. A key component to our CKD Care Coordination program is to increase pre-emptive transplant. At a minimum, we want to work with patients to help them get on a transplant waiting list as early as possible (when their GFR is < 20 instead of waiting until they start dialysis) so that they can get a transplant earlier, and can limit their time on dialysis to the shortest time necessary. We have also followed a patient with a GFR of 7 for seven months and are now in the final stages of approval for a preemptive transplant.
With CKD Care Coordination, we are also educating patients about medical management without dialysis. We strongly believe that all patients deserve the right to decide whether dialysis is the right treatment for them. In Spartanburg, about 10% of patients are selecting medical management and will not receive dialysis services. If a patient chooses medical management without dialysis, we will continue to provide CKD Care Coordination, in partnership with the patient’s nephrologist. In addition, we will arrange for the patient to receive additional services from a local palliative care provider. If the patient is eligible for hospice care, and would like to receive this care, we will help the patient to receive additional services from a local hospice provider. As a team, we will all work together to provide the best care for a patient who selects medical management without dialysis.
After reviewing the successes of the Spartanburg model, we have implemented CKD Care Coordination in fifteen communities served by DCI. We point all this out to demonstrate the kind of changes that the bundle has enabled us to do and to underscore the risk to this type of activity, particularly for smaller not for profits posed by the cut in the proposed rule.
Proposed Payment Reduction
We are very concerned about the severity of the proposed payment cut. For DCI, we are concerned that we will not be able to provide the same quality of care, and access to care, for our patients if the payment reduction is implemented in the amount proposed. In addition, we are concerned that we may not be able to invest in innovative strategies to improve care for patients with kidney disease.
Effect on Non-profit Dialysis Providers
We are even more concerned about the effect of the proposed rule on small providers. We believe that diversity of ownership of dialysis facilities promotes better patient care. Because of this, there is a public interest in preserving economically viable non-profit dialysis organizations, and because most of these organizations are small and local, there is a public interest that the reimbursement environment should allow them to survive. Small providers are often the only providers of essential services in isolated areas. Their presence in the community matters.
The adoption of the currently proposed rule will create a financial environment in which small providers may not be able to survive. Smaller providers do not have the opportunity to receive the same discounts as larger providers and do not have the economy of scale of the larger providers. As a result, many independent providers, including independent nonprofit providers, may find that they can no longer care for their patients. We ask that CMS evaluate the rule with its effect on the small dialysis provider and dialysis patients in mind.