Our friend Jim Sloand to the Ways and Means Commitee.

Testimony By James Sloand, M.D., Statement

Statement of James Sloand, M.D., Medical Affairs U.S., Baxter Healthcare

My name is James Sloand, M.D. and I direct medical affairs for renal services at Baxter Healthcare for the U.S.  I have also been a practicing physician for over 30 years. Baxter’s renal business has long served the needs of people with end stage renal disease (ESRD). ESRD is the most serious form of kidney disease and occurs when the kidneys lose approximately 85-90 percent of their natural function.  Kidney disease is life threatening and requires treatment in order to remove toxins from the bloodstream.  In 1956, the company introduced the first commercially available and disposable dialyzer to act as an artificial kidney in hemodialysis.  Nearly 20 years later, Baxter pioneered peritoneal dialysis a primarily home-based treatment for ESRD patients that is used all over the world.
The development of kidney dialysis therapy and the many improvements made to it over the past several decades have vastly improved survival for patients with end-stage renal disease.  Improvements in the care of patients with kidney disease, for example, have meant that more individuals are undergoing dialysis therapy for longer periods.[1]  As such, total costs will continue to rise as the prevalence of patients on dialysis increases, (estimated to increase by 62% by 2020.[2] )
Finding a way to delay entry into dialysis and to lower the costs of car­ing by preventing hospitalizations for people with chronic kidney disease (CKD) is critical to reducing health care spending.  Patients can play an important role preventing deterioration in health once they have been diagnosed with a chronic condition. Building in patient self-management and empowerment through provider reimbursement policies may be key to reducing costs.[3]
A patient with end stage renal disease has  two different options for renal replacement therapy (dialysis) if a pre-emptive renal transplant is not available: treatment at home with either peritoneal or home hemodialysis  or by in-facility hemodialysis.  Home peritoneal dialysis is underutilized in the U.S. compared with (for example) Canada (7.6% in U.S. versus 37% in Canada in 2005).  A recent study of nephrologists indicated that if maximizing survival, wellness and quality of life were the most important factors in deciding mode for dialysis, 33% should be on PD.[4]  The underutilization of PD in the U.S. may thus have a negative impact on quality of life for patients that might otherwise use this modality and the data show that this deficiency increases costs to the Medicare program:

• MedPAC said in a recent report "Home dialysis offers several advantages related to quality of life and satisfaction to those patients who are able to dialyze at home.”[5]  
• The Centers for Medicare and Medicaid Services states that, "If 5 percent additional patients were to opt for home peritoneal dialysis, which provides added health and quality of life benefits….the potential savings for these 5 percent additional patients could be as much as $295 million."  (Page 20471 Final Regulation on the Medicare Conditions of Coverage for End-stage Renal Disease Patients).  [Note: these savings are through reduced hospitalizations and improved outcomes and over 10 years would result in at least $3 billion in savings.]

A lack of education about different modalities has been one of the significant reasons for underutilization in the U.S.  In fact, only 25% of patients on hemodialysis ever remember receiving information about peritoneal dialysis as an option.[6]  The provision of information to patients is also associated with greater willingness to adhere to therapies[7] and may include delayed progression to ESRD.[8]
 In 2008, the Congress added an education benefit to the Medicare program to educate patients in the final stages of kidney diseases to delay the onset of dialysis and to increase the information on dialysis options for care.  The benefit allows up to six educational sessions for Stage 4 kidney disease patients including instruction on the management of co-morbidities, with the goal of delaying the need for dialysis.  The educational sessions are also required to include a discussion of the treatment options available to patients.  The Centers for Medicare and Medicaid Services (CMS) now has responsibility for implementing this important benefit.  It is my hope that they recognize the need for a collaborative model between the physician and his staff where both contribute to the process to ensure that the therapy is as the law requires: individualized and aiding the patient in managing complications and co-morbidities of kidney failure.
I recommend that Congress further improve the management of kidney disease within the Medicare program by recognizing the direct link with the initial coverage under the Medicaid program for the low-income.  However, almost one-third of all new starts in dialysis begin in Medicaid and then transition after three months to Medicare.   Data show that Medicaid patients are less likely to have access to nephrologists and to critical information on diet.[9]  Increasing information to empower patients on how to manage their co-morbidities and significant metabolic issues-- prior to kidney failure-- is both equitable (increasing patient satisfaction) and, by reducing avoidable hospitalizations during the months immediately preceding and following the initiation of dialysis, it reduces costs for Medicaid program. 
Therefore Congress should specify that Stage 4 CKD patients should be part of targeted Medicaid case management services.[10]  In this instance, the case manager (a nurse or social worker) could ensure through community outreach that Medicaid eligibles with Stage 4 CKD have access to information on kidney disease, to kidney care providers, and they evaluate whether patients are receiving the appropriate information.  Further, similar to the recently enacted Medicare physician and practitioner model for renal education, the case manager would refer the Medicaid eligible to a physician for training on managing their co-morbidities, diet and metabolic issues, as well as the modalities of care and preparing for the appropriate access for dialysis.  It could also be a required case management activity for Medicaid managed care plans, through a case manager and through separate payments to physicians. 
In addition, prevention should be a cornerstone of all aspects of the health care system rather than an afterthought. This shift requires a fundamental change in the way providers are reimbursed in the system to reward those that are increasing the value of the health care services and reducing preventable admissions.  The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) requirement on pay for performance was an important step, as discussed further in my testimony as follows on vaccines for patients with end-stage kidney disease. Dialysis patients have long been recognized as a vulnerable and an underserved population that would benefit from immunizations.  Since 1995, hospitalization rates for dialysis patients for infection have risen 19 percent overall, and 28% for African Americans. The rates of death due to infection are also highest among African Americans.  Studies show that vaccination will result in reduced risk of hospitalization and death from infections.  As a result, the CDC has recommended that all dialysis patients and staff be immunized to improve anti-microbial resistance. 
Patients with ESRD are under immunized (60% in 2002 and no significant improvement in the reported data since then [11]), with an even lower rate for the dual eligible population.  A CMS objective is to increase the annual ESRD patient influenza vaccination rate to 90% by 2010.  Vaccines are cost effective overall for the population over 65, reducing costs by $117 per person.[12]  Specifically, vaccinations reduce the risk of any hospitalization for hemodialysis patients by 7% (see chart below.)

