New Medicare Benefit to Provide Chronic Kidney Disease Patients with Education on Treatment Options

Baxter International Inc. (NYSE: BAX) commends the Centers for Medicare and Medicaid Services (CMS) on announcing implementation plans for a new Medicare benefit that will provide Stage 4 chronic kidney disease patients with coverage for up to six sessions explaining their treatment options, such as transplantation, home peritoneal dialysis (PD), home hemodialysis (HHD) or clinic-based hemodialysis (HD).

The Medicare education benefit for chronic kidney disease patients is part of CMS’ 2010 Physician Fee Schedule Rule, which sets payment rates for more than 7,000 types of services in physician offices, hospitals, and other settings. The rule will go into effect on January 1, 2010.

“These education sessions will provide patients with chronic kidney disease information they need to understand their treatment options and participate in better management of their own care,” said James Sloand, M.D., senior medical director of Baxter’s North American Renal business. “This program empowers individuals to take measures to slow the progression of their kidney failure. It will also help patients prevent complications seen with chronic kidney disease, and enable them to proactively work with their physicians in determining which kidney replacement therapy is best suited to their health and lifestyle.”

In the United States, 26 million adults have chronic kidney disease and millions of others are at increased risk. ¹ People living with end stage kidney disease must depend on renal replacement therapies, usually in the form of dialysis, or transplantation, to make up for lost kidney function in order to survive. When transplantation is not possible, patients can choose to receive dialysis treatment at home, or in a dialysis center or hospital. Among the options:

Peritoneal Dialysis (PD): Globally, home dialysis is widely used today, predominantly in the form of PD. PD works inside the body, using the peritoneal membrane, or abdominal lining, as a natural filter to remove waste from the bloodstream. In this form of dialysis, blood never leaves the body. Dialysis fluid enters the peritoneal cavity through a small, plastic tube, called a catheter, surgically inserted in the abdomen. Extra fluid and waste travels across the peritoneal membrane into the dialysis fluid, which is then drained from the abdomen. There are two types of PD therapy, Automated Peritoneal Dialysis (APD), primarily performed automatically by a machine while a patient sleeps; and Continuous Ambulatory Peritoneal Dialysis (CAPD), that is performed manually three to four times per day by the patient. Both can provide continuous dialysis, 24 hours a day, similar to the continuous waste removal done by the kidneys. Some studies have indicated that PD is associated with high levels of patient satisfaction and personal well-being. ² Home dialysis can offer more flexibility and time for family and social activities and, additionally, is associated with continued employment.

Home Hemodialysis (HHD): HHD presents an additional home-based treatment option for people living with kidney disease. HHD is a form of HD using a machine designed for the home. It can be done at night while the patient is asleep, or during the day. It typically is done three to six times a week and frees patients from traveling to a dialysis clinic or hospital. The length of the dialysis varies. If done during the night (nocturnal HD), it can last as long as the patient wants to sleep, anywhere from five to eight hours. If done during the day (short daily HD), the treatments are usually from two to four hours. HHD offers many of the same benefits as PD, with schedule flexibility, freedom to meet patients’ lifestyles and the potential benefits of more continuous waste removal.

In-Center- or Hospital-Based Hemodialysis (HD): HD removes waste and excess fluid by passage of blood through a filter outside of the body. During a hemodialysis treatment, blood is removed from the body and pumped by a machine through a dialyzer. The dialyzer, also known as an artificial kidney, is the semipermeable membrane that cleans the patient’s blood. Blood is first removed from the body, then cleaned and returned back to the body with the help of the dialyzer. A typical HD schedule is a four-hour session, administered three-times weekly, at a hospital or clinic.

According to a recent study, chronic kidney disease patients often are not presented with treatment options beyond in-center HD therapy. As a result, delays in transplants may occur or home dialysis therapies may not be considered. ³ Currently, 98 percent of patients are considered medically eligible for HD, 87 percent of patients are assessed as medically eligible for PD and 54 percent of patients are judged medically eligible for transplant. ⁴ Many studies have demonstrated that people living with kidney disease who are informed about treatment options and are given a choice more often choose a home therapy.

“We believe that the new Medicare benefit will substantially facilitate the ability of chronic kidney disease patients to select the most appropriate treatment in consultation with their nephrologist,” said Edward R. Jones, M.D., president of the Renal Physicians Association. “As with all therapies, patients should consult their nephrologist before selecting the renal treatment option best suited for their condition and lifestyle.”

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

¹ National Kidney Foundation, National Kidney Foundation: Chronic Kidney Disease, http://www.kidney.org/kidneyDisease/ckd/index.cfm.

² Rubin HR, et.al., “Patient ratings of dialysis care with peritoneal dialysis vs hemodialysis,” Journal of the American Medical Association, no. 291 (2004), 697-703. Juergensen E, et.al., “Hemodialysis and peritoneal dialysis: patients' assessment of their satisfaction with therapy and the impact of the therapy on their lives,” Clinical Journal of the American Society of Nephrology, no. 1 (2006), 1191-1196.

³ Rajnish Mehrotra, et. al. “Patient education and access of ESRD patients to renal replacement therapies beyond in-center hemodialysis,” Kidney International, 2005, Vol. 68, 378-390

⁴ David C. Mendelsshon, et.al., “A prospective evaluation of renal replacement therapy modality eligibility,” Nephrology, Dialysis, and Transplantation, August 28, 2008, 1-7.