With a recent increase in the transfusion rate, and patients concerned that clinics may let hemoglobins drop too low in an effort to save on EPO costs, CMS wants to take a closer look at anemia management in its proposed rule for the quality incentive program for payment year 2015. CMS also wants to make sure clinics are not underreporting patients with hemoglobins above 12 g/dl.

In the proposed rule released on July 2, CMS wants to add a new reporting measure on anemia management. This does not replace the clinical measure for tracking hemoglobins (facilities get penalized for patients with hgb levels >12 g/dl). Rather, the new reporting measure will help the agency monitor all hemoglobin ranges more closely among dialysis patients, whether they are using ESAs or not.

CMS acknowledges they have little ability to monitor lower hemoglobins, a concern in light of recently reported data that transfusions, once a routine procedure to help treat anemia before the arrival of ESAs, is on its way back.

“We have found that the average monthly blood transfusion rate increased from 2.7% in 2010 to 3.2% in 2011. We are working through our ESRD QIP monitoring and evaluation program to further assess this issue. We believe that it is important that we continue monitoring hemoglobin levels in patients to ensure that anemia is properly treated…” CMS adds, “…We plan to continue to monitor the rate of transfusions and may consider the adoption of relevant quality measures through future rulemaking if necessary.”

The agency says it wants to monitor anemia management not only out of concern for patients having lower-than-ideal hemoglobins, but also because they fear that some clinics will avoid reporting patient claims for those individuals with hemoglobins above 12 g/dL.The proposed Anemia Management reporting measure “will play a critical role in patient safety,” CMS says in the proposed rule. “As noted above, our monitoring activities indicate that there has been a slight but noticeable increase in transfusions since the adoption of the ESRD PPS. Additionally, a United States Renal Data System analysis presented in May 2012 found an increase in blood transfusion rates among ESRD patients concurrent with the implementation of the ESRD PPS. Although the association of changes in transfusion rates with the ESRD PPS, FDA label changes, and other factors are not yet known, we believe proactive facility engagement in regular monitoring of patient hemoglobin or hematocrit levels regardless of ESA use is critical to maintaining safe care, protecting the safety of beneficiaries, and monitoring the program effectively. We further believe that the data collected from the proposed measure are necessary for measure development in a clinical area of critical significance to patient safety—anemia and transfusion. Delay in proposing to adopt this reporting measure may prevent us from creating clinical measures for use in future years of the program and pose a risk to patients.”

Clearly, CMS is interested in following more closely the impact of its own policy. That’s a good thing for patients, many who have expressed concern that the current ESA guidelines don’t allow for monitoring hgb levels below 12 g/dl. The reporting measure may also have its roots in a special Technical Expert Panel that met in early May in Baltimore. The topic was anemia management, and experts on the panel focused on concerns that removing the ‘floor’ to the hemoglobin range may reduce hgb levels—down low enough to require blood transfusions.

There are many providers who understand the value of a healthy patient, and are striving for maintaining hgb levels of 10-11 g/dL. That should make patients happy—and keep the community away from a procedure like transfusions that was the only treatment for anemia more than 20 years ago. Let’s move forward, not backward.