Anemia Management in Home Dialysis—How Well Are We Doing?

Are we managing anemia in home dialysis patients as well as we should be?

Patients with ESRD have a known risk of developing anemia, because their damaged kidneys produce less natural erythropoietin to stimulate the bone marrow to make red blood cells, and because toxins circulating in the blood reduce red blood cell survival. Anemia may develop during Stage III CKD and tends to worsen as kidney function declines. Until 1989, dialysis patients relied on anabolic steroids and blood transfusions to manage anemia. In that year, the FDA approved Epogen^® for dialysis patients and Procrit^® for non-dialysis patients, followed by longer-acting Aranesp^® for anemia of chronic kidney disease in 2001. Patients reported that these drugs (called ESAs) improved their quality of life. But…research later showed that drugs to manage anemia could increase the risk of stroke, heart attack, heart failure, blood clots and death. In response, on June 24, 2011, the FDA issued a warning for professionals treating patients with these drugs:

• For patients with CKD on dialysis:
  • Initiate ESA treatment when the hemoglobin level is less than 10 g/dL.
  • If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of ESA .ⁱ

In 2010, CMS began collecting data for the Quality Incentive Payment (QIP) program. At that time, CMS collected data on hemoglobin levels <10 g/dL and >12 g/dL, and used these and data on other clinical measures to assign facility payment cuts in 2012. In 2013 and 2014 for payment years 2015 and 2016 respectively, CMS expects facilities to report only the dose of ESA and hemoglobin/hematocrit level of its patients for the QIP .ⁱⁱ This should not take much effort, since Medicare claims must include the most recent pre-dialysis hemoglobin and hematocrit level prior to the billing month and dose of ESAs provided.

In 2011, CMS began paying ESRD facilities a bundled rate for dialysis, ESRD-related medications (including EPO and iron), and certain labs.ⁱⁱⁱ At the same time, CMS monitored hemoglobin levels over 12—but stopped monitoring hemoglobin levels under 10 g/dL when determining QIP payment cuts for 2013. This policy may have inadvertently created a “perfect storm” by aligning incentives to reduce ESA doses and allow hemoglobin/hematocrit levels to fall.

Effects of the “Perfect Storm” on Hemoglobin Levels

Home PD or HD patients, who don’t come to a dialysis facility three times a week, have less access to EPO and IV iron than in-center patients. Yet, even in-center HD patients have experienced substantial drops in their hemoglobin levels since the PPS took effect: ^iv

Patients on home dialysis have the potential for less closely managed anemia. Dialysis staff and nephrologists may only see these patients monthly at clinic visits, or even less often. And, their Hgb results are far lower than those of in-center patients, especially for those using PD, according to the sample Dialysis Facility Report, in the U.S.:

• 12.3% of ESA-treated HD patients on Medicare had hemoglobin levels <10 g/dL NOTE: Data on home HD patients are not reported separately from in-center HD patients so it’s impossible to know if home HD patients have lower hemoglobin levels.

• 23.8% of ESA-treated PD patients on Medicare had hemoglobin levels <10 g/dL. ^v

Patients with low hemoglobin levels may feel like fish out of water , with shortness of breath, extreme fatigue, low stamina, dizziness, and cognitive changes. Some researchers have discounted patients’ reports of improved quality of life with higher hemoglobin levels. Medical professionals have decided that the risks of better management of anemia supersede the benefits and don’t always provide information to help patients choose what risks they’re willing to take.

The research to date has left some questions unanswered:

• Who is evaluating the effects of poorly managed anemia on home patients?
• Why do so many more PD patients have hemoglobin levels less than 10 g/dL than HD patients?
• Do more home HD patients have hemoglobin levels less than 10 g/dL too?
• Do home patients get to self-administer ESAs or do dialysis clinics not trust them to do this?
• Do dialysis personnel routinely ask patients about work-limiting symptoms, including symptoms of anemia?
• What’s the impact of anemia in home dialysis patients’ symptoms?
• Does the interdisciplinary team look at the relationship of anemia to scores on the KDQOL-36?
• What’s the impact of anemia on activities, including job retention that may have spurred patients to choose a home therapy?

Physicians and dialysis personnel need to inform patients about the risks and benefits of ESAs, and they need to take patients’ needs and goals into consideration. The ESRD Conditions for Coverage require staff to individualize care and help patients achieve their desired level of productive activity. How can we do that when we don’t know what patients’ goals are or what symptoms may be barriers to patients achieving their goals? Data show that we need to do a better job of monitoring, recognizing, and addressing patients’ anemia if we want patients to dialyze to live instead of live to dialyze.