Influenza vaccine delivery and effectiveness[13]
Hospitalization	Reduction in Risk
-Any cause -Influenza -Bacteremia -Respiratory infection	-7%
	-16%
	-24%
	-12%

Mr. Chairman, I request that your Committee urge CMS to include a measure concerning the percentage of vaccines, which is a national Quality Forum, for use in the pay for performance system that is required under the new dialysis payment system, effective January 2011.  The statute provides for flexibility in the measures to be used for dialysis pay for performance, but does not specifically require vaccination for influenza as a measure.  Given that spending on hospital services for patients undergoing dialysis was $7.05 billion a year in 2006, the estimated savings for an increase up to the CMS influenza vaccine target would be $150 million a year, or roughly $800 million over 5 years.  This could be a key part of aligning incentives for excellence of care for providers in the Medicare program and also for reducing disparities for vulnerable kidney patients.
Thank you for this opportunity to submit testimony for the record on health care reform and reforming the delivery system.

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[1] “Technological Change and the Growth of the Health Care System”, Congressional Budget Office, January 2008.
[2] Gilbertson and Collins, USRDS (the NIH US Renal Data System).
[3] “The Healthcare Delivery System: A Blueprint for Reform, from Chapter 5, Second Generation Consumerism: Increasing Consumer Activation to Improve Health Outcomes and Lower Costs for Patients with Chronic Disease by Judith Hibbard, and Katherine Hayes, J.D., Center for American Progress
[4] Mendelssohn et al, 2001
[5] MedPAC
[6] Golper, 2001 
[7] Swatz, Robinson, Davy and Poltoski, 1999
[8] Golper, 2001
[9] Solid, Collins, USRDS, Minneapolis, Medical Research Foundation, 2007
[10] Case management is not the direct provision of medical and related services, but rather is assistance to help beneficiaries receive care by identifying needed services, finding providers, and monitoring and evaluating the services delivered.1 Targeted case management (TCM) refers to case management that is restricted to specific beneficiary groups. Targeted beneficiary groups can be defined by disease or medical
condition, or by geographic regions, such as a county or a city within a state. Targeted populations, for example, may include individuals with chronic physical or mental illness, developmental disabilities, or other groups identified by a state and approved by the Centers for Medicare and Medicaid (CMS). TCM and case management are optional services that states may elect to cover, but which must be approved by CMS through state plan amendment (SPAs).  CRS Report to Congress: Medicaid Targeted Case Management Benefits, March 27, 2008
[11] One large chain recently reported an 85% vaccination rate.
[12] The Efficacy and Cost Effectiveness of Vaccination against Influenza among Elderly Persons Living in the Community, Nichol et al, NEJM September 1994).
[13] Odds ratios for the impact of vaccinations on mortality and morbidity in hemodialysis patients during the period 1998-1999 from  “Influenza vaccine delivery and effectiveness in end stage renal disease”, Gilbertson et al, Kidney International, 2003

New Study Suggests Peritoneal Dialysis May Offer Significant Savings to Medicare

New Study Suggests Peritoneal Dialysis May Offer Significant Savings to Medicare

May 13, 2009

by Astrid Fiano, DOTmed News Writer

The Clinical Therapeutics Journal is publishing a new paper, "The Financial Implications for Medicare of Greater Peritoneal Dialysis Use" by Nancy Neil, PhD, Steve Guest, MD, and several associates. The paper details the use of in-home versus in-center dialysis, including the patterns of dialysis utilization and the results of a budget-impact analysis that indicate if the peritoneal dialysis (PD) share of total dialysis were to increase to 15%, Medicare could yield over one billion dollars in savings over five years.

Dr. Steve Guest, Medical Affairs, Baxter Healthcare, Renal Division, McGaw Park, IL, spoke to DOTmed about the issues and findings in the paper. Dr. Guest first explained that providing care to patients with end stage renal disease (ESRD) is very costly due to the therapy itself but also for the care required to manage the oftentimes concurrent advanced co-morbidities. The overall impact to Medicare is significant as the ESRD Medicare patients represent less than 1% of Medicare enrollees but consume approximately 7% of Medicare resources as measured by payments for medical care billed to Medicare in a given calendar year.

"However, in reality," Dr. Guest said, "the differences in Medicare expenditures between peritoneal dialysis and in-center hemodialysis are very complex with resources being applied to a variety of cost centers."

For example, Dr. Guest described peritoneal dialysis as being most dependent upon disposable resources such as the dialysis solutions and supplies, used to perform the therapy at home. By comparison, in-center hemodialysis is most dependent upon fixed resources, in which investments have been made in bricks and mortar facilities, water treatment capabilities, hemodialysis machines and in-center staffing requirements. "The cost of an unused investment is high and so as not to waste those investments, they must be used to repay the capital outlay." The article is an analysis of these more comprehensive fixed resources used for in-center hemodialysis that include:

-- the facilities in which the hemodialysis is performed;
--the capital investment in the machines themselves;
--the supporting equipment necessary to treat municipal water to become medical grade water and the equipment needed to prepare the dialysate from this treated water;
--ongoing maintenance of the facilities and machines;
-- health personnel, including nurses, technicians, medical assistants, receptionists, etc.

PD does not have the same requirements for a special facility as the home is the site of care. However, Dr. Guest points out that while there is less of a capital investment for peritoneal dialysis, there are significant costs for PD therapy nonetheless: "These costs impact the dialysis providers if they are supplying the patient's dialysis supplies for peritoneal dialysis. But other economies can be realized with home therapy, such as a ratio of 20 patients to 25 patients per nurse for peritoneal dialysis compared to four to six patients per staff member for in-center hemodialysis."

Dr. Guest further detailed the findings regarding the differences in spending. "The differences in spending for hospitalization, outpatient use of erythropoiesis stimulating agents, vitamin D injectables, iron and vascular access reveal that the medical care provided to patients receiving in-center hemodialysis is more costly than that provided to patients on the home-based peritoneal dialysis therapy". Additionally, transportation costs were analyzed as in-center therapy such as hemodialysis requires the typical patient to present to the center at least three times per week for their hemodialysis treatments while peritoneal dialysis, as a home-based therapy, generally requires a patient to visit their nurse and physician only once per month. "This alone represents at least a 12-fold higher monthly cost of transportation for many in-center hemodialysis patients."

"Medicare expenditure differences in favor of peritoneal dialysis compared to in-center hemodialysis are significant" and Dr. Guest states may have been attenuated due to the fact that, in the United States, it appears that peritoneal dialysis patients are generally healthier overall than patients receiving in-center hemodialysis.
In the paper, it is mentioned that factors influencing the lesser use of PD include physician bias and lack of patient awareness due to insufficient exposure to full dialysis options education. Dr. Guest spoke of addressing the factors. "In testimony we recently submitted to the record for the House Ways and Means Committee, we provided recommendations to strengthen the education received by patients living with kidney disease who are Medicaid eligible. Medicaid accounts for one third of the starts on end stage kidney disease. As peritoneal dialysis patients rate greater satisfaction with this therapy compared to in-center hemodialysis, we point out the benefit of both increasing patient satisfaction and reducing overall Medicare costs as the Medicaid eligibles transition onto Medicare after 90 days".

In House testimony by colleague James Sloand, M.D., Medical Affairs U.S., Baxter Healthcare Dr. Sloand referenced that the lack of education about different modalities has been one of the significant reasons for underutilization in the U.S and surveys have shown that only 25% of patients on hemodialysis recall receiving information about the more cost-effective and cost-efficient peritoneal dialysis option. Dr. Sloand also commented that dialysis patients are a vulnerable and an underserved population that would benefit from improved influenza and bacterial pneumonia immunizations and greater vaccination rates could result in reduced risk of hospitalization and death from infections, which could further reduce Medicare expenditures